FDA’s draft guidance clarifies IRB roles

New PIs should be well vetted

The Food and Drug Administration (FDA) has received many lengthy comments expressing concern about its recent draft guidance for IRBs, investigators, and sponsors regarding assessing the qualifications of investigators.

The November 2012 draft guidance suggests that IRBs review the qualifications of clinical investigators who conduct FDA-regulated research. IRBs have a role in reviewing an investigator’s qualifications, the 10-page guidance asserts.

This assessment could be simple and straightforward or more involved, depending on the research and the IRB’s relationship with the investigator, the FDA says.

IRBs also must review the adequacy of the research site, the guidance states.

“FDA’s regulations require that before an IRB can approve research covered by the regulations, the IRB must be able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice,” the draft guidance says.

Shared responsibility

An example from the FDA is of a proposed clinical trial involving medical procedures. “The IRB’s role is to assess the adequacy of the facility’s staff and equipment, including the availability of emergency or specialized care if the need should arise,” the guidance says.

The guidance should encourage IRBs to work in consultation with study sponsors in reviewing evaluations of research sites, but should not be required to replicate their efforts, which is how the draft document is being interpreted, writes Mark Lacy, public policy committee chair of the Society for Clinical Research Sites (SCRS) of Rockville, MD.

Shared responsibility “would help to avoid duplication of effort and the creation of new regulatory burdens and inefficiencies, which would detract from the protection of human subjects,” Lacy writes in a Jan. 22, 2013, letter.

“Finally, we would urge the agency to avoid releasing a guidance that potentially creates confusion by failing to distinguish between investigator-initiated and commercially sponsored research,” he adds.

The FDA’s guidance might not change much for IRBs, notes Harry McGee, MPH, IRB chair at Michigan State University in East Lansing.

“I think the FDA is just emphasizing that you need to be more careful about it,” he says. “At Michigan State, in most cases, we are well familiar with the researchers, and a lot of the research that is being done is from the same researchers and we have their track record.”

The FDA’s guidance mainly will impact IRBs when they’re dealing with a new investigator and research site, he adds.

“We’d look at the investigator’s curriculum vitae, talk to the chair of their department, and we’d talk with someone in the field and ask if they know this person and their work,” McGee explains.

Questions raised

One of the questions raised in response to the draft guidance involved how the assessment would occur if multiple IRBs are reviewing the same protocol.

“What are the responsibilities for each of the IRBs reviewing the studies, particularly those with peripheral roles on the protocol?” asks Jody L. Ference, MS, CIP, CCRA, CIM, director, human subjects protection branch of the Walter Reed Army Institute of Research in Silver Spring, MD.

The guidance also does not specify what type of documentation is sufficient for assessing a site, Ference notes.

“Is documentation of a Federalwide Assurance (FWA) for an institution enough?” Ference writes in the Jan. 17, 2013, letter to the FDA.

“For intervention studies, would it be sufficient and proper for the sponsor to provide a letter stating that a site is appropriate for conducting the specific type of research intended?” Ference asks.

When an IRB is not familiar with the research site or institution, it should gather additional information and engage in a more involved assessment, the FDA states.