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 and authority 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 welfare, autonomy and equal moral status to their review of research projects. These operational guidelines are meant to ensure that independence, yet 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.
Article 6.1 Institutions shall establish independent research ethics boards to review the ethical acceptability of 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 In fulfilling this responsibility, institutions are required to develop the necessary structure of independent REBs for the ethics review of research involving humans.
Where research with human participants takes place within the jurisdiction or under the auspices of an institution, that institution must establish an REB (or REBs) capable of reviewing the ethical acceptability of that research. To ensure integrity and safeguard public trust in the research process, the REB must maintain an arm’s-length relationship with, and act independently from, the parent organization.
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.
Article 6.2 The highest appropriate body within an institution shall establish the research ethics board (REB) or REBs and provide them with sufficient and appropriate financial and administrative independence to fulfil their duties. REBs shall report directly to the highest level of the institution that has the overall responsibility for research involving humans conducted under its auspices or within its jurisdiction.
Application REBs should be established by and report to the highest appropriate 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 or board of directors. The highest body may delegate the reporting function as it deems appropriate.
In order to ensure that REBs are able to operate effectively and independently, institutions should dedicate the appropriate financial and human resources to their support. Institutional policies and procedures should also support and promote the effective and independent operation of REBs. Similarly, institutions should avoid situations that may undermine the independence of REBs. For example, REBs should not report (other than for purely administrative purposes) to institutional officers who are directly responsible for promoting research, as this may result in situations of real or apparent conflict of interest. (See Chapter 7 [“Conflict of Interest”].)
While the REB should have the independence to conduct ethics review free of inappropriate influence, it remains accountable to the institution for the integrity of its processes, including its decision-making processes. REB independence, therefore, does not mean that the REB is immune from scrutiny.
Article 6.3 The institution grants the research ethics board 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 that is 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 must clearly define the types of research that the REB may review. 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. An institution may wish to use different models for the ethics review of research conducted under its auspices. Institutions must have clear written policies describing the mandate of each REB.
Institutions must respect the authority delegated to the REB. While an individual researcher may appeal a decision of an REB, an institution may not override REB decisions simply to promote or prevent a particular research project. Institutions may, however, as a matter of policy, refuse to allow certain types of research to be conducted under its auspices regardless of the ethical acceptability of that research.
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 research ethics board (REB) shall consist of at least five members, of whom:
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. Senior administrators should not serve on the REB (see Article 7.3 in Chapter 7 [“Conflict of Interest”]), in order to avoid the perception of perceived, potential or real conflict of interest.
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 based on the needs of the institution. Institutions should ensure proper gender representation on REBs where possible. Institutions may therefore need to exceed these minimum requirements in order to ensure an adequate and thorough review, or to respond to other local, provincial/territorial or federal requirements or legislation. 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.
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 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, and proportionate to, 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, 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 institutions’ 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 sit 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 with no affiliation 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, 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. Institutions should seek to appoint former research participants as community members. Their experience as research participants provides the REB with a vital perspective and important contributions to the ethics review process. Institutions should provide training opportunities to community members.
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.
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 structure 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 research ethics board 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 maintains 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 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 Research ethics board members shall be appointed by the appropriate body at the highest level of the institution such that their terms 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 Research ethics board (REB) members should have the qualifications, expertise and training necessary to review the ethical issues raised by research proposals that fall within the mandate of their REB.
Application In selecting new members for appointment, the REB should consider the qualifications it needs in order to fulfil the requirements of Article 6.4.
REBs should have adequate expertise, experience and training to understand the research disciplines, methodologies and approaches of the research that it considers for ethics review. Each REB member brings complementary expertise and knowledge. It is not sufficient for an REB to possess the necessary expertise globally, however. It must ensure that the members in attendance at any given meeting have the specific expertise necessary to review the proposals under consideration at that meeting.
All members of the REB should understand core ethics principles and concepts as set forth in this Policy to contribute to the review process. 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 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 research ethics board (REB) Chair is responsible for ensuring that the operations of the REB comply with institutional policies and procedures concerning the ethics review process.
Application The role of the REB Chair is to facilitate the REB review process, operations and procedures, 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 properly and that they are communicated to researchers in writing as soon as possible. The institution should provide the Chair with administrative support in fulfilling his or her role.
Article 6.9 Institutions shall establish quorum rules for research ethics boards subject to the range of competence and knowledge required by this Policy to ensure the soundness and integrity of the ethics review process.
Application Quorum rules should be established by institutions such that REB decisions requiring full review should be adopted only if the members attending the meeting possess relevant competence and knowledge and meet the minimum requirement of membership as outlined in Article 6.4. Among the REB members there should be at least two members who have relevant expertise in the methods or areas of research that are covered by the REB, one member who is knowledgeable in ethics, one member who has no affiliation with the institution but is recruited from the community served by the institution, and one member who is knowledgeable in the law. Quorum should be proportionate to the increases of the REB membership necessary to ensure adequate ethics review.
