R1 – Research Involving Human Participants Procedures

1. Purpose 

This document outlines the essential procedures for the ethical review of research involving human participants in accordance with the TCPS2 (2022).

2. Definitions

Words used in this Procedure shall be read consistently with the definitions set out in Policy R1, Research Involving Human Participants. 

3. Application 

3.1  General

1. RRC Polytech management, faculty, staff, students, and researchers from outside RRC Polytech who require research approval from the RRCP-REB through research ethics protocol submission, can stay informed of RRCP-REB activities via the RRCP-REB College website. The website includes details of:

1. RRCP-REB membership;
2. Research ethics protocol submission deadlines;
3. RRCP-REB meeting dates;
4. REB education and consultation processes;
5. Current RRCP-REB forms required for submission, amendment, renewal, closure, and adverse event reporting.

4. Formation of the Research Ethics Board

4.1  RRC Polytech

1. RRC Polytech is required to establish a Research Ethics Board (“REB”) to review the ethical acceptability of all research involving humans conducted within its jurisdiction or under its auspices. The REB shall be comprised of members who have the expertise to conduct research protocol reviews within the range and volume of the nature of the research conducted at the institution.
2. The RRC Polytech Research Ethics Board (“RRCP-REB”) is established by RRC Polytech’s President.
3. RRC Polytech grants the REB the authority to review the ethical acceptability of research on behalf of the institution, including approving, rejecting, proposing modifications to, or terminating any proposed or ongoing research involving humans in accordance with Policy R1 – Research Involving Human Participants.  
4. RRC Polytech shall ensure that the REB is able to operate effectively and independently in its decision-making.
5. RRC Polytech shall provide the REB with sufficient administrative assistance to ensure adequate record-keeping is maintained, and that proposals are processed administratively in a fashion adequate to the needs of the REB’s work.
6. RRC Polytech shall ensure that the RRCP-REB Chair and its members are compensated for their workloads or by other agreed-upon means to act in their roles as members of the RRCP-REB.

4.2  RRCP-REB 

1. Responsibilities, membership, and governance of the RRCP-REB shall comply with TCPS2 (2022) Chapter 6— Governance of Research Ethics Review and RRC Polytech’s requirements.
2. The RRCP-REB shall:
   1. Establish guidelines in matters relating to the ethical approval of research involving human participants in accordance with TCPS2 (2022) and TAGFA;
   2. Ensure that all members are knowledgeable of the TCPS2 (2022) including completing the TCPS2 (2022) CORE tutorial;
   3. Approve, propose modifications, or terminate any proposed or ongoing research conducted by members of, or within RRCP under the guidance of the TCPS2 (2022) and RRC Polytech policies and procedures;
   4. Provide consultation to researchers on human ethics matters;
   5. Provide periodic opportunities for education on human participants’ ethics to its own members and members of RRC Polytech’s research and scholarly community;
   6. Disclose any real, potential, or perceived conflicts of interest regarding any relationship to researchers (and team members) who have submitted ethics applications.
   7. Ensure members regularly attend scheduled meetings or provide notification of regrets to the REB Chair or REB Administrative Assistant;
   8. Ensure members come prepared to meetings having read the agenda package with comments and questions regarding assigned materials. When unable to attend a meeting, members are encouraged to submit written comments concerning proposals to be reviewed at that meeting;

3. RRCP-REB membership shall follow the requirements set out in TCPS2 (2022) Chapter 6, including:
   1. At a minimum, there shall be two (2) members with expertise in the kinds of research disciplines and fields covered by the REB;
   2. At a minimum, one (1) member shall have expertise in ethics;
   3. One (1) member shall have expertise in the law (advisable generally; required with biomedical research);
   4. One (1) member shall have expertise in working with Indigenous persons or communities;
   5. At a minimum, there shall be one (1) community member with no affiliation with the institution to represent the participant’s perspective;
   6. RRC Polytech’s Senior administrators, RRC Polytech’s General Counsel and any other lawyer representing RRC Polytech may not serve as members of the RRCP-REB;
   7. The RRC-REB may solicit consultation of other ad hoc advisors on an as-needed basis where the current membership does not feel it has the specific expertise to review the ethical acceptability of a research proposal competently (e.g., research involving Indigenous persons or communities);
   8. The need to replace or add members to the RRCP-REB must consider the previously identified areas of research, legal, and ethical expertise.

Appointment of RRCP-REB Members

4. The President, as the highest authority for establishing an REB, is responsible for the appointment of the RRCP – REB Chair and its members on the recommendation of the REB Chair.
   
