Scope
Note: This Procedure is consistent with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS 2 (2022)”), Chapter 6 – Governance of Research Ethics Review.
This procedure forms part of JIBC’s Research Involving Human Participants Ethics Policy (the “Policy”) and should be followed and applied in relation to the free and informed consent of participants in research at JIBC under the Policy. Terms not otherwise defined in this procedure are as defined in the Policy.
Purpose
This procedure sets out the elements of research ethics review including the procedures necessary to establish a Research Ethics Board (“REB”), and operational guidelines for the REB and research ethics review.
Procedural Guiding Principles
Establishment of Research Ethics Boards
Authority, Mandate and Accountability (TCPS 2 (2022), Chapter 6, Articles 6.1, 6.2, and 6.3)
JIBC has established a REB with the authority to review the ethical acceptability of all research involving humans conducted within JIBC or under the auspices of JIBC, that is, by JIBC faculty, staff, administrators or students, regardless of where the research is conducted.
JIBC provides the REB with necessary and sufficient ongoing financial and administrative resources to fulfill their duties through the support of the Dean, Office of Applied Research & Graduate Studies (“OARGS”). The REB is independent in its decision making and is accountable to the highest body that established it for the process of research ethics review.
JIBC grants the REB the mandate to review the ethical acceptability of research on behalf of JIBC, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans. This mandate shall apply to research conducted under the auspices or within the jurisdiction of JIBC.
Research Ethics Board Composition (TCPS 2 (2022), Chapter 6, Article 6.4)
JIBC’s REB will consist of at least 11 members – appointed by the Dean, OARGS, consisting of:
- faculty and/or staff members appointed from each of JIBC Schools (total of 6), nominated by the relevant Dean;
- 1 member appointed from JIBC Office of Applied Research & Graduate Studies, nominated by JIBC’s Vice President Academic;
- 2 members-at-large appointed from JIBC faculty and/or staff by the Dean, OARGS; and
- 2 community members, at least one of whom has no current affiliation with the institution, selected jointly by the Dean, OARGS and JIBC’s Executive Committee.
In addition, to ensure that the REB members possess relevant critical expertise, the membership will consist of:
- at least two members with expertise in relevant research disciplines, fields, and methodologies covered by the REB;
- at least one member knowledgeable in ethics;
- at least one member knowledgeable in the relevant law (but that member should not be the institution's legal counsel or risk manager);
- at least one member knowledgeable with research with Indigenous participants.
Further, in order to ensure breadth of representation:
- The REB must not consist entirely of members of one profession or discipline;
- Every non-discriminatory effort will be made to ensure that membership includes a balance of members whose primary concerns are from natural science and social sciences/humanities perspectives. The Dean, OARGS may appoint up to 2 additional members-at-large or community members to ensure that the REB possess relevant critical expertise and breadth of representation as defined above.
To ensure the independence of REB decision making and to avoid perceived conflicts of interest, institutional senior research administrators shall not serve on the REB.
Non-Voting Members
Two non-voting representatives from OARGS will serve as members on the REB.
Ad Hoc Advisors (TCPS 2 (2022), Chapter 6, Article 6.5)
With approval from the Dean, OARGS, the REB may appoint ad hoc advisors in the event that it lacks the specific expertise or knowledge to review specific research proposals. Ad hoc reviewers are not counted toward quorum nor are they allowed to vote on REB decisions.
Terms of Appointment of Research Ethics Board Members (TCPS 2 (2022), Chapter 6, Articles 6.7 and 6.8)
REB members will be appointed by the Dean, OARGS such that their terms allow for continuity of the ethics review process. Terms will be of three years duration and renewable at the discretion of the Dean, OARGS. Vacant positions may be filled by appointments of one or two year terms, at the discretion of the Dean, OARGS, to ensure rotation of terms and continuity of JIBC’s ethics review process.
JIBC considers the qualifications and expertise the REB needs in appointing and renewing REB members. JIBC provides REB members with necessary training opportunities to effectively review the ethical issues raised by research proposals that fall within the mandate of the REB.
Research Ethics Board Chair (TCPS 2 (2022), Chapter 6, Article 6.8)
The Chair and Vice-Chair shall be elected annually from the membership of the REB, by the members of the REB. Should the Chair or Vice-Chair leave the REB, their position will be filled for the remaining original term by election.
The REB Chair is responsible for ensuring that the REB review process conforms to the requirements of this Policy.
Research Ethics Board Quorum (TCPS 2 (2022), Chapter 6, Article 6.9)
Quorum is established when six members including the Chair (or Vice-Chair) are in attendance. When there is less than full attendance, decisions requiring full review should be adopted only when the members in attendance at that meeting have the specific expertise, relevant competence and knowledge necessary to provide an adequate research ethics review of the proposals under consideration.
Research Ethics Board Meetings and Attendance (TCPS 2 (2022), Chapter 6, Article 6.10)
REB will have regular meetings to discharge its responsibilities, and shall normally meet face to face to review proposed research that is not assigned to delegated review.
Procedures for Research Ethics Board Review
Initial Research Ethics Review (TCPS 2 (2022), Chapter 6, Article 6.11)
Using the Research Ethics Application Form, researchers shall submit their research proposals, including proposals for pilot studies, for REB review and approval of their ethical acceptability prior to the start of recruitment of participants, data collection, access to data or collection of human biological materials. REB review is not required for the initial exploratory phase, which is intended to establish research partnerships or to inform the design of a research proposal, and may involve contact with individuals or communities.
Determining the Level of Research Ethics Review (TCPS 2 (2022), Chapter 6, Article 6.12)
In keeping with a proportionate approach to research ethics review, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (delegated review); the higher the level of risk, the higher the level of scrutiny (full board review).
