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?
Key elements of this interpretation have been integrated into TCPS 2 (2018) – Application of Article 6.14
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 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 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 reed 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, in the Tri-Agency Statement of Principles on Digital Data Management CIHR 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 interventions to current participants, renewal does not involve the recruitment of participants, and the remaining research activities are limited to data analysis."
The response to this interpretation has been superseded by a 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?
Key elements of this interpretation have been integrated into TCPS 2 (2018) – Application of Article 6.12
Delegated review is acceptable for annual renewal of research involving more than minimal risk so long as:
- there have been little or no changes to the research, with no increase in risk to or other ethical implications for the participants since the most recent review by the full REB, and
- the REB Chair remains responsible for determining if the delegated review process is appropriate.
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 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 the most 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 the 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?
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).
9. Does research involving ancient human skeletal remains require REB review?
Research involving ancient human skeletal remains is research involving humans and falls within the scope of TCPS 2. As stated in TCPS 2, REB review is required for "research involving human biological materials, as well as human embryos, fetuses, fetal tissue, reproductive materials and stem cells. This applies to materials derived from living and deceased individuals" (Article 2.1 (b))(emphasis added).
REB review is not required if the research involving ancient human skeletal remains "relies exclusively on secondary use of anonymous information, or anonymous biological materials" and "so long as the process of data linkage or recording or dissemination of results does not generate identifiable information" of a community or group (Article 2.4). Where there is a reasonable prospect that the data linkage will generate identifiable information, REB review is required.
10. What key ethics issues should the REB consider in the review of self-study research?
The REB must assess the ethical acceptability of self-study by considering its foreseeable risks, its potential benefits, and the ethical implications of the research. The researcher may be the sole participant, e.g. a researcher writing a self-study of his/her experience camping alone in the woods. REBs should assess the level of risk that the researcher is willing to assume to himself/herself.
Some self-studies may also involve others with whom the researcher interacts or studies. The level of involvement of others in the research determines whether they are also research participants as defined in the Policy (Application of Article 2.1). If the REB determines that others are involved as research participants, the REB must assess how the researcher plans to manage the consent process. In general, researchers must seek participants’ consent to participate in the self-study. In some exceptional circumstances, the researcher may request an alteration to consent requirements if s/he satisfies the REB that the provisions of Article 3.7A are met. In general, if the material on which self-study is based (e.g., journal entries, recollections) was not originally intended for research, but is later proposed for research purposes, then the consent of the individual(s) and/or communities involved, if any, must be sought.
Out of concern for welfare, regardless of whether or not they meet the definition of research participants, others mentioned in the self-study have a right to privacy protections. Individuals and/or groups mentioned in the study may not be aware that their interactions with the researcher would be included in a research project. The REB should assess whether the dissemination of the research could lead to the identification of individuals and/or communities, and may pose additional risks to participants’ and non-participants’ privacy and confidentiality. This assessment should also consider the research context, and the level and relevance of privacy protections to others mentioned in the self-study. For example, participants, or other individuals implicated in the research, who seek or expect public acknowledgement of their contributions may not have the same expectations or needs for privacy protections.
As with any research that poses risks of identification, the researcher and the REB should work together to minimize and/or manage these risks to individuals and communities who are mentioned in the self-study research (e.g., remove identifiable information, disguise names and identities). See also related interpretation [Scope #13].
11. What should a research ethics board consider when reviewing a research study involving the secondary use of non-identifiable information?
“Information is non-identifiable if it does not identify an individual, for all practical purposes, when used alone or combined with other available information” (Ch. 5 A. Key Concepts, Identifiable Information). Research that relies exclusively on the secondary use of non-identifiable information is subject to REB review in accordance with Article 5.5B. When reviewing research that relies on secondary use of non-identifiable information, an REB must review whether the research respects the terms of consent under which the participants initially provided their data, if this information is available. REBs must also assess the potential for new risks that may not have been foreseeable, and that arise as a result of the secondary use of non-identifiable information in the new research context, particularly “[p]rivacy concerns … when information provided for secondary use in research can be linked to individuals, and when the possibility exists that individuals can be identified in published reports, or through data linkage” (Ch. 5, Section D., Introduction)
REBs should consider factors that may contribute to new risks in the new research context and that can harm participants – the source of the data – or the group or community to which they belong. The risk of re-identification may be heightened with the rapid technological advances that make it harder to achieve anonymity, or where the research targets information about a distinct population such as a cultural group. The re-identification risk may also increase where the data is about a group with unique conditions such as a rare disease, or with unique characteristics such as a geographical location, or where the data contains sensitive information related to, for example, violence or sexual practices.
