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Queen’s REB Guidelines for Remote and Electronic Consent

Version: 1.0

Date: June 07, 2024

© 2024, Queen’s University

This publication is protected by copyright and can be used in accordance with the Creative Commons CC BY-NC-SA license. This license permits distributing, remixing, adapting, and building upon the material in any medium in any format for non-commercial purposes only as long as attribution is given to Queen’s University. If the material is remixed, adapted, or built upon, the resulting material must be licensed in accordance with the Creative Commons CC By-NC-SA license or under identical terms.

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Queen’s University is situated on traditional Anishinaabe and Haudenosaunee Territory.

The purpose of this guideline is to:

• Provide clear guidance on the use of remote and electronic consent (eConsent) when designing a research study and performing consenting procedures.

Informed consent is one of the key ethical principles as outlined in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2), Chapter 3. Traditionally informed consent was conducted in person between a member(s) of the study team and the potential participant with a written informed consent form being signed by both parties to document the informed consent process. Over time new technologies and social norms have change the landscape of the consenting discussion.  Some research can now be conducted virtually, often via online platforms, and therefore the participant and the study team never meet in person during the study. This has meant that the consent process has had to change to adapt to new research methodologies. These changes include the use of remote consent.

Informed Consent

What is informed consent.

Per TCPS (2022) Article 3.2: The key to informed consent is that prospective participants understand the information being conveyed to them by researchers. Researchers and REBs should consider how best to convey that information to facilitate understanding. For example, written documentation may be supplemented with audio and/or visual aids or accompanied by video presentations.

Remote Consent

What is remote.

Remote consent is the process where obtaining consent occurs when the research team and the participant/substitute decision maker are not in the same physical location. Remote consent can be conducted with participants via virtual eConsent, telephone, conference call or video conferencing. Per TCPS 2, Article 3.12: eConsent may be done in person or remotely. Written consent is however in some instances mandatory (e.g per Health Canada regulation or the Civil Code Of Québec). There are other means of providing consent that are ethically acceptable. In some cultures, verbal consent maybe more appropriate. When other means of consent are used, the consent process should still be documented, for example by using a verbal consent log. In addition, it is recommended that a written letter of information with details about the study is given/sent to the participant for their records. Note that in some cases this may not be possible for research design, cultural or safety reasons.

Remote Consent via telephone or videoconferencing

Remote consent can also be conducted with participants via telephone or videoconferencing. When conducting the remote consent discussion over telephone or video conferencing the participant can either be provided with a letter of information that contains all the required elements prior the consent discussion or a verbal consent script containing all the required elements should be created and read to the participants during the consent discussion. This verbal consent process should be documented by the person conducting the consent discussion using a verbal consent log.

Electronic Consent (eConsent)

What is econsent.

eConsent is a form of remote consent. The eConsent method can include the use of multimedia, for example videos or interactive presentation) to develop an interactive and more flexible informed consent experience that is accessible for diverse learning styles.  Examples of eConsent methods include, but are not limited to:

• Videoconferencing/Telephone consent – Video consent using Queen’s approved platforms such as MS teams, Zoom. Telephone consent using a Queen’s telephone number.
• Pre-recorded videos – Visual and audio presentation of the study (this approach is not recommended by the Queen’s Research Ethics Office).
• Pre-recorded Audio – Voiceover of the consent document (this approach is recommended if used as an aid in interactive consent).
• Email Consent – Consent form/letter of information in written form is sent to the participant electronically, often via an online platform.

Use of eConsent methods and platforms will be reviewed by the REB on a case-by-case basis however any eConsent must contain all the required elements per the applicable consent template and the platform(s) being used must met all privacy and security requirements. In addition, the eConsent must be documented in a way that can be audited by the REB and any other regulatory authority.

NOTE: Any material that is being presented to the participant during the consent discussion needs to be submitted and approved by the REB.

Considerations in the use of remote consent via telephone or videoconferencing.

