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Nih clinical research trials and you, guiding principles for ethical research.

Pursuing Potential Research Participants Protections

“When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are,” said Dr. Christine Grady, chief of the NIH Clinical Center Department of Bioethics, to Clinical Center Radio in a podcast.

Clinical research advances the understanding of science and promotes human health. However, it is important to remember the individuals who volunteer to participate in research. There are precautions researchers can take – in the planning, implementation and follow-up of studies – to protect these participants in research. Ethical guidelines are established for clinical research to protect patient volunteers and to preserve the integrity of the science.

NIH Clinical Center researchers published seven main principles to guide the conduct of ethical research:

Social and clinical value

Scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, informed consent.

• Respect for potential and enrolled subjects

Every research study is designed to answer a specific question. The answer should be important enough to justify asking people to accept some risk or inconvenience for others. In other words, answers to the research question should contribute to scientific understanding of health or improve our ways of preventing, treating, or caring for people with a given disease to justify exposing participants to the risk and burden of research.

A study should be designed in a way that will get an understandable answer to the important research question. This includes considering whether the question asked is answerable, whether the research methods are valid and feasible, and whether the study is designed with accepted principles, clear methods, and reliable practices. Invalid research is unethical because it is a waste of resources and exposes people to risk for no purpose

The primary basis for recruiting participants should be the scientific goals of the study — not vulnerability, privilege, or other unrelated factors. Participants who accept the risks of research should be in a position to enjoy its benefits. Specific groups of participants  (for example, women or children) should not be excluded from the research opportunities without a good scientific reason or a particular susceptibility to risk.

Uncertainty about the degree of risks and benefits associated with a clinical research study is inherent. Research risks may be trivial or serious, transient or long-term. Risks can be physical, psychological, economic, or social. Everything should be done to minimize the risks and inconvenience to research participants to maximize the potential benefits, and to determine that the potential benefits are proportionate to, or outweigh, the risks.

To minimize potential conflicts of interest and make sure a study is ethically acceptable before it starts, an independent review panel should review the proposal and ask important questions, including: Are those conducting the trial sufficiently free of bias? Is the study doing all it can to protect research participants? Has the trial been ethically designed and is the risk–benefit ratio favorable? The panel also monitors a study while it is ongoing.

Potential participants should make their own decision about whether they want to participate or continue participating in research. This is done through a process of informed consent in which individuals (1) are accurately informed of the purpose, methods, risks, benefits, and alternatives to the research, (2) understand this information and how it relates to their own clinical situation or interests, and (3) make a voluntary decision about whether to participate.

Respect for potential and enrolled participants

Individuals should be treated with respect from the time they are approached for possible participation — even if they refuse enrollment in a study — throughout their participation and after their participation ends. This includes:

• respecting their privacy and keeping their private information confidential
• respecting their right to change their mind, to decide that the research does not match their interests, and to withdraw without a penalty
• informing them of new information that might emerge in the course of research, which might change their assessment of the risks and benefits of participating
• monitoring their welfare and, if they experience adverse reactions, unexpected effects, or changes in clinical status, ensuring appropriate treatment and, when necessary, removal from the study
• informing them about what was learned from the research

More information on these seven guiding principles and on bioethics in general

This page last reviewed on March 16, 2016

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The following standards and guidelines have been reviewed following the procedures detailed in Association Rule 30-8 Standards and Guidelines and approved by the APA Council of Representatives as APA policy.

As these terms are used in APA policy, “standards” include any criteria, protocols, or specifications for conduct, performance, services, or products in psychology or related areas, including recommended standards. Standards are considered to be mandatory and may be accompanied by an enforcement mechanism.

Criteria for the recognition of organizations that provide certifications in specialties and subspecialties in professional psychology (PDF, 299KB)

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Designation criteria for education and training programs in preparation for prescriptive authority (PDF, 155KB)

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Recognition of organizations that provide certifications in specialties and proficiencies in professional psychology (PDF, 85KB)

Recommended postdoctoral education and training program in psychopharmacology for prescriptive authority (PDF, 150KB)

Up for review in approximately 2029.

Standards and criteria for approval of sponsors of continuing education for psychologists (PDF, 139KB)

Up for review in approximately 2025.

Standards of accreditation for health service psychology: Master’s programs (PDF, 222KB)

Approved February 2021.

As these terms are used in APA policy, “guidelines” include pronouncements, statements, or declarations that suggest or recommend specific professional behavior, endeavor, or conduct for psychologists or for individuals or organizations that work with psychologists. In contrast to standards, guidelines are aspirational in intent.

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Clinical practice guidelines provide recommendations based on an independent systematic review of the research on treatments for specific disorders or health conditions.

Clinical Practice Guideline for the Treatment of Depression Across Three Age Cohorts

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Clinical Practice Guideline for the Treatment of Obesity and Overweight in Children and Adolescents

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Clinical Practice Guideline for the Treatment of Posttraumatic Stress Disorder (PTSD) in Adults

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A taxonomy for education and training in professional psychology (PDF, 186KB)

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Guidelines for education and training in industrial organizational psychology (PDF, 279KB)

Up for review in approximately 2027.

Guidelines for education and training at the doctoral and postdoctoral level in consulting psychology/organizational consulting psychology (PDF, 137KB)

Guidelines on core learning goals for master’s degree graduates in psychology (PDF, 1.3MB)

Up for review in March 2028.

Health service psychology: Preparing competent practitioners (PDF, 37KB)

Up for review in approximately 2019.

National standards for high school psychology curricula

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Preparing high school psychology teachers: Course-based and standards-based approaches (PDF, 275KB)

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Principles for quality undergraduate education in psychology

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Professional practice guidelines are designed to guide psychologists in practice regarding particular roles, populations, or settings, and are supported by the current scholarly literature but do not focus upon specific disorders or treatments.

* Developed by APA’s Practice Directorate to aid psychologists in their practice with special populations.

APA guidelines on evidence-based psychological practice in health care (PDF, 331KB)

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APA guidelines for psychological practice with boys and men (PDF, 443KB)

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APA guidelines for psychological practice with girls and women (PDF, 496MB)

Competencies for psychology practice in primary care (PDF, 586KB)

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Evaluation of dementia and age-related cognitive change (PDF, 488KB)

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Psychological evaluations in child protection matters

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Specialty guidelines for forensic psychology

* Transgender and gender nonconforming people (PDF, 617KB)

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Public interest guidelines and standards provide psychologists with the rationale and guidance for advancing multiculturalism, diversity, and social justice in psychological education, research, and practice.

* Developed by APA’s Public Interest Directorate to aid psychologists in their practice with special populations.

Psychological practice for people with low-income and economic marginalization

Psychological practice with sexual minority persons (PDF, 1.5MB)

Approved March 2021.

Race and ethnicity guidelines in psychology: Promoting responsiveness and equity

Assessment of and intervention with persons with disabilities

* Multicultural guidelines: An ecological approach to context, identity, and intersectionality

Adopted in August 2017.

Science guidelines provide guidance to psychologists who conduct research with both human and nonhuman animals or who are engaged in psychological testing and assessment, in a variety of settings.

APA guidelines for psychological assessment and evaluation (PDF, 659KB)

Ethical conduct of behavioral projects involving human participants by high school students

Ethical conduct in the care and use of nonhuman animals in research

Standards for educational and psychological testing

Use of nonhuman animals in behavioral projects in schools (K–12)

Principles for the validation and use of personnel selection procedures (PDF, 358KB)

Up for review in approximately 2028.

Miscellaneous

APA model legislation for prescriptive authority (PDF, 32KB)

Model act for state licensure of psychologists (PDF, 111KB)

Up for review in approximately 2020.

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Article Contents

Introduction, contents of a research study protocol, conflict of interest statement, how to write a research study protocol.

• Article contents
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• Supplementary Data

Julien Al Shakarchi, How to write a research study protocol, Journal of Surgical Protocols and Research Methodologies , Volume 2022, Issue 1, January 2022, snab008, https://doi.org/10.1093/jsprm/snab008

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A study protocol is an important document that specifies the research plan for a clinical study. Many funders such as the NHS Health Research Authority encourage researchers to publish their study protocols to create a record of the methodology and reduce duplication of research effort. In this paper, we will describe how to write a research study protocol.

A study protocol is an essential part of a research project. It describes the study in detail to allow all members of the team to know and adhere to the steps of the methodology. Most funders, such as the NHS Health Research Authority in the United Kingdom, encourage researchers to publish their study protocols to create a record of the methodology, help with publication of the study and reduce duplication of research effort. In this paper, we will explain how to write a research protocol by describing what should be included.

Introduction

The introduction is vital in setting the need for the planned research and the context of the current evidence. It should be supported by a background to the topic with appropriate references to the literature. A thorough review of the available evidence is expected to document the need for the planned research. This should be followed by a brief description of the study and the target population. A clear explanation for the rationale of the project is also expected to describe the research question and justify the need of the study.

Methods and analysis

A suitable study design and methodology should be chosen to reflect the aims of the research. This section should explain the study design: single centre or multicentre, retrospective or prospective, controlled or uncontrolled, randomised or not, and observational or experimental. Efforts should be made to explain why that particular design has been chosen. The studied population should be clearly defined with inclusion and exclusion criteria. These criteria will define the characteristics of the population the study is proposing to investigate and therefore outline the applicability to the reader. The size of the sample should be calculated with a power calculation if possible.

The protocol should describe the screening process about how, when and where patients will be recruited in the process. In the setting of a multicentre study, each participating unit should adhere to the same recruiting model or the differences should be described in the protocol. Informed consent must be obtained prior to any individual participating in the study. The protocol should fully describe the process of gaining informed consent that should include a patient information sheet and assessment of his or her capacity.

The intervention should be described in sufficient detail to allow an external individual or group to replicate the study. The differences in any changes of routine care should be explained. The primary and secondary outcomes should be clearly defined and an explanation of their clinical relevance is recommended. Data collection methods should be described in detail as well as where the data will be kept secured. Analysis of the data should be explained with clear statistical methods. There should also be plans on how any reported adverse events and other unintended effects of trial interventions or trial conduct will be reported, collected and managed.

Ethics and dissemination

A clear explanation of the risk and benefits to the participants should be included as well as addressing any specific ethical considerations. The protocol should clearly state the approvals the research has gained and the minimum expected would be ethical and local research approvals. For multicentre studies, the protocol should also include a statement of how the protocol is in line with requirements to gain approval to conduct the study at each proposed sites.

It is essential to comment on how personal information about potential and enrolled participants will be collected, shared and maintained in order to protect confidentiality. This part of the protocol should also state who owns the data arising from the study and for how long the data will be stored. It should explain that on completion of the study, the data will be analysed and a final study report will be written. We would advise to explain if there are any plans to notify the participants of the outcome of the study, either by provision of the publication or via another form of communication.

The authorship of any publication should have transparent and fair criteria, which should be described in this section of the protocol. By doing so, it will resolve any issues arising at the publication stage.

Funding statement

It is important to explain who are the sponsors and funders of the study. It should clarify the involvement and potential influence of any party. The sponsor is defined as the institution or organisation assuming overall responsibility for the study. Identification of the study sponsor provides transparency and accountability. The protocol should explicitly outline the roles and responsibilities of any funder(s) in study design, data analysis and interpretation, manuscript writing and dissemination of results. Any competing interests of the investigators should also be stated in this section.

A study protocol is an important document that specifies the research plan for a clinical study. It should be written in detail and researchers should aim to publish their study protocols as it is encouraged by many funders. The spirit 2013 statement provides a useful checklist on what should be included in a research protocol [ 1 ]. In this paper, we have explained a straightforward approach to writing a research study protocol.

None declared.

Chan   A-W , Tetzlaff   JM , Gøtzsche   PC , Altman   DG , Mann   H , Berlin   J , et al.    SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials . BMJ   2013 ; 346 : e7586 .

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Methodology

• What Is a Research Design | Types, Guide & Examples

What Is a Research Design | Types, Guide & Examples

Published on June 7, 2021 by Shona McCombes . Revised on November 20, 2023 by Pritha Bhandari.

A research design is a strategy for answering your   research question  using empirical data. Creating a research design means making decisions about:

• Your overall research objectives and approach
• Whether you’ll rely on primary research or secondary research
• Your sampling methods or criteria for selecting subjects
• Your data collection methods
• The procedures you’ll follow to collect data
• Your data analysis methods

A well-planned research design helps ensure that your methods match your research objectives and that you use the right kind of analysis for your data.

Table of contents

Step 1: consider your aims and approach, step 2: choose a type of research design, step 3: identify your population and sampling method, step 4: choose your data collection methods, step 5: plan your data collection procedures, step 6: decide on your data analysis strategies, other interesting articles, frequently asked questions about research design.

• Introduction

Before you can start designing your research, you should already have a clear idea of the research question you want to investigate.

There are many different ways you could go about answering this question. Your research design choices should be driven by your aims and priorities—start by thinking carefully about what you want to achieve.

The first choice you need to make is whether you’ll take a qualitative or quantitative approach.

Qualitative research designs tend to be more flexible and inductive , allowing you to adjust your approach based on what you find throughout the research process.

Quantitative research designs tend to be more fixed and deductive , with variables and hypotheses clearly defined in advance of data collection.

It’s also possible to use a mixed-methods design that integrates aspects of both approaches. By combining qualitative and quantitative insights, you can gain a more complete picture of the problem you’re studying and strengthen the credibility of your conclusions.

Practical and ethical considerations when designing research

As well as scientific considerations, you need to think practically when designing your research. If your research involves people or animals, you also need to consider research ethics .

• How much time do you have to collect data and write up the research?
• Will you be able to gain access to the data you need (e.g., by travelling to a specific location or contacting specific people)?
• Do you have the necessary research skills (e.g., statistical analysis or interview techniques)?
• Will you need ethical approval ?

At each stage of the research design process, make sure that your choices are practically feasible.

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Within both qualitative and quantitative approaches, there are several types of research design to choose from. Each type provides a framework for the overall shape of your research.

Types of quantitative research designs

Quantitative designs can be split into four main types.

• Experimental and   quasi-experimental designs allow you to test cause-and-effect relationships
• Descriptive and correlational designs allow you to measure variables and describe relationships between them.

With descriptive and correlational designs, you can get a clear picture of characteristics, trends and relationships as they exist in the real world. However, you can’t draw conclusions about cause and effect (because correlation doesn’t imply causation ).

Experiments are the strongest way to test cause-and-effect relationships without the risk of other variables influencing the results. However, their controlled conditions may not always reflect how things work in the real world. They’re often also more difficult and expensive to implement.

Types of qualitative research designs

Qualitative designs are less strictly defined. This approach is about gaining a rich, detailed understanding of a specific context or phenomenon, and you can often be more creative and flexible in designing your research.

The table below shows some common types of qualitative design. They often have similar approaches in terms of data collection, but focus on different aspects when analyzing the data.

Your research design should clearly define who or what your research will focus on, and how you’ll go about choosing your participants or subjects.

In research, a population is the entire group that you want to draw conclusions about, while a sample is the smaller group of individuals you’ll actually collect data from.

Defining the population

A population can be made up of anything you want to study—plants, animals, organizations, texts, countries, etc. In the social sciences, it most often refers to a group of people.

