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Chapter XXIV - IRB Reliance Mechanisms

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BACKGROUND
Relevant guidance from OHRP states that multiple institutions engaged in the same nonexempt human participant research may enter into joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements to avoid duplication of effort. Similarly, FDA regulations permit a sponsor to utilize a single, central IRB for review of multicenter clinical trials.

The purpose of this policy is to define the procedures and standards the GA IRB follows for determining when to accept the review of another IRB for non-exempt human-participant research in which Genetic Alliance principal investigators or staff are engaged, and when to permit another institution, organization or an unaffiliated researcher to rely upon the review of a non-exempt human-participant protocol by the GA IRB.

POLICY STATEMENT
When non-exempt human participant research is being conducted in collaboration with other institutions or with collaborating individual investigators, each collaborating institution and/or collaborating individual investigator engaged in the research must obtain IRB approval from an appropriately authorized IRB. The OHRP guidance document, Guidance on Engagement of Institutions in Human Participants Research will be used as the basis for determining whether the duties contemplated by an investigator constitute engagement in human participant research. Such determinations will be made in collaboration and consultation with authorized representatives of the collaborating institution and/or the collaborating individual investigators, as applicable.

In an effort to streamline IRB reviews for multicenter trials, Genetic Alliance’s Institutional Official (IO) will consider requests to either rely on another institution’s IRB or to serve as the central IRB for other collaborating sites engaged in the trial under the conditions set forth in this policy. The IO in consultation with GA IRB representatives, has the authority to execute Institutional Authorization Agreements (IAAs) or Reliance Agreements (RAs) on behalf of Genetic Alliance. All determinations to rely upon, or to permit another institution to rely upon the GA IRB, shall be documented in these agreements.

GENETIC ALLIANCE IRB RELIANCE ON ANOTHER IRB
Decisions about whether to permit reliance on another IRB shall be determined by the GA IO, after review and recommendation by the GA IRB. Genetic Alliance may rely on another appropriately constituted IRB for the review of cooperative research projects under the conditions set forth below.

In deciding whether or not to rely on another IRB, Genetic Alliance will consider the following criteria:

  • Whether the use of a Central IRB mechanism has been mandated by the study sponsor;
  • The number of proposed studies involved in the collaboration;
  • The anticipated level of risk associated with proposed studies;
  • The terms and conditions of the proposed IIA or RA;
  • Whether the reviewing IRB’s policies and procedures meet Genetic Alliance standards;
  • The location where the interventional human research activities will take place;
  • The capacity of the other institution and its IRB to sufficiently be informed about the local research context and applicable laws and regulations relevant to Genetic Alliance.

In order to initiate discussions with the institution requesting the reliance agreement, the investigator must provide: 1) contact information for the collaborating institution’s IRB and 2) a draft version of the agreement.

Copies of all agreements will be maintained in the both institutions regulatory files.

In order to maintain an accurate record of studies being done at the institution, as well as to manage required ancillary reviews, investigators are required to update the application when appropriate. Updates to the initial application are only required 1) at the time of continuing review, 2) receipt(s) of any amendment(s), 3) receipt(s) of any adverse events, and/or receipt of study termination or closure.

ANOTHER INSTITUTION’S RELIANCE ON THE GA IRB
Genetic Alliance IRB may serve as the IRB of record for review of human participant research for another institution with appropriately executed IRB Authorization or Reliance Agreements.

In deciding whether to provide IRB review for another institution, the GA IO will decide based on the following criteria:

  • The number of studies being proposed under the agreement;
  • The number of sites engaged in the research;
  • The risk level of the study;
  • Whether the study is being conducted under an investigator-initiated IND or IDE;
  • The location where the interventional human research activities will take place;
  • Whether the use of a Central IRB has been mandated by the sponsor;
  • Whether adequate funding is provided to cover the additional costs associated with managing the approval and necessary IRB oversight at the other sites;
  • Genetic Alliance’s capacity to be sufficiently informed about the other institution’s local research context and local applicable laws and rules.

In order to initiate discussions with the institution requesting the RA, the investigator must provide: 1) contact information for the collaborating institutions’ IRBs; and 2) a copy of the proposed protocol and/or consent document (as soon as available).

Genetic Alliance will facilitate communication with the relying institution about IRB actions on the human participant research that is the subject of the Agreement, in accordance with its specific provisions of the Reliance Agreement.

SERVING AS IRB OF RECORD FOR AN ENTITY WITHOUT AN IRB
The GA IRB may serve as the IRB of record for an entity that does not have its own IRB if:

  • Genetic Alliance is directly involved in the conduct of or funding of the human participants research at the entity;
  • The IO approves of the arrangement in advance; c) there are no unresolved conflict of interest issues;
  • The scope of the reliance is limited to the human participant research project in which Genetic Alliance is directly involved; AND
  • The entity enters into an appropriate form of RA with Genetic Alliance.

Agreements will be maintained in the regulatory files of both entities.

SERVING AS IRB OF RECORD FOR A NON-AFFILIATED INDIVIDUAL INVESTIGATOR
When a non-affiliated individual investigator (e.g. an independent investigator without a FWA) is engaged in human participant research, the GA IRB may choose to extend its FWA to cover that individual’s activities. In such cases, an Individual Investigator Agreement (IIA) outlining the terms and conditions of this arrangement must be executed by the IO of Genetic Alliance as well as the individual investigator.

The executed IIAs will be maintained in the regulatory files of both entities.

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