Two levels of research ethics review may apply:
- Full REB review
Research ethics review by the full REB should be the default requirement for research involving humans. - Delegated REB review of minimal risk research
The REB delegates research ethics review to an individual or individuals. Delegates shall be selected from among the REB membership with the exception of the ethics review of student course-based research activities. This can be delegated to the department, faculty or an equivalent level.
Decision Making (TCPS 2 (2022), Chapter 6, Article 6.13)
REBs shall function impartially, provide a fair hearing to the researchers involved, and provide reasoned and appropriately documented opinions and decisions. REBs should make their decisions on the ethical acceptability of research in an efficient and timely manner, and shall communicate all approvals and refusals to researchers in writing, in print or by electronic means, in accordance with their procedures.
Members of REB may not participate in decisions regarding research with which they are involved (as Principal Investigator or in a consultative capacity) or in which they have provided support or expertise (preparing funding and/or ethics approval applications).
Continuing Research Ethics Review (TCPS 2 (2022), Chapter 6, Article 6.14)
The REB shall make the final determination as to the nature and frequency of continuing research ethics review in accordance with a proportionate approach to research ethics review. At minimum, continuing research ethics review shall consist of an annual status report (for multi-year research projects), and an end-of-study report (projects lasting less than one year). Researchers seeking to continue their project must complete a Research Ethics Amendment and Renewal Form.
Reports of Unanticipated Issues (TCPS 2 (2022), Chapter 6, Article 6.15)
Researchers shall report to the REB any unanticipated issue or event that may increase the level of risk to participants or that has other ethical implications that may affect participants’ welfare. Researchers seeking amend their project due to unanticipated issues must complete a Research Ethics Amendment and Renewal Form.
Requests for Changes to Approved Research (TCPS 2 (2022), Chapter 6, Article 6.16)
Researchers shall submit to their REBs in a timely manner requests for substantive changes to their originally approved research. The REB shall decide on the ethical acceptability of those changes to the research in accordance with a proportionate approach to research ethics review. Researchers seeking amend their project must complete a Research Ethics Amendment and Renewal Form.
Record Keeping of Research Ethics Board Documents (TCPS 2 (2022), Chapter 6, Article 6.17)
The REB shall prepare and maintain comprehensive records, including all documentation related to the projects submitted to the REB for review, attendance at all REB meetings, and accurate minutes reflecting REB decisions. Where the REB denies ethics approval for a research proposal, the minutes shall include the reasons for this decision.
Reconsideration and Appeals
Where researchers do not receive ethics approval, or receive approval conditional on revisions that they find compromise the feasibility or integrity of the proposed research, they are entitled to reconsideration by the REB. If that is not successful, they may appeal using the established appeal mechanism in accordance with JIBC’s Research Ethics Appeal Process.
Reconsideration of Research Ethics Board Decisions (TCPS 2 (2022), Chapter 6, Article 6.18)
Researchers have the right to request, and REBs have an obligation to provide, prompt reconsideration of decisions affecting a research project.
The procedure for reconsideration of REB decisions is outlined in JIBC Procedure 3404-009 Research Ethics Appeal.
Appeal of Research Ethics Board Decisions (TCPS 2 (2022), Chapter 6, Articles 6.19 and 6.20)
The REB has an established mechanism and a procedure in place for promptly handling appeals from researchers when, after reconsideration, the REB has refused ethics approval of the research.
The appeal committee shall have the authority to review negative decisions made by an REB. In so doing, it may approve, reject or request modifications to the research proposal. Its decision on behalf of the institution shall be final.
The procedure for appeals of REB decisions is outlined in JIBC Procedure 3404-009 Research Ethics Appeal.
Research Ethics Review during Publicly Declared Emergencies
For the purposes of this Procedure, a publicly declared emergency is an emergency situation that, due to the extraordinary risks it presents, has been proclaimed as such by an authorized public official (in accordance with legislation and/or public policy). Publicly declared emergencies are extraordinary events that arise suddenly or unexpectedly and require urgent or quick responses to minimize devastation.
Preparedness Plans for Research Ethics Review during Publicly Declared Emergencies (TCPS 2 (2022), Chapter 6, Article 6.21)
In collaboration with their researchers, JIBC and the REB have a preparedness plan for emergency research ethics review. Research ethics review during publicly declared emergencies may follow modified procedures and practices.
Research Ethics Review Policy and Procedures during Publicly Declared Emergencies (TCPS 2 (2022), Chapter 6, Article 6.22)
Research ethics policies and procedures for emergencies take effect once an emergency has been publicly declared. They should cease to apply as soon as is feasible after the end of the publicly declared emergency.
Respecting Core Principles: Limiting Exceptions (TCPS 2 (2022), Chapter 6, Article 6.23)
REBs should give special care to requests for exceptions to the principles and procedures outlined in this Policy during publicly declared emergencies.
Review of Sponsor-Researcher Contracts (TCPS 2 (2022), Chapter 6, Article 6.24)
It is the responsibility of JIBC to review clauses in sponsor-researcher contracts related to confidentiality, publication, and access to data. JIBC requires that any clauses related to confidentiality and publication be consistent with the researchers’ duties to:
- disclose new information that may affect participant welfare or consent to the REB and participants; and
- report research findings in a timely manner without undue restriction.
JIBC will also ensure that sponsor-researcher contracts:
- stipulate that researchers, primarily the principal investigator, should assume the primary role and responsibility for the analysis, interpretation, and preparation of the findings for publication;
- permit principal investigators to access all study data;
- permit researchers to access all study data collected at their respective sites; and
- permit all researchers to access all study data in cases where no principal investigator is named.