Date: February 4, 1997

To: Assurance Branch Staff

From: Chief, Assurance Branch

Division of Human Subject Protections, OPRR, OD

Subject: Update - Suitability of a Designated Institutional Review Board (IRB)

As you know, the Office for Protection from Research Risks (OPPR) delegates to the Division of Human Subject Protections (DHSP) the assessment of satisfactoriness for assurances by applicant institutions to comply with 45 CFR Part 46 for the protection of human research subjects. Such assurances to comply pertain to research that is conducted or supported by the Department of Health and Human Services (DHHS) or otherwise sponsored and required by election of an institution (i.e., any public or private entity or Agency) with an applicable assurance on file with OPRR.

This memorandum draws upon the general requirements for review of assurances that are conceptually outlined in Section 103 and, for purposes of this memorandum, Section 103(d) in particular. Evaluation of assurances and negotiation of flexible operational alternatives within the applicable conceptual requirements are the purview of Assurance Coordinators within the Branch. However, deviations from these regulatory requirements and the following standing considerations should occur only in extraordinary circumstances and must be approved by myself, or other person authorized to act as or in lieu of the Branch Chief.

It is constructive to periodically restate these criteria for reinforcement and the convenience of all. In particular, the opportunity presents itself to reemphasize that portion of standing guidance that relates to the suitability of any designated IRB that is independent of the institution for which satisfactory assurance of compliance with 45 CFR Part 46 is required.

As you know, the typical sequence of events that is followed in reviewing the operational suitability of a designated IRB commences with fulfillment of membership requirements which are found at Sections 107 and 304. The former deals with all human subject research and the latter with research that proposes to involve prisoners. When appropriate, they are additive. In those rare instances when an institution in need of a Single Project Assurance (SPA) seeks to rely upon the IRB of another institution which is not otherwise involved in the research, the institution may do so if the following conditions are fulfilled:(a) the IRB membership must have familiarity with site-specific circumstances pertinent to human subjects to include the nature of risks for the duration of the research, (b) the requesting institution does not possess an IRB, and (c) the IRB institution must co-sign the required Assurance or Agreement, as is customary practice, and provide a copy of a current IRB membership roster that identifies those persons familiar with circumstances of the requesting institution. If (c) cannot be fulfilled with existing voting membership, the IRB review may occur with at least provision of an added nonvoting consultant to the IRB by the requesting institution for the initial and all continuing convened meetings.

In addition, where more than one institution is engaged in the same research and each possesses an applicable IRB, OPRR relies upon its standing guidance. Other existing mechanisms provide for similar reliance between institutions that are engaged in the same research when they both possess a Multiple Project Assurance (MPA). The same approach applies between institutions in possession of a Cooperative Project Assurance (CPA) and between MPA and CPA institutions, so long as all applicable conditions are met (see above conditions).

In addition, in light of the above cited general conditions and options, the following considerations may be routinely employed in the determination of satisfactoriness with regard to the designation of a reviewing IRB that is independent of an institution in possession of an applicable OPRR-approved assurance to comply with 45 CFR 46 (i.e., an IRB not institutionally based):

• Prior to approval of an assurance, OPRR must review and approve any contract between: (1) an institution that assures OPRR of compliance with 45 CFR 46 and (2) an independent IRB that agrees to provide IRB services in compliance with procedural requirements of 45 CFR 46 as related, for example, to IRB membership, functions, review responsibilities, criteria for approval, and recordkeeping. The contract or other clarifying documentation must explicitly state how the institution's responsibilities under 45 CFR 46 will be carried out and enable the institution to fulfill its obligation as specified in its assurance to OPRR (e.g., procedures for prompt delivery of minutes and other records for retention by an institution not otherwise affiliated with the IRB).
• No arrangement between an institution and an independent IRB may contain disincentives, impediments, or conflicts of interest which may hamper the exercise of an IRB's function or objectivity throughout the duration of a research activity involving human subjects by or under the direction of the institution which the IRB serves (e.g., fee, employment or other arrangements that discourage prompt, continuing, flexible, or objective response to the need for even unforeseeable IRB action).
• Any IRB, independent or not, must possess and maintain the diversity of membership and/or consultant input to ensure its ability to objectively account, amongst other things, for local institutional, population, legal, and cultural influences on risk to subjects, to compare those risks to anticipated benefits, and make decisions about the equitable selection of subjects. In order to avoid a conflict of interest, no "unaffiliated" IRB member may have an equity interest (e.g., partnership, stocks, or profit-sharing) in the organization providing IRB review nor may any member be paid more than reasonable compensation for IRB services.

Hence, contracts or other clarifying documentation that: (1) merely allude to 45 CFR 46, (2) discourage the objectivity or continuing use of the IRB through the nature of fee arrangements or otherwise, or (3) do not employ effective local representation in convened meetings would not be considered by OPRR to comply with 45 CFR 46.

Clifford C. Scharke, D.M.D., M.P.H.

cc: Dr. Gary Ellis, OPRR

Dr. Melody Lin, OPRR

Dr. Tom Puglisi, OPRR

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