Procedure for Ethics Approval of Research Involving Human Participants

1. Purpose 

This procedure establishes the process for the review and approval of research projects involving human participants by the Loyalist College Research Ethics Board (REB).

This procedure also outlines other required processes for research projects involving human participants through the college: mandatory reporting, course-based research reviews, and appeals of REB decisions, as well as direction for reviews undertaken during publicly declared emergencies

2. Application 

This procedure applies to all research involving human participants conducted in affiliation with Loyalist College. This procedure is applicable to all employees, students, and any other individual who engages with college employees, students, equipment, and/or facilities for research activities involving human participants, as well as databases of information used within a study about such individuals.

Should a research proposal include an Indigenous component, RES 103 Conducting Research by and with Indigenous Peoples and Communities applies in addition to this procedure.

In the event of a discrepancy between the Tri-Agency policies and this policy, the Tri-Agency requirements will prevail.

3. Roles and Responsibilities  

The College will:

• Maintain the Loyalist College Research Ethics Board (REB);
• Ensure REB membership meets the REB membership requirements established in the TCPS2 and is responsive to the variability of research activities conducted by the college;
• Ensure the REB is provided with ongoing financial and administrative resources to fulfill their duties and respect the independence and authority of the REB to render decisions about the ethical acceptability of proposed research projects; and
• Provide research ethics training opportunities to REB members, researchers, and students.

The Research Ethics Board (REB) members will:

• Review proposed research projects involving human participants applications for ethical integrity and adherence to the TCPS2;
• Ensure that all decisions are made impartially and all applications receive a fair hearing;
• Adopt a proportionate approach to research ethics review to ensure the level of review is determined by the level of risk presented by a proposed research project;
• Provide a documented explanation of any decision;
• Determine the nature and frequency of continuing review, aligning with a proportionate approach; and
• Respond to and investigate any concerns, complaints, or comments received concerning the ethical conduct of research involving human participants.

The REB Chair(s) will:

• Ensure that the REB review process conforms to college and TCPS2 policies and procedures;
• Provide overall leadership for REB members and REB review processes;
• Monitor the REB’s decisions for consistency; and
• Ensure all decisions are documented and communicated in a timely manner.

The Manager, Research Administration will:

• Receive all procedural forms and research project proposals to assist in coordinating the REB;
• Liaise with researchers to ensure that research ethics processes are efficient and adhere to college policies and procedures;
• Support administrative functions of the REB; and
• Support researcher(s) in addressing REB comments and concerns to achieve approval status for research proposals, as needed.

Researcher(s) will:

• Maintain knowledge and understanding of all applicable college and Tri-Agency policies and procedures;
• Submit, in a timely manner, all applicable forms and supporting documents to the REB for initial and continuing review. Research activities must not commence or continue until approval by the REB is granted; and
• Immediately report any unanticipated issue or adverse event to the REB that may increase the level of risk to participants or has other ethical implications that may affect participant welfare.

4. Procedure

4.1 Pre-REB Review Practices

Researchers are required to complete the online TCPS2 CORE-2022 Course on Research Ethics and Loyalist Research Ethics Essentials. A copy of the certificates of completion must be submitted with the research proposal.

An REB review is not required for the initial exploratory phase of a research project, which may involve contact with individuals or communities intended to establish research partnerships or to inform the design of a research proposal. However, the REB must provide their review and approval prior to the start of any research activities, including the recruitment of participants.

If the proposed research activities have been previously approved by a Research Ethics Board at another institution, consult RES 104A Procedure for Institutional Approval of External Research Involving Human Participants for additional pre-REB approval requirements.

4.2 Initial Research Project Ethics Review Request Submission

Researchers will submit their completed research proposals for REB review using Appendix B Application for Ethics Review to the Manager, Research Administration. The Manager, Research Administration will ensure completion of the proposal and act as the liaison between the applicant and the REB throughout the application, approval, and reporting processes.

