TO: Secretariat on Responsible Conduct of Research

DATE: January 25, 2017

RE: TCPS 2 (2014) - Proposed Revisions for Public Consultation ________________________________________________________________________

Dear Secretariat on Responsible Conduct of Research, In response to the call for public comments, Wilfrid Laurier University’s Research Ethics Board (REB) is pleased to provide feedback on the proposed revisions to the 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. Laurier’s REB welcomes the proposed revisions and has identified areas where further clarification is requested. Please find attached comments submitted on behalf of Laurier’s REB for your consideration. Thank you for providing us an opportunity to be involved in this process. Sincerely,

Robert Basso, PhD Rosemary A. McGowan, PhD, CAPM Chair, University Research Ethics Board Vice-Chair, University Research Ethics Board Wilfrid Laurier University Wilfrid Laurier University

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C O M M E N T S O N P R O P O S E D R E V I S I O N S T O T H E T C P S 2 ( 2 0 1 4 )

Please note, the line numbers used throughout refer to the line numbers presented in the ‘Proposed Revision of Tri-Council Policy Statement; Ethical Conduct for Research Involving Humans’ document.

Chapter 2. SCOPE AND APPROACH

Article 2.1, Application, lines 30-42: Laurier’s REB would like to offer support for this

section, as pilot studies still involve some level of risk and a proportionate approach

to review is appropriate. It would be helpful to include some further clarification on

other research activities not considered a part of pilot studies for the purposes of this

Policy.

Article 2.1, Application, line 34: Here, and throughout the document, it would be

helpful to operationally define risk.

Article 2.3, Application, lines 57- 69: We appreciate the additional clarification

regarding observational research and support the inclusion of this information.

Article 2.5A, lines 96-97: We would like to express concern with the addition of Article

2.5A. We are concerned that without any type of ethics oversight for these projects

outlined in the TCPS 2, participants such as “fellow students, family members, or

members of the general public…” may not be afforded any type of protection (e.g.,

publication of their data, disclosure of participant identities, etc.) Students involved in

course-based research activities are learning about the various elements of research

involving human subjects (e.g., research design, questionnaire/survey development,

participant interviewing or focus groups, data storage, etc.), and an important

element of this research process is developing an understanding that research

involving human participants involves an ethical component. By indicating that

“Institutions may decide…” the revised guidelines are really giving institutions

permission to have these course-based research studies exempt from any type of

review. As a result, the ethics review process would not be a part of a student’s

foundational understanding of the research process involving humans; due to this

lack of education and proportionate review, there is a danger of participants not

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being treated in an ethical manner, or with accordance to institutional policies.

Finally, if researchers wish to later use the course-based data for secondary use of

information, because there was no original consent form indicating that secondary

analysis may be conducted, participants will not have a say in how their data is used

in subsequent studies. For this reason, review at the departmental, faculty, or

equivalent level should be considered mandatory within institutions. Article 2.5A,

Application, lines 106-107: In concurrence with the previously stated concerns, rather

than stating that “Institutions may decide to review such activities…” this could state

that “Institutions must review such activities…” or “Institutions should review such

activities…”

Section B, Concepts of Risks and Potential Benefits, lines 139-145: We would like to

express support for acknowledging the special risks that may be associated with

research involving communities.

Section B, Concepts of Risks and Potential Benefits, lines 144-145: It would be helpful

to operationally define “benefit to the community.” To clarify, would this be “social,

behavioural, psychological, physical, or economic” as identified for risk? It is unclear

what benefits means in terms of the researcher’s responsibility/commitment to the

community.

Article 2.10, lines 150-236: We would like to express support for the addition of

guidance on research-attributable risks and research benefit misconception.

Article 2.11, Application, line 214: “…special efforts may be required…” It is very

important for researchers to distinguish between their dual roles and therefore we

suggest revising the wording from ‘may’ to ‘shall.’

Chapter 3. THE CONSENT PROCESS

Article 3.1, Application, lines 265-283: We appreciate the additional clarification that

recruitment is a part of the Consent process. However, this section currently notes:

“Recruitment may involve several stages of contact and screening that precede the

seeking of consent to participate in research.” It is important to provide additional

clarification here regarding medical information. That is, if researchers are collecting

personal medical information as a part of the screening process this should not

precede the seeking of consent.

Chapter 4. FAIRNESS AND EQUITY IN RESEARCH PARTICIPATION

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Article 4.8, Application, line 387: “For this reason, and based on respect for

participant expectations and protection of the public good, researchers, REBs and

institutions have an ethical responsibility to make reasonable efforts to publicly

disseminate research findings in a timely manner and without undue restriction”

Please provide clarification on the nature of the responsibility that REBs have to make

reasonable efforts to publicly disseminate research findings.

Article 4.8, Application, line 399: “All findings should be published.” Please provide

additional clarification regarding this statement as it is unclear what “all findings”

refers to as all is a very inclusive term.

Article 4.8, Application, line 409: We would like to offer support for anonymizing data

prior to sharing with peers. However, further consideration should be given to

qualitative data, as in this case de-identified data may be missing some context.

Further, it would be helpful to clarify what “making data available” is referring to in

this section.

Chapter 5. PRIVACY AND CONFIDENTIALITY

Article, 5.1, Application, line 451: “Researchers, REBs and institutions share the

responsibility for protecting participant confidentiality.” Clarity is requested regarding

what the legal implications for REBs are when breaches of confidentiality occur.

Chapter 6. GOVERNANCE OF RESEARCH ETHICS REVIEW

Article 6.4, Application, line 547: “At least two members should have the relevant

knowledge…” Please clarify, is this a recommendation or a requirement? For smaller

institutions or for very specialized areas of research, it may not be possible to fulfill

this requirement for each ‘area’ of research.

Article 6.12, Application, lines 628-629, 634-635, 642-652: As previously noted, the

exemption of course-based research activities from any type of review is a concern

and the removal of these lines should be reconsidered.

Chapter 7. CONFLICTS OF INTEREST

Section E. Community Conflicts of Interest, lines 767-768: It would be helpful to

provide additional clarification here regarding situations where the researcher is a

member of the community. Specifically, additional clarification regarding

considerations for participatory action research would be helpful.

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