Policy for handling incomplete IRB protocols

Review of IRB protocols.

An IRB is charged with performing a thorough review of each protocol requiring IRB review. In the Federal regulations, section 45 CFR 46.111, Criteria for IRB approval of research, provides an outline of what it means to perform a thorough review. Briefly summarized, the following eight requirements must be satisfied in order to approve an IRB protocol:

1. Risk is minimized.

2. Risk/benefit ratio is appropriate.

3. Subject selection is equitable.

4. Informed consent process is adequate.

5. Documentation of informed consent process is adequate.

6. A data monitoring plan is in place when appropriate.

7. Confidentiality/privacy is appropriately maintained.

8. Special protections are included for vulnerable populations.

At IUSB, the Summary Safeguard Statement and additional forms (where vulnerable populations are involved) are designed to explicitly solicit information pertaining to each of these eight requirements. When key portions of these documents are left blank or when other necessary documents are omitted, the IUSB IRB cannot fulfill its duty to perform a thorough review of an IRB protocol. Therefore, there should be no IRB review of such a protocol until the principal investigator (PI) supplies the necessary information. This conclusion leads to the following policy.

Policy.

An incomplete IRB protocol should be returned to the PI for completion. Upon completion of the protocol by the PI, IRB review of the protocol may commence.

Elaboration of this policy.

The intention behind this policy is not to hold up the review of an IRB protocol that is missing relatively minor, isolated pieces of information. In such cases, the IRB can work with the PI to obtain the missing information as part of the normal back-and-forth review process.

When multiple sections of the Summary Safeguard are left blank, however, the IRB protocol should be returned to the PI for completion. Similarly, where an informed consent document or study information sheet is required, but not included in the protocol, the protocol should be returned for completion. Also, where the actual research will require some sort of instrument (e.g. a survey for survey research, a questionnaire for questionnaire research, interview topics/questions for interview-based research), if the instrument is not included with the protocol, the protocol should be returned for completion.

The rationale for returning an incomplete IRB protocol to its PI for completion, without even preliminary feedback, is that the missing information might substantially change the character of the protocol that was originally submitted.

Approved by the IUSB IRB : 10/9/09