In November 2012, FDA issued the new draft guidance document titled “Guidance for IRB’s, Clinical Investigators and Sponsors: IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed.” Per 21 CFR 812.43, the Sponsor is responsible for selecting investigators qualified by training and experience. However, IRBs play a role in reviewing investigator qualifications as well. They review the investigational plan and must only approve them if they feel that risks to subjects are minimized or reasonable in relation the proposed benefits of the research being conducted. In order to do so, they too must review the qualifications of the investigator who will be conducting the research. An unqualified investigator equals increased risk to subjects.
So how does FDA recommend they do so?
- For investigators which the IRB is already familiar with, they can confirm their qualifications with an institutional official.
- Obtain the curriculum vitae, medical license, or verify professional memberships of the investigator and/or study staff for which the IRB is less familiar with.
- For investigations that are high risk, involve vulnerable subjects, or utilize new technologies or surgical procedures the IRB should also review the investigators experience with the test article or procedure as well as their contributions to the field in that area.
- Special attention should be paid to any investigator initiated research, research outside the investigators area of expertise, and any study that involves significant risk to subjects.
- IRB’s should regularly check FDA’s website to review
- Whether an investigator has been inspected and the results of the inspection
- The list of disqualified investigators
- The list of investigators who have been notified of the initiation of a disqualification proceeding
Another way IRBs ensure the investigational plan does not put subjects at unnecessary risk is by reviewing the adequacy of the research site where it will be conducted. Many times an IRB will be familiar with the research site and this is a fairly easy process. However, there may be times when the IRB needs to gather additional information in order to make this determination as to whether the study involves the potential for medical emergency. In this case the IRB would need to determine the site has the staffing and resources to accommodate such occurrences. This could be as simple as verifying that the site is part of a major medical center.
Finally, the draft guidance clarifies the IRB’s role in determining whether or not an IND or IDE is required for the investigation they are reviewing. Per 21 CFR 812.20, the Sponsor (or a Sponsor-Investigator) is actually responsible for making this determination based on whether an investigation is significant risk or not. The draft guidance states that IRBs should routinely ask how the Sponsor has determined risk and whether or not they considered submitting an IDE. Per the guidance, if the IRB is unsure, or feels differently than the Sponsor they should hold approval until clarification can be obtained. This may involve requesting a copy of FDA’s determination, which is the final say in the matter. FDA also recommends that IRBs have written policies for how they review and make significant risk versus non-significant risk determinations.
Do you work for an IRB? We’d love to hear your take on the new draft guidance, or any others tips you may have in these areas.
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