Guidelines: Research Conducted in Hospital/Clinical/Medical Facilities

With a few exceptions, research conducted within a hospital or in conjunction with a hospital and/or medical facility requires REB approval from both the medical facility and the York REB (the HPRC). Given that the Hospital/Medical facility REB will have greater clinical expertise with regards to reviewing the protocols, the YORK REB requires the Hospital/Medical facility REB to review and approve the protocol prior to the protocol being submitted for review and approval by the HPRC.

However, as such research is often collaborative in nature and/or multi-jurisdictional in oversight, there are a number of mechanisms available to both researchers and the HPRC to address the complexities of ethics review. To avoid duplication of effort and to streamline the review process, and absent a reciprocal agreement with the medical institutions, researchers should be advised of the following when submitting a protocol for review:

• If the medical institution undertakes a full-board review[1] of the research ethics protocol, then a delegated review will be required by the York U REB (the HPRC)
• If the hospital does not require a full board review but rather undertakes a delegated review, then further review by the York U REB (the HPRC) is not required. The HPRC may accept the medical institution’s REB approval certificate as appropriate review and approval of the protocol.

NOTE: Regardless of which review is being conducted, the Office of Research Ethics must be copied on or receive a copy of the results of the medical institution’s review. The Following is a summary chart outlining the decision points:

Research Risk Level	Medical Institution	YorkU
Minimal risk research	Delegated Review	No review required*
More than minimal risk research	Full-board Review	Delegated review required

Further, as the research will be conducted in a clinical setting, the primary contact for REB queries will be the hospital’s REB, though York REB will also remain as a contact in most instances.

Process

Researchers should:

1. Submit the relevant ethics protocol to and obtain approval from the Hospital/Medical facility REB;
2. Submit the appropriate HPRC protocol package to ORE:
   • If the research is more than minimal risk and/or receives full board review from the Hospital/medical institution :
     • Approval certificate from the hospital/medical facility REB
     • HPRC protocol form to the HPRC for review and approval;
   • If the research is minimal risk and receives delegated review from the Hospital/medical institution:
     • Approval certificate from the hospital/medical institution.

NOTES: Protocols for research to be conducted in hospital/medical settings will not be accepted for review by the HPRC unless Hospital/medical facility REB approval is appended.

[1] Please consult the Senate Policy on Research Involving Human Participants for definitions of Full versus Delegated review.