For example, will you focus on people from a specific demographic, region or background? Are you interested in people with a certain job or medical condition, or users of a particular product?

The more precisely you define your population, the easier it will be to gather a representative sample.

• Sampling methods

Even with a narrowly defined population, it’s rarely possible to collect data from every individual. Instead, you’ll collect data from a sample.

To select a sample, there are two main approaches: probability sampling and non-probability sampling . The sampling method you use affects how confidently you can generalize your results to the population as a whole.

Probability sampling is the most statistically valid option, but it’s often difficult to achieve unless you’re dealing with a very small and accessible population.

For practical reasons, many studies use non-probability sampling, but it’s important to be aware of the limitations and carefully consider potential biases. You should always make an effort to gather a sample that’s as representative as possible of the population.

Case selection in qualitative research

In some types of qualitative designs, sampling may not be relevant.

For example, in an ethnography or a case study , your aim is to deeply understand a specific context, not to generalize to a population. Instead of sampling, you may simply aim to collect as much data as possible about the context you are studying.

In these types of design, you still have to carefully consider your choice of case or community. You should have a clear rationale for why this particular case is suitable for answering your research question .

For example, you might choose a case study that reveals an unusual or neglected aspect of your research problem, or you might choose several very similar or very different cases in order to compare them.

Data collection methods are ways of directly measuring variables and gathering information. They allow you to gain first-hand knowledge and original insights into your research problem.

You can choose just one data collection method, or use several methods in the same study.

Survey methods

Surveys allow you to collect data about opinions, behaviors, experiences, and characteristics by asking people directly. There are two main survey methods to choose from: questionnaires and interviews .

Observation methods

Observational studies allow you to collect data unobtrusively, observing characteristics, behaviors or social interactions without relying on self-reporting.

Observations may be conducted in real time, taking notes as you observe, or you might make audiovisual recordings for later analysis. They can be qualitative or quantitative.

Other methods of data collection

There are many other ways you might collect data depending on your field and topic.

If you’re not sure which methods will work best for your research design, try reading some papers in your field to see what kinds of data collection methods they used.

Secondary data

If you don’t have the time or resources to collect data from the population you’re interested in, you can also choose to use secondary data that other researchers already collected—for example, datasets from government surveys or previous studies on your topic.

With this raw data, you can do your own analysis to answer new research questions that weren’t addressed by the original study.

Using secondary data can expand the scope of your research, as you may be able to access much larger and more varied samples than you could collect yourself.

However, it also means you don’t have any control over which variables to measure or how to measure them, so the conclusions you can draw may be limited.

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As well as deciding on your methods, you need to plan exactly how you’ll use these methods to collect data that’s consistent, accurate, and unbiased.

Planning systematic procedures is especially important in quantitative research, where you need to precisely define your variables and ensure your measurements are high in reliability and validity.

Operationalization

Some variables, like height or age, are easily measured. But often you’ll be dealing with more abstract concepts, like satisfaction, anxiety, or competence. Operationalization means turning these fuzzy ideas into measurable indicators.

If you’re using observations , which events or actions will you count?

If you’re using surveys , which questions will you ask and what range of responses will be offered?

You may also choose to use or adapt existing materials designed to measure the concept you’re interested in—for example, questionnaires or inventories whose reliability and validity has already been established.

Reliability and validity

Reliability means your results can be consistently reproduced, while validity means that you’re actually measuring the concept you’re interested in.

For valid and reliable results, your measurement materials should be thoroughly researched and carefully designed. Plan your procedures to make sure you carry out the same steps in the same way for each participant.

If you’re developing a new questionnaire or other instrument to measure a specific concept, running a pilot study allows you to check its validity and reliability in advance.

Sampling procedures

As well as choosing an appropriate sampling method , you need a concrete plan for how you’ll actually contact and recruit your selected sample.

That means making decisions about things like:

• How many participants do you need for an adequate sample size?
• What inclusion and exclusion criteria will you use to identify eligible participants?
• How will you contact your sample—by mail, online, by phone, or in person?

If you’re using a probability sampling method , it’s important that everyone who is randomly selected actually participates in the study. How will you ensure a high response rate?

If you’re using a non-probability method , how will you avoid research bias and ensure a representative sample?

Data management

It’s also important to create a data management plan for organizing and storing your data.

Will you need to transcribe interviews or perform data entry for observations? You should anonymize and safeguard any sensitive data, and make sure it’s backed up regularly.

Keeping your data well-organized will save time when it comes to analyzing it. It can also help other researchers validate and add to your findings (high replicability ).

On its own, raw data can’t answer your research question. The last step of designing your research is planning how you’ll analyze the data.

Quantitative data analysis

In quantitative research, you’ll most likely use some form of statistical analysis . With statistics, you can summarize your sample data, make estimates, and test hypotheses.

Using descriptive statistics , you can summarize your sample data in terms of:

• The distribution of the data (e.g., the frequency of each score on a test)
• The central tendency of the data (e.g., the mean to describe the average score)
• The variability of the data (e.g., the standard deviation to describe how spread out the scores are)

The specific calculations you can do depend on the level of measurement of your variables.

Using inferential statistics , you can:

• Make estimates about the population based on your sample data.
• Test hypotheses about a relationship between variables.

Regression and correlation tests look for associations between two or more variables, while comparison tests (such as t tests and ANOVAs ) look for differences in the outcomes of different groups.

Your choice of statistical test depends on various aspects of your research design, including the types of variables you’re dealing with and the distribution of your data.

Qualitative data analysis

In qualitative research, your data will usually be very dense with information and ideas. Instead of summing it up in numbers, you’ll need to comb through the data in detail, interpret its meanings, identify patterns, and extract the parts that are most relevant to your research question.

Two of the most common approaches to doing this are thematic analysis and discourse analysis .

There are many other ways of analyzing qualitative data depending on the aims of your research. To get a sense of potential approaches, try reading some qualitative research papers in your field.

If you want to know more about the research process , methodology , research bias , or statistics , make sure to check out some of our other articles with explanations and examples.

• Simple random sampling
• Stratified sampling
• Cluster sampling
• Likert scales
• Reproducibility

 Statistics

• Null hypothesis
• Statistical power
• Probability distribution
• Effect size
• Poisson distribution

Research bias

• Optimism bias
• Cognitive bias
• Implicit bias
• Hawthorne effect
• Anchoring bias
• Explicit bias

A research design is a strategy for answering your   research question . It defines your overall approach and determines how you will collect and analyze data.

A well-planned research design helps ensure that your methods match your research aims, that you collect high-quality data, and that you use the right kind of analysis to answer your questions, utilizing credible sources . This allows you to draw valid , trustworthy conclusions.

Quantitative research designs can be divided into two main categories:

• Correlational and descriptive designs are used to investigate characteristics, averages, trends, and associations between variables.
• Experimental and quasi-experimental designs are used to test causal relationships .

Qualitative research designs tend to be more flexible. Common types of qualitative design include case study , ethnography , and grounded theory designs.

The priorities of a research design can vary depending on the field, but you usually have to specify:

• Your research questions and/or hypotheses
• Your overall approach (e.g., qualitative or quantitative )
• The type of design you’re using (e.g., a survey , experiment , or case study )
• Your data collection methods (e.g., questionnaires , observations)
• Your data collection procedures (e.g., operationalization , timing and data management)
• Your data analysis methods (e.g., statistical tests  or thematic analysis )

A sample is a subset of individuals from a larger population . Sampling means selecting the group that you will actually collect data from in your research. For example, if you are researching the opinions of students in your university, you could survey a sample of 100 students.

In statistics, sampling allows you to test a hypothesis about the characteristics of a population.

Operationalization means turning abstract conceptual ideas into measurable observations.

For example, the concept of social anxiety isn’t directly observable, but it can be operationally defined in terms of self-rating scores, behavioral avoidance of crowded places, or physical anxiety symptoms in social situations.

Before collecting data , it’s important to consider how you will operationalize the variables that you want to measure.

A research project is an academic, scientific, or professional undertaking to answer a research question . Research projects can take many forms, such as qualitative or quantitative , descriptive , longitudinal , experimental , or correlational . What kind of research approach you choose will depend on your topic.

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Understanding Research Ethics

• First Online: 22 April 2022

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• Sarah Cuschieri 2  

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As a researcher, whatever your career stage, you need to understand and practice good research ethics. Moral and ethical principles are requisite in research to ensure no deception or harm to participants, scientific community, and society occurs. Failure to follow such principles leads to research misconduct, in which case the researcher faces repercussions ranging from withdrawal of an article from publication to potential job loss. This chapter describes the various types of research misconduct that you should be aware of, i.e., data fabrication and falsification, plagiarism, research bias, data integrity, researcher and funder conflicts of interest. A sound comprehension of research ethics will take you a long way in your career.

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Department of Anatomy, Faculty of Medicine and Surgery, University of Malta, Msida, Malta

Sarah Cuschieri

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Cuschieri, S. (2022). Understanding Research Ethics. In: A Roadmap to Successful Scientific Publishing. Springer, Cham. https://doi.org/10.1007/978-3-030-99295-8_2

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Study Design 101: Practice Guideline

• Case Report
• Case Control Study
• Cohort Study
• Randomized Controlled Trial
• Practice Guideline
• Systematic Review
• Meta-Analysis
• Helpful Formulas
• Finding Specific Study Types

A statement produced by a panel of experts that outlines current best practice to inform health care professionals and patients in making clinical decisions. The statement is produced after an extensive review of the literature and is typically created by professional associations, government agencies, and/or public or private organizations.

Good guidelines clearly define the topic; appraise and summarize the best evidence regarding prevention, diagnosis, prognosis, therapy, harm, and cost-effectiveness; and identify the decision points where this information should be integrated with clinical experience and patient wishes to determine practice. Practice guidelines should be reviewed frequently and updated as necessary for continued accuracy and relevancy.

Practice guidelines are also known as "Evidence-based guidelines" and "Clinical guidelines."

• Created by panels of experts
• Based on professional published literature
• Practical guidance for clinicians
• Considered an evidence-based resource

Disadvantages

• Slow to change or be updated
• Not always available, especially for controversial topics
• Expensive and time-consuming to produce
• Recommendations might be affected by the type of organization creating the guideline

Design pitfalls to look out for

The panel should be composed of a variety of experts with assorted affiliations.

Is the panel composed of members from a variety of professional associations, government agencies and/or institutes? Does one organization/association predominate?

Fictitious Example

A practice guideline focusing on the best way to prevent sunburn when wearing sunscreen involved forming a multidisciplinary panel of experts (dermatologists, oncologists, sunscreen chemists, etc.). These experts searched the literature and identified 123 research articles on sunscreen and sunburn prevention for appraisal. The research was then reviewed by a member of the panel with critical appraisal experience in order to identify only those high-quality research articles that permit making recommendations. Ninety-seven high-quality studies were selected. These articles were read and synthesized by the panel to create a formal guideline recommendation. Based on the literature, the guideline recommended that the best way to prevent sunburn is to wear UVA blocking sunscreen daily. However, there was insufficient evidence in the literature to make any recommendations about newer sunscreen formulations. This identified the need for further research on this topic.

Real-life Examples

Chou, R., Deyo, R., Friedly, J., Skelly, A., Hashimoto, R., Weimer, M., ... Brodt, E. (2017). Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline . Annals Of Internal Medicine, 166 (7), 493-+. https://doi.org/10.7326/M16-2459

A group from The American College of Physicians reviewed the current evidence to determine which nonpharmacologic options are effective in treating low back pain (both acute and chronic). New treatment options appeared in the literature since 2007 (prior guideline on this topic) and several show "small to moderate, usually short-term effect on pain" including tai chi, mindfulness-based stress reduction, yoga as well as continued support for prior treatment recommendations including exercise, psychological therapies, multidisciplinary rehabilitation, spinal manipulation, massage, and acupuncture. There were greater effects on pain than on function, and the strength of evidence for several of these interventions is low.

Lennon, S., Dellavalle, D., Rodder, S., Prest, M., Sinley, R., Hoy, M., & Papoutsakis, C. (2017). 2015 Evidence Analysis Library evidence-based nutrition practice guideline for the management of hypertension in adults. Journal of the Academy of Nutrition and Dietetics, 117 (9), 1445-1458.e17. https://doi.org/10.1016/j.jand.2017.04.008

This guideline addresses the role of nutrition in managing hypertension in adults. Seventy studies were evaluated, resulting in eight recommendations to reduce blood pressure in adults with hypertension, based on moderate levels of evidence: "provision of medical nutrition therapy by an RDN [registered dietitian nutritionist], adoption of the Dietary Approaches to Stop Hypertension dietary pattern, calcium supplementation, physical activity as a component of a healthy lifestyle, reduction in dietary sodium intake, and reduction of alcohol consumption in heavy drinkers. Increased intake of dietary potassium and calcium as well as supplementation with potassium and magnesium for lowering BP are also recommended."

Related Terms

National Guideline Clearinghouse (NGC)

The National Guideline Clearinghouse was a public resource for evidence-based clinical practice guidelines maintained by the Agency for Healthcare Research and Quality (AHRQ) . It was taken offline in 2018 after federal funding ended.

Now test yourself!

1. Practice guidelines are available for almost any condition you'll encounter in your patients.

a) True b) False

2. Practice Guidelines are typically written by which of the following?

a) Public or private organizations b) Government agencies c) Professional associations d) The National Guideline Clearinghouse e) b, c and d only f) a, b, and c only

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This chart lists the major biomedical research reporting guidelines that provide advice for reporting research methods and findings. They usually "specify a minimum set of items required for a clear and transparent account of what was done and what was found in a research study, reflecting, in particular, issues that might introduce bias into the research" (Adapted from the EQUATOR Network Resource Centre ). The chart also includes editorial style guides for writing research reports or other publications.

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Regulations: Good Clinical Practice and Clinical Trials

Fda regulations relating to good clinical practice and clinical trials.

Here are links to FDA regulations governing human subject protection and the conduct of clinical trials.

• Electronic Records; Electronic Signatures (21 CFR Part 11)
• Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)
• Protection of Human Subjects (Informed Consent) (21 CFR Part 50)
• Financial Disclosure by Clinical Investigators (21 CFR Part 54)
• Institutional Review Boards (21 CFR Part 56)
• Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)
• Investigational New Drug Application (21 CFR Part 312)
• Applications for FDA Approval to Market a New Drug (21 CFR Part 314)
• Bioavailability and Bioequivalence Requirements (21 CFR Part 320)
• New Animal Drugs for Investigational Use (21 CFR Part 511)
• New Animal Drug Applications (21 CFR Part 514)
• Applications for FDA Approval of a Biologic License (21 CFR Part 601)
• Investigational Device Exemptions (21 CFR Part 812)
• Premarket Approval of Medical Devices (21 CFR Part 814)

Preambles to GCP Regulations

Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process.

The "preamble" to each of these publications includes all of the printed information immediately preceding the codified regulation. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments . The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation (as the case may be) of the regulation.

