Reviewing the Draft Guidance on IRB Responsibilities

Wednesday, February 20, 2013

FDA's  new draft guidance on IRB responsibilities is short, sweet, and to the point. Which begs the question, is FDA trying to fit all their future guidance documents into "tweets"?

Okay, maybe its not that short, but the draft guidance does focus on only three points: 1) clinical investigator qualifications, 2) adequacy of the research site, and 3) whether an IND or IDE approval from FDA is required. In case you missed it, here's a recap of the draft guidance:


Point 1: Qualification of clinical investigators are typically covered by the study Sponsor. However, this guidance reminds IRBs that ensuring investigator qualifications does fall under IRB responsibility as a part of acceptability of the proposed research. If the investigator isn't qualified, then the acceptability of the study is suspect, so IRBs should make it part of their review process to ensure that investigators have the appropriate credentials and qualifications (FDA has some suggestions in the guidance for that too).

As a reminder, the FDA website has information about investigator inspections and results as well as those investigators that have been disqualified or are in the process of being disqualified.

Point 2: The IRB is also responsible for the acceptability of the proposed research in terms of institutional commitments and regulations, acceptable law, and standards of professional conduct and practice. There is nothing new here, but our guess is it was probably included due to the number of new devices, new surgical techniques, combination products and companion diagnostics that are becoming common place in today's environment.

In most cases, the IRB is usually familiar with the investigator(s) and the institution at which the study will be conducted (this may be trickier for independent IRBs than it is for institutional IRBs). In studies using new and novel devices or techniques, the IRB should be prepared to assess the adequacy of the facility's staff and equipment, including the availability of emergency or specialized case if the need arises.

Point 3: This section deals with IND/IDE requirement, and it contains an important point that we have advised quite a few clients on recently. It has to do with whether an IND or IDE is needed, and  whether a study is considered a significant risk, a non-significant risk, or IDE-exempt.

All device studies fall into one of these three categories. If it is a significant risk, it requires FDA to approval the IDE. A non-significant risk study would require an abbreviated IDE, but no FDA review. The third class of studies are exempt from any IDE. What most sponsors don't know is that the determination of which category a proposed study would fall into can be made by the IRB, and doesn't require a FDA determination through a pre-submission.

The Sponsor is responsible for making the initial determination of whether an IDE is required and for providing the IRB with the rationale for its determination. It is essential that the Sponsor be very clear in the information supplied to the IRB that they have determined the study to be a non-significant risk. Particularly for companion diagnostics, details about the diagnostic must be provided, as well as a risk - benefit discussion demonstrating that the risks to the patient are minimal. Things to consider are the condition of the subjects being enrolled in the study (e.g. healthy versus in poor health with no proven therapies available) and the risk of a wrong result - assigning a patient to the wrong arm of the study, or denying them a potentially beneficial therapy.

For drugs and biologics, the draft IRB guidance recommends that the Sponsor contacts the appropriate review devision withing CDER or CBER if they are not sure whether the IND regulations apply. Inorder to help with this question, FDA has published a draft guidance document: Determining Whether Human Research Studies Can Be Conducted without an IND. The IRB relies on the Sponsor to provide the basis for the IRB's determination of whether an IND is required. If it is sufficient, the IRB will move forward accordingly.

FDA can also assist in the IDE decisions, and has published a guidance document Practices for Handling Inquiries Regarding the Need for an Investigational Device Exemption Application for Research Involving Medical Devices.

Tags: CDRH, Clinical Studies, CoDx, FDA

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