TCPS 2 (2018) – Chapter 6: Governance of Research Ethics Review
- A. Establishment of Research Ethics Boards
- B. Procedures for Research Ethics Board Review
- C. Reconsideration and Appeals
- D. Research Ethics Review during Publicly Declared Emergencies
- E. Review of Sponsor-Researcher Contracts
This chapter sets out the elements of research ethics review including the procedures necessary to establish a research ethics board (REB), and operational guidelines for the REBs and research ethics review, both initially and throughout the course of the research project. It also includes guidelines for the conduct of research ethics review during publicly declared emergencies.
A key goal in establishing an appropriate governance structure for research ethics review is to ensure that REBs operate with a clear mandate, authority and accountability; and that roles and responsibilities are clearly defined. REBs need independence in their decision-making process to carry out their role effectively and to properly apply the core principles of this Policy – Respect for Persons, Concern for Welfare, and Justice – to their ethics review of research projects. These operational guidelines are meant to be flexible enough to apply in various contexts, at institutions of various sizes, and to the full range of research disciplines, fields and methodologies.
A. Establishment of Research Ethics Boards
Authority, Mandate and Accountability
Institutions shall establish or appoint an REB (or REBs) to review the ethical acceptability of all research involving humans conducted within their jurisdiction or under their auspices, that is, by their faculty, staff or students, regardless of where the research is conducted, in accordance with this Policy.
Each institution is accountable for the research carried out in its own jurisdiction or under its auspices. In fulfilling this responsibility, where research involving humans takes place within the jurisdiction or under the auspices of an institution, that institution shall establish the necessary structure of an REB (or REBs) capable of reviewing the ethical acceptability of that research. In fulfilling this responsibility, institutions may opt to appoint an external REB in accordance with the Agreement on the Administration of Agency Grants and Awards by Research Institutions.Footnote 1 Any such appointment should be based on an official agreement clarifying the ultimate responsibility of the institution for the ethical acceptability of research undertaken within its jurisdiction or under its auspices. To demonstrate their accountability, institutions may wish to issue public reports summarizing the institution’s activities and initiatives relevant to the ethics review of research involving humans, its research ethics administration, and relevant research ethics education and training.
The number of REBs and the expertise of their members will depend on the range and volume of research for which that institution is responsible, in accordance with Articles 6.4 and 6.5 relating to REB composition. Large institutions may find it necessary to create more than one REB to cover different areas of research or to accommodate a large volume of research. Small institutions may wish to explore regional cooperation or alliances for access to an REB based on formal agreements between the institutions (Article 8.1).
Members of an institution (i.e., its faculty, staff and students) may be affiliated with other institutions, or may be engaged in consulting or other professional activities in a separate enterprise, or in student co-op work or field placements. If members of the institution make reference to their affiliation to the institution or use any of its resources when engaging in research, they should submit their research proposals to their institutional REB for research ethics review in accordance with this Policy. Where student co-op work or field placements involve components of research that require research ethics review, institutions and organizations hosting co-op student researchers may consider specifying in advance (e.g., in policies, agreements or contracts for co-op student placements) the roles and responsibilities pertaining to the ethics review of research involving humans of the host organization versus those of the institution.
Should the institution determine that some situations warrant an exception to the requirement for REB review, the basis and conditions for case-by-case exceptions shall be clearly documented in the institutional policies. Case-by-case exceptions may be determined by such factors as the degree to which the members’ affiliation with the institution is their primary affiliation, or by how practical it is to distinguish the capacity in which the member is conducting the research, and the participants’ reasonable perceptions of this capacity. Other factors include the availability of other avenues through which the member may address the guidance in this Policy outside the institution, including the possibility of sharing responsibility for research ethics review, and the methods in place to address real, potential or perceived conflict of interest issues.
The highest body within an institution shall: establish the REB or REBs; define an appropriate reporting relationship with the REBs; and ensure the REBs are provided with necessary and sufficient ongoing financial and administrative resources to fulfill their duties. REBs are independent in their decision making and are accountable to the highest body that established them for the process of research ethics review.
The highest body of the institution that establishes the REB or REBs could be an individual, such as the president, rector or chief executive officer, or an equivalent body, such as a governing council, board of directors, or council of administration. Institutions determine the highest body based on their individual governance structures and taking into consideration whether other responsibilities of those bodies may conflict with the responsibility for establishing an REB. Institutions shall have in place written procedures for the appointment, renewal and removal of REB members, including Chairs.
For the integrity of the research ethics review process, and to safeguard public trust in that process, institutions shall ensure that REBs are able to operate effectively and independently in their decision making. Disagreement between the researcher and the REB over a decision that cannot be resolved through discussion and reconsideration can be resolved through the normal appeal process (Articles 6.18 to 6.20).
Institutional policies and procedures shall also support and promote the independence of REBs in their decision making so that REBs may be free of inappropriate influence, including situations of real, potential or perceived conflicts of interest (Chapter 7).
It is critical that institutions provide appropriate administrative resources to REBs (e.g., research ethics administration staff, a research ethics office) for the effective and efficient operation of the REB. The means by which this support may be provided will vary by institution, but may include REB coordination, support in policy development and interpretation, record keeping, and provision of research ethics training opportunities to REB members, researchers and students. The research ethics administration staff may provide important ethics expertise in support of the REB’s ethical analysis and discussion. Research ethics administration staff should also have the necessary qualifications, as well as initial and continuing training, to appropriately perform their roles and responsibilities. Institutions should recognize the integral role of research ethics administration staff and research ethics office(s), as applicable, in supporting the REB in fulfilling its mandate.
As an entity that draws its authority and resources from the institution, the REB remains accountable to the highest body of the institution that established it for the integrity of its processes.
