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Cooperative Research Review

As permitted and encouraged by applicable federal regulations to eliminate duplicative efforts the Butler IRB has approved the following Procedure for Accepting Approval of Another Institution's IRB.

I. Eligibility for Consideration

This Procedure for Accepting Approval of Another Institution's IRB applies only to Human Subject Research meeting the eligibility requirements set forth below. For clarity and consistency, it is noted that "Human Subject Research" is defined within Definitions 1 and 2 of the Butler University Policies and Procedures for the Protection of Human Subjects in Research (the "Butler IRB Policy"). The Butler IRB will evaluate on a case-by-case basis requests from investigators for the Butler IRB to accept and rely upon another institution's IRB approval in lieu of submitting a protocol (using the Butler University application form) to the Butler IRB for review and approval, consistent with 45 CFR 46.114.

Research is eligible for consideration only if:

1. The researcher has submitted, as an investigator, a protocol to another qualified IRB OR the researcher has been asked to join an ongoing research project where approval has already been obtained from another qualified IRB;
2. A Butler University faculty member, employee, or student is a participating researcher in the project; and
3. The research will be conducted entirely at another institution.

Research that involves substantial use of Butler facilities, resources, supplies, or equipment, or that specifically targets Butler students or personnel as subjects, must be reviewed by the Butler IRB and is not eligible for consideration.

II. Materials to be Submitted

The researcher must submit the following documentation to the Butler IRB prior to beginning any data collection:

1. A completed, signed Application Form for Accepting Approval from Another IRB
2. Documentation establishing that the institution whose IRB approves the protocol has a current Federal wide assurance with OHRP;
3. A copy of the Protocol approved by the qualified IRB; and
4. A copy of the letter of approval from the other institution's IRB.

Note: The above materials must be submitted before a Butler investigator (faculty, staff or student) can participate in a research project that has already received approval from another IRB.

III. Review Process, Authority for Review

The Butler IRB Chair or his/her appointed representative will review the Application for Accepting Approval of Another Institution's IRB. The IRB chair or his/her appointed representative shall have the sole authority to determine whether the research qualifies, based upon eligibility and submitted materials, for accepting another IRB's review and determination.

IV. Outcome

If all required materials have been submitted and the research meets the eligibility requirements for accepting approval of another institution's IRB, the Butler IRB Chair or his/her appointed representative will, within 5 days of receipt of materials, send the investigator a letter accepting the approval from the other institution's IRB.

If, after reviewing the submitted materials, the Butler IRB Chair or his/her appointed representative, determines that the research fails to meet the eligibility requirements for accepting approval from another institution's IRB, the investigator will be required to submit the protocol to the Butler IRB for approval before data collection can begin. If data collection has already begun, the Butler IRB Chair or his/her appointed representative have the authority to require the investigator to cease data collection or take any other action deemed necessary under the circumstances. Likewise, if the investigator fails to submit all of the required materials before beginning data collection, the Butler IRB Chair or his/her appointed representative have the authority to require the investigator to immediately cease data collection or take any other action deemed necessary under the circumstances. The investigator will be notified, in writing, within 5 days of the IRB determination, and the investigator shall have an opportunity to respond in person or in writing, pursuant to page 6, Section 3 of the Butler IRB Policy.

The Butler IRB will follow the approval dates for the protocol as determined by the off-site IRB approval. Expiration of off-site IRB approval for a protocol means that the Butler IRB acknowledgement has also expired.