Procedure for Institutional Approval of External Research Involving Human Participants

1. Introduction and Purpose 

Planned research activities conducted by external researchers, including community and industry partners and/or researchers affiliated with other academic institutions, periodically seek to engage Loyalist College employees and/or students as research participants.

The purpose of this procedure is to establish the institutional approval process for external research involving Loyalist College employees or students as participants. Institutional approval is separate from, and does not replace, any approval of the Loyalist College Research Ethics Board (REB) required under RES 104 Ethical Conduct of Research Involving Human Participants.  

2. Application 

This procedure applies to external researchers who are not affiliated with Loyalist College and who seek to recruit or involve Loyalist College employees or students as participants in research.

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 procedure, the Tri-Agency requirements will prevail.

3. Definitions  

External Researcher(s) will:

• Work with the Manager, Research Administration to complete a request for institutional approval; and
• Obtain institutional approval prior to seeking the college’s REB approval.

The Manager, Research Administration will:

• Receive and manage all submitted forms and research applications from external researcher(s) for college research approval processes; and
• Liaise with external researcher(s) to ensure that the process is efficient and adheres to college policies and procedures.

The Executive Director, Indigenous Engagement and Applied Researchwill:

• Ensure that any proposed research projects by external individuals meet college and Tri-Agency standards to conduct research involving human participants; and
• Provide oversight of research activities involving college employees or students through an approval and reporting process.

The College Executive Team will:

• Provide oversight of external research activities through their review and approval of requests involving college employees and students within their area of responsibility.

4. Procedure

Step One. The researcher(s) will send a request through email to the Manager, Research Administration, and attach Appendix G Request for Institutional Approval to Engage Loyalist College Employees or Students in Research Form.

Step Two. The submission will be reviewed by the Executive Director, Indigenous Engagement and Applied Research for alignment with the college’s overall strategic priorities. If the request is denied, the Executive Director, Indigenous Engagement and Applied Research will inform the Manager, Research Administration, who will communicate the decision with the researcher(s).

Step Three. If the request is approved, the Executive Director, Indigenous Engagement and Applied Research will forward the submission to the College Executive Team member(s) with responsibility for the group(s) the submission seeks to engage for their review and approval.

Approvals, concerns, or recommendations from this review will be communicated with the Executive Director, Indigenous Engagement and Applied Research. A meeting may be held to discuss the project and arrive at a collaborative decision.

Step Four. The Executive Director, Indigenous Engagement and Applied Research will communicate the decision to the Manager, Research Administration.

The Manager, Research Administration will communicate the decision to the researcher(s). Decisions include approval, rejection, or approval with recommendations to the proposed research project.

For projects requiring changes, the researcher must make the required revisions and re-submit the affected documents prior to receiving approval. The Manager, Research Administration will review and assess the revisions for completeness and issue the approval letter.

Step Four. Upon approval, the researcher(s) will submit the proposal to the Loyalist College REB following the process outlined within RES 104B Procedure for Ethics Approval of Research Involving Human Participants.

Step Six. Once the project has been approved by the REB, the Manager, Research Administration will provide a copy of the REB approval letter to the Executive Director, Indigenous Engagement and Applied Research and the approving College Executive Team member(s) for their awareness.

Step Seven. The recruitment of participants and commencement of research activities may only proceed once all approvals have been obtained and confirmed. 

5. Reporting Requirements through the Research Process Lifespan

If the research is expanded to include other institutions, the researcher is responsible for contacting the Research Ethics Board at each participating institution. The researcher must provide copies of each institution’s REB approval letter to the Loyalist College REB before research activities begin at any site. In the event of an adverse event, premature termination of the study, or any revision to the study or its participant population, a disclosure must be made to the Executive Director, Indigenous Engagement and Applied Research alongside the disclosure to the REB following RES 104B Procedure for Ethics Approval of Research Involving Human Participants.

6. Withdrawal or Suspension of Approval  

The Executive Director, Indigenous Engagement and Applied Research, or the CET member(s) involved in the approval process, may withdraw their approval at any time if concerns arise regarding the research project or the conduct of the researcher(s).

The withdrawal or suspension of approval will be communicated to the Manager, Research Administration, who will deliver the change in status to the researcher(s), the Loyalist College Research Ethics Board, and the Research Centre Manager (if applicable).

7. Proportionate Review Approach

• RES 104 Ethical Conduct of Research Involving Humans Participants
• RES 104B Procedure for Ethics Approval of 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

8. 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