The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

Part 50- Informed Consent

• Protection of Human Subjects; Informed Consent; Final Rule (46 FR 8942, January 27, 1981)
• Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations (53 FR 45678, November 10,1988)
• Protection of Human Subjects; Informed Consent; Proposed Rule [text] | [ PDF ] (60 FR 49086, September 21, 1995)
• Protection of Human Subjects; Informed Consent [text] | [PDF] (60 FR 66530, December 22, 1995)
• Protection of Human Subjects; Informed Consent, Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rule [text] | [PDF] (61 FR 51498, October 2, 1996)
• Protection of Human Subjects; Informed Consent Verification; Final Rule [text]  |  [PDF]  (61 FR 57278, November 5, 1996)
• Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule [text] | [PDF]  (64 FR 54180, October 5, 1999)
• Medical Devices; Exception from General Requirements for Informed Consent; Interim Final Rule [text] | [PDF]  (71 FR 32827, June 7, 2006)
• Informed Consent Elements [text] | [PDF] (76 FR 256, January 4, 2011)
• Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Advance Notice of Proposed Rulemaking (ANPRM) [text] [PDF] (76 FR 44512, July 26, 2011)
• Extension of Comment Period [text] | [PDF] (83 FR 65322, December 20, 2018)
• Reopening of Comment Period [text] | [PDF]  (84 FR 5968, February 25, 2019)

Additional Safeguards for Children in Clinical Investigations of FDA Regulated Products; 21 CFR 50, Subpart D

• Interim Final Rule[text]  |  [PDF]   (66 FR 20589-600, April 24, 2001)
• Final Rule [text] | [PDF] (78 FR 12937, February 26, 2013

Part 56- Institutional Review Boards

• Protection of Human Subjects, Standards for Institutional Review Boards for Clinical Investigations Proposed Rule (43 FR 35186, August 8, 1978)
• Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations (46 FR 8958, January 27, 1981)
• Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations; Notice   (46 FR 8980, January 27, 1981)
• Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations; Proposed Rule (53 FR 45678, November 10, 1988)
• Federal Policy for the Protection of Human Subjects; Final Rule (56 FR 28003, June 18, 1991)
• FDA Policy for the Protection of Human Subjects; Final Rule (56 FR 28025, June 18, 1991)
• Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure [text] | [PDF]   (63 FR 60353, November 9, 1998)
• Human Drugs and Biologics: Determination That Informed IS NOT Feasible or Is Contrary to the Best Interests of Recipients; Revocation of 1990 Interim Final Rule; Establishment of New Interim Final Rule [text]  | [PDF]   ( 64 FR 54180, October 5, 1999)

IRB Registration Requirements 21 CFR 56.106

• Proposed Rule [text] | [PDF] (69 FR 40556, July 6, 2004)
• Final Rule [text] | [PDF] (74 FR 2358, January 15, 2009)

IRB Shopping: Requiring Sponsors and Investigators to Inform Institutional Review Boards of Any Prior Institutional Review Boards Reviews

• Advance Notice of Proposed Rulemaking [text]  [ PDF ]  (67 FR 10115, March 6, 2002)
• Advance Notice of Proposed Rulemaking; Withdrawal [text]   [PDF]   (71 FR 2493, January 17, 2006)  

IRB Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations

• Proposed Rule [text]  | [PDF] (83 FR 57378, November 15, 2018)
• Extension of Comment Period [text] | [PDF]  (83 FR 65322, December 20, 2018)
• Reopening on Comment Period [text] | [PDF]  (84 FR 5968, February 25, 2019)

Part 54- Financial Disclosure by Clinical Investigators

• Financial Disclosure by Clinical Investigators; Public Hearing [text] | [PDF]  ( 60 FR 29801, June 6, 1995 )
• Financial Disclosure by Clinical Investigators; Proposed Rule [text] | [PDF ] (63 FR 5233, February 2, 1998)
• Financial Disclosure by a Clinical Investigator; Final Rule [text]  |  [PDF] (63 FR 72171-81, December 31, 1998)

Part 210- Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General

• Current Good Manufacturing Practice Regulations and Investigational New Drugs [text]  |  [PDF]   (January 17, 2006)

Part 312- Investigational New Drug Application

• Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations (48 FR 26720, June 9, 1983)
• New Drug and Antibiotic Regulations (50 FR 7452, February 22, 1985)
• New Drug, Antibiotic, and Biologic Drug Product Regulations (52 FR 8850, March 19, 1987)
• Investigational New Drug Applications and New Drug Applications [text] | [PDF] ( September 8, 1995)
• Investigational New Drug Applications and New Drug Applications [text]  | [PDF]   ( February 11, 1998)
• Disqualification of a Clinical Investigator [text] | [PDF] (February 16, 1996)
• Disqualification of a Clinical Investigator [text] | [PDF] (September 5, 1997)
• Expedited Safety Reporting Requirements for Human Drug and Biological Products [text] | [PDF] (62 FR 52237, October 7, 1997)
• Clinical Hold for products intended for life threatening conditions [text]  | [PDF] (65 FR 34963-71, June 1, 2000)
• Human Subject Protection; Foreign Clinical Studies Not Conducted Under an Investigational New Drug Application; Final Rule [text] | [PDF] (73 FR 22800, April 28, 2008)
• Proposed Rule [text]  | [PDF] (75 FR 7412, February 19, 2010)
• Withdrawal Notice [text]  | [PDF] (83 FR 49023, September 28, 2018)
• Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans; Final Rule [text]  |  [PDF]   (75 FR 59935, September 29, 2010)
• Disqualification of a Clinical Investigator [text]  | [PDF]  (77 FR 25353, April 30, 2012)

Part 314 – Applications for FDA Approval to Market a New Drug Part 601 – Applications for FDA Approval of a Biologic License

• New Drug and Biological Drug Products; Evidence Needed to Demonstrate Effectiveness of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible; Final Rule [text] | [PDF]  (67 FR 37988, May 31, 2002)

Part 320- Bioavailability and Bioequivalence Requirements

• Retention of BE and BA Testing Samples; Final Rule [text] (58 FR 25918, April 28, 1993)
• Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans;Final Rule [text] | [PDF] (75 FR 59935, September 29, 2010)

Part 812- Investigational Device Exemptions

• Medical Devices; Current Good Manufacturing Practice (CGMP)Quality System Regulations [text] | [PDF] ( 61 FR 52602, October 7, 1996)
• Treatment Use of Investigational Devices [text] | [PDF] ( 62 FR 48940, September 18, 1997)
• Withdrawal of Intraocular Lenses Regulation (Part 813) [text]  |  [PDF]   ( 62 FR 4164, January 29, 1997)
• Disqualification of Clinical Investigators [text] | [PDF] ( 62 FR 12087, March 14, 1997)
• FDA Modernization Act of 1997: Modifications to the List of Recognized Standards [text] | [PDF] ( 64 FR 37546, July 12, 1999)
• Medical Devices; Investigational Device Exemptions (Modifications to the Medical Device and/or Study Protocol); Final Rule [text] | [PDF] ( 63 FR 64617, November 23, 1998)
• Disqualification of a Clinical Investigator [text]  | [PDF] ( 77 FR 25353, April 30, 2012)

Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

• Proposed Rule [text] [PDF] (78 FR 12664, February 25, 2013)
• Final Rule [text] [PDF] (83 FR 7366, February 21, 2018)

Part 814- Premarket Approval of Medical Devices

• Medical Devices; Humanitarian Use Devices Part V ; Final Rule [text] | [PDF] ( 61 FR 33232, June 26, 1996)
• 30-Day Notices and 135-Day PMA Supplement Review; Final Rule [text] | [PDF] ( 63 FR 54042, October 8, 1998)
• Humanitarian Use of Devices; Final Rule [text]  | [PDF] (63 FR 59217, November 3, 1998)
• Medical Devices; Exception from General Requirements for Informed Consent; Interim Final Rule [text] | [PDF] (71 FR 32827, June 7, 2006)

Miscellaneous

• Determination of Mode of Action in Combination Products (PDF - 13KB) (70 FR 49848, August 25, 2005) [text] This rule defines "mode of action" and "primary mode of action" and sets forth the algorithm FDA will use to assign combination products to an agency component for regulatory oversight.
• Administrative Practices and Procedures; Good Guidance Practices; Proposed Rule [text] [PDF] (65 FR 7321, February 14, 2000)
• Administrative Practices and Procedures; Good Guidance Practices; Final Rule [text] [PDF] (65 FR 56468, September 19, 2000)
• Index and Copies of Presiding Officer Reports and Commissioner Decisions on the Eligibilty of a Clinical Investigator to Continue to Receive Investigational Products; Availabilty [text]  | [PDF] (66 FR 45317-8, August 28, 2001)
• Part 11 Electronic Records; Electronic Signatures [text]    | [PDF] ( 62 FR 13430, March 20, 1997)
• Privacy Act of 1974; Altered Sysytem of Records, Including Addition of Routine Use(s) to an Existing System of Records Notification of an altered system of records, including the addition of new routine use [text]   | [PDF] (63 FR 55873-6, October 19, 1998)

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National Institute of Environmental Health Sciences

Your environment. your health., what is ethics in research & why is it important, by david b. resnik, j.d., ph.d..

December 23, 2020

The ideas and opinions expressed in this essay are the author’s own and do not necessarily represent those of the NIH, NIEHS, or US government.

When most people think of ethics (or morals), they think of rules for distinguishing between right and wrong, such as the Golden Rule ("Do unto others as you would have them do unto you"), a code of professional conduct like the Hippocratic Oath ("First of all, do no harm"), a religious creed like the Ten Commandments ("Thou Shalt not kill..."), or a wise aphorisms like the sayings of Confucius. This is the most common way of defining "ethics": norms for conduct that distinguish between acceptable and unacceptable behavior.

Most people learn ethical norms at home, at school, in church, or in other social settings. Although most people acquire their sense of right and wrong during childhood, moral development occurs throughout life and human beings pass through different stages of growth as they mature. Ethical norms are so ubiquitous that one might be tempted to regard them as simple commonsense. On the other hand, if morality were nothing more than commonsense, then why are there so many ethical disputes and issues in our society?

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One plausible explanation of these disagreements is that all people recognize some common ethical norms but interpret, apply, and balance them in different ways in light of their own values and life experiences. For example, two people could agree that murder is wrong but disagree about the morality of abortion because they have different understandings of what it means to be a human being.

Most societies also have legal rules that govern behavior, but ethical norms tend to be broader and more informal than laws. Although most societies use laws to enforce widely accepted moral standards and ethical and legal rules use similar concepts, ethics and law are not the same. An action may be legal but unethical or illegal but ethical. We can also use ethical concepts and principles to criticize, evaluate, propose, or interpret laws. Indeed, in the last century, many social reformers have urged citizens to disobey laws they regarded as immoral or unjust laws. Peaceful civil disobedience is an ethical way of protesting laws or expressing political viewpoints.

Another way of defining 'ethics' focuses on the disciplines that study standards of conduct, such as philosophy, theology, law, psychology, or sociology. For example, a "medical ethicist" is someone who studies ethical standards in medicine. One may also define ethics as a method, procedure, or perspective for deciding how to act and for analyzing complex problems and issues. For instance, in considering a complex issue like global warming , one may take an economic, ecological, political, or ethical perspective on the problem. While an economist might examine the cost and benefits of various policies related to global warming, an environmental ethicist could examine the ethical values and principles at stake.

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Many different disciplines, institutions , and professions have standards for behavior that suit their particular aims and goals. These standards also help members of the discipline to coordinate their actions or activities and to establish the public's trust of the discipline. For instance, ethical standards govern conduct in medicine, law, engineering, and business. Ethical norms also serve the aims or goals of research and apply to people who conduct scientific research or other scholarly or creative activities. There is even a specialized discipline, research ethics, which studies these norms. See Glossary of Commonly Used Terms in Research Ethics and Research Ethics Timeline .

There are several reasons why it is important to adhere to ethical norms in research. First, norms promote the aims of research , such as knowledge, truth, and avoidance of error. For example, prohibitions against fabricating , falsifying, or misrepresenting research data promote the truth and minimize error.

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Second, since research often involves a great deal of cooperation and coordination among many different people in different disciplines and institutions, ethical standards promote the values that are essential to collaborative work , such as trust, accountability, mutual respect, and fairness. For example, many ethical norms in research, such as guidelines for authorship , copyright and patenting policies , data sharing policies, and confidentiality rules in peer review, are designed to protect intellectual property interests while encouraging collaboration. Most researchers want to receive credit for their contributions and do not want to have their ideas stolen or disclosed prematurely.

Third, many of the ethical norms help to ensure that researchers can be held accountable to the public . For instance, federal policies on research misconduct, conflicts of interest, the human subjects protections, and animal care and use are necessary in order to make sure that researchers who are funded by public money can be held accountable to the public.

Fourth, ethical norms in research also help to build public support for research. People are more likely to fund a research project if they can trust the quality and integrity of research.

Finally, many of the norms of research promote a variety of other important moral and social values , such as social responsibility, human rights, animal welfare, compliance with the law, and public health and safety. Ethical lapses in research can significantly harm human and animal subjects, students, and the public. For example, a researcher who fabricates data in a clinical trial may harm or even kill patients, and a researcher who fails to abide by regulations and guidelines relating to radiation or biological safety may jeopardize his health and safety or the health and safety of staff and students.

Codes and Policies for Research Ethics

Given the importance of ethics for the conduct of research, it should come as no surprise that many different professional associations, government agencies, and universities have adopted specific codes, rules, and policies relating to research ethics. Many government agencies have ethics rules for funded researchers.

• National Institutes of Health (NIH)
• National Science Foundation (NSF)
• Food and Drug Administration (FDA)
• Environmental Protection Agency (EPA)
• US Department of Agriculture (USDA)
• Singapore Statement on Research Integrity
• American Chemical Society, The Chemist Professional’s Code of Conduct
• Code of Ethics (American Society for Clinical Laboratory Science)
• American Psychological Association, Ethical Principles of Psychologists and Code of Conduct
• Statement on Professional Ethics (American Association of University Professors)
• Nuremberg Code
• World Medical Association's Declaration of Helsinki

Ethical Principles

The following is a rough and general summary of some ethical principles that various codes address*:

Strive for honesty in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, research sponsors, or the public.

Objectivity

Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.

Keep your promises and agreements; act with sincerity; strive for consistency of thought and action.

Carefulness

Avoid careless errors and negligence; carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.

Share data, results, ideas, tools, resources. Be open to criticism and new ideas.

Transparency

Disclose methods, materials, assumptions, analyses, and other information needed to evaluate your research.

Accountability

Take responsibility for your part in research and be prepared to give an account (i.e. an explanation or justification) of what you did on a research project and why.

Intellectual Property

Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.

Confidentiality

Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.

Responsible Publication

Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.

Responsible Mentoring

Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.

Respect for Colleagues

Respect your colleagues and treat them fairly.

Social Responsibility

Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.

Non-Discrimination

Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors not related to scientific competence and integrity.

Maintain and improve your own professional competence and expertise through lifelong education and learning; take steps to promote competence in science as a whole.

Know and obey relevant laws and institutional and governmental policies.

Animal Care

Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.

Human Subjects protection

When conducting research on human subjects, minimize harms and risks and maximize benefits; respect human dignity, privacy, and autonomy; take special precautions with vulnerable populations; and strive to distribute the benefits and burdens of research fairly.