REBs should also assess measures that the researchers propose to minimize any new risks associated with the secondary use of non-identifiable information in new research contexts. REBs may require that researchers engage in discussions with people whose perspectives or expertise can help identify the ethical implications of the research, and suggest ways to minimize any associated risks. For example, “[w]here the information can be identified as originating from a specific community or a segment of the Indigenous community at large, seeking culturally informed advice may assist in identifying risks and potential benefits for the source community” (Article 9.21). REBs may determine that community engagement is required in accordance with Articles 9.1 and 9.2 to seek guidance on secondary use of information originating from the Indigenous community, unless the researchers satisfy the REB that secondary use is consistent with an existing research agreement (see Article 9.20).
REBs should also recognize that secondary use of non-identifiable information may have potential benefits for participants, groups or communities to which they belong. This should be taken into account in the review of the balance of risks and benefits of the research.
See also related interpretation [Scope #17], and Guidance on Depositing Existing Data in Public Repositories.
12. Does TCPS 2 require that researchers submit an amendment to their REB when a change to the composition of the research team occurs during the course of research? New
As stated in TCPS 2, and highlighted in public interpretations (REB Review #2, #3, #4), the role of the REB does not end with the provision of an initial ethics review. Specifically, “research ethics review shall continue throughout the life of the project” (Article 2.8). The life of a project includes “all stages of a research project” (Application, Article 2.8). It does not end with the completion of data collection, but also includes data analysis, as well as result interpretation and dissemination.
Researchers are required to “submit to their REBs in a timely manner requests for substantive changes to their originally approved research” (Article 6.16). Thus, it is the responsibility of the researcher to determine whether a change to the composition of the research team is substantive and should be submitted to the REB for review. Determining whether it constitutes a substantive change depends primarily on a consideration of the information that formed the basis of participants’ consent.
TCPS2 does not specifically require that the names of all members of the research team be mentioned in the consent process. According to the Application of Article 3.2, the information generally required for informed consent includes, amongst other things, “the identity of the researcher, the identity of the funder or sponsor, [and] an indication of who will have access to information collected about the identity of participants”. This includes informing prospective participants about whether the researcher plans to share research data with individuals outside of the research team, or deposit the data in an open-access public repository after data collection is complete (Guidance on Depositing Existing Data in Public Repositories). Providing this information is important to ensure that consent is informed (Article 3.2) and ongoing (Article 3.3).
Therefore, a key question that researchers should ask themselves when considering whether they shall inform the REB of a change to the composition of their research team is the following:
Considering the specific context of the research and the information provided to participants during the consent process, does this change constitute a departure from what participants consented to in the first place?
To answer this question, researchers may need to refer back to their documentation of the consent process. Most of the time, changing the composition of the research team does not constitute a substantive change to the terms of consent. However, where it does, the researcher must submit an amendment to the REB. This would be the case, for instance, where the information initially provided to participants about who would have access to their data was very specific, and the researcher now wishes to provide such access to more or different people.
Subsequently, where it is determined by the REB that this information is relevant to participants’ ongoing consent, the researcher shall work with the REB to determine whether participants must be informed, and if so, which participants to inform, and how to inform them (Articles 6.15 and 11.8).
These requirements still hold even if the REB has previously determined that continuing ethics review is no longer required. Some institutions may have additional administrative requirements regarding changes to approved research. When facing uncertainty in determining whether a change to the composition of the research team may cause participants to reconsider their consent and require an amendment, the researcher should reach out to the REB for guidance.
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