• During telephone or videoconferencing consent, participants should be given enough time to ask questions. The verbal consent script should include pauses and spaces for participants to ask questions.
• The consent discussion, over phone or video conferencing, should be conducted in a location that is quiet and allows for privacy for both the participant and the study team.  
• The participants should be provided with a written letter of information either prior to or directly after the consenting process. This can be sent via email (using a secured link) or regular mail.
• For regulated studies remote consent must follow all the regulatory requirements.
• For video conferencing Queen’s IT approves the use of Queen’s zoom and Microsoft teams. If you plan to use another platform they will be reviewed by the REB (and sometimes Queen’s IT)  on a case by case basis. If an online platform is used that is not supported by Queen’s IT, the researcher is recommended to undergo a security activation process (SAP) through IT. The researcher understands that they agree to the risk of using a non-approved platform.  
• The consent discussion should not be recorded.

Remote Consent via Email Contact

eConsent occurs when the consent form/letter of information in written form is sent to the participant electronically, often via an online platform, and they provide consent electronically.

For low-risk studies, such an anonymous survey, electronic consent can be completed using implied consent where a consent statement is presented to participants and they agree to participation without verbally speaking to someone.

For higher risk studies or for studies where the participant’s name is required to be associated with the consent an electronic signature should be used. Note that email is not a secure way for electronically signed consent to be sent as email communication can easily be intercepted. If a signed consent is being sent, then it must be encrypted and password protected. Queen’s OneDrive can be used to send signed electronic consents using the controlled permissions function.

Considerations in the use of Remote Consent via Email Contact

• The electronic consent form/letter of information must contain all the required elements as outlined in the applicable Queen’s consent template and must be compliant with all regulatory requirements.
• For Health Canada regulated studies the use of electronic consent is generally acceptable if all regulatory requirements are met. The system must be validated, the consent must contain all required elements and the consent must be sorted for 15 years per Health Canada regulations.
• Online platforms can be used if they meet the requirement listed above and they meet Queen’s privacy and security requirements.  At Queen’s two platforms are approved by IT for electronic consent Queen’s Qualtrics and RedCap. However other platforms may be used and will be reviewed by the REB (and in some cases IT) on a case-by-case basis. If an online platform is used that is not supported by Queen’s IT, the researcher is recommended to undergo a security activation process (SAP) through IT. The researcher understands that they agree to the risk of using a non-Queen’s approved platform.  More information about the SAP can be found here: https://www.queensu.ca/its/security-assessment-process.

Health Canada and US regulated studies and documenting consent

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Queen’s REB Guidelines on Remote and Econsent (PDF 135 KB)

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• Nettle-induced Urticaria Treatment Study (NUTS): demonstrating the joy of research through a randomised, blinded, placebo-controlled trial
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• http://orcid.org/0000-0001-6099-0948 Rajendra Raman ,
• Tom Beddis ,
• Paul Bonhomme ,
• Maggie Currer ,
• Daniel Day ,
• Chloe Haigh ,
• Elspeth Pitt ,
• Alexander Robertson ,
• Heather Robertson ,
• Bappa Roy ,
• Jennifer Wood
• Emergency Department, Victoria Hospital , NHS Fife , Kirkcaldy , UK
• Correspondence to Dr Rajendra Raman, Victoria Hospital, Emergency Department, NHS Fife, Kirkcaldy, UK; rajendra.raman{at}nhs.scot

The use of dock leaves to ease the discomfort of nettle stings is a well-known folk remedy in the British Isles, yet has never been tested in a clinical trial. A group of Emergency Department doctors designed and conducted the Nettle-induced Urticaria Treatment Study (NUTS) as a research training and team-building exercise to address this gap in the Emergency Medicine evidence base.

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https://doi.org/10.1136/emermed-2024-213915

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Introduction

The common nettle Urtica dioica is an abundant native plant in the British Isles. 1 Nettle stems and leaves are covered in trichomes, specialised stinging hairs with a brittle tip that snaps off when touched, exposing a sharp point through which a combination of bioactive substances (histamine, acetylcholine and serotonin) is injected into the skin. 2 3 Many thousands of people are probably stung by nettles every year in the UK, and while TOXBASE records no cases of severe or fatal poisoning, most people regard nettle stings as unpleasant and look for a remedy.