   The procedure for the appointment of the RRCP-REB Chair and Members shall be as follows:
   • The appointment of the RRCP-REB Chair and members will be for a term of 2 years, subject to one renewal.
   • Nominations for RRCP-REB membership may be made by the Chair and by Current RRCP-REB members, the Research, Partnerships and Innovation Office, Deans or Directors, the College Community or by a letter of self-nomination to the RRCP-REB Chair. The RRCP-REB Chair will recommend the nominations to the President for approval. Upon approval, the President will send a letter of appointment to the nominee.
   • Recommendations for renewal will be made by the REB Chair and approved by the President. Upon approval, the President will send a letter of renewal to the RRCP-REB member. 
   • Recommendations for termination of members will be made by the REB Chair and approved by the President. Upon approval, the President will send a letter of termination to the RRCP-REB member.
5. REB Chair, Vice Chair and Meeting Quorum 
   • One (1) qualified individual with knowledge of the TCSP, ethical review process, and relevant College research policies will be nominated to act as Chair of the RRCP-REB.
   • The Chair of the RRCP-REB is responsible for ensuring the ethical review processes conform to the requirements of Policy R1;
   • The RRCP-REB members will collectively select one member to act as Vice Chair in the event that the assigned Chair is in conflict of interest with a submitted protocol; 
   • Quorum for full ethical reviews conducted at RRC-REB meetings will be 50% in combination with members in attendance at the meeting having the relevant competence and knowledge necessary to provide an adequate research ethical review of the proposal(s) under consideration; 

4.3  Submissions to the RRCP-REB 

1. A REB protocol submission is required for all proposed research that involves surveying, interviewing, or gathering data from any human subject (including students and colleagues).
2. All Principal Researchers named on any research protocol submission, including submissions from researchers outside of RRC Polytech, and instructors submitting course-based research protocols, will be required to submit proof of completion of the TCPS2 (2022) Core tutorial. The current tutorial can be found online. Protocols will not be reviewed without proof of completion of the TCPS2 (2022)-2 CORE tutorial.
3. All REB applications must be made in writing in the prescribed form. The most recent version of the application form can be found online.
4. Applications are to be submitted electronically to reb@rrc.ca.
5. Protocols that have been pre-approved by a REB at another Canadian post-secondary institution and which meet TCPS2 (2022) standards can be submitted to the RRCP-REB. The submission must include approved forms and approval certificates from the original institution of approval. An Addendum for Pre-Approved Protocols must also be included with the submission. The required addendum form can be found online. The RRCP-REB reserves the authority to review the project for ethical compliance with RRC Polytech’s policies and TCPS2 (2022).
6. Questions about the application process can be directed to the staff contact listed online.

5. Initial Research Ethical Review

5.1

Applications received by the RRCP-REB will be reviewed using a proportionate approach. Upon initial review of a protocol submitted to the RRCP-REB, the level of review conducted will be dependent upon the degree of risk to the Human Participants of the study. Degree of risk will be screened initially by the Chair, or another REB Member designated by the Chair, prior to a decision being made about the level of review required. 

5.2

In accordance with the initial screening, one of the following levels of review will apply to the protocol:

1. Full RRCP-REB Review – Full ethical review is the default requirement for research involving humans. Full reviews are mandatory in the case of research that is considered more than minimal risk; however, the RRCP-REB can choose to conduct a full review on any submissions as deemed necessary by any RRCP-REB member.
2. Delegated RRCP-REB review of minimal risk research where the RRC-REB is the primary board of approval – A delegated process can be implemented at the discretion of the REB Chair or their designate. The Chair or their designate will select 1-2 members with the appropriate expertise specific to the protocol to conduct an ethical review of that protocol. One of the delegated members may be the Chair of the ethics board.
3. Delegated RRCP-REB review of minimal risk research where the RRCP-REB is the secondary board of approval – These would mainly be submissions from researchers external to RRCP who are submitting a protocol already approved by a REB at another institution. These protocols may undergo Chair-only approval, or the Chair may delegate a protocol review to one or more members with the relevant expertise.
4. Course-based research applications – Research ethical review may also be undertaken by non-REB members (e.g., course instructors) for student course-based research. The RRCP-REB has the authority to assign proxy status to an instructor to review the ethical practices of students registered in courses they are teaching and who are conducting research for assignment purposes.

6. Continuing Research Ethical Review 

6.1

A researcher’s relationship with the RRCP-REB does not end upon successful approval of a research project. There are many additional points in the research process which may require returning to the RRCP-REB for additional approvals, reporting of research activities, or reporting of adverse events. Researchers are responsible for knowing when they must make additional submissions or reports to the RRCP-REB related to an approved project and for supplying these reports in a timely manner.

6.2

In the case of adverse-event reporting, the report must be made immediately after the adverse event. Potential adverse events could include but are not limited to:

1. Privacy breaches;
2. Lost or stolen data;
3. Unanticipated conflicts of interest;
4. Physical or emotional harm to a participant caused by participation in a research intervention.