* Adapted from Shamoo A and Resnik D. 2015. Responsible Conduct of Research, 3rd ed. (New York: Oxford University Press).

Ethical Decision Making in Research

Although codes, policies, and principles are very important and useful, like any set of rules, they do not cover every situation, they often conflict, and they require interpretation. It is therefore important for researchers to learn how to interpret, assess, and apply various research rules and how to make decisions and act ethically in various situations. The vast majority of decisions involve the straightforward application of ethical rules. For example, consider the following case:

The research protocol for a study of a drug on hypertension requires the administration of the drug at different doses to 50 laboratory mice, with chemical and behavioral tests to determine toxic effects. Tom has almost finished the experiment for Dr. Q. He has only 5 mice left to test. However, he really wants to finish his work in time to go to Florida on spring break with his friends, who are leaving tonight. He has injected the drug in all 50 mice but has not completed all of the tests. He therefore decides to extrapolate from the 45 completed results to produce the 5 additional results.

Many different research ethics policies would hold that Tom has acted unethically by fabricating data. If this study were sponsored by a federal agency, such as the NIH, his actions would constitute a form of research misconduct , which the government defines as "fabrication, falsification, or plagiarism" (or FFP). Actions that nearly all researchers classify as unethical are viewed as misconduct. It is important to remember, however, that misconduct occurs only when researchers intend to deceive : honest errors related to sloppiness, poor record keeping, miscalculations, bias, self-deception, and even negligence do not constitute misconduct. Also, reasonable disagreements about research methods, procedures, and interpretations do not constitute research misconduct. Consider the following case:

Dr. T has just discovered a mathematical error in his paper that has been accepted for publication in a journal. The error does not affect the overall results of his research, but it is potentially misleading. The journal has just gone to press, so it is too late to catch the error before it appears in print. In order to avoid embarrassment, Dr. T decides to ignore the error.

Dr. T's error is not misconduct nor is his decision to take no action to correct the error. Most researchers, as well as many different policies and codes would say that Dr. T should tell the journal (and any coauthors) about the error and consider publishing a correction or errata. Failing to publish a correction would be unethical because it would violate norms relating to honesty and objectivity in research.

There are many other activities that the government does not define as "misconduct" but which are still regarded by most researchers as unethical. These are sometimes referred to as " other deviations " from acceptable research practices and include:

• Publishing the same paper in two different journals without telling the editors
• Submitting the same paper to different journals without telling the editors
• Not informing a collaborator of your intent to file a patent in order to make sure that you are the sole inventor
• Including a colleague as an author on a paper in return for a favor even though the colleague did not make a serious contribution to the paper
• Discussing with your colleagues confidential data from a paper that you are reviewing for a journal
• Using data, ideas, or methods you learn about while reviewing a grant or a papers without permission
• Trimming outliers from a data set without discussing your reasons in paper
• Using an inappropriate statistical technique in order to enhance the significance of your research
• Bypassing the peer review process and announcing your results through a press conference without giving peers adequate information to review your work
• Conducting a review of the literature that fails to acknowledge the contributions of other people in the field or relevant prior work
• Stretching the truth on a grant application in order to convince reviewers that your project will make a significant contribution to the field
• Stretching the truth on a job application or curriculum vita
• Giving the same research project to two graduate students in order to see who can do it the fastest
• Overworking, neglecting, or exploiting graduate or post-doctoral students
• Failing to keep good research records
• Failing to maintain research data for a reasonable period of time
• Making derogatory comments and personal attacks in your review of author's submission
• Promising a student a better grade for sexual favors
• Using a racist epithet in the laboratory
• Making significant deviations from the research protocol approved by your institution's Animal Care and Use Committee or Institutional Review Board for Human Subjects Research without telling the committee or the board
• Not reporting an adverse event in a human research experiment
• Wasting animals in research
• Exposing students and staff to biological risks in violation of your institution's biosafety rules
• Sabotaging someone's work
• Stealing supplies, books, or data
• Rigging an experiment so you know how it will turn out
• Making unauthorized copies of data, papers, or computer programs
• Owning over $10,000 in stock in a company that sponsors your research and not disclosing this financial interest
• Deliberately overestimating the clinical significance of a new drug in order to obtain economic benefits

These actions would be regarded as unethical by most scientists and some might even be illegal in some cases. Most of these would also violate different professional ethics codes or institutional policies. However, they do not fall into the narrow category of actions that the government classifies as research misconduct. Indeed, there has been considerable debate about the definition of "research misconduct" and many researchers and policy makers are not satisfied with the government's narrow definition that focuses on FFP. However, given the huge list of potential offenses that might fall into the category "other serious deviations," and the practical problems with defining and policing these other deviations, it is understandable why government officials have chosen to limit their focus.

Finally, situations frequently arise in research in which different people disagree about the proper course of action and there is no broad consensus about what should be done. In these situations, there may be good arguments on both sides of the issue and different ethical principles may conflict. These situations create difficult decisions for research known as ethical or moral dilemmas . Consider the following case:

Dr. Wexford is the principal investigator of a large, epidemiological study on the health of 10,000 agricultural workers. She has an impressive dataset that includes information on demographics, environmental exposures, diet, genetics, and various disease outcomes such as cancer, Parkinson’s disease (PD), and ALS. She has just published a paper on the relationship between pesticide exposure and PD in a prestigious journal. She is planning to publish many other papers from her dataset. She receives a request from another research team that wants access to her complete dataset. They are interested in examining the relationship between pesticide exposures and skin cancer. Dr. Wexford was planning to conduct a study on this topic.

Dr. Wexford faces a difficult choice. On the one hand, the ethical norm of openness obliges her to share data with the other research team. Her funding agency may also have rules that obligate her to share data. On the other hand, if she shares data with the other team, they may publish results that she was planning to publish, thus depriving her (and her team) of recognition and priority. It seems that there are good arguments on both sides of this issue and Dr. Wexford needs to take some time to think about what she should do. One possible option is to share data, provided that the investigators sign a data use agreement. The agreement could define allowable uses of the data, publication plans, authorship, etc. Another option would be to offer to collaborate with the researchers.

The following are some step that researchers, such as Dr. Wexford, can take to deal with ethical dilemmas in research:

What is the problem or issue?

It is always important to get a clear statement of the problem. In this case, the issue is whether to share information with the other research team.

What is the relevant information?

Many bad decisions are made as a result of poor information. To know what to do, Dr. Wexford needs to have more information concerning such matters as university or funding agency or journal policies that may apply to this situation, the team's intellectual property interests, the possibility of negotiating some kind of agreement with the other team, whether the other team also has some information it is willing to share, the impact of the potential publications, etc.

What are the different options?

People may fail to see different options due to a limited imagination, bias, ignorance, or fear. In this case, there may be other choices besides 'share' or 'don't share,' such as 'negotiate an agreement' or 'offer to collaborate with the researchers.'

How do ethical codes or policies as well as legal rules apply to these different options?

The university or funding agency may have policies on data management that apply to this case. Broader ethical rules, such as openness and respect for credit and intellectual property, may also apply to this case. Laws relating to intellectual property may be relevant.

Are there any people who can offer ethical advice?

It may be useful to seek advice from a colleague, a senior researcher, your department chair, an ethics or compliance officer, or anyone else you can trust. In the case, Dr. Wexford might want to talk to her supervisor and research team before making a decision.

After considering these questions, a person facing an ethical dilemma may decide to ask more questions, gather more information, explore different options, or consider other ethical rules. However, at some point he or she will have to make a decision and then take action. Ideally, a person who makes a decision in an ethical dilemma should be able to justify his or her decision to himself or herself, as well as colleagues, administrators, and other people who might be affected by the decision. He or she should be able to articulate reasons for his or her conduct and should consider the following questions in order to explain how he or she arrived at his or her decision:

• Which choice will probably have the best overall consequences for science and society?
• Which choice could stand up to further publicity and scrutiny?
• Which choice could you not live with?
• Think of the wisest person you know. What would he or she do in this situation?
• Which choice would be the most just, fair, or responsible?

After considering all of these questions, one still might find it difficult to decide what to do. If this is the case, then it may be appropriate to consider others ways of making the decision, such as going with a gut feeling or intuition, seeking guidance through prayer or meditation, or even flipping a coin. Endorsing these methods in this context need not imply that ethical decisions are irrational, however. The main point is that human reasoning plays a pivotal role in ethical decision-making but there are limits to its ability to solve all ethical dilemmas in a finite amount of time.

Promoting Ethical Conduct in Science

Do U.S. research institutions meet or exceed federal mandates for instruction in responsible conduct of research? A national survey

 Read about U.S. research instutuins follow federal manadates for ethics in research 

Learn more about NIEHS Research

Most academic institutions in the US require undergraduate, graduate, or postgraduate students to have some education in the responsible conduct of research (RCR) . The NIH and NSF have both mandated training in research ethics for students and trainees. Many academic institutions outside of the US have also developed educational curricula in research ethics

Those of you who are taking or have taken courses in research ethics may be wondering why you are required to have education in research ethics. You may believe that you are highly ethical and know the difference between right and wrong. You would never fabricate or falsify data or plagiarize. Indeed, you also may believe that most of your colleagues are highly ethical and that there is no ethics problem in research..

If you feel this way, relax. No one is accusing you of acting unethically. Indeed, the evidence produced so far shows that misconduct is a very rare occurrence in research, although there is considerable variation among various estimates. The rate of misconduct has been estimated to be as low as 0.01% of researchers per year (based on confirmed cases of misconduct in federally funded research) to as high as 1% of researchers per year (based on self-reports of misconduct on anonymous surveys). See Shamoo and Resnik (2015), cited above.

Clearly, it would be useful to have more data on this topic, but so far there is no evidence that science has become ethically corrupt, despite some highly publicized scandals. Even if misconduct is only a rare occurrence, it can still have a tremendous impact on science and society because it can compromise the integrity of research, erode the public’s trust in science, and waste time and resources. Will education in research ethics help reduce the rate of misconduct in science? It is too early to tell. The answer to this question depends, in part, on how one understands the causes of misconduct. There are two main theories about why researchers commit misconduct. According to the "bad apple" theory, most scientists are highly ethical. Only researchers who are morally corrupt, economically desperate, or psychologically disturbed commit misconduct. Moreover, only a fool would commit misconduct because science's peer review system and self-correcting mechanisms will eventually catch those who try to cheat the system. In any case, a course in research ethics will have little impact on "bad apples," one might argue.

According to the "stressful" or "imperfect" environment theory, misconduct occurs because various institutional pressures, incentives, and constraints encourage people to commit misconduct, such as pressures to publish or obtain grants or contracts, career ambitions, the pursuit of profit or fame, poor supervision of students and trainees, and poor oversight of researchers (see Shamoo and Resnik 2015). Moreover, defenders of the stressful environment theory point out that science's peer review system is far from perfect and that it is relatively easy to cheat the system. Erroneous or fraudulent research often enters the public record without being detected for years. Misconduct probably results from environmental and individual causes, i.e. when people who are morally weak, ignorant, or insensitive are placed in stressful or imperfect environments. In any case, a course in research ethics can be useful in helping to prevent deviations from norms even if it does not prevent misconduct. Education in research ethics is can help people get a better understanding of ethical standards, policies, and issues and improve ethical judgment and decision making. Many of the deviations that occur in research may occur because researchers simply do not know or have never thought seriously about some of the ethical norms of research. For example, some unethical authorship practices probably reflect traditions and practices that have not been questioned seriously until recently. If the director of a lab is named as an author on every paper that comes from his lab, even if he does not make a significant contribution, what could be wrong with that? That's just the way it's done, one might argue. Another example where there may be some ignorance or mistaken traditions is conflicts of interest in research. A researcher may think that a "normal" or "traditional" financial relationship, such as accepting stock or a consulting fee from a drug company that sponsors her research, raises no serious ethical issues. Or perhaps a university administrator sees no ethical problem in taking a large gift with strings attached from a pharmaceutical company. Maybe a physician thinks that it is perfectly appropriate to receive a $300 finder’s fee for referring patients into a clinical trial.

If "deviations" from ethical conduct occur in research as a result of ignorance or a failure to reflect critically on problematic traditions, then a course in research ethics may help reduce the rate of serious deviations by improving the researcher's understanding of ethics and by sensitizing him or her to the issues.

Finally, education in research ethics should be able to help researchers grapple with the ethical dilemmas they are likely to encounter by introducing them to important concepts, tools, principles, and methods that can be useful in resolving these dilemmas. Scientists must deal with a number of different controversial topics, such as human embryonic stem cell research, cloning, genetic engineering, and research involving animal or human subjects, which require ethical reflection and deliberation.

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Comprehensive guidelines for appropriate statistical analysis methods in research

Affiliations.

• 1 Department of Anesthesiology and Pain Medicine, Daegu Catholic University School of Medicine, Daegu, Korea.
• 2 Department of Medical Statistics, Daegu Catholic University School of Medicine, Daegu, Korea.
• PMID: 39210669
• DOI: 10.4097/kja.24016

Background: The selection of statistical analysis methods in research is a critical and nuanced task that requires a scientific and rational approach. Aligning the chosen method with the specifics of the research design and hypothesis is paramount, as it can significantly impact the reliability and quality of the research outcomes.

Methods: This study explores a comprehensive guideline for systematically choosing appropriate statistical analysis methods, with a particular focus on the statistical hypothesis testing stage and categorization of variables. By providing a detailed examination of these aspects, this study aims to provide researchers with a solid foundation for informed methodological decision making. Moving beyond theoretical considerations, this study delves into the practical realm by examining the null and alternative hypotheses tailored to specific statistical methods of analysis. The dynamic relationship between these hypotheses and statistical methods is thoroughly explored, and a carefully crafted flowchart for selecting the statistical analysis method is proposed.

Results: Based on the flowchart, we examined whether exemplary research papers appropriately used statistical methods that align with the variables chosen and hypotheses built for the research. This iterative process ensures the adaptability and relevance of this flowchart across diverse research contexts, contributing to both theoretical insights and tangible tools for methodological decision-making.

Conclusions: This study emphasizes the importance of a scientific and rational approach for the selection of statistical analysis methods. By providing comprehensive guidelines, insights into the null and alternative hypotheses, and a practical flowchart, this study aims to empower researchers and enhance the overall quality and reliability of scientific studies.

Keywords: Algorithms; Biostatistics; Data analysis; Guideline; Statistical data interpretation; Statistical model..