The use of broad-leaved dock Rumex obtusifolius to rub on nettle stings is a well-known folk remedy in the British Isles 4 . This practice is referenced by Chaucer ( Troilus and Criseyde : ‘Netle in, dokke out…’) so is at least 600 years old, and probably much older. No convincing biochemical mechanism has been suggested to explain why dock leaves help with nettle stings. It is possible that rubbing the area and/or the cooling effect of sap evaporating from a crushed leaf may be soothing; if so any large, fresh and non-toxic leaf would do the job, and dock may have become the leaf of choice simply because it grows in similar habitats to nettle ( online supplemental figure 1 ). 2

Supplemental material

To our knowledge the effect of dock on nettle stings has never been tested in a clinical trial. We conducted a research training and team-building exercise by designing the Nettle-induced Urticaria Treatment Study (NUTS), a randomised, double-blind, active placebo-controlled trial which follows in a long tradition of medical self-experimentation. 5

The participants were the authors of this paper, a group of healthy Emergency Department doctors. Each participant acted as their own control by having treatment applied to one of their arms and active placebo to the other.

Nettle stems of 30 cm with leaves attached were freshly harvested on the day of the study from one small area and confirmed to sting prior to the study. Stems were handled by the tip and base only, to avoid discharging trichomes prematurely.

Choice of placebo was considered at length. An appropriate active placebo (to mimic the physiological but not the therapeutic effect of the experimental intervention) 6 required a leaf of similar size, shape and texture to dock leaves, that was neither anti-inflammatory (eg, comfrey Simphytum spp) nor toxic (eg, foxglove Digitalis purpurea ). Thus, a domesticated plant of no known toxicity ( Lactuca sativa var. Longifolia – the sweet gem lettuce) was chosen.

Nettle stems were brushed ten times over demarcated areas of the flexor aspect of the participant’s right and left forearms simultaneously, two stems to each arm. The participant then applied a blindfold. After 60 seconds (to simulate the time it might take to find a dock leaf under field conditions) the participant rolled a die. If an odd number was rolled, dock leaf was applied to their right arm and active placebo to their left. For even numbers the arms were reversed.

Two dock leaves were rubbed on the designated intervention arm for 60 seconds, and two lettuce leaves rubbed on the placebo arm simultaneously. All leaves were then disposed of in an opaque bag, before the participant removed their blindfold. For consistency, one individual (not blindfolded) applied treatment and placebo to all study participants; the leaves were passed to this person in two identical bags, and she was unaware of which bag contained which leaf for each run of the experiment.

To assess blinding, after the 60 second treatment participants were asked which arm they thought was treated with dock and which with lettuce. Participants rated the discomfort felt in each arm at minutes 1–5, 10, 15 and 20 after stinging. The vague term ‘discomfort’ was used to integrate the varied sensations provoked by nettle stings, sometimes described as burning, itching, tingling or just ‘stinging’. Based on a single previous study of the sting of the nettle tree Dendrocnide moroides , 7 we asked participants to rate discomfort on a scale from 0 (‘no discomfort at all’) to 5 (‘the most discomfort you could imagine from a nettle sting’). This score was tracked until resolution of symptoms, and so was named the Insult to Complete Healing (ITCH) score.

The primary outcome was absolute reduction in ITCH score between minute 1 or 2 (whichever was greater) and minute 5 (3 minutes post-treatment). Secondary outcomes included absolute reduction in ITCH score at 10 and 20 minutes. We also recorded the Observable Urticaria / Count of Hives (OUCH) score as the total number of discrete wheals visible within the demarcated area at 5, 10, 15 and 20 minutes. Participants photographed their own forearms at these time points, and OUCH scores were counted at a later date by an observer blinded to treatment arm to determine peak OUCH and time to peak OUCH.

