VHA to begin audits of research affiliates

These will impact all IRBs affiliated with VAs

This spring, the Veterans Health Administration (VHA) will begin to conduct routine not-for-cause audits of institutions and IRBs that are affiliated with Veterans Affairs (VA) research.

"This is a prospective, on-site visit that reviews compliance with regulations for humans, animals, and research safety," says David Miller, PhD, director of the Southern Region Office of Research Oversight for the VHA in Decatur, GA.

These audits will not be the result of a known compliance problem or due to a whistle-blower or federal agency referral, as is the case with the standard for-cause audits, he notes.

"It’s a routine review that takes the tack that we’d like to make the medical center aware of any minor, as well as major compliance issues, before they escalate or get out of hand," Miller explains.

All institutions and IRBs, including those based at universities, that are used as the IRB of record by a VA or that review protocols from VA researchers are eligible for the audit.

"We will have a team of three to four individuals go out to each VA facility," Miller reports. "The team will spend the better part of a week and look at standard operating procedures [SOPs], IRB minutes, and will do a random review of actual source documentation and study folders."

The review team will interview institutional officials, including administrative officers, and will help the facility take a closer look at its human research protection program, he notes.

"We’ll only look at those records that specifically pertain to VA protocols," Miller adds.

Study coordinators will be asked to provide everything they’re required to maintain on site, including serious adverse events, he says.

"The assumption is that everything is fine, and we just take a look at what they have, and we’ll review pharmacy logs," Miller explains. "If we find something questionable, we may need to go to the clinical record to review progress notes."

Reviewers will look at individual files and informed consent documents as well.

Institutions and IRBs will be given a couple of months notice before the audits are scheduled, so there will be no surprises, Miller says.

"We may ask for documents to review even before we go out to the site so we can look at them here and not have to spend hours in an office, and we’ll give facilities a list of people we want to interview," he reports.

To prepare for one of these audits, institutions and IRBs should review the regulations and make certain they are complaint with the letter and spirit of the law, Miller recommends.

Both the VA and the Food and Drug Administration (FDA) have checklists they could follow, and the Office for Human Research Protections (OHRP) has a list of common findings that might be helpful to review, he says.

"Our findings are very similar to OHRP’s," Miller says. "We find that policies are out of date, there’s a lack of continuing review, and people are missing parts of their informed consent documents, or have had the inappropriate use of expedited or exempt reviews."

IRBs need to make certain their membership rosters are up to date and that they have the appropriate mix of people on the IRB, he notes.

Also, one area that sometimes poses problems for VA-affiliated IRBs is that there’s an additional committee called the research and development committee (R&D) committee that needs to be sent the IRB’s minutes in a timely fashion, Miller says.

"Universities don’t have R&D committees, but VAs do, and they need to send the minutes to the R&D committee for review," Miller explains. "IRBs know they need to do this, but the issue is getting them the minutes in a timely way."

Another problem area is that investigators are not permitted to start a study until they have received approval from both the IRB and the R&D committee, and IRBs need to make sure investigators know this rule, Miller says.

"We want to get the word out so that investigators and institutions don’t make unforced errors, like in tennis where someone serves you a ball and you just look at it," he explains.

Once an audit is complete, the reviewers will note any regulatory issues that need to be addressed and ask the facility to create an action plan to correct the deficiencies, and then the VHA office will track these corrections until they are complete, Miller says.

"If we find best practices and things a facility is doing very well, then we’ll certainly note that," he adds.