6.3  

With the exception of changes made to eliminate an apparent immediate hazard to a research participant, changes to research ethics protocols can only be made after permission has been granted by the RRCP-REB.

6.4

Continuing human ethics submissions from researchers will undergo Chair-only approval or be delegated by the Chair to an RRC-REB member with the relevant expertise. These subsequent submissions may include: 

1. Amendments to research projects previously deemed minimal risk;
2. Annual renewals of minimal risk research;
3. Annual renewals of more than minimal risk research where the remaining research activities are of minimal risk to participants or do not describe significant changes to the continuing research from its most recent full RRC-REB review;
4. Study closure form submission for completed projects;
5. Adverse event reporting forms.

6.5

Continuing research submissions may require full RRCP-REB review if substantial changes are being made to a project that is deemed more than minimal risk. Some adverse-event reports may require full RRC-REB review and decision-making as deemed necessary by the RRC-REB Chair.

7. Decisions by the Research Ethics Board

7.1  

The RRCP-REB will keep complete records of each research submission. Minutes will be recorded at each full board meeting which will include rationale for the RRCP-REB decisions on individual protocols. Decisions after ethical review will be communicated to the researcher in a timely manner in accordance with the degree of scrutiny required. 

7.2

Designation of an ethics protocol as minimal risk is at the discretion of the RRCP-REB. 

7.3

Delegated reviewers of initial submissions or continuing research submissions reserve the right to call upon other reviewers within the REB or refer the protocol back to the full REB if it is determined that a full board ethical review is required. 

7.4

In the case where a delegated reviewer determines a protocol should be refused ethical approval, the decision shall be referred to the full RRC-REB for review and endorsement before communicating the decision to the researcher.

8. Appeals of Research Ethics Board Decisions

8.1

Researchers have the right to request a reconsideration of any RRCP-REB decision on a research project. Researchers must submit their request for reconsideration in writing to the Chair of the RRCP-REB within one month of the original decision with a detailed explanation of the rationale for requesting reconsideration. The RRC-REB will reconsider a protocol based on such a request in a timely fashion after the request.

8.2

If upon reconsideration, the RRCP-REB upholds its decision to not approve the research, the researcher may appeal the decision to RRC Polytech’s Vice-President, Indigenous Strategy, Business Development and Research (“VP”).    

8.3

Appeals to the VP must be made in writing. A copy of the appeal letter should also be sent to the RRCP-REB Chair. The VP will convene a Research Ethics Appeal Committee that has the same membership expertise as outlined for the original REB. 

8.4

The researcher must submit all the original protocol and relevant Appendices along with a copy of the feedback they received from the RRCP-REB. Alternatively, the VP may choose to enter into an agreement with a REB at another post-secondary institution for the purposes of addressing the concerns outlined in the appeal.

8.5

The timeline for a decision will depend upon identifying a secondary review committee but could take up to 4 months. 

9. REB Recording and Reporting 

9.1

A Certificate of Ethical Approval signed by the RRCP-REB Chair, Vice Chair (in the event of Chair conflict of interest), or delegated RRCP-REB member (in the case of course-based research reviews and scholarship of teaching and learning applications) will be issued to the Principal Researcher. The Researcher is then responsible for submitting copies of the certificate to other required internal or external departments. Ethical certificates may need to be shared with research partners, research collaborators, Academic Deans, Chairs, or Program Managers, the REBs at other affiliated institutions, grant funding bodies, and the finance managers at RRC to authorize the release of project funding.

9.2

The RRCP-REB will provide regular reports of activities to the Director of Research, Partnerships, and Innovation (“RPI”). The Director, RPI, may attend RRCP-REB meetings as a non-voting ex-officio role.

9.3

The RRCP-REB Chair will prepare and/or present an annual report to the VP, Academic.

9.4

The Chair and members of the RRCP-REB will be responsible for the review, revision, and/or replacement of this policy on a, at minimum, bi-annual basis, in consultation with the Director of Research, Partnerships, and Innovation and the VP, Academic.

Resources Consulted in Preparation of this Policy and Procedure:

• Brandon University Research Ethics Committee (BUREC), Policies and Procedures (2018)
• British Columbia Institute of Technology, Research Ethics for Human Participants (2018)
• British Columbia Institute of Technology, Ethical Practice for Research Involving Human Participants (2018)
• College of the Rockies, Ethical Conduct for Research Involving Human Subjects (2017)
• George Brown College, Research Ethics Policy (2012)
• Saskatchewan Polytechnic, Ethics of Research Involving Human Participants Policy (2020)
• Saskatchewan Polytechnic, Ethics of Research Involving Human Participants Procedure (2020)
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022)