Nine individuals took part in the study, and all completed data collection.

Three participants correctly stated which arm had been treated with dock, three were incorrect, and three were completely unable to say, suggesting that participants were adequately blinded.

The median absolute reduction in ITCH score at 5 minutes was 3 points for dock vs 2 points for lettuce, which was not statistically significant ( figure 1 ; 2-tailed Paired Sign Test, p=1).

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Median ITCH scores at minute 1 or 2 (whichever was greater, representing maximum pre-treatment discomfort) and at minute 5 in dock and lettuce treated arms. Possible ITCH scores range from 0 (‘no discomfort at all’) to 5 (‘the most discomfort you could imagine from a nettle sting’).

For secondary outcomes ( figure 2 ) while there was a statistically significant decrease in ITCH score with time across both study arms, there was no significant difference between dock and lettuce arms.

Median ITCH scores at minute 1 or 2 (whichever was greater, representing maximum pre-treatment discomfort) and minutes 5, 10 and 20 in dock and lettuce treated arms. Two Way ANOVA, p=0.0056 for time, p=0.391 for treatment arm.

The median peak OUCH score was 27 in the dock arm and 20 in the lettuce arm, while the median time to peak OUCH was 5 minutes in both arms, neither of which were statistically significant ( online supplemental figures 2 and 3 ).

In this randomised trial on eighteen nettled forearms belonging to nine individuals, reduction in discomfort at 5 minutes was 1 point greater with dock than with lettuce.

Though representing a 16.7% difference in favour of dock, this was not statistically significant, and mirrored the difference of 1 point in the initial ITCH score.

We observed that the discomfort of nettle stings eased rapidly over 15–20 minutes in both the dock and the lettuce arms, but that the effect was not significantly different between the two interventions. It is possible that the same relief would have occurred with no treatment at all, and our study design does not permit us to conclude that either dock or lettuce is better than simply doing nothing. This was quite deliberate. Patient/Public Involvement work from other studies suggests that children in particular do not consider doing nothing to be an acceptable option when they are in pain, 8 and we feel this may well be applicable to nettle stings.

Limitations of our study include our small sample size, which was dictated by volunteer number and precluded any power calculation. Nonetheless, we believe this to be the first clinical trial of this ancient treatment, and a signal towards benefit in the primary outcome suggests that an appropriately powered superiority trial should follow. Alternatively, if a few other Emergency Department research teams were to replicate our design, a participant-level meta-analysis of multiple small studies could reach a statistically valid conclusion.

Ultimately, the goal of this study was to get our team talking about research in Emergency Medicine, providing a practical opportunity to explore concepts such as blinding, placebo choice and measurement while investigating a benign condition. We conclude that dock leaf may work for nettle stings, lettuce may be just as good, relief comes quickly either way, and research training in Emergency Medicine can be made extremely entertaining.

Ethics statements

Patient consent for publication.

Not applicable.

Ethics approval

No ethical approval was sought for this study. This was a team-building exercise in which all participants were willing volunteers who had previous lived experience of nettle stings and were thus aware of the risks of taking part.

Acknowledgments

We thank Dr Charlotte Beddis for assistance with statistical analyses and Dr Karin Purshouse for comments on the first draft of the manuscript.

• Wheeler KGR
• Ensikat H-J ,
• Wessely H ,
• Engeser M , et al
• Leo GS , et al
• Jensen JS ,
• Bielefeldt AØ ,
• Hróbjartsson A
• Christina Leung T-W ,
• Williams DH ,
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Supplementary materials

Supplementary data.

This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

• Data supplement 1
• Data supplement 2

Handling editor Edward Carlton

Contributors RR conceived the study. RR, TB, PB, MC, DD, CH, EP, AR, HR, BR and JW collaborated in the design of the study and participated in data collection. The manuscript was drafted by RR and edited and approved by all other authors.

Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

Competing interests None declared.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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In July 2023, the American Association for Cancer Research held the second Childhood Cancer Predisposition Workshop at which international experts in pediatric cancer predisposition met to update the previously published 2017 consensus statements on pediatric cancer predisposition syndromes. Since 2017, advances in tumor and germline genetic testing and increased understanding of cancer predisposition in pediatric cancer patients have led to significant changes in clinical care. Here, we provide an updated genetic counseling framework for pediatric oncology professionals. The framework includes: (1) referral indications and timing; (2) somatic and germline genetic testing options; (3) testing for adult-onset cancer predisposition syndromes in children with and without cancer; (4) evolving genetic counseling models to meet the increased demand for genetic testing; (5) barriers to cancer genetic testing and surveillance in children; and (6) psychosocial and equity considerations regarding cancer genetic testing and surveillance in children. Adaptable genetic counseling services are needed to provide support to pediatric oncology provider teams and diverse patients with pediatric cancer, cancer predisposition, and their families.

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Giant piezotronic effect in ferroelectric field effect transistor

• Research Article
• Published: 27 July 2024

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• Haiming Zhang 1 , 2 ,
• Mengshuang Chi 2 , 3 ,
• Shidai Tian 2 , 4 ,
• Tian Liang 1 , 2 ,
• Jitao Liu 2 , 3 ,
• Xiang Zhang 2 , 3 ,
• Lingyu Wan 1 ,
• Zhong Lin Wang 2 , 3 , 5 &
• Junyi Zhai 2 , 3  

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The piezotronics effect utilizes a piezopotential to modulate and control current in piezo-semiconductors. Ferroelectric materials, as a type of piezoelectric materials, possess piezoelectric coefficients that are significantly larger than those found in conventional piezoelectric materials. Here, we propose a strain modulated ferroelectric field-effect transistor (St-FeFET) utilizing external strain instead of gate voltage to achieve ferroelectric modulation, which eliminates the need for gate voltage. By applying a very small strain (0.01%), the St-FeFET can achieve a maximum on-off current ratio of 1250% and realizes a gauge factor (GF) of 1.19 × 10 6 , which is much higher than that of conventional strain sensors. This work proposes a new method for realizing highly sensitive strain sensors and presents innovative approaches to the operation methods of ferroelectric field-effect transistors as well as potential applications for coupling of strain sensors and various devices across different fields.

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Acknowledgements

This research was supported by the National Natural Science Foundation of China (No. 52192611), Beijing Municipal Natural Science Foundation (No. Z230024), and the Fundamental Research Funds for the Central Universities.

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Center on Nanoenergy Research, School of Physical Science & Technology, Guangxi University, Nanning, 530004, China

Haiming Zhang, Tian Liang & Lingyu Wan

Beijing Key Laboratory of Micro-Nano Energy and Sensor, Center for High-Entropy Energy and Systems, Beijing Institute of Nanoenergy and Nanosystems, Chinese Academy of Sciences, Beijing, 101400, China

Haiming Zhang, Mengshuang Chi, Shidai Tian, Tian Liang, Jitao Liu, Xiang Zhang, Zhong Lin Wang & Junyi Zhai

School of Nanoscience and Engineering, University of Chinese Academy of Science, Beijing, 100049, China

Mengshuang Chi, Jitao Liu, Xiang Zhang, Zhong Lin Wang & Junyi Zhai

School of Electronic Science and Engineering, University of Electronic Science and Technology of China, Chengdu, 610054, China

Shidai Tian

Georgia Institute of Technology, Atlanta, GA, 30332, USA

Zhong Lin Wang

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Correspondence to Lingyu Wan , Zhong Lin Wang or Junyi Zhai .

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Zhang, H., Chi, M., Tian, S. et al. Giant piezotronic effect in ferroelectric field effect transistor. Nano Res. (2024). https://doi.org/10.1007/s12274-024-6849-1

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Received : 20 May 2024

Revised : 28 June 2024

Accepted : 29 June 2024

Published : 27 July 2024

DOI : https://doi.org/10.1007/s12274-024-6849-1

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