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Revised Draft 2nd Edition of the TCPS (December 2009)

Chapter 6

GOVERNANCE OF RESEARCH ETHICS REVIEW

This chapter sets out the process of research ethics review: the elements necessary to establish a research ethics board (REB) and operational guidelines for the REBs and the review process, 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 operational independence 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 REBs

Authority, Mandate and Accountability

Article 6.1 Institutions shall establish or appoint REB(s) 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.

Application  Each institution is accountable for the research carried out in its own jurisdiction or under its auspices. In fulfilling this responsibility, where research with human participants 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 REB at another institution in accordance with the Memorandum of Understanding between the Agencies and institutions1. Such appointment should be based on an official agreement. 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 administration and education.

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 the articles below relating to composition and membership.

Members of an institution, that is 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. To enable the consistent application of this Policy, members of the institution should obtain REB approval of the ethical acceptability of their research if they engage in research involving humans related to one of their other organizational affiliations or to their supplemental professional activities. Should the institution assess that some situations warrant an exception, the basis and conditions for case-by-case exceptions shall be clearly documented in their institutional policies. Case-by-case exceptions may be determined by such factors as the degree to which the member’s affiliation with the institution is his/her primary affiliation, by how practical it is to distinguish the capacity in which the member is conducting the research, and the research participants’ reasonable perceptions of this. 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 methods to address real, potential or perceived conflict of interests issues.

Similarly, the requirement for REB review applies to research dimensions of student co-op work or field placements that are part of, and credited to, educational programs to provide exposure to the field and allow application of the knowledge and skills acquired from those programs. Where co-op placements involve components of research, institutions and organizations hosting co-op student researchers may consider specifying in advance, in policies, agreements or contracts for co-op student placements, the roles and responsibilities pertaining to ethics review of research involving humans of the host organization versus those of the institution.

Article 6.2  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 fulfil their duties. REBs are independent in their decision making and are accountable for the process of ethics review.

Application  REBs shall be established by and have an appropriate reporting relationship to the highest body of the institution. This 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 shall have in place written procedures for the appointment, renewal and removal of REB members.

For the integrity of the research ethics 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 over a decision that cannot be resolved through discussion and reconsideration can be resolved through the normal appeal process. (See Articles 6.17 to 6.19).

Institutional policies and procedures shall also support and promote the effective and independent operation of REBs. REBs should have the independence to conduct ethics reviews free of inappropriate influence, including situations of real, potential or perceived conflict of interests. (See Chapter 7).

As an entity that draws its authority and resources from the institution, the REB remains accountable to the institution for the integrity of its processes.

Article 6.3 The institution grants 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 human participants. This applies to research conducted under the auspices or within the jurisdiction of the institution, using the considerations set forth in this Policy.

Application The institution shall delegate the authority of the REB 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 such that it covers as broad a range of research consistent with a manageable workload and relevant competence. 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. (See Chapter 8).

Institutions shall respect the authority delegated to the REB. An institution may not override REB decisions simply to promote or prevent a particular research project.

REB Composition

Basic REB 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.

Article 6.4  The REB shall consist of at least five members, of whom:

(a)  at least two members have expertise in relevant research disciplines, fields, and methodologies covered by the REB;

(b)  at least one member is knowledgeable in ethics;

(c)  at least one member is knowledgeable in the law (but that member should not be the institution’s legal counsel or risk manager); and

(d)  at least one community member who has no affiliation with the institution.

Each member shall 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.

Application  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. While each member shall be formally appointed to provide the perspective of one of the above categories as the member’s primary responsibility, they 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]).

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 in order to ensure an adequate and thorough review, or to respond to other local, provincial/territorial or federal legal or regulatory requirements. For example, for 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. Community representation should be proportionate to the size of the REB. Institutions are encouraged to establish a pool of substitute members (see below).

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, education, or topics involving Aboriginal 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 have different contextual and disciplinary knowledge in ethics than has a member of 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, for example – 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.

In some instances, the legal issues 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.

Community member: The community member shall not be affiliated with the institution and should not be currently engaged in scientific, legal or academic work. 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, local communities. The role of community members on REBs during the research ethics process is both unique and at arm’s length from the institution. Their primary role is to reflect the perspective of the research participant. This is particularly important when research participants are vulnerable and/or risks to research participants are high.