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Speaker 1: After the title page and abstract, the reader's first true interaction with your research paper is the introduction. Your introduction will establish the foundation upon which your readers approach your work, and if you use the tips we discuss in this video, these readers should be able to logically apply the rules set in your introduction to all parts of your paper, all the way through the conclusion. What exactly is the purpose of the introduction? Think about your paper as a chronological story. It will begin at point A, the introduction, and move in time towards point B, the discussion and conclusion. Since your introduction includes content about the gaps in knowledge that your study aims to fill, the results you elaborate on in your discussion section should therefore be somewhat familiar to the reader, as you have already touched upon them in the introduction section. The introduction must answer two main questions. Why was this particular study needed to fill the gaps in knowledge? And why does this particular gap need filling? Imagine our entire plane of knowledge as an incomplete puzzle. The pieces snapped together are what is established, or what is known. The missing piece is the gap in knowledge, or what is currently unknown. This is what your study will be helping to explain. So the context you provide in the introduction must first identify that there is a knowledge gap in what it is, it must explain why it needs to be filled, and then briefly summarize how this study intends to fill that gap and why. The introduction is one of the most compact parts of the research paper, since it is not very long but needs to essentially give a complete overview of the context in which your study is taking place, and your specific reasons for doing the study. Most tend to be around 10% of the total length of your paper. The introduction consists of background information about a topic being studied, the rationale for undertaking the study, or for filling the gap with this particular information, key references to preliminary work or closely related papers appearing elsewhere, a clarification of important terms, definitions, or abbreviations to be used in the paper, and a review of related studies in which you give a brief but incisive analysis of work that heavily concerns your study. It could be a very similar study or one that supports the findings of your new study. So how should you structure your introduction? As you can see in this figure, your introduction should start broadly and then narrow until it reaches your hypothesis. The first thing you want to do is state your area of research and then immediately show what is already known. This is also known as background information. Then move on to what is unknown, the problem or gap you want to resolve. Finally, you should discuss how you will resolve this problem using a clear hypothesis. In step one, you will show what is already known. Start with a strong statement that reflects your research subject area and ask questions or post statements to frame the problems your study explores. You can ask general questions here to guide your readers to the problem and show them what we already know. For instance, what do we know about breathing capability of bottlenose dolphins? Use keywords from your title, the exact language of your study that is, to zero in on the problem at hand and show the relevance of your work. Avoid stating background information that is too broad in nature. You don't need to state too many obvious facts that your readers would know. If you are writing about bottlenose dolphins, for instance, you probably don't need to explain to them that mammals breathe oxygen. At the beginning of the introduction, you should also be sure to cite all of the sources that you use for background information and support. Only provide the necessary background information. Don't focus extensively on background, but use it to set up the context for doing this study. You should also review only relevant, up-to-date primary literature that supports your explanation of our current base of knowledge. In the second part of your introduction, you should answer the question, what is the knowledge gap? Here you will highlight areas where too little information is available. Explain how and why we should fill in that gap. What does this missing information do to impede our understanding of a process or system? And you should identify what logical next steps can be developed based on existing research. By showing you have examined current data and devised a method to find new applications and make new inferences, you're showing your peers that you are aware of the direction your research is moving in, and you're showing confidence in your decision to pursue this paper study. In the last part of your introduction, you will show how your study fills in the knowledge gap. This is where you state your purpose and give a clear hypothesis or objective of the study. The hypothesis is a very short 1-2 sentence supposition or explanation of what will happen in your study. This is quite often written as an if-then format. If X and Y are present, then Z will occur. Here you should also try to answer the question, if we fill this gap, what useful information will the readers gain? Many researchers have difficulty when it comes to deciding when to write their introduction. It is important to consider the order you draft your research paper, for as you recall, everything else in the research paper must flow from the introduction. Therefore, because it is one of the most difficult sections to nail down, consider writing the introduction second to last, after the materials and methods, results, and discussion section, and just before the conclusion. This will ensure you effectively lay a groundwork for the rest of your paper, and you can use the research you have already compiled to ensure that everything in your introduction is pertinent and accurate. In addition to content and organization, writers of research papers should also be aware of grammar and style issues that directly affect the readability and strength of their printed work. Here are some guidelines for writing the introduction section. Try and write in the active voice when possible. This will shorten your sentences and enhance the impact of your information. Always strive for concise sentences. This will allow you to get in all of the necessary information in this compact introduction section. Use stronger verbs when possible. This also impacts sentence length and strength of writing. Be careful not to overuse first-person pronouns such as I and we, and always organize your thoughts from the broad to the specific, as we have seen in our model. A strong introduction will encourage readers to read your entire research paper and help get your work published in scientific journals. For more information and tips on manuscript writing and journal submissions, visit the resources page at wordvice.com.

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A Latinx Resource Guide: Civil Rights Cases and Events in the United States

1942: bracero program.

• Introduction
• 1911: Meeting of the Mexicanist Congress
• 1917: Jones-Shafroth Act
• 1938: Pecan Shellers Strike
• 1938: Spanish Speaking People's Congress
• 1942: People v. Zamora (sic) 1943: Zoot Suit Riots
• 1946: Mendez v. Westminster
• 1954: Hernandez v. Texas
• 1962: United Farm Workers Union
• 1966: Katzenbach v. Morgan
• 1966: Miranda v. Arizona
• 1966: The Cuban Adjustment Act of 1966
• 1967: Tierra Amarilla Land Grant & Courthouse Raid
• 1968: East Los Angeles Walkouts
• 1968: The Young Lord's Organization/Party
• 1970: National Chicano Moratorium
• 1973: San Antonio ISD v. Rodriguez
• 1974: Southwest Voter Registration Education Project
• 1974: Serna v. Portales
• 1975: U.S. v. Brignoni-Ponce
• 1976 and 2006: Congressional Leadership
• 1978: Madrigal v. Quilligan
• 1982: Plyler v. Doe
• 1986: Immigration Reform and Control Act of 1986
• 1987: INS v. Cardoza-Fonseca
• 1990: Temporary Protection Status (TPS)
• 1991: American Baptist Churches (ABC) v. Thornburgh
• 1994: California's Proposition 187
• 1999: Vieques Island Protests
• 2002: Development Relief and Education for Alien Minors (DREAM) Act & 2012: Deferred Action for Childhood Arrivals (DACA)
• 2012: Arizona v. United States
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An executive order called the Mexican Farm Labor Program established the Bracero Program in 1942. This series of diplomatic accords between Mexico and the United States permitted millions of Mexican men to work legally in the United States on short-term labor contracts. These agreements addressed a national agricultural labor shortage during WWII and implicitly, they redressed previous depression-era deportations and repatriations that unjustly targeted Mexican Americans who were U.S. citizens. Upon its termination in 1964, the Bracero Program had brought more than four million Braceros (arms) to work in U.S. agriculture and on railroads.

During World War II, the U.S. sought labor from millions of Braceros, who would return to their country of origin after their work permit expired. El Paso, Texas, the U.S. point of entry from Ciudad Juarez, served as a recruitment center for the program, which the U.S. Agricultural Department and independent farmer associations administered with the Farm Bureau managing English-language contracts. The United States and Mexico agreed on a set of protocols that would protect Braceros from discrimination and poor wages. Nonetheless, discrimination continued and Braceros experienced surcharges for room and board, deducted pay, and exposure to deadly chemicals.

The Bracero Program concluded on December 31, 1964 as mechanization became more widespread. Ultimately, the program resulted in an influx of undocumented and documented laborers, 22 years of cheap labor from Mexico, and remittances to Mexico by Braceros.

• Related Online Resources
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• The Chicano Civil Rights Movement Hear these four songs inspired by the Chicano movement and part of the The Library of Congress Celebrates the Songs of America collection
• Good Neighbors: Stories from Latin America in World War II Read a post by Victoria Giron on Stories from Latin America in World War II (Headlines and Heroes Blog: August 28, 2018).
• Immigration and Relocation in U.S. History Read the Immigration story of Mexican Americans provided by the Immigration and Relocation in U.S. History Exhibition.
• Mexican Agricultural Laborers See these 29 photographs of Mexican agricultural laborers in California by photographer Marjory Collins.
• Searching for My Family Read a post by poet Rachelle Linda Escamilla on Searching for Her Family (Four Corners of the World Blog: January 7, 2019).
• Viva la Causa! Dolores Huerta and Hispanic Heritage Month Read a post by Jennifer Davis on Dolores Huerta and Hispanic Heritage Month (In Custodia Legis Blog: October 3, 2018).

Staff in the Hispanic Reading Room can provide access to these books at the Library of Congress. If you cannot visit the Library in person, please contact us using Ask a Librarian for assistance. In many cases, you can also find these materials at your local library.

The following titles link to fuller bibliographic information in the Library of Congress Online Catalog. Links to additional online content are included when available.

The following external websites can be useful for expanding your research on the Bracero Program.

• Bracero History Archive (Website) External Part of the Bracero History Archive web presentation, this page provides a brief history of Bracero Program with history and resources
• The Bracero Program (Website) External Slideshow provided by the University of Northern Colorado with an overview history of the Bracero Program
• Bracero Program (Website) External Archive and resources on the Bracero Program provided UCLA's Labor Center
• Bracero Program Images (Website) External See a compile of images of the Bracero Program provided by the USCIS History Library.
• Depression, War, and Civil Rights (Website) External Part of the Hispanic Americans in Congress web presentation, this page provides a brief history of Bracero Program and the Great Depression.
• Lesson 2: Making A Living Topic 3: Agriculture External Learn more about the braceros working the sugar beet fields in North Dakota's Red River Valley. This historical article is provided by the North Dakota Studies.
• My Grandfather, The Bracero by Paola Alonso External The Bracero Program through the perspective of one participant, Evaristo Guerrero Sierra, as told by his granddaughter and author of this external article.

Stockton (vicinity), California. Mexican agricultural laborers arriving by train to help in the harvesting of beets. 1943 Library of Congress Prints and Photographs.

Marjory Collins, photographer. Stockton (vicinity), California. Mexican agricultural laborers arriving by train to help in the harvesting of beets. 1943. Library of Congress Prints and Photographs.

Marjory Collins, photographer. Stockton (vicinity), California. Mexican agricultural laborers topping sugar beets. 1943. Library of Congress Prints and Photographs.

Mexican workers recruited and brought to the Arkansas valley, Colorado, Nebraska and Minnesota by the FSA (Farm Security Administration)... 1943. Library of Congress Prints and Photographs Division.

Marjory Collins, photographer. Stockton (vicinity), California. Mexican agricultural laborers harvesting sugar beets. 1943. Library of Congress Prints and Photographs.

Earl Theisen, photographer. Cars entering the United States at the Mexican border. 1952. Library of Congress Prints and Photographs Division.

Bain News Service. Japanese on fruit farm, California. between 1910 and 1915. Library of Congress Prints and Photographs Division.

Dorothea Lange, photographer. Mexicans entering the United States. United States immigration station, El Paso, Texas. 1938. Library of Congress Prints and Photographs Division.

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• Next: 1946: Mendez v. Westminster >>
• Last Updated: Jul 3, 2024 11:51 AM
• URL: https://guides.loc.gov/latinx-civil-rights

• Open access
• Published: 04 September 2024

Targeting emotion dysregulation in depression: an intervention mapping protocol augmented by participatory action research

• Myungjoo Lee   ORCID: orcid.org/0000-0002-8301-7996 1 ,
• Han Choi   ORCID: orcid.org/0000-0003-0406-5605 2 &
• Young Tak Jo   ORCID: orcid.org/0000-0002-0561-2503 1  

BMC Psychiatry volume  24 , Article number:  595 ( 2024 ) Cite this article

Metrics details

Depression is a highly prevalent and often recurrent condition; however, treatment is not always accessible or effective in addressing abnormalities in emotional processing. Given the high prevalence of depression worldwide, identifying and mapping out effective and sustainable interventions is crucial. Emotion dysregulation in depression is not readily amenable to improvement due to the complex, time-dynamic nature of emotion; however, systematic planning frameworks for programs addressing behavioral changes can provide guidelines for the development of a rational intervention that tackles these difficulties. This study proposes an empirical and theoretical art-based emotion regulation (ER) intervention using an integrated approach that combines intervention mapping (IM) with participatory action research (PAR).

We used the IM protocol to identify strategies and develop an intervention for patients with major depressive disorder (MDD). As applied in this study, IM comprises six steps: (a) determining the need for new treatments and determinants of risk; (b) identifying changeable determinants and assigning specific intervention targets; (c) selecting strategies to improve ER across relevant theories and research disciplines; (d) creating a treatment program and refining it based on consultations with an advisory group; (e) developing the implementation plan and conducting a PAR study to pilot-test it; and (f) planning evaluation strategies and conducting a PAR study for feedback on the initial testing.

Following the steps of IM, we developed two frameworks for an art-based ER intervention: an individual and an integrative framework. The programs include four theory- and evidence-based ER strategies aimed mainly at decreasing depressive symptoms and improving ER in patients with MDD. We also developed a plan for evaluating the proposed intervention. Based on our preliminary PAR studies, the intervention was feasible and acceptable for adoption and implementation in primary care settings.

The application of IM incorporated with PAR has resulted in an intervention for improving ER in depression. While changing behavior is perceived as a challenging and elaborate task, this method can be useful in offering a clear structure for developing rational interventions. Further refinement is necessary through rigorous research.

Peer Review reports

Depression is a highly prevalent and often recurrent condition that severely impairs psychological functioning and quality of life. According to the Global Health Data Exchange, depression affects 3.8% of the world’s population and, as “a major contributor to the overall global burden of disease,” is associated with substantial societal and personal costs [ 1 , 2 ]. Due to its enormous impact on public health, the World Health Organization (WHO) predicts that depression will rank first among all causes of the burden of disease by 2030 [ 3 ]. As depression is frequently comorbid with other mental and physical disorders, it is particularly challenging to identify risk factors and develop effective interventions.

Depression is a disorder of emotion. Disordered affect is a hallmark of depressive episodes, characterized by complex but apparent abnormalities of emotional functioning [ 4 , 5 ]. Many factors may be associated with the disorder; however, its symptoms evidently indicate failures in emotional self-regulation [ 6 ]. Emotion regulation (ER) refers to an individual’s ability to modulate the intensity, frequency, and duration of emotional responses [ 7 , 8 ]. Decades of empirical research have shown that depression is associated with increases in unpleasant emotions and decreases in positive emotions [ 9 , 10 ]. It has been proposed that difficulties in ER in depression significantly contribute to dysfunctional emotions [ 10 , 11 ].

The complexity and time-dynamic nature of emotion make emotion dysregulation in depression particularly challenging to tackle. Most situations in daily life that evoke emotions are ambiguous. It remains unclear how patients can enhance their ER abilities in treatment [ 12 ]. Dysfunctional ER is a fundamental risk factor for the onset of depression and a range of psychiatric disorders [ 13 , 14 ]; however, the evidence base is diffuse and broad, as its mechanisms remain poorly specified [ 12 , 15 , 16 ]. Although some studies have developed psychological interventions to improve ER, research in this area remains limited [ 12 , 17 , 18 ]. Some have argued that teaching a wide range of ER strategies might not be effective in enhancing patients’ emotional functioning [ 12 , 17 ]. Of note, there is a lack of research on the use of art psychotherapy in this context.

An intervention mapping (IM) study systematically rooted in the evidence and theories of basic affective science is required to increase the likelihood of changing behaviors in ER. To target emotional dysregulation, a systematic, participatory, and integrated approach that benefits from efficient behavior change is crucial [ 19 ]. Accordingly, this study determines effective ways of enhancing patients’ ER capacities and developing an optimized art-based psychotherapy intervention for depression. For this purpose, we followed the standard IM protocol [ 20 ]. While developing a treatment may be time-consuming and burdensome, this study provides a straightforward, stepwise decision-making procedure. Along with its use of participatory action research (PAR), this study aims to benefit from the engagement of patients and mental health professionals in a collaborative manner. This type of collaboration is a practical and powerful tool for developing specialized interventions.

