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Dear colleagues,

Over the years there have been varying and inconsistent interpretations with respect to ethical practices when the Tri-Council Financial Monitoring Visit teams have come to institutions to do their audits.

Indeed, there is even a specific reference in the MOU at the end of item (f) in section 2.1, which states that "in any case, the research must maintain REB approval for the duration of the project". Click here to see "Schedule 2: Ethics Review of Research Involving Humans" of the MOU.

In light of this, I have requested an official interpretation from the Interagency Advisory Panel on Research Ethics (PRE) on when research ethics approval is indicated under the current TCPS.

As this will not be posted immediately on the PRE website, I wanted to share the response recently received from PRE on this important matter.

Regards,

Alex Karabanow
Ryerson University

Subject: 221_HAA_2010 - Response to your Request for Interpretation: Beginning and End of Requirement for REB Review

Dear Alex,

This is in response to your question of 3 May, 2010 in which you seek guidance on the stage in the research process at which initial research ethics board (REB) review would be required. You also inquire at what stage REB review would no longer be required. In your question, you refer to both the first edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998, as well as the revised draft TCPS of 2009. Further revisions to the 2009 draft TCPS are under way and a final version of the second edition is forthcoming this fall. In the meantime, the first edition remains the official version.

As you’ve indicated in your question, the first edition of the TCPS does not provide definitive guidance on when initial REB review would be required. The 2009 draft TCPS provides guidance in Article 6.11 that “Researchers shall submit their research project for REB review and approval of its ethical acceptability prior to the start of recruitment of research participants or access to data.” The same article clarifies that “REB review is not required for the initial exploratory phase involving contact with individuals or communities intended to establish research partnerships or the design of a research study.”

In your question, you inquire about the rationale for this allowance. You are correct in concluding that this could be because no “research participants” are involved at this early stage of the research. There are two rationales in the application of Article 6.11 of the 2009 draft TCPS: (i) One where no participants or potential research participants are involved at this early stage of the research “…research may at their initial stages not involve humans, but require, for example, engaging the research team, setting up equipment, and other preparatory stages. This may precede REB review.” (ii) Another rationale where it entails interaction with humans, such individuals are not considered “human participants” as defined in the TCPS, “some types of research using quantitative, qualitative research or a combination of these methods, as well as collaborative or community-based research…may entail prior contact or dialogue with individuals or communities of interest as a normal and integral component to establish research collaborations or partnerships prior to the actual design of the study.” A definition of “human participants” is provided in the application of the 2009 draft TCPS, Article 2.1, as “…those individuals whose data or responses to intervention, stimuli, or questions by the researcher are relevant to answering the research question”.

As for the stage at which REB review and approval would no longer be required, as you’ve noted, neither the TCPS first edition nor the 2009 draft TCPS make this definitive determination. The reason for not making this determination is that research projects, disciplines, or methods of study vary, and the involvement of humans as research participants in the research also varies. For the purposes of REB involvement, the end of the project involving human participants may be defined as the point after which there is no further contact between the researcher and participants. REB involvement would end at that point. This point might come, for example, at the end of data collection when the researcher has no intent of further contact with participants or after data analysis because some follow-up contact with participants may be needed or possible. In some cases, researchers undertake to report back to individuals, or to the community or group from whom they collected data. In these cases, contact with participants would only end once they have reported their findings in accordance with this undertaking. This would occur after data analysis, interpretation of the findings, and/or drafting of the research report. REB involvement would likely end at this point. These are only illustrative examples, and are not intended to be an exhaustive list of scenarios.

Institutions should develop policies that establish criteria to determine the end point at which REB review would no longer be required. Such policies should take into consideration the different types of research designs (short-time project, longitudinal research, research involving an Aboriginal community with reporting back requirements, etc.). Such policies and associated procedures should guide the REB, researchers, and the institution to determine at what point in the life-cycle of the project REB involvement is no longer required. This is consistent with the general guidance in the application of Article 6.14 of the 2009 draft TCPS that “For some types of research (e.g. qualitative research or longitudinal research), there may be some difficulty in establishing start or end dates. For these cases, the REB should work with researchers to determine a reasonable timeline for… determining the completion date depending on the discipline and method of study.”

We hope you will find this guidance helpful in facilitating the implementation of the TCPS within your institution.

Regards,

- Hanan

Hanan Abdel-Akher

Senior Policy Analyst, Secretariat on Research Ethics (SRE) ~ Analyste principale des politiques, Secrétariat en éthique de la recherche (SER)

Tel: (613) 996-2564 ~ Fax : (613) 996-7117 ~ Hanan.Abdel-Akher@pre.ethics.gc.ca

Navigating the ethics of human research ~ Piloter l'éthique de la recherche humaine