The institution shall grant the REB the mandate to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans. This mandate shall apply to research conducted under the auspices or within the jurisdiction of the institution, using the considerations set forth in this Policy.
The institution shall delegate to the REB the authority to review the ethical acceptability of research through its normal process of governance. In defining the scope of the REB’s mandate, the institution shall clearly define the jurisdiction of the REB to cover a range of research consistent with relevant disciplinary competence and a manageable workload. Where the institution requires more than one REB, it should establish a mechanism to coordinate the operations of all its REBs, and clarify their relationship with each other, and with other relevant bodies or authorities. Institutions shall have clear written policies describing the mandate of each REB. An institution may wish to use different models for the ethics review of research conducted under its auspices (Chapter 8).
Institutions shall respect the authority delegated to the REB. An institution may not override an REB decision to reject a research proposal. An appeal of the REB decision to reject a research proposal can only be brought in accordance with Section C of this chapter.
An REB approval applies to the ethical acceptability of the research and does not, in itself, constitute authorization for the research to proceed.
Research Ethics Board Composition
Basic Research Ethics Board Membership Requirements
The membership of the REB is designed to ensure competent independent research ethics review. Provisions respecting its size, composition, terms of appointment and quorum are set out below.
The REB shall consist of at least five members, including both men and women, of whom at least:
- two members have expertise in relevant research disciplines, fields and methodologies covered by the REB;
- one member is knowledgeable in ethics;
- one member is knowledgeable in the relevant law. That member should not be the institution’s legal counsel or risk manager. This is mandatory for biomedical research and is advisable, but not mandatory, for other areas of research; and
- one community member has no affiliation with the institution.
It is advisable that each member be appointed to formally fulfill the requirements of only one of the above categories.
To ensure the independence of REB decision making, institutional senior administrators shall not serve on the REB.
This minimum requirement for REB membership brings to bear the necessary basic background, expertise and perspectives to allow informed independent reflection and decision making on the ethics of research involving humans. At a minimum, the REB shall have members appointed in one capacity only for each of the membership categories. Where the size of the REB exceeds the minimum requirements, additional members may fulfill more than one capacity. In any case, REB members can contribute to the review based on their experience, expertise or knowledge in more than one of the categories above (Article 6.4[a] to [d]).
As an entity created and supported by the institution, an REB is encouraged to build strong relationships with its host institution and senior administration. The involvement of administrative staff dedicated to research ethics functions (e.g., the research ethics office administrator or director) may be relevant and appropriate to support REB procedures. However, an institutional senior administrator (e.g., vice-president of research, director general or director of business development) should not serve on an REB, or directly or indirectly influence the REB decision-making process (Articles 6.2 and 6.10). The mere presence of a non-voting institutional senior administrator at REB meetings may be a source of real, potential or perceived conflict of interest, and may therefore undermine the independence of the REB by unduly influencing REB deliberations and decisions (Article 7.2).
The size of an REB may vary based on the diversity of disciplines, fields of research and methodologies to be covered by the REB, as well as on the needs of the institution. In appointing REB members, institutions should strive for appropriate diversity. Institutions may need to exceed the minimum REB membership requirements to ensure adequate and thorough reviews as well as reasonable workload for REB members, or to respond to other local, provincial/territorial, or federal legal or regulatory requirements. For example, in the case of REB review of clinical trials, provincial/territorial or federal regulations may outline specific membership requirements in addition to the requirements set out in this Policy. Where REBs mainly review student research, they may consider adding a student REB member. Additional community representation should be commensurate with the size of the REB. Institutions are encouraged to establish a pool of substitute members (see below). Where research ethics administration staff have the requisite experience, expertise and knowledge comparable to what is expected of REB members, institutions may appoint them (based on the written policies and procedures of the institution) to serve as non-voting members on the REB.
Relevant Expertise in Research Content and Methodology
At least two members should have the relevant knowledge and expertise to understand the content area and methodology of the proposed or ongoing research, and to assess the risks and potential benefits that may be associated with the research (Article 6.4[a]). For example, REBs reviewing oncology research, population and public health research, research involving First Nations, Inuit or Métis peoples, or research using qualitative methodologies, should have members that are knowledgeable and competent to address those fields of research, disciplines and methodologies.
Knowledgeable in Ethics
Knowledge of ethics of research involving humans is key within the REB membership as a whole. A member knowledgeable in ethics (Article 6.4[b]) needs to have sufficient knowledge to guide an REB in identifying and addressing ethics issues. A balance of ethics theory, practice and experience offers the most effective path to knowledge in ethics for REB membership. The kind and level of knowledge or expertise needed on the REB will be commensurate with the types and complexities of research the REB reviews. For example, a member knowledgeable in ethics serving on a social sciences and humanities REB may need to have different contextual and disciplinary knowledge in ethics than a member knowledgeable in ethics serving on a biomedical REB.
Knowledgeable in the Law
The role of the member knowledgeable in the law (Article 6.4[c]) is to alert REBs to legal issues and their implications (e.g., privacy issues), not to provide formal legal opinions or to serve as legal counsel for the REB. To avoid undermining the independence and credibility of the REB, the institution’s legal counsel or risk manager should not be a member of the REB. In-house legal counsel might be seen to identify too closely with the institution’s financial interest in having research go forward or, conversely, may be unduly concerned with protecting the institution from potential liability. Any external legal counsel hired on a case-by-case basis by the institution should not serve as a member of that institution’s REBs while working for the institution.
An understanding of relevant legal issues and contexts is advisable for all REBs, although for non-biomedical research such insights may be sought from an ad hoc advisor whom the REB consults only for specific research projects. Where REBs review research on complex topics that regularly require advice on legal issues, they should appoint a member knowledgeable in the relevant law. In some instances, the legal issues that may be identified by the REB will necessitate further scrutiny and even formal legal advice by the legal counsel to the institution. Legal liability is a separate issue for institutions to handle through mechanisms other than the REB.