Intervention mapping protocol

This study mapped out the process of development based on IM, a program-planning framework. IM provides a step-by-step process for planning theory/evidence-based interventions from the needs to potential methods addressing those needs [ 20 , 21 ]. Since its development in the healthcare field in 1998, IM has been widely used and applications have emerged in other fields, including health promotion. It has been used to develop intervention programs to better target specific behaviors, including health, discrimination, and safety behaviors [ 22 ]. In particular, mental health researchers have largely applied the IM approach for either creating new interventions or adapting existing ones: strategies have been developed for the treatment and prevention of depression through IM, such as an internet-based intervention for postpartum depression [ 23 ], an online-coaching blended program for depression in middle-aged couples [ 24 ], a return-to-work intervention for depression [ 25 ], music therapy for depressive symptoms in young adults [ 26 ], and life-review therapy for depressive symptoms in nursing home residents [ 27 ]. The use of IM has proven to be a useful instrument for the development and optimization of treatments for depression that are tailored to different contexts and target populations.

Over the course of the development of the entire program, four perspectives characterizing IM are applied: (a) a participation approach that engages intended participants, allies, and implementers in program development, implementation, and evaluation; (b) a systems approach acknowledging that an intervention is an event occurring in a system that includes other factors influencing the intervention; (c) a multi-theory approach that stimulates the use of multiple theories; and (d) an ecological approach recognizing the relevance of social, physical, and political environmental conditions.

The IM protocol includes six core steps: (i) justifying the rationale for developing a new treatment; (ii) selecting targeted determinants and setting treatment goals; (iii) determining theoretical and empirical methods for behavior change; (iv) developing a treatment and program materials; (v) planning for adoption and implementation; and (vi) specifying the evaluation design [ 20 , 21 , 28 ]. The development process is cumulative: subsequent steps are based on completed tasks from the previous step. Figure  1 presents the six steps of IM. This article presents the details of our study methods and the results as the six steps of the IM process.

Overview of the intervention mapping (IM) process [ 20 ]

Steps 1–3 of IM: Literature review

To address Steps 1, 2, and 3, we conducted a literature review using PubMed, ProQuest, Scopus, PsycArticles, and Google Scholar. Search strategies were devised using subject headings such as “emotion regulation,” “depression,” “emotional psychopathology,” “emotion regulation therapy,” and “art psychotherapy” as appropriate for each database. Furthermore, the program planners identified and included additional free text words. Due to the heterogeneity of emotion-related processes, the search strategies for Steps 1–3 were broad [ 15 ]. Additionally, we conducted an inclusive literature review of relevant databases to identify articles related to art-based interventions for ER, limited to published articles in English. This literature study identified effective ER strategies for improving regulatory capacities in depression. We describe the theoretical details related to ER and ER strategies in the Results section.

Steps 4–6 of IM: Participatory action research combined

Steps 4–6 of IM occasionally incorporate further studies for pilot testing and refining the intervention under development. As such, our study added participatory components to the IM process. PAR is “a participatory and consensual approach towards investigating problems and developing plans to deal with them.” [ 29 ] PAR empowers research participants compared with other approaches, where study participants are often considered subjects who passively follow directions [ 30 ]. The involvement of patients, care providers, and health professionals in research design is increasingly recognized as an essential approach for improving the quality of primary care [ 31 ] and bridging the gap between research and health care [ 32 ]. Indeed, PAR has been applied in many fields and achieved successful results, particularly in the field of mental health [ 33 ].

In particular, patient involvement is a meaningful partnership with stakeholders, including patients, carers, and public stakeholders, who actively participate in improving healthcare practices [ 31 ]. Involvement can occur at different levels and commonly includes patient engagement and advisory boards [ 32 ]. We conducted participatory action studies to combine systematic studies with the development of practical treatments [ 33 ] and anticipated the benefits of experiential knowledge. Figure  2 elaborates on how we incorporated PAR in the IM framework. It also presents our strategies to address the IM protocol and the results from each step. As described in Fig.  2 , the PAR in this current study comprises three phases:(a) consultation with an advisory board; (b) initial testing of intervention; and (c) mixed methods feedback studies using focus group interviews and survey research.

Study procedure combined with PAR, strategies applied for each step, and results for each step

Noted. The figure specifies strategies to adopt in addressing the six steps of IM protocol and the actions for each step. It represents how IM can be applied and how it can augment its protocols through PAR. In the application of IM, this study relied on literature research and empirical studies: we conducted a literature study to address Steps 1–3 and combined the participatory action approach with IM methodology to address Steps 4–6

(a) PAR 1: Consultation with the advisory board

First, we established an advisory board that included a psychiatrist, an expert on methodology, a trained integrative medicine professional, and a professor in a graduate art psychotherapy program. The advisory board provided feedback at the individual level and comments during subsequent consultations. We engaged and managed the advisory board throughout Step 4, the intervention development process.

(b) PAR 2: Initial testing of intervention being developed 

In addition, we conducted a participatory action study to facilitate patient engagement and elicit their voices in a collaborative relationship with researchers. Based on voluntary participation, this study aimed to pretest art-based ER strategies and treatment designs. We conducted an art therapy program as part of routine inpatient therapeutic programs involving willing patients. The participants’ reports of their experiences during the sessions were obtained using structured questionnaires and unstructured interviews. For research purposes, we conducted a retrospective chart review for therapeutic sessions between February 2023 and February 2024. This review was approved by the Institutional Review Board of Kangdong Sacred Heart Hospital (IRB no. 2024–02-019) and exempted from requiring patients’ informed consent because it was part of a routine clinical practice.

(c) PAR 3: A mixed-method approach

In this study, we employed a mixed-methods approach to plan evaluation strategies by combining a quantitative online survey with focus group interviews. The primary aim of this study is to ensure that the intervention developed in Step 4 can be adopted and maintained over time. For this purpose, we are gathering feedback regarding the initial interventions from clinic staff, consisting of nurses and psychiatrists. This PAR study is currently ongoing and will last for four months. At the environmental level of the organization, the process will be managed to best leverage the intervention in primary care settings. This study was approved by the Institutional Review Board of Kangdong Sacred Heart Hospital (IRB no. 2023–12-002). PAR 2 and PAR 3 are currently being conducted; the results of those studies will be available after their completion.

This section focuses on the explanation of outputs obtained through the IM protocol. The details of the theoretical and empirical bases, designed frameworks, and strategies for the implementation and evaluation of the program are categorized into six steps:

Step 1. Needs and Logic for the Program

For the first step, we identified the target group and analyzed their determinants. This step included determining the rationale and need for a new art-based ER intervention for depression. The target population comprised patients diagnosed with major depressive disorder (MDD). Predefined behaviors targeted were core symptoms of major depression, namely, consistent depressed mood and anhedonia [ 6 ].

Theoretical evidence

Prior research has highlighted difficulties in ER contributing to the etiology and maintenance of numerous psychiatric symptoms, such as depression, chronic anxiety, post-traumatic stress disorder, eating disorders, and worry [ 15 , 34 , 35 , 36 , 37 , 38 , 39 , 40 ]. In particular, research on depression has emphasized that apparent failure to modulate emotions is a hallmark of this disorder [ 6 ] and has attempted to link it to emotional abnormalities in depression [ 10 , 11 ]. ER, which influences the onset, magnitude, and duration of emotional response [ 41 ], is a distinct and differentiated higher-order construct from emotion itself (i.e., fear, anxiety, and depression) at different levels of analysis (e.g., behavioral or neural) [ 42 , 43 ]. From this perspective, ER is an important determinant affecting lower-order factor variability, whereas emotion determines variance downwards in the lower-order indicators [ 42 ].

A literature review revealed that ER difficulties play a role in understanding psychological health in major depression. This suggests the importance of altering problematic patterns of emotional reactivity in depression and identifies emotion dysregulation as a determinant of the predefined target behaviors [ 17 , 44 , 45 , 46 , 47 ]. According to imaging studies utilizing functional magnetic resonance imaging (fMRI), functional abnormalities in specific neural systems support the processing of emotion and ER in patients with depressive disorders [ 6 ]. Moreover, decades of empirical evidence supports the notion that depressive symptoms, characterized by consistently elevated depressed mood and relatively low positive mood, are associated with difficulties in ER [ 9 , 10 , 16 ]. Our review allowed us to analyze and specify the determinants of depressive symptoms (Fig.  3 ). Without this analysis, it would be challenging for psychological treatments to address emotion dysregulation in MDD.

Summary of the determinants influencing symptoms of major depression

Needs assessment for a new intervention

Although emotion dysregulation is a critical target in psychological treatments, intervention research examining ER is limited [ 18 , 48 ]. Psychotherapeutic approaches, including cognitive-behavioral and acceptance-based behavioral treatments, have positive effects on overall ER, and studies suggest that these improvements may mediate further improvements for psychiatric outcomes [ 18 , 48 ]: examples include cognitive behavioral therapy approaches (CBT) [ 49 , 50 ], acceptance and commitment therapy (ACT) [ 51 ], dialectical behavioral therapy (DBT) [ 52 , 53 ], and acceptance-based behavioral therapy (ABBT) [ 54 ]. However, most research assessing treatment efficacy precludes making any decisions about clinical mechanisms essential for improving ER. This is because they examine the impact of non-ER-focused interventions or interventions to target ER as part of a comprehensive program [ 18 , 48 ]. Due to the multi-component nature of the interventions, the specific components contributing to changes in ER remains unclear and whether the changes underlie improvements in other distressing symptoms has not yet been clarified. Thus, efforts to identify and inform the development of interventions leading to adaptive ER based on these studies are limited.

At present, patients who have distress disorders, such as generalized anxiety disorder (GAD), MDD, and particularly GAD diagnosed along with comorbid depression, often fail to respond well or experience sufficient gains from treatments: however, the reason for their lack of response is unknown [ 17 , 55 ]. Between 50 and 80% of patients receiving interventions for emotional disorders achieve the status of “responder.” [ 17 ] Between 50 and 60% of GAD patients showed meaningful improvement in response to treatment with traditional CBT [ 55 ]. While ER-focused interventions, such as the Unified Protocol (UP) [ 56 ], Emotion Regulation Group Therapy (ERGT) [ 57 ], and enhanced CBT emphasizing ER [ 58 ] were found to be effective in improving ER, research investigating these remains limited [ 18 , 59 , 60 ]. No substantial changes were found in the essential dimensions of ER after the application of several ER-focused interventions, implying that these were not present in a sufficient dose to promote ER [ 53 , 61 , 62 ]. Further, recent research identifying treatment response predictors for ERGT showed relatively few significant predictors [ 63 ]. In particular, the findings from a study that examined a treatment designed to enhance inpatient CBT for depression suggest that the addition of ER skills to CBT may not sufficiently change ER, although improvements were noted in ER strategies and depressive symptoms [ 58 ]. Another problem arises from the manualized CBT protocols, which are distinct and complex to use [ 17 , 64 ]. These protocols make it difficult to access and use CBT.

The limitations of the current interventions suggest the need for developing an ER-specific treatment. Designing more effective and targeted interventions requires a specific understanding of affective science to provide a broad framework for ER treatments. For example, recently, it has been identified that emotions can be generated and regulated not only through a top-down process but also through a bottom-up process: [ 65 ] current models of emotion generation and its regulation are based on these two processes, which are opposed but interactive [ 66 ]. The top-down mechanism is based on a view that focuses on cognition, where either individuals’ goal states or cognitive evaluations are thought to influence the variations in their emotional responses [ 67 ]. These processes are mapped to prefrontal cortical areas. Meanwhile, bottom-up mechanisms refer to processes based on a stimuli-focused view: in this mode of processing, emotions are mostly elicited by perceptions [ 68 ]. In everyday life, emotion can be processed through interactions between the bottom-up and top-down mechanisms [ 69 ].

Most research to date, however, has focused on top-down ER strategies, and few studies have focused on bottom-up regulation procedures [ 65 ]. In particular, CBT-based treatments, which are mainstream psychotherapies, focus on instruction in an array of cognitive means of coping with emotions; CBT traditionally tends to deal more directly with cognitive rather than emotional processes. One top-down strategy is cognitive reappraisal, an active component of most CBT-based treatments [ 70 ]. However, studies suggest that relying primarily on this strategy may be less effective for certain disorders, including depression, than treatments employing a flexible approach [ 65 ]. Such an approach would be straightforward and essential for researchers as they synthesize different research results, such as findings concerning bottom-up ER and its clinical implications for the investigation of interventions.

One intervention approach to bottom-up experiential ER is art psychotherapy. This type of treatment, which targets emotion dysregulation, may hold promise for improving ER in cases of depression. Patients with depression can benefit from experiential ER that emphasizes bottom-up means of coping with their emotional experiences over the course of art-based ER intervention. This perspective is supported by behavioral and neurocognitive findings indicating difficulties in top-down regulatory processes in individuals with depression [ 71 , 72 , 73 , 74 ]. Research examining neural activities between individuals with and without depression indicated different patterns between them: when downregulating negative emotions, individuals with depression show bilateral prefrontal cortex (PFC) activation, whereas individuals without depression show left-lateralized activation [ 74 ]. When given an effortful reappraisal task, moreover, the relationship patterns of individuals with depression between activation in the left ventrolateral PFC and the amygdala are different from those of individuals without depression. These findings indicate that the pathophysiology of depression underlies struggles of downregulation [ 74 ].

Thus, it is vital to design a new intervention for depression that focuses not only on top-down ER but also on bottom-up ER. In particular, this study examines art-based ER in the form of a client-centered and experiential psychotherapeutic approach allowing patients to attempt top-down and bottom-up regulation. While pursuing active engagement in art-based ER practices, patients can process their emotional experiences in a way that produces greater fine-tuning and depth. Art-based treatment is open and non-interventional as well as less demanding cognitively, enabling it to reach a diverse population with depressive symptoms. More promisingly, art-based ER primarily deals with visible and tangible works leading to visual representations. Emotional memory is perceptual [ 75 ], implying that art-based practices can influence its retrieval and manipulative process: the artworks that patients make in treatments are visual representations that are identical or similar to their emotional experiences. Importantly, creation involves colors, images, and spaces acting as new stimuli, allowing patients to manipulate and generate new emotions through a bottom-up process. As processes of emotion generation interact with those of ER [ 67 ], an art-based experiential approach can facilitate adaptive ER, potentially benefiting individuals who have emotional dysfunction.

However, few studies have explored ER in depression within the field of art psychotherapy [ 76 ]. The therapeutic strategies applied in relevant studies [ 77 , 78 , 79 ] are not explicitly identified or targeted with respect to the mechanisms of ER. For instance, earlier literature tested the effects of art therapy on ER in psychiatric disorders; most of these approaches focused on improving psychopathological symptoms related to specific disorders and considered ER to be a secondary therapeutic outcome. Thus, we identified a need to develop an effective art-based intervention specifically targeting emotion dysregulation in major depression.

