RCR Framework Interpretations: Breaches of TCPS 2

What process should institutions and REBs follow when a concern arises with respect to a possible breach of TCPS 2?

For ease of reading, the response to this question has been broken down into sections.

  1. Introduction

    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.

  2. 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.

    • B.2 Institution

      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.

  3. 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.

  4. 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.

  5. 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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