The community member shall not be affiliated with the institution. The community member requirement (Article 6.4[d]) is essential to help broaden the perspective and value base of the REB, and thus advances dialogue with, and accountability to, relevant communities. In addition to a broad-based representation from the community, it is highly desirable that institutions seek to appoint former participants on REBs. Their experience as participants provides the REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that members are not currently engaged in research or legal work as their principal activities.
The role of community members on REBs during the ethics review process is unique and at arm’s length from the institution. Their primary role is to reflect the perspective of the participant. This is particularly important when participants are vulnerable and/or risks to participants are high.
To maintain effective community representation, the number of community members should be commensurate with the size of an REB and should increase as the size of an REB increases. Institutions should provide training opportunities to community members (Article 6.7).
Institutions should consider the nomination of substitute REB members so that REBs can continue to function when regular members are unable to attend due to illness or other unforeseen eventualities. The appointment of substitute members should not, however, alter the REB membership composition as set out in this article. Substitute members should have the appropriate knowledge, expertise and training to contribute to the research ethics review process.
Ad Hoc Advisors
The REB should have provisions for consulting ad hoc advisors in the event that it lacks the specific expertise or knowledge to review the ethical acceptability of a research proposal competently.
In the event that the REB is reviewing a project that requires particular community or participant representation or specific disciplinary or methodological expertise not available from its members, it should have provisions for consulting ad hoc advisors. Consultation with an ad hoc advisor shall not alter the composition and representation of the REB as outlined in Article 6.4.
Ad hoc advisors are consulted for a specific research ethics review and for the duration of that review. Should this occur regularly, the membership of the REB should be modified to ensure appropriate expertise on the REB. For example, in cases where ethics review of research on topics related to Indigenous peoples is regularly required, the REB membership should be modified to ensure that relevant and competent knowledge of and expertise in Indigenous cultures are captured within its regular membership.
While ad hoc advisors may complement the REB through their experience, knowledge or expertise, their input is a form of consultation that may or may not be considered in the final decision of an REB. They are not REB members and, as such, do not necessarily have the knowledge and experience gained from reviewing research proposals as members. Ad hoc advisors should not be counted in the quorum for an REB, nor be allowed to vote on REB decisions.
Terms of Appointment of Research Ethics Board Members
In appointing REB members, institutions shall establish their terms to allow for continuity of the research ethics review process.
In appointing REB members, institutions should arrange the terms of members and their rotation to balance the need to maintain continuity with the need to ensure diversity of opinion, and the opportunity to spread knowledge and experience gained from REB membership throughout the institution and community. The REB membership selection process should be fair and impartial. Institutions should have written policies that define the process of appointing REB members.
In appointing and renewing REB members, institutions should consider the qualifications and expertise their REBs need. Institutions should provide REB members with necessary training opportunities to effectively review the ethical issues raised by research proposals that fall within the mandate of their REB.
An REB should have adequate expertise, experience and training to understand the research disciplines, methodologies and approaches of the research that it considers for research ethics review. Although an REB possesses the necessary expertise globally, each REB member brings specialized and complementary expertise and knowledge, or relevant experience to the ethics review of research involving humans.
Institutions should ensure that all REB members receive appropriate education and training in ethics review of research involving humans, to enable them to fulfill their duties. This includes providing training opportunities for all members in core principles and understanding of this Policy, basic ethics standards, applicable institutional policies, and legal or regulatory requirements. It includes an understanding of the role and mandate of REBs and responsibilities of REB members. Training should be tailored to the types and complexities of the research the REB reviews. This training should be offered both upon the appointment of new members, and periodically throughout a member’s tenure.
Institutions should promote and recognize the contribution of REB members to the research ethics review process, as a valued and essential component of the research enterprise.
Research Ethics Board Chair
The REB Chair is responsible for ensuring that the REB review process conforms to the requirements of this Policy.
The role of the REB Chair is to provide overall leadership for the REB and to facilitate the REB review process, based on institutional policies and procedures and this Policy. The Chair should monitor the REB’s decisions for consistency and ensure that these decisions are recorded accurately and communicated clearly to researchers in writing as soon as possible by the Chair or his or her designate. Institutions shall provide the necessary resources and adequate administrative support to enable the REB Chair to fulfill his or her responsibilities.
Research Ethics Board Quorum
Institutions shall establish quorum rules for REBs that meet the minimum requirements of membership representation outlined in Article 6.4. When there is less than full attendance, decisions requiring full review should be adopted only when the members in attendance at that meeting have the specific expertise, relevant competence and knowledge necessary to provide an adequate research ethics review of the proposals under consideration.
Institutions shall establish REB quorum rules subject to the range of competence and knowledge required by this Policy to ensure the soundness and integrity of the research ethics review process. To maintain quorum when REB members are geographically dispersed or in unexpected circumstances (e.g., emergencies), input from member(s) is allowed by other means, such as the use of technology (Article 6.10).
Ad hoc advisors, observers, research ethics administration staff and others attending REB meetings should not be counted in the quorum for an REB. Nor should they be allowed to vote on REB decisions (Article 6.5). Decisions without a quorum are not valid or binding.
Research Ethics Board Meetings and Attendance
REBs shall have regular meetings to discharge their responsibilities, and shall normally meet face to face to review proposed research that is not assigned to delegated review.
Face-to-face meetings are essential for adequate discussion of, and effective REB decision making on, research proposals, and for the collective education of the REB. The face-to-face medium provides interactive dynamics that tend to heighten the quality of communications and decisions.
Planning regular meetings is essential to fulfilling REB responsibilities. Where a member is frequently absent, the REB should have some mechanism for reviewing whether that member should continue to serve on the REB. Unexpected circumstances such as emergencies may prevent member(s) from attending the REB meeting. In these exceptional cases, input from member(s) by the use of technology (e.g., phone or video link) would be acceptable.