To maintain effective community representation, the number of community representatives 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. (See Article 6.7).

In addition to a broad-based representation from the community, it is highly desirable that institutions seek to appoint former research participants on REBs. Their experience as research participants provides the REB with a vital perspective and important contributions to the ethics review process.

Substitute members: 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 use 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 ethics review process.

Ad hoc Advisors

Article 6.5 The REB should have provisions for appointing ad hoc advisors in the event that it lacks the specific expertise or knowledge to review a research proposal competently.

Application  In the event that the REB is reviewing a project that requires particular community or research participant representation, or a project that requires specific expertise not available from its members, it should have provisions for appointing ad hoc advisors. The REB shall maintain its composition and representation as outlined in Article 6.4.

Ad hoc advisors are appointed for a specific task and for the duration of the 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 review of research on topics related to Aboriginal peoples is regularly required, the REB membership should be modified to ensure that relevant and competent knowledge and expertise of Aboriginal cultures are captured within its regular complement.

While an ad hoc advisor may complement the REB through his or her experience, knowledge or expertise, his or her input is a form of consultation that may or may not be considered in the final decision of an REB. He or she is not an REB member and, as such, does not necessarily have the knowledge and experience gained from reviewing applications as a member. 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 REB Members

Article 6.6 In appointing REB members, institutions shall establish their terms to allow for continuity of the ethics review process.

Application  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.

Article 6.7 In appointing and renewing REB members, the institution should consider the qualifications and expertise the REB needs, and should provide REB members with necessary training to review the ethical issues raised by research proposals that fall within the mandate of the REB.

Application  An REB should have adequate expertise, experience and training to understand the research disciplines, methodologies and approaches of the research that it considers for ethics review. While an REB possesses the necessary expertise globally, each REB member brings specialized and complementary expertise and knowledge, or relevant experience.

Institutions should ensure that all REB members receive appropriate education and training in the ethics review of research involving humans, to enable them to fulfil their duties. This includes training 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 on the appointment of new members and periodically throughout a member’s tenure.

Institutions should promote and recognize the contribution of REB members to the ethics review process, as a valued and essential component of the research enterprise.

Article 6.8  The REB Chair is responsible for ensuring that the REB review process conforms to the requirements of this Policy.

Application  The role of the REB Chair is to provide overall leadership for the REB and 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 that they are clearly communicated to researchers in writing as soon as possible. Institutions shall provide the necessary resources to enable the REB Chair to fulfil his or her responsibilities.

REB Quorum

Article 6.9 Institutions shall establish quorum rules for REBs subject to the range of competence and knowledge required by this Policy to ensure the soundness and integrity of the ethics review process.

Application  REB quorum shall be at least five members, shall meet the minimum requirement of membership representation outlined in Article 6.4, and shall take into account the presence at a given meeting of the specific expertise, relevant competence and knowledge necessary to provide an adequate ethics review of the proposals under consideration at that meeting.

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 (see Article 6.5). Decisions without a quorum are not valid or binding.

REB Meetings and Attendance

Article 6.10 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.

Application     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 and effectiveness of communications and decisions.

Planning regular meetings is essential to fulfilling REB responsibilities. A schedule of REB meetings should be communicated to researchers for the planning of ethics review of their research. Regular attendance by REB members at meetings is important, and frequent absences should be construed as a notice of resignation. Unexpected circumstances such as emergencies may prevent individual member(s) from attending the REB meeting. In these exceptional cases, input from member(s) by other means (e.g. use of technology) would be acceptable.

Videoconferencing, teleconferencing and 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, such as 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. Respecting the principles of this Policy, institutions should consider developing written procedures for the occasional use of videoconferences 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 for example establish the stage at which REB review and approval would be required, or facilitate the review. Such informal meetings cannot, however, substitute for the formal review process.

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. However, individuals who are not REB members should be aware of how their institutional functions, how their roles may be perceived at REB meetings, and how they have the potential to unduly influence REB members in their decision making procedures. (See Chapter 7).

