Roles and Responsibilities
1. What are the responsibilities of researchers according to TCPS 2?
Researchers have a responsibility "to ensure that research involving humans meets high scientific and ethical standards that respect and protect the participants" (Chapter 1, Ethics Framework, Importance of Research and Research Ethics). This responsibility does not end when a study receives REB approval but continues for the entire lifecycle of the research. For research participants, researchers are the front line representatives of research ethics and have primary responsibility for implementing the core principles of TCPS 2: Respect for Persons, Concern for Welfare and Justice.
Researchers affiliated with an institution eligible to administer Agency funds are expected to be knowledgeable about TCPS 2 guidance relevant to their research, and to apply this guidance to the design and conduct of their research. Researchers should ensure that all team members under their supervision are trained to conduct ethically acceptable research in accordance with TCPS 2 (Application of Article 6.14). They should also be aware of their professional and other institutional responsibilities, as well as their legal obligations in the conduct of their research.
2. What responsibility does the researcher have in sharing the results of research with research participants? New
The TCPS recognizes the importance of sharing the results of the research with participants, and states that “informing participants of the research results is as important as dissemination of results to the research community.” (Preamble of Article 4.8). Researchers are strongly encouraged to offer to participants an accessible summary of research results, unless it is impracticable to do so, e.g. when participants or their authorized third party may be deceased, or difficult to track due to insufficient identifiers, cost, or time elapsed. Research ethics boards (REBs) are also strongly encouraged to ask researchers to include in their initial application their plan to share the research results with participants, and to report on its implementation in their final report to the REB.
In general, there are benefits to sharing at least a summary of the research results with participants. Disseminating the results of research may contribute to building participants’ and society’s trust in research. Sharing a summary of the results also respects participants who volunteered their time, effort and information to research, and acknowledges their contribution and assumption of risk. There may be a benefit to the participants of knowing a summary of results, even if there is uncertainty that the results may apply to them. For example, sharing a summary of a study that finds that 60% of participants in a trial of radiation for a disease develop another disease or condition is useful for participants to know, so they recognize the value of following up regularly with their physician. A summary of results may also afford the researcher an additional opportunity to inform participants of the potential benefits of the research, and its probable impact on the participants’ and others’ wellbeing. In doing so, researchers adhere to the core principles of Respect for Persons, and Concern for Welfare.
The format of sharing the results should respect the core principle of Justice in treating participants equitably. The Policy states that the “[R]esults of the research should be made available to them [participants] in a culturally appropriate and meaningful format, such as reports in plain language in addition to technical reports” (Application of Article 4.8). A number of options and formats exist for the researcher to provide copies or access to publications or lay summaries to the participants. For example, the researcher may consider providing the summary results directly back to the participants, indicate a website to which the participants may go to retrieve results, or provide face-to-face results directly or in a group setting. Where possible and appropriate, a permanent record, paper or electronic, is preferred such that participants can reference these reports in the future.
In some contexts, researchers may wish, or may have a duty, to share the individual research results with participants (see incidental findings addressed in Article 3.4). In addition, key guidance on disseminating research results to Indigenous communities can be found in Articles 9.11, 9.17 and 9.22. In some areas of research, such as genetics, the ramifications of research results go beyond the individual participant to involve others with whom the individual shares genetic ancestry. For this type of research, researchers should be guided by the provisions relevant to sharing research results with and beyond participants– see Article 13.2 and other guidance in Chapter 13.
3. What process should institutions and REBs follow when a concern arises with respect to a possible breach of TCPS 2? New
For ease of reading, the response to this question has been broken down into sections.
Most researchers conduct their research with human participants responsibly and in accordance with the Tri-Council Policy Statement: Ethical Conduct of Research Involving Humans (TCPS 2).
A failure to respect the guidance in TCPS 2 may constitute a breach of the Tri-Agency Framework: Responsible Conduct of Research (“RCR Framework”). When a concern arises that a researcher may have breached a provision of TCPS 2, institutions and their REBs must work together to ensure both due process and consideration of participant welfare.
This interpretation seeks to clarify the distinct, but sometimes overlapping roles of institutions and their Research Ethics Boards (REBs), when responding to such concerns.