Videoconferencing, teleconferencing or use of other technologies may be regarded as necessary for meetings when REB members are geographically dispersed and there is no other way of holding an effective REB meeting, or when exceptional or exigent circumstances significantly disrupt or limit the feasibility of face-to-face REB meetings (e.g., during a public emergency). All efforts should be made to ensure that technical difficulties do not prevent the maintenance of quorum throughout the meeting. Use of such technologies requires the Chair to ensure active participation of members not physically present. Institutions should consider developing written procedures for the occasional use of video conferences or other technologies by an REB.
In the design phase of their research prior to the formal ethics review process, researchers may consult informally with REBs. Such dialogue can establish the stage at which REB review and approval would be required, or it can facilitate the review. Such informal meetings cannot, however, substitute for the formal review process. A schedule of REB meetings should be communicated to researchers for the planning of ethics review of their research.
On occasion, REBs may need to consult other resources within or outside the institution for advice and may invite experts to attend their meetings. REBs should consider whether the institutional functions of other individuals attending their meetings could exercise undue influence or provide elements of power imbalances or coercion that would affect REB review, deliberations and decisions (Articles 6.4 and 6.5 and Chapter 7).
REBs should establish a process for the basis of arriving at decisions requiring full REB review. For example, they may arrive at decisions by consensus, and where this is not possible resort to a vote. REBs should hold general meetings, retreats and workshops to enhance educational opportunities that may benefit the overall operation of the REB, to discuss any general issues arising out of the REB’s activities, or to revise relevant policies.
B. Procedures for Research Ethics Board Review
Initial Research Ethics Review
Researchers shall submit their research proposals, including proposals for pilot studies, for REB review and approval of their ethical acceptability prior to the start of recruitment of participants, data collection, access to data or collection of human biological materials. REB review is not required for the initial exploratory phase, which is intended to establish research partnerships or to inform the design of a research proposal, and may involve contact with individuals or communities.
REB review and approval of the ethical acceptability of research are required before recruitment, formal data collection involving participants, access to data, or collection of human biological materials.
Researchers shall submit sufficient details to enable the REB to make an informed review of the ethical acceptability of the research.
Some types of research using quantitative or qualitative research methods, or a combination of methods as well as collaborative or community-based research (Chapters 9 and 10), may entail prior contact and dialogue with individuals or communities to establish research collaborations or partnerships prior to the actual design of the research. Other research may not involve humans in the initial stages but may require preparatory work, for instance, observing a research setting, taking notes, or setting up equipment. These activities may precede REB review. If, however, the researcher later wishes to use any information gathered from individuals or communities during the exploratory phase as research findings, this intention must be made clear when the researcher submits the application for ethics review, along with any provisions for seeking the consent of those who contributed the information.
As an integral component of their research design, researchers may undertake pilot studies involving participants (Article 2.1). Some of the ethical issues to consider in the review of pilot studies concern recruitment and sample size. Although pilot studies may offer indirect benefits to groups and to society by informing the design of the main study (and other similar studies), they often provide no direct benefits to participants. Researchers have an ethical responsibility to fully disclose the purpose and nature of the pilot study and the likelihood of benefits to participants during recruitment and when seekingconsent. When reviewing pilot studies, REBs should ensure that recruitment and consent materials provide this information and describe how the findings of the pilot study will be used to determine the feasibility of conducting a larger study (see also Article 3.2). When considering the ethical acceptability of pilot studies, REBs should keep in mind that the main purpose of a pilot study is not to provide a definitive answer(s) to the research question(s). Accordingly, the number of participants specified may not equal the sample size that would be required in the main study. The researcher should provide justification for the sample size based on the focus of the pilot study: to test feasibility and/or to inform study design.
The level of REB review for pilot studies should follow a proportionate approach to research ethics review (Article 2.9). REB Chairs should ensure that REB members with the relevant expertise are involved in the review process (Articles 6.4 and 6.5).
Determining the Level of Research Ethics Review
In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review).
REBs shall assess the level of risk that the research under review poses to participants to determine the appropriate level of research ethics review (delegated or full REB review). (For a full discussion of the proportionate approach to research ethics review, see Chapter 1, Section C, and Article 2.9). This applies to both initial research ethics review (Article 6.11) and continuing research ethics review (Article 6.14).
With the support of their institutions, REBs may develop their own mechanisms under which delegation of the conduct of research ethics review, decision making, and the associated reporting processes will occur. Those mechanisms and procedures should be made public. It is the REB, based on its established procedures and through its Chair, that decides on the level of review for each research proposal.
Two levels of research ethics review may apply:
Full REB review
Research ethics review by the full REB should be the default requirement for research involving humans.
Delegated REB review of minimal risk research
The REB delegates research ethics review to an individual or individuals. Delegates shall be selected from among the REB membership with the exception of the ethics review of student course-based research activities. This can be delegated to the department, faculty or an equivalent level as indicated below.
Where it is determined that the research is of minimal risk (defined in Chapter 2 of this Policy), an REB may authorize a delegated research ethics review in accordance with its institutional policies and written procedures. Delegated reviewer(s) shall be selected from the REB membership: the REB Chair or another member (see Article 6.4 on the appointment of research ethics administration staff to the REB as non-voting members). Research ethics review may also be undertaken by non-REB members for student course-based research, as outlined below. Delegated reviewers who are non-members or non-voting members of the REB must have experience, expertise and knowledge comparable to what is expected of an REB member.
The REB may decide that its Chair or other REB member(s) may review and approve categories of research that are confidently expected to involve minimal risk. Delegated reviewers may call on other reviewers within the REB or refer projects back to the full REB if they determine that full board review is required. Where delegates consider a negative decision (i.e., one that would refuse ethics approval), this decision shall be referred to the full REB for review and endorsement before communicating the decision to the researcher.
