Academic medical facilities falling under federal scrutiny

NIH official promotes self-regulation by facilities as the most effective response

Last year, the National Institutes of Health (NIH) awarded nearly $16 billion in grants, cooperative agreements, and contract support to more than 50,000 scientists at more than 2,000 institutions. Yet, one recent study reported that 15 institutions receiving significant NIH funding did not even have conflict-of-interest policies.

That’s bad news for research organizations because, if there is pervasive noncompliance these days, chances are it’s going to be discovered and the institution likely will pay stiff penalties, warns Debra Fields, chief compliance officer at City of Hope National Medical Center in Duarte, CA.

The array of federal agencies scrutinizing this area includes NIH, the Food and Drug Administration (FDA), and at least five other federal agencies. The Health and Human Services Office of Inspector General added its name to that list when it highlighted the areas of research and clinical trials in its latest Work Plan.

The ramifications of noncompliance range from suspension of institutional research and debarment of investigators to the loss of public confidence and with it the loss of research participants and funding. It also can lead to congressional investigations and private civil actions.

NIH is scrutinizing numerous areas of research at academic medical facilities, especially conflicts of interest and research objectivity issues, says Wendy Baldwin, director of extramural research at NIH, where she coordinates activities and policies of extramural research, which account for 85% of the NIH budget.

Baldwin warns academic medical centers that if they are not able to have compliance driving "normative behavior," they probably are going to fail. "If the only reason your investigators do something to comply is because you can cite a line in a federal rule, your life is going to be miserable," she says.

Baldwin says that NIH’s rule on conflicts of interest goes to the underlying principle that NIH expects its investigators to be objective in their research.

"I am worried about investigators that are so motivated by fame that they might take a shortcut," she says. But that is one of the many areas that cannot be regulated, she adds.

"Management of conflict cannot be done through a formula," Baldwin says. The hardest challenge hospitals will have in this arena is oversight of institutional review boards (IRB). "Some of the reviews of IRBs have made it sound like the IRBs should be doing reviews of financial conflicts of interest," she asserts.

"I think that is going down an inappropriate path, because you already have someone doing a review of financial conflict of interest," says Baldwin.

She says it is not necessarily within the skill set of the IRB, and it creates tremendous problems on campuses.

Rather, Baldwin says whoever runs compliance and the IRB should learn to interact when they have a case that crosses their boundaries. "I don’t think moving financial conflict of interest over to the IRB is actually the solution," she says.

Developing methods to manage conflicts of interest helps illustrate how complex these issues can be.

"If for some reason, there is a conflict that cannot be eliminated, it must be managed," Baldwin says. "This is where your compliance office and your IRB need to be talking."

Public disclosure is one popular method. Monitoring of the research by an independent reviewer is another. "Maybe you can put in an independent observer or speak with the investigator or other scientists about the project," she explains.

Another major threat is possible qui tam relators, Fields warns. "Employees are becoming more and more aware of compliance issues and what’s in it for them if noncompliance is uncovered and the institution has not dealt with it," she says.

In the past, she says, disgruntled employees made accusations about discrimination and sexual harassment. Now the issues that they bring up deal with research misconduct, fabricated data, and improper safety logs.

In addition to high-profile cases involving human-subject protection cases, many others deal with pre-award and post-award grant administration issues and the potential expense associated with them.

Baldwin says NIH is planning to increase its proactive compliance site visits, which it started in 2001 to help institutions understand what they had to do to be in compliance.

She also predicts that later this year, her office will meet with the General Accounting Office and medical center executives to provide the research community with an increased understanding of NIH’s complex policies.