If the proposed research activities have been previously approved by a Research Ethics Board at another institution, the researcher(s) will submit a copy of the original application submitted to their home REB, the approval letter from their home REB, and any proposed participant facing materials to the Manager, Research Administration.

For course-based research projects, faculty members will complete Appendix B Application for Ethics Review on the first instance that the assignment is included in a course. Upon approval, the professor must submit Appendix C Renewal or Amendment Request Form annually in addition to a completed Appendix F Acknowledgement of Course-based Research Form upon each offering of the course in which the research project is included and submit it to the Manager, Research Administration.

For projects that involve personal health information, Appendix I Privacy Impact Self Assessment must be completed and submitted with Appendix B Application for Ethics Review. This form will be required regardless of the level of risk for the project.

4.3 Determining the Level of Ethics Review

The selection of the level of the REB’s review will be determined by the level of foreseeable risks to participants, in accordance with the TCPS2 proportionate approach to research ethics review.

Full REB Review

Review by the full REB is the default requirement for research involving humans that is more than minimal risk.

Delegated REB Review

In a delegated review, the REB assigns one or more individuals to conduct the research ethics review of minimal-risk research proposals, amendment requests, and annual reviews. Reviewers will be selected from among the current REB membership.

Course-based Research

In the case of previously approved course-based research studies, Appendix C Renewal or Amendment Request Form and Appendix F Acknowledgement of Course-based Research Form will be completed by the professor and submitted for consideration to the Manager, Research Administration. If an REB review is required, the Manager, Research Administration will liaise with the professor and student(s) to submit Appendix B Application for Ethics Review for REB review. REB approval must be acquired prior to the commencement of any research activities in such instances. 

4.4 Consent

Researchers will utilize Appendix H Information Letter and Informed Consent Form Checklist and Appendix B Application for Ethics Review to detail adherence to the principles of participant consent for the REB’s review and approval. Research involving minors will be required to provide assent and the consent of a parent or legal guardian as directed by Appendix B Application for Ethics Review.

4.5 Disclosure of Conflict of Interest

REB Member Conflict of Interest

Loyalist College’s REB members have an obligation to disclose real, potential, or perceived conflicts of interest. When necessary, the REB may decide that some of its members must withdraw from deliberations and decisions.

Researcher Conflict of Interest

Researchers must disclose any real, potential, or perceived individual conflicts of interest, as well as any institutional conflicts of interest of which they are aware through the completed Appendix B Application for Ethics Review. Upon discussion with the researcher, the REB will determine the appropriate steps to manage the conflict of interest.

4.6 Privacy

Researchers are required to outline their provisions to maintain participant privacy and data security within Appendix B Application for Ethics Review for REB review and approval. The Manager, Research Administration may support researchers seeking college assistance in protecting participant information.

4.7 REB Decisions

After receiving a completed Appendix B Application for Ethics Review and all required supporting documentation, the REB will review and respond to the proposal with one of the following decisions:

• Approved: the REBwill include a signed approval letter with an approval notice; the project is able to proceed.
• Pending Approval: minor revisions are required; the researcher must make the required revisions and re-submit the affected documents prior to receiving their approval letter. The Manager, Research Administration will review and assess revisions for completeness and issue the approval letter.
• Pending: major revisions are required; the researcher must make the required revisions and re-submit their application for REB review.
• Not approved: considerable concerns related to the ethics associated with the proposed research project have been noted and the proposal has been denied by the REB. Researchers may choose to appeal this decision, as outlined below.
• Reconsideration of REB Decisions and Appeals

Should a principal investigator disagree with the REB’s decision, they may submit an appeal to the Executive Director, Indigenous Engagement and Applied Research or their designate. Appeals should

5. Reconsideration of REB Decisions and Appeals

Should a principal investigator disagree with the REB’s decision, they may submit an appeal to the Executive Director, Indigenous Engagement and Applied Research or their designate. Appeals should occur within 10 business days of the REB’s final decision being communicated to the principal investigator and be in writing.