What are the main responsibilities of institutions and Research Ethics Boards (REBs) when addressing allegations that a researcher may have breached TCPS 2?
Section 4 of the RCR Framework indicates that the Institution is responsible for conducting an inquiry or investigation into allegations of breach of the RCR Framework. This includes allegations of breach of TCPS 2. It is the Institution’s designated point of contact for RCR matters (“RCR Contact”) or their delegate that takes the lead in coordinating the inquiry and/or investigation.
In the event that the inquiry or investigation confirms that a breach of TCPS 2 has occurred, the Institution is also responsible for: a) ensuring that measures for rectifying or mitigating the breach are carried out, b) imposing a recourse, if warranted, against those who were found to have committed a breach, and c) reporting to the Agencies, through the Secretariat, when Agency funds are involved.
At the same time, Article 6.3 of TCPS 2 gives REBs the authority and responsibility to approve, reject, propose modifications to, or terminate any research involving humans at the Institution. This responsibility is essential to safeguarding participant welfare.
Good communication between REBs, REB administrators, and RCR contacts is essential in order to ensure that the inquiry and, if necessary, the investigation are carried out smoothly and that research participants are protected throughout.
B.1 Research Ethics Board (REB)
The REB’s specific responsibilities may vary according to the nature of the allegation. They may include:
- informing the RCR contact of the concern as soon as possible, if the REB is the first to become aware of the concern;
- collaborating with the RCR inquiry/investigation process by:
- providing any relevant documents to the RCR Contact, or his/her delegate, upon request;
- responding to questions posed by the RCR contact or his/her delegates; and/or
- providing advice on matters such as how to interpret TCPS2 and appropriate measures for participant protection.
To avoid the perception of conflict of interest, REB members and Chairs should not sit on investigation committees for allegations relating to research that they or their Board had a role in approving.
If the research is still active, the REB should decide independently, based on the information available to it through communication with the RCR contact, whether to suspend its approval of the research, or allow the research to continue, while the Institution’s inquiry or investigation is underway and after it has been completed. The decision will depend on the nature of the allegation and whether the alleged breach has the potential to affect the safety of participants.
As part of its responsibility to conduct an inquiry or investigation, the Institution must appoint an individual or committee, depending on circumstances, to gather evidence, interview affected parties, determine the facts of the matter, and make a determination as to whether a breach of TCPS 2 occurred.
If the process confirms that TCPS 2 was breached, the Institution must determine actions to be taken in response. Examples of such actions may include, but are not limited to:
- taking disciplinary action against those who committed the breach;
- ensuring that measures to correct the research record are taken;
- requiring those who committed the breach, and possibly other parties at the Institution, to take further training in research ethics and RCR;
- determining how to manage the data that was collected while the researcher was in breach of TCPS 2; and/or
- taking measures to minimize or mitigate harm to research participants.
The Institution should work closely with the REB to obtain all evidence relevant to its investigation.
It should provide the REB with any information that the REB may require to fulfil its mandate under Article 6.3 of TCPS 2.
In addition, the Institution should seek the REB’s advice when it makes decisions about matters for which the REB has expertise, for example, measures to mitigate harm to participants.
Do REBs have the authority to take actions against a researcher personally?
The REB’s authority is with respect to the research itself, not the researcher. While an REB h as the authority to suspend or terminate approval of a research project, actions such as requiring a researcher to seek additional training in research ethics, or requiring the researcher to destroy research data, are the Institution’s responsibility.
Are there any TCPS 2 compliance situations that REBs may address directly, without referring the matter to the Institution’s RCR contact for an inquiry or investigation?
It may be possible for an REB to address certain concerns with TCPS 2 compliance, for example, an overdue annual report. REBs and institutions should discuss these situations on a case-by-case basis before determining how to proceed or, if they occur frequently, establish written policies and procedures to address the most common situations.
What information about RCR matters should institutions share with REBs?
Institutions have the responsibility and the discretion to determine what information may be shared about an RCR matter and with whom. The Institution’s decision may depend on a number of factors including, but not limited to, provincial legislation, institutional policies, and the provisions of collective agreements.
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