REBs should also hold general meetings, retreats and educational workshops to enhance educational opportunities that may benefit the overall operation of the REB, discuss any general issues arising out of the REB’s activities, or revise relevant policies.

B. Procedures for REB Review

Initial Research Ethics Review

Article 6.11 Researchers shall submit their research project for REB review and approval of its ethical acceptability prior to the start of recruitment of research participants or access to data. Subject to Article 10.1, REB review is not required for the initial exploratory phase involving contact with individuals or communities intended to establish research partnerships or the design of a research study.

Application     REB review and approval of the ethical acceptability of research is required before recruitment or the formal data collection involving research participants. Similarly, as an integral component of their research design, researchers may undertake pilot studies involving research participants whose data will be used in the full implementation of a larger study. For the conduct of such pilot studies, researchers should seek consent from prospective participants and obtain REB approval before recruitment or the formal data collection involving research participants.

Some types of research using quantitative, qualitative research, or a combination of these methods as well as collaborative or community-based research (see Chapters 9 and 10) may entail, prior contact and dialogue with individuals or communities of interest as a normal and integral component to establish research collaborations or partnerships prior to the actual design of the study. Other research may at their initial stages not involve humans, but require for example engaging the research team, setting up equipment, and other preparatory stages. This may precede REB review.

Article 6.12     REBs shall follow a research ethics review process proportionate to the level of risk in research under review.

Application     REBs shall assess the level of risk that the research under review poses to participants to determine the appropriate proportionate approach to use in the ethics review. (See Article 2.9).

With the support of their institutions, REBs may develop their own mechanisms under which delegation of the conduct of review, decision making, and the associated reporting process will occur. Those mechanisms and procedures should be made public. It is the REB, through its chair, that decides on the level of review to be utilized.

Two levels of ethics review may apply:

1. Full REB review

Ethics review by the full REB should be the default requirement for research involving human participants.

2. Delegated REB review of minimal-risk research

The REB delegates ethics review to an individual or individuals. Delegates may be selected from among the REB membership or at the faculty or department level.

Where it is determined that the research is of minimal risk (defined in Chapter 2 of this Policy), an REB generally may authorize a delegated ethics review and decision making, in accordance with its institutional policies. The REB may decide that its Chair or another individual(s) (e.g. delegated reviewer[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 revert back to the full REB.

In delegating the conduct of review, the REB should carefully select delegated reviewer(s) and should ensure that all delegated reviewers who are not members of the REB have the appropriate expertise and training to review all aspects of the proposal consistent with this Policy. In selecting delegated reviewers and in the process of delegation, special attention should be given to situations of real, potential or perceived conflict of interests as outlined in Article 7.3.

Examples of categories that may be delegated for 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 research will no longer involve new interventions to current research participants, does not involve the recruitment of new research participants, and the remaining research activities are limited to data analysis;
  • evidence that conditions or other requirements laid down by the REB in an initial review have been met.
An institution may decide that ethics review of research that is carried out by undergraduate students as part of their course work may be reviewed by a delegated review process that complies with this Policy. The REB should set out criteria for determining which categories of research proposals are suitable for consideration through this means, and establish procedures, such as who is responsible for implementing and overseeing the approval mechanisms. Where an undergraduate student is carrying out research that is part of a faculty member’s own research program, such research should be reviewed by the regular REB procedures.

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, through its chair, in a timely and appropriate manner, thus permitting 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 continues to be responsible for the ethics of all research involving human participants within its jurisdiction.

Article 6.13 The REB shall function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical acceptability of research in a timely manner, and shall communicate approvals and refusals to researchers in writing in print or by electronic means.

Application  The REB shall accommodate reasonable requests from researchers and may initiate invitations to researchers to participate in discussions about their proposals, but 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. (See Article 6.17).

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 mandated by the institution. In such instances, the minority position may be communicated to the researcher.

Participation by the researcher in such discussions is often very helpful to both REBs and researchers. Such discussions 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 Ethics Review

Article 6.14  The REB shall make the final determination as to the nature and frequency of the continuing ethics review in accordance with a proportionate approach to ethics review. At minimum, continuing ethics review shall consist of an annual status report on the research, followed by an end-of-study report.

