Need grows for research compliance programs

Increased federal scrutiny on compliance with the research-oriented regulations is driving a need for the establishment of research compliance programs, says Debra Fields, chief compliance officer at City of Hope National Medical Center in Duarte, CA.

One reason this is more important than ever is that almost 50% of all research funding now comes from federal and state grants. Even with many privately funded grants, Food and Drug Administration rules will apply.

Wendy Baldwin, director of extramural research at the National Institutes of Health (NIH), says that institutional oversight is the only truly effective route to compliance because institutions are much more likely to know if they have an investigator with a conflict that could interfere with his or her objectivity, even if NIH has not written a rule about it.

She says the most important area to examine is roles and responsibilities. "We know that, in many cases on institutional campuses, people do not have a clear understanding of what their role is and how their role interacts with someone else’s."

Fields agrees that the most important question to ask concerning the volume of regulations on research is where responsibility is assigned for compliance. "Most institutions have taken a very fragmented approach to this," she says. "Many of the noncompliance issues have come up because people expect someone else to be worrying about a certain set of regulations."

Fields says that when City of Hope took a close look at all of the assurances and certifications it was making, it wanted to have proof that it was complying with all those areas. "We took the opportunity to look at everything we certify, make a list, and ask within our organization who is responsible for this," she reports.

Then a memo was sent to the responsible person, informing him or her about the certification and asking how that area is monitored to ensure the organization is in compliance. "That was a very useful exercise, which enabled us to identify certain gaps, develop policy in certain areas, and appropriately assign responsibility," she reports.

Fields says it also is important to remember that it is the primary investigator (PI) who personally takes responsibility on the certification as well as the institution. "PIs must be reminded of that because they are mainly concerned with the science relating to the award and often will sign these assurances with blind faith," says Fields.

There are several good operational reasons to have a research compliance program, says Fields. "One of them is just the opportunity to focus on your entire research enterprise and make sure that it is functioning as one connected locomotive instead of several disconnected parts," she says.

Fields says her organization looked at the Office of Inspector General’s (OIG) model guidance for hospitals and other entities and attempted to do the same for research, to integrate research into its general corporate compliance program, which not only addresses regulatory compliance but also corporate ethics.

Here are several more reasons to have a research compliance program, Fields says:

  • It demonstrates a strong commitment to honesty and responsible corporate citizenship to the community. Fields says this is important with Medicare billing and especially important for clinical trials. "We need to be good stewards of public funds and make sure we are treating our human subjects with the highest possible care," she says.
  • It reinforces employees’ sense of right and wrong. Fields says a research compliance program gives then a structure to address problems when they find them.
  • It’s cost-effective. "Ultimately, it is cost-effective because, hopefully, you will circumvent problems before they happen," she says.
  • It provides a tool for monitoring employee and contractor behavior to promptly correct any misconduct.
  • Customer service and quality of patient care are enhanced. "We on the administration side of our organization try to view our PIs and scientists as our customers," Fields says. "We want to make sure that we are doing everything possible to administer our research program in such a way as to make their work as easy as possible."
  • It assists with the mitigation of any sanction imposed by the government.
  • It’s preferable to waiting for the OIG to impose a corporate integrity agreement.
  • It protects corporate directors from personal liability.

Questions to ask

Wendy Baldwin, director of extramural research at the National Institutes of Health, says medical centers should ask themselves these questions:

  • Who is responsible for financial conflict of interest?
  • Do they know how to get the information to deal with it? Do they understand what the policies and procedures are?
  • Do you have something on-line that gives them some guidance about what to do?