Step 2: Formulation of change objectives

The second step required the specification of intervention goals, which involved moving from understanding what influences depressive symptoms, especially in terms of emotional abnormalities in depression, to clarifying what needs to be changed. Based on the needs assessment, the overall expected outcome was “a decrease in depressive symptoms and an improvement in ER.” In this process, the analysis of the determinants in Step 1 resulted in selecting key determinants to target, which were provided by a comprehensive review of the empirical literature and research evidence. It is difficult to understand generative and regulatory emotion processes that are enacted internally without the instigation of extrinsic stimuli [ 80 ]. Thus, it can be challenging to identify the right determinants to target and design an effective treatment that addresses problems related to ER. Based on our review, we determined and chose four important and changeable determinants and further divided them into five key determinants (see Table  1 ).

To apply IM, the construction of matrices of change consisting of performance and change objectives forms the basis for program development [ 20 , 81 ]. Overall, the program objectives were subdivided into performance objectives expected to be accomplished by the target group in the proposed intervention. While drawing on the key determinants and performance objectives, more general objectives, namely, change objectives, were formulated. The result of Step 2 is this change matrix, which further forms the basic factors for designing the intervention for major depression.

Step 3: Theory- and evidence-based strategies selection

In IM, Step 3 entails selecting theoretically grounded and evidence-based methods and strategies. For this process, we first conducted a comprehensive review of theories and empirical studies for therapeutic strategies, including the following characteristics: (i) they need to be confirmed as an efficient ER strategy based on empirical research evidence; (ii) they need to be effective not only in decreasing depressive symptoms but also in improving ER capacities of patients; and (iii) they can be translated into art-based practices. In iterations of reviewing theories related to and research evidence with regard to emotion regulatory strategies, we identified appropriate, theoretically sound therapeutic strategies for at least one program target.

Once an ER method was selected, we translated this method into art-based emotion regulation (ABER) strategies for practical applications. Practical applications refer to the practical translation of the chosen behavior change methods [ 19 , 20 , 21 , 81 ]. The end product of Step 3 is an initial set of theory- and evidence-based strategies selected and translated to address emotion dysregulation in major depression. Table 2  lists the strategies with supporting evidence and applications: art-based distraction, art-based positive rumination, art-based self-distancing (SD), and art-based acceptance. Based on an integrative view of emotional processing, which posits interactions between top-down and bottom-up systems [ 67 , 69 , 82 , 83 ], these strategies aim to modulate emotions through the use of top-down and bottom-up mechanisms.

In particular, as art-based ER involves visual-spatial processing that could exert influence as new sets of stimuli, this approach could lead to a more experiential bottom-up ER. For instance, distraction and cognitive defusion are usually considered cognitive forms of ER; however, both are translated and applied to art-based strategies. Individuals’ performance in art-based ER would differ from that on a given cognitive task, as their immersion experiences in the artistic and creative process involve the generation of colors, images, and spatial features, which may elicit new bottom-up processing. This may be associated with the superior ER effects of art-based distraction, as shown in some studies that compared the ER effects of artistic activities with those of non-artistic activities, such as completing verbal puzzles [ 98 , 99 , 100 ].

In addition, art-based SD promotes intuitive and experiential ER. Individuals are trained to adopt a self-distanced perspective in some treatments while reflecting on their emotions, such as mindfulness-based stress reduction (MBSR) and ERT. They meditate to take a decentered stance. Art-based SD may help those who have difficulty creating an internal distance. As individuals create visual forms of their inner feelings and thoughts, a spatially generated distance from the artworks representing their experiences allows them to adopt and maintain a more self-distanced perspective. As such, art-based SD is more intuitive but requires less mental energy. Importantly, this art-based experiential distancing may reconstrue individuals’ appraisals by facilitating a bottom-up mechanism.

Step 4: Program development

Step 4 concerns creating an actual program plan, leading to the ABER intervention model proposed in the current study. The intervention's elementary components, organization, and structure were created based on the findings of the preparation steps (Steps 1–3). Once the list of therapeutic strategies and their practical applications was generated, we designed a structured intervention framework that would be feasible and realistic to deliver in primary care settings.

The intervention framework developed in Step 4 is based on the process model of ER [ 7 ], supported by considerable empirical research [ 101 , 102 , 103 ]. Based on the extended model, a series of steps involved in the process of regulation with different ER strategies are considered while designing the conceptual framework. Accordingly, the primary areas of the intervention involve emotion perception, attention, and cognition. We developed specific art-based ER strategies, focusing primarily on antecedent- rather than response-focused regulation. Further, this intervention is meant to complement the process model in a framework that is designed to apply one or more strategies in a single session: this would be ideal for improving ER in real life, as current research on ER has found that people generally try multiple strategies simultaneously [ 104 ], whereas the process model examines a within-situation context, within which a single ER strategy is utilized [ 12 ]. In addition, we find that this treatment will be effective in improving ER as it attempts both top-down and bottom-up ER: actively engaging in artworks through the use of the body, a patient can apply experiential self-focus [ 64 ]. In treatment with art-making, patients can be provided with sufficient time and space to find personal meaning in their experiences and process emotions, which enables them to achieve change.

Table 3 presents an overview of the proposed intervention frameworks. As shown, we designed two frameworks to guide the intervention: an individual framework for short-term intervention and an integrative framework for long-term intervention. Each style of the ABER model draws on a different implementation design to build the framework, and each model has slightly different aims. In Step 4, the advisory board reviewed the draft frameworks, including the determinants, performance and change objectives, and therapeutic strategies. The advisory board acted as a support group throughout the review process, helping tailor the program to the target population. In response to the board’s reviews, supplementary resources were added.

Individual framework

First, a plan for an individual framework was devised that accounted for the scope and phase of a short-term intervention. As shown in Fig.  4 , this framework focuses on producing initial or short-term behavioral changes pertaining to achieving short-term clinical efficacy. That is, the individual model does not aim only at emotional changes in patients, such as increases or decreases in specific emotions. The therapeutic aim is not set in an emotion-specific manner, but in terms of effectiveness, it relates to the use of regulatory strategies [ 105 ]. Accordingly, an expected outcome is to increase the quantity and frequency of adaptive ER strategies. Patients are trained in rudimentary ER skills, including one or several combination ABER strategies, as designed in the previous step. These practices aim to enhance attentional, followed by cognitive control. The expected duration of individual sessions is around 1–1.5 h.

Individual intervention model diagram. Noted. The panel shows the individual intervention model in an inpatient setting as an example: each patient (patient i ) has a different time of admission (t 0 ) and inpatient discharge (t d ). Thus, the number of participating patients can differ per session. During the hospital stay, patients are trained in rudimentary emotion regulation (ER) skills, including one or a combination of several art-based ER strategies (aber i ). The application of the therapeutic strategies is flexible: it depends on the patient’s cognitive functions, depressive symptoms, and severity of the symptoms. The time of inpatient discharge (t d ) affects each patient’s treatment duration

Integrative framework

While an individual framework comprises a single phase, an integrative framework includes stepwise sequential phases. In addition to skill development in the individual treatment, three phases of the integrative model are designed to foster adaptive motivational responses and cognitive-behavioral flexibility, which enables patients to achieve greater emotional clarity [ 106 ]. In the integrative treatment, all three phases are performed for 6–12 weeks.

The first phase of the integrative model begins with psychoeducation, in which the patient is taught the concept of ER and the importance of identifying his or her habitual reactions, such as in terms of rumination and dampening [ 91 ], that have characterized his or her life. This therapeutic process is important because ER is an automatic process requiring the consideration of motivation [ 107 ]. Psychoeducation regarding ER and monitoring patients’ responses to emotional experiences precede the skill development procedure. For instance, for patients’ self-monitoring, retrospective self-report questionnaires can capture data on ER skill use. While these methodologies are easy to use and cost-efficient [ 108 ], they are demanding tools for use in capturing natural fluctuating patterns in ER [ 109 ]. As an alternative, ecological momentary assessment can be used in treatment to capture situational context and adaptiveness of the skill use [ 108 ]. In addition to patients’ self-monitoring, a psychotherapist should monitor their emotional responses during and between therapy sessions: psychotherapists function as human raters. Because self-monitoring may not be feasible for all patients, assessing the typical patterns with which patients use maladaptive emotion regulatory strategies is important. Specifically, therapists need to assess a patient’s ER repertoire: the quantity of ER strategies, the frequency of strategy use, and how the patient’s strategy use changes.

The second phase entails adopting and implementing ER strategies with processes resembling those of the individual model. These processes entail the selection and repetition of adaptive strategies. They differ from the individual model in that the duration of Phase II can vary from one patient to another depending on the severity of depressive symptoms and the frequency of maladaptive strategies used. The ER practices delivered in Phase II are art-based tasks through which therapists and patients explore and try adaptive strategies. As shown in Fig.  5 , the intervention program includes four ABER strategies selected and translated in Step 3: art-based distraction, art-based SD, art-based positive rumination, and art-based acceptance. The patients work with therapists in 4–8 1.5-h sessions to engage in art-based practices.

Summary steps and components for the integrative intervention model

Finally, the integrative framework includes a third phase for evaluation. While the previous sessions in Phase II focus on skill development, the sessions in Phase III focus on assessing changes in patients. All individual progress in ER is tracked and monitored. In this task, therapists help patients assess changes in their emotion-regulatory skill use and their achievements in terms of self-perception, effectiveness, and adaptiveness. Patients are given opportunities to take a broad view of the changes in their artworks during all treatment phases. Furthermore, patients receive a few tasks as homework to briefly review their strategy use in daily life from the beginning of the treatment until the current moment. The review process helps them assess their progress and supports their strengthening. It takes 6–12 weeks to complete the integrative treatment course, depending on the clinical impression. For instance, the duration of Phase II is expected to take 4–8 weeks, according to the clinical impression. A therapist or clinician renders his or her impression regarding the degree of the patients’ severity of depressive symptoms, use of maladaptive ER strategies, willingness to participate in the intervention, and insight into their treatment.

Step 5: Adoption and implementation

Implementation is an essential aspect of program development. In Step 5 of IM, the focus is on planning the adoption and implementation of the proposed intervention. This process is required at the environmental level [ 21 ] and ensures successful adoption and sustainable use in collaborating organizations. Thus, pilot tests can be conducted to gain practical insights into implementation decisions and refine the intervention. Using a PAR framework, we pilot-tested the individual model to ensure that the intervention is appropriate and helpful for patients. This PAR pilot study was performed to inform future practices while connecting intervention research with actual action in a primary care setting.

The advisory group’s results, which indicated that the intervention needed to be sufficiently pliable to be used in a variety of primary care settings, informed and supported the step for pretesting. Implementation was prepared in a primary care setting, in which the program was pretested with a steering group of psychiatrists, nurses, and an art psychotherapist. Two clinicians were in charge of informing the intervention program and facilitating patient involvement. The therapist, who had received appropriate training and instruction, was responsible for delivering the intervention and supporting all practical aspects of patient engagement. With support from the therapist, the patients were in charge of applying one or a combination of two strategies in therapeutic sessions.

We performed this initial testing in a psychiatric ward in Seoul. Between February 2023 and February 2024, during the first two phases of the pilot testing, approximately 24 sessions were conducted, and 45 inpatients, including 16 patients with depressive disorders, voluntarily participated in the program. At the end of each session, the participants were asked to report their experiences through free narratives and complete a short questionnaire survey (quantitative and free-text comments) that provided additional information regarding their involvement. The mean time expenditure for the patients was 1.1 h (SD: 18.0; range: 0.5–2). Patients’ emotional experiences were reflected in their artworks, and Fig.  6 shows a short overview of their art products. The detailed findings from these pilot trials are outside the scope of the IM protocol and will be available in a future publication.

Examples of the art products of the participating patients with depression. Noted. Figure 6 briefly outlines patient engagement through their artworks made during the treatment sessions in the first pilot phase: a shows an artwork a patient made in a treatment session, which applied art-based acceptance; b shows an artwork showing a patient’s reflection on his experience, which applied art-based self-distancing and acceptance; c and d show artworks in which patients apply art-based positive rumination and distraction. Different art materials were provided in each session depending on the ER strategies used. The art-based practices of ER promoted relaxation and expression of the patient’s inner feelings and thoughts

Step 6. Evaluation plan

The sixth step of IM is the planning of evaluation strategies to assess the potential impacts of the proposed intervention [ 20 ]. For this purpose, we designed two phases based on a PAR framework: patient feedback and expert feedback. The rationale for this plan was that comprehensive evaluations could investigate the necessity of refinement and what is needed to produce a more feasible and effective intervention. In particular, we expected that the engagement of patients as well as health professionals in the evaluation process would integrate the organizational perspective into patient-oriented quality improvements. From these two phases, we developed questions and measures for evaluation, conducting preliminary PAR studies to determine the feasibility and efficacy of the complete program. Table 4 presents the evaluation strategies for gaining patient and expert feedback. Meanwhile, Table  5 presents an overview and timeline of PAR 2 and PAR 3.

First, we developed a set of patient-reported outcome measures to obtain patient feedback. Quantitative assessments of treatment satisfaction, perceived helpfulness of treatment, and perceived difficulty were conducted following the end of a therapeutic session. Patient evaluations must be carried out regularly during treatment to assess the efficacy of the integrative model. At the end of the program, unstructured or semi-structured interviews are recommended to explore patients’ experiences of the treatment process. In addition, we planned a two-phase mixed-methods study to obtain feedback from participating healthcare professionals using an online survey and focus group interviews. The assessments included process measures, such as perceived difficulty, program appropriateness, and recommendations for improvements to its implementation on a professional level. A web-based survey was disseminated among clinicians and nurses to assess the feasibility of the intervention. Together, this enabled us to increase the time efficiency and cost-effectiveness of the evaluation process.

Feasibility was assessed in five ways. First, the feasibility with which patients participated in the program was described. In our preliminary study, for instance, we calculated the percentage of patients approached for program participation relative to those who did not. Second, the feasibility of retaining patients in a treatment session was reported. To capture the feasibility of retention in treatment, we calculated the percentage of patients who failed to complete treatment compared with the percentage of those who completed it. Third, the feasibility of administering treatment was measured with a self-reported survey of patients’ perceived difficulty in participation and a survey of healthcare professionals’ perceived difficulty in implementation. To report the feasibility of administering treatment, we calculated the mean hours a patient spent in completing treatment. In addition to feasibility, acceptability was operationalized in three ways: a quantitative self-report survey of patient satisfaction, patient perceptions of helpfulness of treatment, and patient willingness to recommend program participation were used. In our preliminary study, we developed responses for the patient survey and calculated the means and standard deviations for each item.

We received patient feedback in the first two pilot phases (PAR 2), and the results showed that the intervention program was feasible and acceptable for implementation in the primary care setting (the mean scores were as follows: Treatment satisfaction = 4.82, Perceived helpfulness of treatment = 4.57, Perceived difficulty = 4.45). The patients provided further recommendations for improved intervention in free-text comments. In addition to this patient feedback, we began conducting PAR3 in February 2024. The feedback research is being conducted through an online questionnaire that includes multiple-choice questions and open-ended questions, with focus group interviews being conducted virtually through Zoom. The results for PAR 2 and PAR 3 will be reported in separate articles.