Application  Research is subject to continuing ethics review from the date of initial REB approval until completion of the study. (See Article 2.8) At the time of first 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. For research projects lasting longer than one year, researchers should submit at minimum an annual report with sufficient details to enable the REB to make an informed judgment about the ethical acceptability of the research. For research lasting less than one year, an end-of-study report may suffice.

For some types of research (e.g. qualitative research or longitudinal research), there may be some difficulty in establishing start or end dates. For 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 study. 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.

Research that involves minimal or no risk to the research participant should be held to the minimum requirements for continuing ethics review, that is, a short annual report. Following 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 a more extensive continuing ethics review. This could include, for example, 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 or sponsors.

While REBs make the final decision about the nature and frequency of continuing ethics review, continuing ethics review should be understood as a collective responsibility, to be carried out with a common interest in maintaining the highest ethical standards. For example, researchers have a responsibility to monitor their research to ensure that the research is conducted in an ethical manner. Researchers are responsible for supervising all team members in the application of the research procedures and for ensuring that they are versed in the conduct of ethical research. Institutions should provide necessary resources to REBs to assist them in fulfilling their continuing ethics review responsibilities.

Departures from Approved Research

Article 6.15 REBs shall make decisions on the ethical acceptability of researchers’ departures from the originally approved research in accordance with a proportionate approach to research ethics review.

Application Three categories of departures from approved research may occur during the conduct of research. These include (1) unanticipated or unexpected events or issues that the researcher did not anticipate or expect when originally submitting the research for ethics review; (2) changes that the researcher makes to the approved research; and (3) deviations from approved research when unavoidable single-incident departures from the originally planned research procedure occur.

In the conduct of their approved research, researchers should be cognizant of the requirement to report to their REB, in a timely manner, departures from approved research that have ethical implications and/or change the level of risk to participants, which could adversely affect their welfare. Any non-trivial or substantive changes to the research should not be implemented without documented approval or acceptance by the REB, except when necessary to eliminate an immediate hazard(s) to the research participants.

Institutions shall have an established process for the REB to review and take appropriate action regarding departures from approved research, including reporting to senior administration and other administrative units where necessary and appropriate.

The level of REB review required to assess the changes or deviations from approved research that have ethical implications and/or change the level of risk to participants shall follow a proportionate approach to ethics assessment, including changes to the continuing ethics review process. It is not the size of the change that dictates the review process, but rather the ethical implications and risk associated with the proposed change. In general, regardless of the term of approval, projects will need to be re-reviewed or amended if the context surrounding the research project changes. Although the REB holds responsibility for reviewing the ethics of research in light of changes in context, the researcher has a responsibility to be familiar with the environment in which the research is being conducted and to notify the REB about changes that may affect the ethics of the research.

The final decision as to which type of deviations to report to the REB is up to the REB. The report to the REB should include a description of the incident, including details of how the researcher(s) dealt with the situation. The point in reporting is informational and educational; it is to enable the REB to better protect research participants in future research projects. Depending on the nature of the event or issue, REBs may require that researchers adjust their procedures to prevent such events from re-occurring during the research project. An REB may stipulate a timeframe for the reporting of such events.

In the case of clinical trials, unexpected or unanticipated events and reporting requirements are defined and addressed in Chapter 11 of this Policy. In some cases, such events may be identified by Data and Safety Monitoring Boards or study sponsors. If the event has immediate implications for the safety of research participants, the REB may require that the research be halted until the matter can be addressed. (See Articles 11.3 and 11.4).

In still other kinds of research (especially in the social sciences and humanities), it is not always clear before the research is undertaken what events may occur during the course of the research project. Here, researchers should report any event that occurred as a result of the research and that may affect the welfare of the research participants. In case of doubt on the potential impact of the departure from approved research on the level of risk to participants, researchers should consult with their REBs. Researchers and REBs may work together to develop a list of types of reportable events.

Record Keeping of REB Documents

Article 6.16 REBs shall prepare and maintain comprehensive records, including all documentation related to the studies submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting research ethics decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision.

