1. Can the delegated review process applicable to minimal risk course-based research also apply to minimal risk undergraduate and graduate thesis research?
To fall within the delegated review of minimal risk course-based research activities (described in the Application of Article 6.12) , the intent of the activity should be primarily to provide students with exposure to their field of study (e.g., interviewing techniques), as part of their skill development. If such activities are used for the purposes of research they should be reviewed according to the regular institutional REB procedures. Theses involving human participants typically meet the TCPS 2 definition of research requiring REB review and should be reviewed by the REB following a proportionate approach outlined in Article 6.12. Regardless of the review strategy, the REB continues to be responsible for the ethical acceptability of research involving humans within its jurisdiction.
2. When does REB-approved research no longer require ongoing REB review?
TCPS 2 does not make a determination regarding the stage at which REB review and approval would no longer be required. The reason for not making this determination is that research projects, disciplines, or methods of study vary, and the duration of the involvement of humans as research participants 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, taking into account the risk of the research to participants. The end-point for REB involvement 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, in case some follow-up contact with participants is needed. In some cases, researchers report back to participants, or to the community or group from whom they collected data. In these cases, contact with participants would only end after data analysis, interpretation of findings, and dissemination. REB involvement would likely end at this point. These are only illustrative examples, and are not intended to be an exhaustive list of scenarios.
Institutional ethics policies should include provisions that assist REBs, researchers and the institution to determine when continuing research ethics review is no longer required. Such provisions should take into consideration the different types of research designs (short-term project, longitudinal research, research with reporting back requirements, etc.). They should also consider issues such as the extent of any remaining risk to participants, the nature of the plans (if any) for future interaction with participants; the status of any commitments or agreements made to participants, for example, with respect to reporting findings; and/or the relative likelihood of future unanticipated events, material incidental findings, or new information.
3. Continuing research ethics review: What if a researcher does not submit an annual report to the REB and continues to conduct research in the absence of a renewal of REB approval? Revised February 2016
The researcher’s failure to submit an annual status report means that the researcher would not be in compliance with TCPS 2 requirements regarding continuing ethics review (Article 6.14). At the time of its initial review of research, an REB determines the frequency of continuing ethics review (Article 6.14) and communicates it to the researcher. While an institution may put in place a system for notifying its researchers that their ethics approval is about to expire, it is the researcher’s responsibility to maintain ethics approval for his/her study throughout the life of the project.
If the researcher has been notified that ethics approval for a study will expire by a certain date and fails to submit a report by the specified date, the REB has the authority to terminate its approval of the ethical acceptability of the research (Article 6.3). The REB should notify the institution of its decision to terminate its approval. It is up to the institution to determine how it will proceed to ensure the non-compliant research is either brought into compliance or is stopped. The ultimate responsibility for ensuring compliance with TCPS 2 rests with the institution by virtue of having signed the Agreement on the Administration of Agency Grants and Awards by Research Institutions with the Agencies.
4. Continuing research ethics review: What if a researcher obtains ethics approval but the research procedure deviates from the approved proposal, and the researcher does not seek ethics approval for the modification?
If the change to research is a necessary reaction to an unanticipated event Article 6.15 would apply. If the change is a result of a researcher’s planned deviation from the original study Article 6.16 would apply. In either case, the nature of the departure from the approved research will determine when the researcher should have informed the REB or sought renewed research ethics approval. In both cases, if earlier notification was required and the date of the unanticipated issue report or the request for change has passed, the researcher would be conducting research not in compliance with TCPS 2. The REB may formally notify the researcher and the institution that its approval for the research is suspended or revoked and may investigate whether the level of risk to participants was altered or increased as a result of the unreported change. It is up to the institution to act to ensure that the non-compliant research does not proceed.
5. What is the appropriate duration for data retention in TCPS 2?
TCPS 2 does not specify the required length of time for retention of research data. Data retention periods tend to vary depending on the research discipline, research purpose and kind of data involved. TCPS 2 underscores the importance of data retention as a matter to be considered by research ethics boards in their review of studies that collect identifiable personal information about research participants (see application to Article 5.3) In TCPS 2, a number of factors are relevant to defining periods of data retention. Researchers' plans for preserving or destroying participants' data should be appropriate to the field of research in light of its best practices and professional, ethical and legal norms. For example, under Division 5 of the Health Canada Food and Drug Regulations which pertains to clinical trials of drugs, sponsors are required to maintain records for a period of 25 years. As another example, CIHR’s Open Access Policy requires grant recipients to retain original data sets arising from CIHR-funded research for a minimum of five years after the end of the grant.
6. When does the following become eligible for delegated review: "annual renewals of more than minimal risk research where the research will no longer involve new interventions to current participants, renewal does not involve the recruitment of new participants, and the remaining research activities are limited to data analysis."
The response to this interpretation has been superseded by a new text in TCPS 2 (2014). See Application of Article 6.12 for guidance on this topic.
7. Can TCPS 2 be interpreted broadly to allow annual ethics review of more than minimal risk research by delegated review so long as there has been little or no change in the study and no increase in the risks?
Delegated review is acceptable for annual renewal of research involving more than minimal risk so long as:
While the Panel recognizes that the Application of Article 6.12 states explicitly that delegated review should only be used for minimal risk research, the Panel has considered other guidance in TCPS 2 in arriving at the above interpretation. This includes whether a full board annual review is necessary for the protection of participants (Concern for Welfare, Respect for Persons and Justice) if there have been no substantive changes to the study and no increase in risks or other ethical implications since themost recent review by the full REB. It is also based on the notion of proportionality in ethics review, that "is intended to direct the most intensive scrutiny, time and resources, and correspondingly, the most protection, to the most ethically challenging research" as outlined in the Application of Article 2.9. Where no change in risk has occurred since the most recent full REB review, the same level of scrutiny is no longer needed.
The REB Chair is responsible for making a determination of the level of research ethics review (full board or delegated review) as outlined in the Application of Article 6.12: "It is the REB, based on its established procedures and through its Chair, that decides on the level of review for each research proposal." Article 6.14 is also relevant: "At the time of initial review, the REB has the authority to determine the term of approval, and the level at which continuing ethics review occurs in accordance with a proportionate approach to research ethics review."
REBs should respect other relevant guidelines/policies (such as ICH-GCP) that may require a full REB review of the annual renewal of specific types of research.
8. Can ethics review be delegated for research involving only a small number of participants? NEW
The decision of whether to delegate research ethics review is a function of the level of risk, not the number or the source of prospective participants. When it is determined that research poses minimal risk to participants, an REB may authorize a delegated research ethics review in accordance with its institution’s policies and written procedures (Article 6.12).