An institution may decide that ethics review of minimal risk course-based research activities with a primarily pedagogical purpose can be delegated to non-REB members at the institution’s department, faculty or equivalent level. Such pedagogical activities are normally required of students (at all levels) with the objective of providing them with exposure to research methods in their field of study (e.g., interviewing techniques). If these activities are used for the purposes of research (e.g., as part of a researcher’s own research program), they should be reviewed by the regular institutional REB procedures. Theses or equivalent research projects involving human participants typically meet this Policy’s definition of research (Application of Article 2.1) and should be reviewed by the REB following a proportionate approach (Article 6.12). The REB should establish written procedures and set out criteria for determining which categories of research proposal may be eligible for this type of review, and should specify who is responsible for implementing and overseeing the approval mechanisms.
In delegating research ethics review, the REB should carefully select delegated reviewer(s) and ensure that all delegated reviewers who are non-voting members of the REB have the appropriate experience, expertise, training and resources required to review the ethical acceptability of all aspects of the proposal in accordance with this Policy. In the selection of delegated reviewers, special attention should be given to the assessment of real, potential or perceived conflicts of interest (Article 7.3).
Examples of categories that may be delegated for research ethics review include:
- research that is confidently expected to involve minimal risk;
- minimal risk changes to approved research;
- annual renewals of approved minimal risk research;
- annual renewals of more than minimal risk research where the remaining research-attributable risk is minimal. For example, the research will no longer involve new interventions to current participants and no additional participants will be enrolled in the study; and
- annual renewals of more than minimal risk research in which there has been:
- no significant changes to the research;
- 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 has determined that the delegated review process is appropriate.
Note that other applicable guidelines or policies (such as the ICH Guideline for Good Clinical Practice) may require a full REB review of the annual renewal for specific types of research.
An REB that implements a delegated review process shall require that the actions and decisions of the delegated reviewer(s) be well documented and formally reported to the full REB, in a timely and appropriate manner. Where the delegated review is conducted by non-voting members or non-members of the REB, this formal report shall be made through the Chair. This will permit the REB to maintain oversight over the decisions made on its behalf so as to protect the interests of participants. Accountability requires that, regardless of the review strategy, the REB continue to be responsible for the ethics of all research involving humans within its jurisdiction.
REBs shall function impartially, provide a fair hearing to the researchers involved, and provide reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to researchers in writing, in print or by electronic means, in accordance with their procedures.
The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposals. The REB may also invite researchers to attend an REB meeting to provide further information about their proposals. In either case, the researchers shall not be present when the REB is making its decision. When an REB is considering a negative decision, it shall provide the researcher with all the reasons for doing so and give the researcher an opportunity to reply before making a final decision (Article 6.18).
In the event that a minority within the REB membership considers a research project unethical, even though it is acceptable to a majority of members, an effort should be made to reach consensus. Consultation with the researcher, external advice or further reflection by the REB may be helpful. If disagreement persists, a decision should be made in accordance with the process agreed upon, and documented by the REB. In such instances, the minority position may be communicated to the researcher.
Participation by the researcher in REB discussions is often very helpful to both REBs and researchers. It may result in a deferral of the REB’s decision until the researcher has considered the discussions and possibly modified the proposal. Such discussions are an essential part of the educational role of the REB.
Continuing Research Ethics Review
The REB shall make the final determination as to the nature and frequency of continuing research ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report (projects lasting less than one year).
Research is subject to continuing research ethics review from the date of initial REB approval and throughout the life of the project (Article 2.8). 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. As with initial review, continuing ethics review could be full board review or delegated review based on the level of risk of the research (Article 6.12). The level of research ethics review may be adjusted over the life of the project based on the level of risk.
For research projects lasting longer than one year, researchers shall submit, at minimum, an annual report with sufficient details to enable the REB to make an informed judgment about the continued ethical acceptability of the research. For research lasting less than one year, an end-of-study report may suffice.
Institutional ethics policies should include provisions that assist REBs, researchers and institutions to determine when continuing research ethics review is no longer required. Such provisions should consider different types of research designs (e.g., short-term project, longitudinal research, research with reporting back requirements). They should also consider issues, such as: the extent of any remaining risk to participants; the nature of plans (if any) for future interaction with participants; the status of any commitments to or agreements with participants (e.g., with respect to reporting findings); and/or the relative likelihood of future unanticipated events, material incidental findings, or new information.
For some types of research (e.g., qualitative research or longitudinal research), there may be some difficulty in establishing start or end dates. In these cases, the REB should work with researchers to determine a reasonable timeline for continuing ethics review, and for determining the completion date dependent on the discipline and method of research. The reporting schedule for continuing ethics review may be adjusted throughout the life of the project. This would be necessary, for example, if the risk level of the research increases as a result of the addition of new procedures, or is re-assessed in light of changes to the approved research (Articles 6.15 and 6.16).
Research that involves minimal or no risk to participants should be held to the minimum requirements for continuing ethics review, that is, an annual report. Consistent with a proportionate approach, an REB has the option of requesting more frequent and/or more substantive reports if necessary. Research that poses greater than minimal risk may require more extensive continuing ethics review. This may include more frequent reporting to the REB, monitoring and review of the consent process, review of participant records, and site visits. Other reporting mechanisms for continuing ethics review may be required by funders, sponsors or regulators.
Continuing research ethics review should be understood as a collective responsibility to be carried out with a common interest in maintaining the highest ethical standards:
- Institutions have a responsibility to provide necessary resources to REBs to assist them in fulfilling their continuing ethics review responsibilities.
- REBs make the final decision about the nature and frequency of continuing ethics review.
- Researchers’ responsibilities include monitoring their research to ensure that it is conducted in an ethical manner, reporting unanticipated issues (Article 6.15) or changes to the research (Article 6.16), supervising all team members in the application of the research procedures, and ensuring that they are properly qualified and versed in the conduct of ethical research.
Reports of Unanticipated Issues
Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants or that has other ethical implications that may affect participants’ welfare.
Over the course of the implementation of the approved research project, issues may arise that the researcher did not anticipate when originally submitting the research for ethics review. Unanticipated issues include unexpected reactions by participants to a research intervention (e.g., unintended stimulation of traumatic memories, unforeseen side effects of a medication or natural health product), as well as unavoidable single incidents (e.g., a translator not available for a day, or a failure to follow correct research procedure for one participant on one occasion). They may be minor or serious in magnitude, with short- or long-term implications.
Any unanticipated issue that increases the level of risk to participants or has other ethical implications should be reported to the REB without delay. Changes that are necessary to eliminate an immediate risk(s) to the participants may be implemented as needed, but must be reported to the REB at the earliest opportunity. For clinical trials, reporting requirements for safety data or unanticipated issues are also addressed in Chapter 11 (Articles 11.6 and 11.8). If the incident or issue has immediate implications for the safety of participants, the REB may withdraw ethics approval, which would require that the research be halted or modified until the matter can be addressed (Articles 6.3, 11.8 and 11.9). It may require submission of a revised research proposal for REB review.
Minor deviations from the research (e.g., a slight increase or decrease of testing time, a wording adjustment on a question) should not require immediate reporting to the REB, but may be summarized in annual status reports (Article 6.14). In some types of qualitative research, for example, emergent design (Article 10.5), the research design evolves over time, so adjustments to the research are to be expected and need not be reported to the REB, unless they alter the level of risk or have other ethical implications for participants (Article 6.16).
The report to the REB should include a description of the unanticipated issue or incident, including details of how the researcher(s) dealt with the situation. Reports may be submitted by researchers or, in some cases, by data safety monitoring boards (Articles 11.6 and 11.8). The point in reporting is to enable the REB and the researcher to better protect participants. Depending on the nature of the issue, and in consultation with researchers, REBs may require that researchers adjust their procedures to prevent its recurrence during the research project.
Requests for Changes to Approved Research
Researchers shall submit to their REBs in a timely manner requests for substantive changes to their originally approved research. REBs shall decide on the ethical acceptability of those changes to the research in accordance with a proportionate approach to research ethics review.
In general, it is not the size of the change that dictates the ethics review process, but rather the ethical implications and risk associated with the proposed change. In case of doubt on the potential impact of the change to approved research on the level of risk to participants, researchers should consult with their REBs. Changes that substantially alter the nature of the approved research may be assessed as a new research project and require a new REB review.
In the conduct of their approved research, researchers should be aware of the requirement to report to their REBs, in a timely manner, proposed changes from approved research that affect participants at any stage of the process including, but not limited to, changes to the consent form, changes to the tasks or interventions involved in the research, or changes to measures to protect privacy and confidentiality. Any substantive change to the research should not be implemented without documented approval by the REB, except when necessary to eliminate an immediate risk(s) to the participants.
Requests for changes to approved research may receive delegated or full REB review depending on the level of risk to participants that the changes represent. REB evaluation of these requests can result in a change to the assessed risk of the research and a corresponding change in the level of continuing ethics review.
REBs should give special attention to circumstances that may necessitate change in long-term research, such as new knowledge, equipment or instruments, or new or revised applicable policies and laws that may develop over the lifetime of a research project.
Record Keeping of Research Ethics Board Documents
REBs shall prepare and maintain comprehensive records, including all documentation related to the projects submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting REB decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision.
REBs need to act, and to be seen to be acting, fairly and reasonably. Institutions shall provide REBs with the necessary resources to enable them to maintain complete study files, including the original research proposal, as well as annual and end-of-study reports. When deciding the retention period of their files, REBs should be guided by their institutional record-keeping policies and other relevant legal or regulatory requirements. Files, minutes and other relevant documentation shall be accessible to authorized representatives of the institution, researchers, sponsors and funders when necessary to assist internal and external audits, or research monitoring, and to facilitate reconsideration or appeals.
The minutes of REB meetings shall clearly document the REB’s decisions, any dissents and the reasons for them. REB decisions should be supported by clear references (e.g., date of decision, title of project), documentary basis for decision (i.e., documents or progress reports received and reviewed), the plan for continuing ethics review and timelines, reasons for decisions, and any conditions or limitations attached to the approval. Providing reasons for REB decisions is optional when ethics approval is granted.
REBs should have written procedures for its management of record keeping and other submitted reports. REBs shall maintain reports and decisions on unanticipated issues or changes to approved research, including details of how the researcher dealt with or is proposing to deal with the situation and the REB’s response or decision (Articles 6.15 and 6.16).
The research ethics administration should also maintain general records related to REB membership and qualifications of members (e.g., copies of curriculum vitae, participation in relevant research ethics training).
C. Reconsideration and Appeals
Where researchers do not receive ethics approval, or receive approval conditional on revisions that they find compromise the feasibility or integrity of the proposed research, they are entitled to reconsideration by the REB. If that is not successful, they may appeal using the established appeal mechanism in accordance with the institution’s procedures.
Reconsideration of Research Ethics Board Decisions
Researchers have the right to request, and REBs have an obligation to provide, prompt reconsideration of decisions affecting a research project.
Researchers and REBs should make every effort to resolve disagreements they may have through deliberation, consultation or advice. If a disagreement between the researcher and the REB cannot be resolved through reconsideration, the researcher shall have the option of appealing the REB decisions through the established appeal mechanism (Article 6.19). REBs should establish timelines to promptly conduct reconsiderations and issue their decisions.