Application REBs need to act, and to be seen to be acting, fairly and reasonably. Institutions shall provide REBs the necessary resources to enable them to maintain complete study files, including the original application, as well as annual and end-of-study reports. This should be guided by their institutional record-keeping policies and other relevant legal or regulatory requirements when deciding the retention period of their files. Minutes and other relevant documentation shall be accessible to authorized representatives of the institution, researchers, sponsors and funders when applicable 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 and 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 maintain reports and decisions on departures from approved research, including a description of the unexpected or unanticipated event, change or deviation; details of how the researcher dealt with the situation; and the REB’s approval or acceptance of such changes.

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 training).

C. Reconsideration and Appeals

Where researchers do not receive ethics approval upon initial review, or receive approval with conditions 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 to a separate review board.

Reconsideration of REB Decisions

Article 6.17 Researchers have the right to request, and REBs have an obligation to provide, reconsideration of decisions affecting a research project.

Application REBs should follow principles of natural and procedural justice in their decision making. This includes providing a reasonable opportunity to be heard; reasoned grounds for the decisions, and the opportunity for rebuttal. (See Article 6.13). Researchers and REBs should make every effort to resolve disagreements they may have through deliberation, consultation or advice. If a disagreement cannot be resolved by the researcher and REB, the researcher shall have the option of appealing the REB decision through the established appeal mechanism. (See Article 6.18).

In the case of protocols reviewed by delegated review, requests by the researcher for reconsideration of a delegated review decision should be forwarded by the researcher for review by the full REB. The onus is on researchers to justify on what grounds they request reconsideration and indicate the breaches to the research ethics process or the elements of the delegated REB decision that are not supported by this Policy.

Appeal of REB Decisions

Article 6.18 Institutions shall have an established mechanism and a procedure in place for entertaining appeals from researchers when they cannot reach agreement with REBs through discussion and REB reconsideration.

Application In cases when researchers and REBs cannot reach agreement through discussion and reconsideration, an institution shall provide access to an established appeal process for the review of an REB decision.

By nature of its role and lack of frequency of meeting, an appeal body is typically ad hoc. Therefore, the appeal mechanism may be an ad hoc committee or a permanent committee, as long as individuals involved in the appeal process have the relevant knowledge and competence to review REB decisions and procedures based on this Policy. (See Article 6.4). An appeal body shall be established by the same body that created the REB. Members of the REB whose decision is under appeal shall not serve on that appeal body.

It should be stressed that the appeal process is not a substitute for REBs and researchers working closely together to ensure high-quality research, nor is it a forum to merely seek a second opinion.

Small 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.

It is not the role of the three federal research Agencies who are responsible for this Policy to entertain any appeals of REB decisions.

Article 6.19 The appeal body shall have the authority to approve, reject or request modifications to negative decisions made by an REB. An appeal body can overturn negative decisions made by an REB. Its decision shall be final.

Application Researchers have the right to request an appeal of an REB decision once the period of reconsideration has expired or the reconsideration process has been exhausted and the REB has issued a final decision. The onus is on the researchers to justify on what grounds – for example, content, procedures, conflict of interests of REB member(s), or disagreement on interpretation of this Policy – they request an appeal and indicate the breaches to the research ethics process or the elements of the REB decision that are not supported by this Policy.

The appeal body 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 body, but cannot be present when the appeal body deliberates and makes a decision. Appeal body decisions shall be final, and should be communicated in writing (in print or by electronic means) to researchers and to the REB the decision of which was appealed.

D. Research Ethics Review During Publicly Declared Emergencies

There is a growing awareness of the need for institutional planning to respond to public emergencies and the associated potential challenges for research ethics review. Public 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 institutional, community and individual lives.

This section addresses research ethics review within the context of the official declaration of public emergencies, which initiates emergency procedures and provides special responsibilities and powers to authorized officials in accordance with provisions of the law. Given the extraordinary circumstances that research participants are potentially subjected to in public 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 such emergencies. It should be noted that the following articles and the requirement for consent will not apply to research undertaken by federal, provincial and territorial public health officials operating under statutory powers during public health emergencies.

Institutional Emergency Research Ethics Preparedness Plans

Article 6.20     In concert with their researchers, institutions and their REBs should develop emergency research ethics preparedness plans. Research ethics review during emergencies may follow modified procedures and practices.