In this paper, we proposed conceptual frameworks for an intervention that targets emotion dysregulation in depression. IM was used as the conceptual protocol to develop the intervention. To the best of our knowledge, this is the first art-based ER intervention incorporating previous theories, research evidence, and review data in relation to affective science and intervention research, combining PAR components with IM. We developed the intervention following the rationale and stepwise process of IM, which identifies theory- and evidence-based strategies to address key barriers to ER. In addition, to evaluate the developed intervention, preliminary PAR studies were conducted, including the acceptability of the trials and the ABER intervention to patients; the rate of recruitment, attendance, and attrition; perceived difficulties in intervention implementation; and psychological outcomes. Consequently, the intervention is theoretically underpinned and supported by empirical evidence regarding ER and the results of our pilot studies.

The current study benefits from integrating the PAR approach into the IM framework in two ways. First, using PAR studies in the IM resulted in the cogeneration of knowledge among academic researchers, implementers, and the intended participants. PAR ensured experiential knowledge to deliver content that addressed difficulties in ER in collaborative partnerships. Another contribution was enhancing the feasibility and acceptability of the proposed intervention. In particular, preliminary PAR studies helped investigate whether modifications were needed before the intervention’s adoption. Even though IM is a time-consuming process, the use of PAR made it more cost-effective and time-efficient.

In addition to these strengths, it is crucial to acknowledge and affirm the study’s limitations. First, the current study offers only preliminary evidence for the given conceptual framework. Although the proposed intervention may precisely target emotional dysfunction in depression, such as in the restrictive use of adaptive ER skills with repetitive use of maladaptive strategies, the integrative and individual frameworks of ABER have not been evaluated through randomized clinical trials. As the current study pilot-tested the intervention in an inpatient setting that served an acute, transdiagnostic population, implementers could extend the use of these frameworks by performing a fine-grained analysis of treatment contexts (e.g., by adapting the model for depressed outpatients in primary care). As such, the intervention must be examined and refined on the basis of the results of empirical studies on multidisciplinary design. In addition, this article did not examine the therapists’ capability of delivering treatment, fidelity of implementation, and feasibility of measuring tools. Intervention researchers interested in these variables are encouraged to extend our models by testing the broad contextual variables that influence its process. Similarly, further research is required to investigate standardized forms of assessment in treatment (e.g., a measurable rating scale for patient monitoring) to increase the efficiency of the intervention.

Conclusions

This article proposes empirical and theoretical intervention frameworks that can improve ER in depression. This IM study is unique, as the development process incorporates PAR components. Moreover, the intervention consists of four art-based regulatory strategies that enrich the present literature on intervention research targeting dysfunctional ER in major depression. Our participatory action studies demonstrate that, in a primary care setting, the individual protocol is feasible and acceptable for implementation. This result represents a potential step forward toward filling a gap in current mental health treatments for patients with MDD. Despite the tiresome and time-consuming process of intervention development, the application of IM augmented by PAR is helpful in optimizing chances for an effective behavior change. Further testing is required to assess the impact of the therapeutic program proposed in this study.

Availability of data and materials

The author confirms that the data generated or analysed during this study are included in this published article: however, raw datasets are not publicly available due to local legal restrictions. Since the data being generated by PAR2 and PAR3 are outside the scope of the current intervention mapping study, they are available elsewhere.

Abbreviations

Art-based emotion regulation

Cognitive-behavioral therapy

• Emotion regulation

Emotion Regulation Group Therapy

Generalized anxiety disorder

• Intervention mapping

Mindfulness-based stress reduction

Major depressive disorder

• Participatory action research

The Self-Assessment Manikin

Self-distancing

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The present researchers express their gratitude to the Kangdong Sacred Heart Hospital for its help and support in this research. Appreciation is also extended to all participating patients, clinicians, health care professionals, and the advisory board in all steps of the development. There are no individuals or funding organizations, other than the co-authors, who contributed directly or indirectly to this article.

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ML contributed to plan and design the study with support from the rest of the study team. YT registered the trial. ML collected, and analyzed participant data. ML drafted and edited the manuscript. All authors reviewed and/or approved the final manuscript for submission.

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Lee, M., Choi, H. & Jo, Y.T. Targeting emotion dysregulation in depression: an intervention mapping protocol augmented by participatory action research. BMC Psychiatry 24 , 595 (2024). https://doi.org/10.1186/s12888-024-06045-y

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Researchers in London, Ont., say they were able to detect awareness in a comatose patient with a brain injury — a finding that could significantly impact patient care.

Karnig Kazazian, a research associate at Lawson Health Research Institute and the London Health Sciences Centre, says a neuroimaging technique was used to shine a light into three patients’ brains to find activity in response to different commands.

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The patients had already been deemed clinically unresponsive, meaning they had not reacted when asked to give a thumbs up, wiggle their toes or open and close their eyes.

But Kazazian says one of the patients showed significant neurological activity in the correct part of the brain when they were asked to imagine playing tennis.

He says the finding, published recently in The Proceedings of the National Academy of Sciences journal, builds on previous research that suggests 15 per cent of comatose patients have some cognitive awareness even if they appear unresponsive.

Kazazian says the technology should be made available to intensive care units across the country, as it could help doctors and family members make decisions about whether to continue aggressive care if the patient shows signs of awareness.

“By showing that some patients might still be ‘in there’ despite behaviourally showing no signs, you can imagine that this would really greatly influence that decision of whether or not you stay on life support or transition to passing away peacefully,” said Kazazian, who was co-lead author of the study.

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The researchers also saw activity in the part of the patient’s brain responsible for processing auditory information when they played “complex stories.”

But the task of imagining playing a game of tennis — a test the researchers repeated five times — was the most telling sign of awareness, Kazazian said.

It triggered activity in the patient’s premotor cortex — the part of the brain that imagines movement.

“Previous work from our group has shown that you have to be conscious in order to imagine playing tennis. You have to be ‘in there’ because that’s not something that you just automatically do without any awareness,” Kazazian said.

In a less robust response, another unresponsive patient appeared to have the ability to passively perceive speech, the study found. A third patient showed no response to any of the task commands.

The light technology, called functional near infrared spectroscopy (fNIRS), shines light into the brain.

“More light absorption means more brain activity,” he said.

Before using fNIRS on the three comatose patients, the researchers tested it on more than 100 healthy participants to determine what tasks and commands were most effective at eliciting brain activity.

More research is needed with more patients to determine whether or not the brain activity detected is associated with a patient’s prognosis, Kazazian said.

His research group is in the midst of doing that with ICU patients whose families give consent.

The team will also study whether or not the fNIRS technology can be used to communicate with patients while they are comatose, Kazazian said.

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• v.14; 2019 Jun

Study reporting guidelines: How valid are they?

Associated data.

Reporting guidelines help improve the reporting of specific study designs, and clear guidance on the best approaches for developing guidelines is available. The methodological strength, or validation of guidelines is however unclear. This article explores what validation of reporting guidelines might involve, and whether this has been conducted for key reporting guidelines.

1. Introduction

Comprehensive reporting can reduce reporting bias, enable informed decision making in clinical practice, limit duplication of effort and inform subsequent research [ 1 ]. The quality of reporting of research activity continues to be inadequate, presenting readers with difficulties in judging the reliability of research findings, or how best to interpret results for individual settings [ 2 , 3 ].

Reporting guidelines have been developed to help improve the reporting of specific study designs. If followed by authors this should enable users to understand the design, conduct and analysis of the research, to critically appraise and review the findings and interpret the conclusions appropriately [ 4 ].

A guideline is a checklist, diagram or explicit text which guides authors in reporting research, and should be developed using explicit methodology [ 2 ]. Many already exist, mostly as checklists, and clear guidance, including a checklist of recommended steps, for developing such tools is available [ 2 ].

2. Use of guidelines

A search of the websites of five leading medical and health research journals (BMJ, Journal of the American Medical Association (JAMA), Lancet, New England Journal of Medicine (NEJM) and BMC Trials) identified the reporting guidelines included in the journals’ instructions to authors. These journals were purposively sampled as they: are prominent in the publication of a wide range of research topics and study designs; each publish significant volumes of research over a 3-month period (RCT publication rate, range 1–10 per month; 4–31 per quarter); and represent a range of impact factors (Range: 2.067 to 79.258).

All five journals require the use of the CONSORT reporting guidelines for randomised controlled trial (RCT) manuscripts. For RCTs, the BMJ also specifically recommend use of the TIDieR checklist to ensure accurate and complete reporting of a trial intervention [ 5 ]. BMC Trials, BMJ, JAMA and Lancet promote the use of reporting guidelines for other study designs and refer authors to the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network database of reporting guidelines [ 6 ].

The EQUATOR Network is an international multidisciplinary group that promotes transparent and accurate health research reporting through use of reporting guidelines. The network provides access to a comprehensive range of such guidelines in a searchable database ( http://www.equator-network.org ). However, there is evidence that simply having reporting guidelines, even with journal endorsement of their use, is insufficient [ 7 ].

The EQUATOR Network takes an inclusive approach and are clear that there is no indication of methodological strength, or validation of the guidelines listed. The reporting guidelines for the main study types, such as CONSORT for RCTs, STROBE for observational studies, and STARD for diagnostic/prognostic studies, are highlighted on the front page of the EQUATOR Network website. We decided to explore what validation of reporting guidelines might involve.

3. Validation

Validation is ‘the action of checking or proving the validity or accuracy of something’ [ 8 ] principles already well established in the development of health care and research documentation.

In the UK the National Institute for Health and Care Excellence (NICE) requires validation of guidelines designed to inform decisions in health, public health and social care ( https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance ). As a minimum, validation comprises stakeholder review, with fieldwork to trial implementation and discussions with service users, with external review also included if warranted, for example for guidelines in complex or sensitive areas ( https://www.nice.org.uk/process/pmg20/chapter/the-validation-process-for-draft-guidelines-and-dealing-with-stakeholder-comments ).

A number of initiatives provide standards for the development and validation of patient reported outcome measures (PROMs) for research [ [9] , [10] , [11] ]. This includes identifying the scope and focus of the measure, reviewing literature, engaging relevant stakeholders, and consensus assessment. Guidance for the development of health research reporting guidelines suggests similar features to those used for PROMs: 1) Literature review; 2) Delphi process; 3) Identification of key items; 4) Meeting with collaborators; 5) Iterative revision and review; 6) Pilot testing, all of which are derived from the authors’ comprehensive experience in the development of reporting guidelines [ 2 ]. While there are many similarities in the proposed activities for the development of PROMs and reporting guidelines, unlike PROMS, methods of validation of reporting guidelines are not explicitly mentioned.

In 2016 we conducted a systematic literature search using MEDLINE to identify validation methods commonly used for PROMs. Search strategies are provided in Supplementary Document 1. Our pre-defined inclusion criteria were for studies: focused on PROMs; detailing a validation method; references other publications regarding validation. Two authors independently screened the search results against the inclusion criteria, identified 73 relevant papers. Details of the included papers are provided in Supplementary Document 2. Data on PROM type, validation method, and if this was noted as a strength or limitation were extracted and a summary of the validation methods identified is detailed in Table 1 , Table 2 .

Types of validation method used for PROMS development.

Combinations of validation methods used for PROMS development.

By far the most common method of validation was use of statistical testing either as a single validation method or in combination with other methods. The most common combination was statistical testing in conjunction with comparison with similar measures. This corresponds to guidance published in 2011 which indicates that comparison and correlation with similar, existing measures is critical in the development of PROMS [ 10 ].

4. Are reporting guidelines validated?

Having established the methods of validation, we went on to see which had been used in the reporting guidelines highlighted on the EQUATOR Network homepage.

We conducted a literature search in 2018 to identify papers reporting the development of guidelines for the main study types as highlighted on the EQUATOR network website. Two researchers independently extracted information about the development and validation methods reported; disagreements were resolved through discussion. We excluded papers where content analysis was the sole measure used, as this was not explicitly identified as a validation activity. The results are summarised in Table 3 .

Validation methods used in reporting guidelines for main study types.

The methods described within the papers matched the principles outlined in the guidance for the development of health research reporting guidelines [ 2 ]. While some guideline developers utilised multiple components and others were more selective, we believe the overarching principles remained. In the absence of clear statements, a pragmatic interpretation would say, for example, that evidence synthesis requires a literature review, and having done a literature review, or convened a stakeholder meeting, it can be supposed that validation methods were used. Of note here, is that although following the key principles, this activity is not noted as being ‘validation’. This could account for why this term is not, used in the context of promoting the use of reporting guidelines.

5. Discussion

Reporting guidelines, are available for a wide range of health care research methodologies [ 6 ]. Many journals request their use to increase transparent research reporting, however mandated use is rare, despite evidence that reporting guidelines can have a positive impact on completeness of reporting [ 7 , 21 ].

Validation is important to ensure the validity and accuracy of tools used within the conduct and reporting of research. Whilst the validation of PROMS is frequently reported, we have identified that while validation activities for reporting guidelines do occur, the activities are not always explicitly reported as such. This may occur because some validation activities are also part of the development process, for example a consensus exercise. Reporting of the development of future reporting guidelines for research, may benefit from clearly identifying the work undertaken to ensure the accuracy of the guidelines proposed. This could be within a ‘Validation’ section of a guideline publication or by simple use of the words ‘validated/validation’ in the context of the activity being reported. For completeness of reporting, it may also be appropriate to request use of a development and validation checklist, for example that provided by Moher et al. {2}, where guideline development is reported.

The EQUATOR Network database currently contains around 406 reporting guidelines which cover a variety of research methodologies, many either specialised or narrow in scope. It is unclear how many of these included validation activities in their development, and we have not been able to identify any post development or publication validation work from our literature search. Ensuring validation activities are not only undertaken but also clearly reported could add weight to the value of reporting guidelines for both those promoting their use and those authoring papers. By understanding what validation looks like, we would suggest that journals and peer reviewers could be encouraged to mandate the use of validated checklists.

Despite being included as one of the elements for the development of health research reporting guidelines, it is surprising that a limited number of the guideline development papers used pilot testing prior to publication. Given that reporting guidelines are intended to ensure transparent reporting across similar research methodologies, pilot testing may be applicable to the development of reporting guidelines.

Although we used systematic review methods to identify and select papers, we acknowledge that some may have been missed, however any impact from missed papers is likely to be limited.

6. Conclusion

The reporting of guidelines while including details of their development, frequently fail to explicitly identify validation activities even when they have clearly been undertaken. While this may appear to be a semantic or even pedantic issue, emphasising that reporting guidelines have been validated could help encourage authors to use the guidelines, publishers and journals to mandate checklist submission with manuscripts, and peer reviewers to monitor accuracy of completion. An improvement in any, and ideally all, of these approaches would be beneficial in promoting high quality research and reducing research waste.

Conception and design: CA, AB.

Analysis and interpretation of data: CA, MN, SJ.

Drafting of the article: CA.

Critical revision for important intellectual content: AB, MN, SJ.

Conflicts of interest

CA, MN, SJ declare they have no conflicts of interest. AB is a member of the PRISMA-P group.

Appendix A Supplementary data to this article can be found online at https://doi.org/10.1016/j.conctc.2019.100343 .

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Appendix A. Supplementary data

The following are the Supplementary data to this article: