³ÉÈË´óƬ

1.0 PURPOSE

This standard operating procedure (SOP) describes the processes for determining when research meets the criteria for delegated ethics review and the associated delegated review procedures.

2.0 SCOPE

This SOP pertains to Research Ethics Boards (REB) that review human participant research in compliance with applicable regulations and guidelines.

3.0 RESPONSIBILITIES

All REB members and REB Office Personnel are responsible for ensuring that the requirements of this SOP are met.

The REB Chair or designee determines if research is eligible for delegated review. In some circumstances, the REB Chair or designee may delegate this task to qualified REB Office Personnel; however, the responsibility for oversight remains with the REB Chair or designee.

The REB Chair, designee, or qualified REB member(s) is responsible for conducting the delegated review.

REB Office Personnel are currently delegated to perform the following tasks on behalf of the REB:

• Acknowledgement/Approval of Minor Administrative Changes
• Administrative review of Initial Applications and Event Forms
• Acknowledgement/Approval of Team Member Changes (not for PI changes)
• Acknowledgement/Approval of Study Closures
• Acknowledgment of Protocol Deviation/Adverse Events
• Approval of Renewals with No Changes/Increase in Risk
• Approval of Case Report Forms
• Approval of Non-Recruitment/Secondary Data Use Protocols
• Preliminary Reviews of LOI/CFs
• Preliminary Reviews for New Applications Requiring Full Board Review
• Preliminary Reviews for Amendments Requiring Full Board Review
• Preliminary Reviews for New Applications Requiring Delegated Review
• Preliminary Reviews for Amendments Requiring Delegated Review
• Preliminary Principal Investigator (PI) Responses to Delegated Reviews
• Preliminary Reviews for PI Responses to Full Board Reviews
• Preliminary Reviews for Protocol Deviations/Adverse Events/Serious Adverse Events

4.0 DEFINITIONS

See Glossary of Terms.

5.0 PROCEDURE

REBs should adopt a proportionate approach to ethics assessment based on the general principle that the more invasive or harmful the proposed and ongoing research, the greater should be the care in assessing the research. Full Board review by an REB should be the default requirement for all research involving human participants unless the REB decides to authorize delegated review based primarily on the harms expected to arise from the research. While all research must be reviewed adequately, requirements for proportionate review allow the REB to provide a higher level of scrutiny and correspondingly more protection for the most ethically challenging research.

In practice, the proportionate review implies different levels of REB review for different research projects. The two levels typically used by REBs are Full Board review or delegated review by one or more experienced REB members, as determined by the REB Chair or designee.

5.1    Determination of Qualification for Delegated Review

5.1.1    Full Board review is the default for most new research projects submitted to the REB; however, some research may be eligible for delegated review.

5.1.2    Submissions that meet the following criteria may be eligible for delegated review:

• Research projects that involve no more than minimal risk,
• Minor or minimal risk changes to approved research,
• Continuing review of approved minimal risk research,
• Continuing review of research that is more than minimal risk for which enrolment is closed permanently and all research-related interventions for all participants are complete, and the only remaining research activities are post-intervention activities or follow-up of participants or, where the remaining research activities are limited to data analysis or, where no participants have been enrolled, and no additional risks have been identified,
• Continuing review of research that is more than minimal risk when there has been little or no modification of the research and when there has been no increase in risk to or other ethical implications for participants since the initial review by the full REB, if permissible under all applicable governing Regulations,
• The submission by the Researcher in response to the REB review as a condition of approval, as authorized by the Board,
• Changes to consent documents that do not affect the rights and welfare of research participants involve increased risk, affect data integrity, or require significant changes in research procedures,
• Reportable events include adverse events and safety updates such as Data and Safety Monitoring Boards (DSMB) reports.

5.1.3    The REB Chair or designee may use delegated review procedures for the review of other types of minor changes including, but not limited to, the following:

• Participant materials such as recruitment posters or scripts, diaries, validated questionnaires, and clinical trial identification/wallet cards.
• Authorized translations of English versions of documents previously- approved by the REB.

5.1.4    The REB Chair or designee may be authorized by the full Board to use delegated review procedures to review miscellaneous items, such as changes to meeting minutes that previously received approval with conditions at a Full Board meeting.

5.1.5    When determining if an initial review of research or modifications to previously approved research are eligible for delegated review, the REB Chair or designee will take into consideration the methods used to conduct the research, recruitment practices, participant population, confidentiality of data, and all regulatory and ethics guidance requirements as applicable.

5.2    Delegated Review Process

5.2.1    Qualified REB Office Personnel will perform an initial screening of the submission. Research ethics coordinators will also perform a preliminary ethical review of the submission. Those submissions that meet a pre-defined set of criteria for delegated review as determined by the REB may be forwarded for delegated review. For all other submissions, the REB Chair or designee will determine whether the submission meets the criteria for delegated review.

5.2.2    For research that meets the criteria, delegated review may be conducted by the REB Chair, or by one or more qualified REB members as designated by the REB Chair or designee. The initial delegated study should be conducted by the primary and secondary reviewers within 2 weeks of review assignment date. The re-review of a delegated study should be conducted by the primary and secondary reviewers within 1 week of the re-assignment date.

5.2.3    The REB Chair or designee reviewing research under delegated review must not have a conflict of interest in the research.

5.2.4    In reviewing the research under delegated procedures, the REB Chair or designee may exercise all of the authorities of the REB, except that they may not disapprove the research; the research may be disapproved only after the REB has reviewed it at a Full Board meeting.

5.2.5    REB member(s) conducting a delegated review will contact the REB Chair or designee to request the expertise of an ad hoc advisor, if applicable. Ad hoc advisors may not participate in the final decision regarding approval of the research.

5.2.6    If the REB Chair or designee subsequently determines that the level of risk for the submission is greater than minimal, the submission will be referred to a Full Board meeting for review.

5.2.7    The REB Chair or designee will record the decision regarding the research designation (i.e., either requiring FB or delegated review) and the review outcome. The responsible REB Office Personnel may issue the review or decision letter.

5.3    Notification of the REB

5.3.1    At its next Full Board meeting, the REB will be informed of research that was reviewed and approved using delegated review procedures.

5.4    Documentation

5.4.1    The type of REB review conducted (i.e., Full Board or delegated) is documented in the REB records and noted in the decision letter issued to the Researcher, where appropriate.

5.4.2    The REB will be provided with a list of submissions that were reviewed and approved using delegated review procedures from the time that the agenda for the previous REB meeting was issued.

6.0 REFERENCES

See References.