Application Preparedness plans should outline policies and procedures for addressing research ethics review during and concerning public health outbreaks, natural disasters and other public emergencies. Research ethics policies and procedures and their implementation should adhere rigorously to a rule of reasonable, fair and principled design and use for emergency purposes.

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 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 meet; what research needs should be planned in advance of, or done 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 ethics review; and what evaluation methods need to be developed. 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-type research such as researchers in relevant biomedical, environmental and social science areas, and what special consent provisions may be made in emergency research. (See 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 consider the following:

  • what constitutes “essential” research during the emergency;
  • the initial 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 review process for departures from approved research, because new information may become available very rapidly during emergencies. (See Article 6.15).
REB procedures may warrant reasonable adjustments to address the timing, locale, expertise, form and scope of review, and the holding of REB meetings during emergency situations. (See Article 6.10). Special attention could be given to REB procedures to review and approve research (e.g. full or delegated ethics reviews, quorum rules, or special agreements with other institutions), while considering the impact of the emergency on research participants, researchers, REB members, institutional staff and others. 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 ad hoc advisors with relevant expertise (see Articles 6.4 and 6.5), negotiate reciprocity agreements with other institutions for REB reviews (see Article 8.1), and revisit how scholarly review would be applied in such instances.

Research ethics review should be proportionate to 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. Research ethics review during or regarding public emergencies is even more important than under normal circumstances and may require even greater care and scrutiny, since everyone (research participants, researchers and REB members themselves) may be rendered more vulnerable by the nature of the emergency.

Application of Research Ethics Review Policy and Procedures in Publicly Declared Emergencies

Article 6.21 The application of research ethics policy and procedures for emergencies is limited to the duration of officially declared public emergencies and should cease as soon after the declared emergency as is feasible.

Application Research ethics review policies and procedures for declared emergencies should be applied only to compelling public necessities occasioned by a public emergency. Public emergencies for the purposes of this Policy are limited to those that are declared by an authorized public official. This section therefore applies to narrow, limited and exceptional circumstances. Because emergencies present extraordinary public risks that warrant special responses, legislation or public policies usually require that they be officially proclaimed or declared. The exercise of those responsibilities may temporarily modify normal procedures or practices.

Respecting Core Principles: Limiting Exceptions

Article 6.22 REBs should give special care to requests for exceptions to the principles and procedures outlined in this Policy during publicly declared emergencies.

Application  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 such emergency. To preserve the values, purpose and protection that the principles of this Policy advance, the onus for demonstrating a reasonable public-emergency exception to an ethical principle or procedure should fall on those claiming the exception.

To guide fair and reasonable implementation for emergency circumstances, any exception to or infringement of ethics principles and procedures need to be demonstrably justified by those urging the infringement. Sometimes a proposed infringement or exception will not be justified for research purposes. Justified exceptions to or infringement of ethics principles and procedures should correspond directly, and be calibrated, to the benefit targeted by the goal of the policy. Exceptions should be narrowly tailored to address the necessities occasioned by the public emergency, such that the least restrictive or least intrusive means necessary to achieve the policy goal are relied on. This approach – consistent with international bioethics and human rights norms – maximizes respect of ethical principles and helps to ensure that exceptions or infringements 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, potential participants, researchers, and institutions that may not normally be considered vulnerable may become so by the very nature of public emergencies. Those already vulnerable may become acutely so. REBs and researchers should ensure appropriate evaluation of the risks and potential benefits posed by any proposed research, including provisions for greater-than-normal attention to risk, where applicable. The increased public risks and devastation on which public emergencies are declared threaten autonomy and physical, emotional, institutional and social welfare or safety. They also bring inherent tensions and pressures that may impact deliberative decision making. Research ethics policy and review for public emergencies should recognize that in such situations the affected population, as individuals or as a body, may become more vulnerable. Therefore, the need to respect participants and be concerned about their welfare shall be accordingly addressed. (See Article 4.6 ).

Endnote

[1] Memorandum of Understanding on the Roles and Responsibilities in the Management of Federal Grants and Awards at www.nserc-crsng.gc.ca/NSERC-CRSNG/Policies-Politiques/MOURoles-ProtocolRoles/index_eng.asp