Ad hoc advisors, observers and others attending REB meetings should not be counted in the quorum for an REB nor be allowed to vote on REB decisions (see Article 6.5). Decisions without a quorum are not valid or binding.
Article 6.10 Research ethics boards shall have regular face-to-face meetings to discharge their responsibilities.
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. REBs shall meet face-to-face to review proposed research that is not assigned to delegated review.
Planning regular meetings is essential to fulfilling REB responsibilities. 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 and use of other technologies may occasionally 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. Respecting the principles of this policy, institutions should develop written procedures for the occasional use of videoconferences or other technologies by an REB.
REBs and researchers may request informal meetings with each other prior to the formal review process to 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 or observers 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 could affect REB members in a way that would affect REB research ethics review deliberations and decisions. 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 [“Conflict of Interest”]).
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.
Article 6.11 Researchers should submit their research project for research ethics board review and approval prior to the start of the formal data collection.
Application For some types of methodologies, such as in qualitative research or fields of research such as those involving Aboriginal peoples, the design of the study may not be known at the onset, but only after the researcher has engaged with prospective participants.
Prior dialogue with individuals or communities of interest is a normal component in community-based research or in some types of fields or disciplines of research. This may precede REB review.
Article 6.12 Research ethics boards shall follow a research ethics review process proportionate to the level of risk in research under review.
Application REBs must 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. At the time of initial review of the research, the REB has the authority to determine the level at which continuing ethics review occurs (e.g., frequency of reports, required details in reports). The level of review and reporting schedule may be adjusted throughout the life of the project if the need arises in situations where the risk level of the research increases because of the discovery of new information or changes in procedures.
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, an REB generally may authorize a delegated ethics review, 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.
Examples of categories delegated for ethics review include:
An REB that decides to authorize a delegated review process must 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, thus permitting the REB to maintain surveillance over the decisions made on its behalf so as to protect the interests of participants.
REBs retain the authority to accept the report as presented or to request a more rigorous review process. It is imperative that delegated reviewer(s) be accountable to the full REB. With the support of their institutions, REBs may develop their own mechanisms under which delegation of the conduct of review and the associated reporting process will occur. Those mechanisms and procedures should be made public.
Article 6.13 The research ethics board shall function impartially, provide a fair hearing to those involved and provide reasoned and appropriately documented opinions and decisions. Approvals and refusals need to be communicated in writing to researchers in print or by electronic means.
Application The REB shall accommodate reasonable requests from researchers to participate in discussions about their proposals, but those researchers must 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.
The formal REB decision on whether to approve the research will often be preceded by extensive discussion of ethical concerns and of possible means of improving certain aspects of the research. These may include the research design or the information to be provided in the process of free and informed consent that affect the welfare or autonomy of participants or others affected by the research. 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 position of those disagreeing 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.
Article 6.14 As part of ethics review, research ethics boards should consider the appropriate mechanism for scholarly review of more-than-minimal-risk research, informed by the traditions for scholarly review in various disciplines.
Application Where it is determined that the research presents more than minimal risk to participants, the full REB should consider some of the following mechanisms in their review:
REBs should normally avoid duplicating previous professional peer-review assessments unless there is a good and defined reason to do so. However, they may request that the researcher provide them with the full documentation of those reviews.
When evaluating the merit and the scholarly standards of a research proposal, the REB should be concerned with a global assessment of the degree to which the research might further the understanding of a phenomenon, and not be driven by factors such as personal biases or preferences. REBs should not reject research proposals because they are controversial, challenge mainstream thought, or offend powerful or vocal interest groups. The primary tests to be used by REBs should be ethical probity and high scientific and scholarly standards.
Article 6.15 The research ethics board 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.
Application Research is subject to continuing ethics review from the date of initial REB approval until completion of the study. At the time of first review, the REB should determine the term of approval. 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. The reporting schedule for continuing ethics review may be adjusted throughout the life of the project if the need arises in situations where the risk level of the research increases because of the discovery of new knowledge or addition of new procedures.
Research that involves minimal or no risk to the research participant should be held to the minimum standard of continuing ethics review - for example, a short annual report. Research that poses greater-than-minimal risk may require a more extensive continuing ethics review. This could include more frequent reporting to the REB, review of the consent process, and review of participant records, etc. Other reporting mechanisms for continuing ethics review may be required by funding 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 and scientific standards. For example, researchers must 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.
Article 6.16 Research ethics boards 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 well-being or 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 must 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.
In the case of clinical trials, unexpected or unanticipated events and reporting requirements are defined in International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance E6: Good Clinical Practice: Consolidated Guideline (ICH-GCP) . An REB may stipulate a timeframe for the reporting of such events. 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 and protection 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 Chapter 11 [“Clinical Trials”].)