The onus is on researchers to justify the grounds on which they request reconsideration by the REB and to indicate any alleged breaches to the established research ethics review process, or any elements of the REB decision that are not supported by this Policy.
Appeal of Research Ethics Board Decisions
Institutions shall have an established mechanism and a procedure in place for promptly handling appeals from researchers when, after reconsideration, the REB has refused ethics approval of the research.
In cases when researchers and REBs cannot reach agreement through reconsideration, the institution shall provide access to an established appeal process for the review of an REB decision. The researcher and the REB must have fully exhausted the reconsideration process, and the REB must have issued a final decision before the researcher initiates an appeal.
Based on its written institutional policies, the same authority that established the REB shall establish or appoint an appeal committee that reflects a range of expertise and knowledge similar to that of the REB, and that meets the procedural requirements of this Policy. An appeal committee may be an ad hoc or a permanent committee. Members of the REB whose decision is under appeal shall not serve on that appeal committee.
It should be stressed that the appeal process is not a substitute for REBs and researchers working closely together to ensure high quality ethical research, nor is it a forum to merely seek a second opinion.
Institutions may wish to explore regional cooperation or alliances, including the sharing of appeal boards. If two institutions decide to use each other’s REB as an appeal board, a formal letter of agreement between institutions is required (Chapter 8).
It is not the role of the three federal research agencies that are responsible for this Policy to consider any appeals of REB decisions.
The appeal committee shall have the authority to review negative decisions made by an REB. In so doing, it may approve, reject or request modifications to the research proposal. Its decision on behalf of the institution shall be final.
Researchers have the right to request an appeal of an REB decision. An appeal can be launched for procedural or substantive reasons. The onus is on the researchers to justify the grounds on which they request an appeal and to indicate any breaches to the research ethics review process or any elements of the REB decision that are not supported by this Policy.
The appeal committee shall function impartially, provide a fair hearing to those involved, and provide reasoned and appropriately documented opinions and decisions. Both the researcher and a representative of the REB shall be granted the opportunity to address the appeal committee, but neither shall be present when the appeal committee deliberates and makes a decision. Appeal committee decisions on behalf of the institution shall be final and should be communicated in writing (in print or by electronic means) to researchers and to the REB whose decision was appealed. Recourse to judicial review may be available to the researcher.
D. Research Ethics Review during Publicly Declared Emergencies
This section addresses research ethics review within the context of the official declaration of public emergencies. For the purposes of this Policy, a publicly declared emergency is an emergency situation that, due to the extraordinary risks it presents, has been proclaimed as such by an authorized public official (in accordance with legislation and/or public policy).
Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly and require urgent or quick responses to minimize devastation. Examples include hurricanes and other natural disasters, large communicable disease outbreaks, catastrophic civil disorders, bio-hazardous releases, environmental disasters, and humanitarian emergencies. They tend to be time-limited. They may severely disrupt or may destroy normal functioning of institutions and communities, as well as individual lives. Once an emergency has been designated a publicly declared emergency, authorities may exercise special responsibilities and powers to deal with the situation, and the exercise of those responsibilities may temporarily modify normal procedures or practices. This section therefore applies to narrow, limited and exceptional circumstances.
There is a growing awareness of the need for institutional planning to respond to publicly declared emergencies and the associated potential challenges for research ethics review. Given the extraordinary circumstances that participants are potentially subjected to in publicly declared emergencies, special attention and effort should be given to upholding the core principles of Respect for Persons, Concern for Welfare, and Justice when reviewing the ethics of research to be conducted in emergencies. It should be noted that the following articles and the requirement for consent will not apply to public health activities undertaken by federal, provincial and territorial public health officials operating under statutory powers during publicly declared health emergencies.
Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies
In collaboration with their researchers, institutions and their REBs should develop preparedness plans for emergency research ethics review. Research ethics review during publicly declared emergencies may follow modified procedures and practices.
Preparedness plans should outline policies and procedures for addressing research ethics review during public health outbreaks, natural disasters and other publicly declared emergencies. Research ethics policies and procedures, and their implementation, should adhere rigorously to a rule of reasonable, fair, and principled design and use during publicly declared emergencies.
Through their emergency preparedness plans, institutions, researchers and their REBs need to anticipate the pressures, time constraints, priorities and logistical challenges that may arise to ensure quality, timely, proportionate and appropriate research ethics review. The plan and its policies should proactively address basic operational questions. Examples include, but are not limited to, how emergencies may affect research and research ethics review in institutions; how REBs conduct business or meetings; what research needs should be planned in advance of, or addressed after, an emergency; what research, if any, needs to be done during an emergency; what qualifies as time-sensitive or “essential” research; what procedures govern the research ethics review process in emergency circumstances; and what evaluation methods need to be developed for post-response evaluations to inform any revisions to the institution’s emergency procedures. It is important to pilot test the emergency procedures and plans in advance.
Policies should try to anticipate the extraordinary circumstances or demands occasioned by emergencies and set priorities among them. For example, REBs should try to work collaboratively with researchers who would likely be involved in emergency research (e.g., relevant biomedical, environmental and social science researchers), and determine what special consent provisions may be made (Chapter 3). Institutions might consider the use of an instrument to identify and triage the kinds of research that should be designed before, undertaken during or conducted after officially declared public emergencies. Likewise, a plan to help prioritize REB reviews during emergencies should take into account the following:
- what research is “essential” research during the emergency;
- the initial ethics review process of new research projects arising from the emergency (e.g., research involving interviews with first responders and victims to understand human response during a disaster, such as a tornado or earthquake);
- continuing ethics review of research undertaken prior to the occurrence of the emergency; and
- the ethics review process for changes to approved research, because new information may become available and require action very rapidly during emergencies (Articles 6.15 and 6.16).