The Executive Director, Indigenous Engagement and Applied Research (or their designate) will strike an ad hoc committee within 10 business days of receiving the appeal. The ad hoc committee will be made up of at least three individuals with the necessary skills and expertise, are without conflict of interest, and will not include Loyalist College senior administrators. The ad hoc committee will include at least one external member who has no current affiliation with the college. This committee will review the REB application and all appendices, the REB’s decision, and the appeal submission. The ad hoc committee may invite the researcher or member(s) of the REB for a conversation regarding the appeal to gather more information.

The ad hoc committee will make a final decision and provide a written decision with rationale to the Executive Director, Indigenous Engagement and Applied Research who will communicate the decision to the principal investigator as soon as reasonably possible. This decision is final and cannot be appealed.

6. Reporting Requirements throughout the Research Project Life Span  

6.1 Ongoing Review

All ongoing research activities are subject to continuing ethics review, which at minimum consists of an annual report submitted by the principal investigator to the REB Chair.

Where the REB perceives there to be more than minimal risk to participants, they may request more frequent reporting consistent with the nature of the research activities.

6.2 Renewal Requests

Loyalist College REB approves research projects for one year. Researchers may extend the time limit of an approved project currently underway before REB approval expires using Appendix C Renewal or Amendment Request Form. If an REB approval has lapsed and a researcher requires an extension to the REB’s approval, they must resubmit the entire application to the REB.

6.3 Amendment Requests

The principal investigator is responsible for notifying the REB immediately using a completed Appendix C Renewal or Amendment Request Form if any significant changes in the research methodology or methods are anticipated. Researchers will also utilize this form to declare any changes to the principal investigator or funding for the project. The research activities may not continue until approval has been granted by the REB.

6.4 Adverse Events Reporting

The principal investigator is responsible for reporting any injury, adverse event, or detrimental incident experienced by a research participant that is/may be related to the research procedures. Any undesirable experience or response is considered an adverse event. An adverse event may be emotional, psychological, or physiological in nature.  

The principal investigator must notify the Manager, Research Administration of the occurrence of the adverse event immediately using Appendix D Adverse Event Form.

7. Research Ethics Review during Publicly Declared Emergencies

The college is committed to working with the REB and researchers to develop preparedness plans to ensure that quality, timely, and appropriate research ethics review continues. Research ethics review during publicly declared emergencies may follow modified procedures and practices. In such circumstances, the REB will duly consider requests for exceptions to the principles outlined within this policy and procedure. Such policies and procedures will take effect once an emergency has been publicly declared and cease to apply as soon as is feasible after the end of the publicly declared emergency.

8. Related Documents

• RES 104 Ethical Conduct of Research Involving Humans Participants
• RES 104A Procedure for Institutional Approval of External Research Involving Human Participants
• RES 104B Appendix A Loyalist College Research Ethics Board Terms of Reference
• RES 104B Appendix B Application for Ethics Review
• RES 104B Appendix C Renewal or Amendment Request Form
• RES 104B Appendix D Adverse Event Form
• RES 104B Appendix E Project Completion or Termination Form
• RES 104B Appendix F Acknowledgement of Course-based Research Form
• RES 104A Appendix G Request for Institutional Approval to Engage Loyalist College Employees or Students in Research Form
• RES 104B Appendix H Information Letter and Informed Consent Form Checklist
• RES 104B Appendix I Privacy Impact Self Assessment
• ADMIN 107 Conflict of Interest
• RES 101 Financial Administration of Research Funds
• RES 102 Responsible Conduct of Research
• RES 103 Conducting Research by and with Indigenous Peoples and Communities

9. References

• Fixing Long-Term Care Act, 2021
• Personal Health Information Protection Act, 2004
• Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), 2022