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 safety and well-being of the research participants. In many cases, researchers will simply need to use their best judgment as to what should be reported to the REB. In other cases, the researchers and REBs may work together to develop a list of types of reportable events.
Article 6.17 Research ethics boards (REBs) shall prepare and maintain comprehensive files, including accurate minutes reflecting research ethics review decisions and attendance of all REB meetings, as well as all documentation related to the studies submitted to the REB for review.
Application REBs need to act, and to be seen to be acting, fairly and reasonably. REBs should maintain complete study files, including the original application, as well as annual and end-of-study reports. REBs should be guided by their institutional record-keeping policies and other relevant legislation or requirements when deciding the retention period of their files. Minutes and other relevant documentation must be accessible to authorized representatives of the institution, researchers, sponsors and research agencies 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 is mandatory when a proposal is refused; it is optional when it is approved.
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 REB should also maintain general records related to REB membership and qualifications of members (e.g., copies of curriculum vitae, participation in training).
Appeals of REB decisions follow a two-tiered approach. The first step - reconsideration - must be exhausted before a researcher may proceed to the second step - the appeal process.
Article 6.18 Researchers have the right to request, and research ethics boards have an obligation to provide, reconsideration of decisions affecting a research project.
Application REBs are to follow principles of natural and procedural justice in their decision-making. Such principles include providing a reasonable opportunity to be heard; an explanation of the reasons for opinions or decisions; and the opportunity for rebuttal, fair and impartial judgment, and reasoned grounds for the decisions. Researchers and REBs should make every effort to resolve their disagreement through deliberation, consultation or advice. If a disagreement cannot be resolved by the researcher and REB, recourse to the appeals process may be considered.
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. Researchers must justify on what grounds they request a 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.
Application Institutions must have an established mechanism and procedure in place for entertaining appeals.
By nature of their role and lack of frequency of meeting, appeal committees are typically, de facto, 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).
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 6.20 The scope of any appeal will be limited to assessment of the consistency of the research ethics board’s decision with this Policy.
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. Researchers must justify on what grounds 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 Committee will determine whether the REB acted outside its mandate and/or committed a breach of the process for ethics review as set out in the most recent version of the institution’s guidelines or policies and this Policy.
The Appeal Committee has no jurisdiction to make a decision regarding the ethical acceptability of the research study involved in the process under appeal. It should be stressed that the appeals process is not a substitute for the REB’s and the researcher’s working closely together to ensure high-quality research, nor is it a forum to merely seek a second opinion. It is expected that an appeal will be an exceptionally rare occurrence.
The Appeal Committee shall do one of the following:
The Appeal Committee shall function impartially, provide a fair hearing to those involved, and provide reasoned and appropriately documented opinions and decisions. Approvals and refusals should be communicated in writing to researchers in print or by electronic means.
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 life.
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 welfare, autonomy in the decision-making process, and the equal moral status of all humans in such emergencies.
Article 6.21 In concert with their researchers, institutions and their research ethics boards 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 ethics review in institutions/REBs; 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, 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:
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, negotiate reciprocity agreements with other institutions for REB reviews, 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 core ethics 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.
Article 6.22 The application of research ethics policy and procedures for emergencies is limited to officially declared public emergencies. It should cease immediately after such declaration is withdrawn.
Application 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. In extreme instances, public emergencies might warrant the suspension of some civil liberties. The ethical rationale behind such powers and duties is beneficence-based public necessity: that the exceptions to, and infringements of, principles such as autonomy may prove necessary to preserve or protect human life or public health, safety, order and welfare. An important concern regarding such powers is that they not be used beyond the scope of the emergency, nor used arbitrarily or unreasonably or otherwise abused. For such reasons, they are circumscribed. Research ethics review policies and procedures for declared emergencies should, accordingly, be applied only to compelling public necessities occasioned by a public emergency.
Article 6.23 Research ethics boards should give special care to requests for derogations from the principles outlined in this Policy involving or 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 and procedural standards. 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 procedural standard should fall on those claiming the exception.
To guide fair and reasonable implementation for emergency circumstances, any derogations from or infringement of ethics principles and standards need to be demonstrably justified by those urging the infringement. Sometimes a proposed infringement or derogation will not be justified for research purposes. Justified derogations from or infringement of ethics principles and standards should correspond directly, and be calibrated, to the benefit targeted by the goal of the policy. Derogations 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 equal moral status 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 equal moral status advances a fair and balanced distribution of burdens and 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 well-being 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 promote, protect and respect the welfare and autonomy of participants must be accordingly addressed (see Article 4.4 in Chapter 4 [“Research Involving Vulnerable Persons or Groups”]).