REB procedures may warrant reasonable adjustments to address the timing, locale, expertise, form and scope of research ethics review, and the holding of REB meetings during emergency situations (Article 6.10). Special attention could be given to REB procedures to review and approve research (e.g., full or delegated research ethics reviews, quorum rules, or special agreements with other institutions), while considering the impact of the emergency on participants, researchers, REB members, institutional staff, and others. It is also important to coordinate research efforts and research ethics review processes within and across institutions. REB members may become unavailable (e.g., due to illness, relocation, or quarantine by public authorities). Institutions and REBs should explore the nomination of substitute REB members and consultation with ad hoc advisors with relevant expertise (Articles 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB reviews (Article 8.1), and revisit how scholarly review (Article 2.7) would be applied in emergency situations.
Research ethics review should be commensurate with the necessities occasioned by the emergency because of the critical interplay between public urgencies, essential research and a continuing commitment to the core principles even in the face of acute public necessity. Indeed, research ethics review during publicly declared emergencies is even more important than under normal circumstances, and may require even greater care, since everyone (participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.
Research Ethics Review Policy and Procedures during Publicly Declared Emergencies
Research ethics policies and procedures for emergencies take effect once an emergency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly declared emergency.
Because emergencies present extraordinary public risks that warrant special responses, legislation or public policies usually require that they be officially proclaimed or declared. Research ethics review procedures that have been established for use during publicly declared emergencies should be applied only after an authorized public official declares a public emergency. These procedures therefore apply to very narrow, limited and exceptional circumstances. Institutions and REBs must endeavour to return to normal operating procedures as soon as possible after public officials have declared that the emergency is over.
Respecting Core Principles: Limiting Exceptions
REBs should give special care to requests for exceptions to the principles and procedures outlined in this Policy during publicly declared emergencies.
Especially during times of emergency, researchers, REBs and institutions need to be vigilant and exercise due diligence in respecting ethical principles, procedures and the law in effect during the emergency to preserve the values, purpose and protection that the principles of this Policy advance.
To guide fair and reasonable implementation of these principles in emergency circumstances, any exception to, or infringement of, ethics principles and REB procedures must be demonstrably justified by those urging the exception or infringement.
Where exceptions to or infringements of ethics principles and REB procedures are justified, they should be narrowly tailored to address the necessities occasioned by the publicly declared emergency, such that they rely on the most restrictive or least intrusive means necessary to achieve the Policy goal: the promotion and guidance of ethical conduct in research. This approach – consistent with international bioethics and human rights norms – maximizes respect for ethical principles and helps to ensure that exceptions and the means to implement them are not unduly broad, overreaching or unjustifiably invasive.
Recognizing and respecting the principle of Justice means that research ethics review policies and procedures for publicly declared emergencies shall be used in a manner that is not discriminatory or arbitrary. The commitment to justice advances a fair and balanced distribution of risks and potential benefits even in the face of public emergencies.
REBs and researchers should be aware that individuals, prospective participants, researchers, and institutions may not normally be considered vulnerable, but may become so by the very nature of public emergencies. Those already vulnerable may become acutely so (Article 4.7). The increased public risks and devastation that cause public emergencies to be declared can threaten autonomy and physical, emotional, institutional and social welfare or safety. They also bring inherent tensions and pressures that may impact deliberative decision making. Taking all of this into consideration, REBs and researchers should ensure that the risks and potential benefits posed by any proposed research are appropriately evaluated, including provisions for greater than normal attention to risk, where applicable.
E. Review of Sponsor-Researcher Contracts
The rights of sponsors with respect to the analysis of data, interpretation of results and publication of findings, and ownership thereof, are typically described in sponsor-researcher contracts. In the context of clinical trials, they are often referred to as “clinical trial agreements.” These contracts may seek to place restrictions on access to data and the publication of findings, either directly or through provisions that seek to protect their intellectual property rights to research procedures, data, or other information.
Institutions should ensure that sponsors’ legitimate interests are reasonably balanced against researchers’ ethical and legal obligations to participants and their duty to disseminate data and research findings.
It is the responsibility of institutions to review clauses in sponsor-researcher contracts related to confidentiality, publication, and access to data. They shall require that any clauses related to confidentiality and publication be consistent with the researchers’ duties to:
- disclose new information that may affect participant welfare or consent to REBs and participants; and
- report research findings in a timely manner without undue restriction.
Institutions shall also ensure that sponsor-researcher contracts:
- stipulate that researchers, primarily the principal investigator, should assume the primary role and responsibility for the analysis, interpretation, and preparation of the findings for publication;
- permit principal investigators to access all study data;
- permit researchers to access all study data collected at their respective sites; and
- permit all researchers to access all study data in cases where no principal investigator is named.
Institutions must be satisfied that clauses will not impede researchers from reporting new information relevant to participants’ consent and/or welfare. They must be assured that such information will be reported in time to allow REBs to address any risks to participants.
Institutions shall make sponsor-researcher contracts available to REBs upon request. In addition, institutions must require the satisfactory amendment or removal of any restrictions in sponsor-researcher contracts that unduly limit either the content of the scientific information that may be disseminated or the timing of dissemination.
Contracts should ensure that principal investigators have the necessary access to original study data, and the opportunity to analyze them, to ensure that they can report study findings fairly and accurately, particularly with respect to efficacy and safety. Normally, it is the responsibility of the named principal investigator to examine the entire data set and to ensure that data are not inappropriately excluded from analyses and disseminations of findings.
The onus to justify restrictions on dissemination or access to data should lie with the one seeking any such restriction, usually the researcher or sponsor. Restrictions on information that participants would reasonably consider relevant to their welfare or that are required to give appropriate context to a manuscript or other publication, are seldom, if ever, justified (Articles 11.6 and 11.8).
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