To avoid duplication of review, the CHS will consider accepting review responsibilities, or ceding review to another IRB, when the following conditions are met.

1. Accepting Review Responsibilities

The CHS will accept reviewing responsibilities on a case-by-case basis, including but not limited to the following situations:

• When the primary work involving participants takes place on Faculty of Medicine property under the jurisdiction of an Investigator from the Faculty of Medicine and the secondary institution’s involvement is primarily financial or limited to minimal risk activities, or
• When the study involves a secondary institution or institution’s personnel but is initiated by an Investigator from the Faculty of Medicine. Such studies may include clinical rotation curriculum of students, program evaluations, surveys and questionnaires.

2. Ceding review to other Institutions

The CHS may cede reviewing authority to another IRB under one or more of the following conditions:

• The Faculty of Medicine acts solely as the funding recipient of an award and no research activities will be taking place at HMS or HSDM facilities;
• The Faculty of Medicine is the recipient of a prime funding award and provides a subcontract for human studies work to be performed at another institution that either has or will have IRB approval for the human studies work;
• The involvement of the Faculty of Medicine Investigator is limited to data analysis collected through the other institution or other minimal risk, engaged activities.
• The other institution’s reviewing IRB is more properly constituted to review a certain scope or topic of work, or may have knowledge of the local research context.

The CHS will ordinarily not cede review if any research activities conducted at HMS or HSDM require direct intervention or interactions with study participants.

3. Requesting Ceded (or ‘Designated’) Review

The following documents must be submitted to the CHS for consideration of ceding review to another IRB:

• IRB Review Designation Request form
• IRB approval letter from the reviewing IRB

Please see the CHS Policies and Procedures (Section 7) pertaining to ceded review, particularly where it relates to continuation of research, amendments, serious and/or continuing non-compliance, and unanticipated problems involving research participants and/or others.

Updated: 21-Oct-2009