Researchers to face stricter ethics policy

Changes to the conflict of interest policy that binds the University’s researchers were presented to a faculty governing body Friday, the first formal step to put GW in line with guidelines mandated by one of its largest sources of grants.

Health researchers who work with federal dollars will soon face stricter disclosure rules for grants. All research universities must update their policies to adhere to new conflict of interest guidelines issued by the National Institutes of Health last year.

Vice Provost for Faculty Affairs Dianne Martin, who leads a group of seven administrators and faculty in health and law that began working on changes to the policy in December, presented a draft of the policy to the Faculty Senate Executive Committee, which includes University President Steven Knapp. The policy will be up for approval by the entire Faculty Senate and the Board of Trustees in May, after it faces the Faculty Senate subcommittee on ethics April 6.

New conflict of interest rules for health researchers:

  • Financial disclosure threshold lowered from $10,000 to $5,000
  • Must disclose sponsored travel
  • Required training for researchers
  • Public accessibility for conflict of interest cases

“There will be more training, more oversight and a lower bar in terms of what you have to report,” Martin said. “There will be a definite push that you do more reporting as grants come in and people submit proposals. We have to be very rigorous about this.”

Michael Castleberry, chair of the Faculty Senate’s executive committee, said the committee was just the first stop for the policy changes, which are now required of all U.S. research universities by the NIH. The federal agency instituted new rules last August to push universities to take a stronger stance in policing researchers after the NIH took criticism from congressional leaders in 2008 about relaxed policies.

“Conflict of interest covers a lot of sins. When you’re hired as a full-time member of the faculty of the University, but you’re still getting grants and have consultative relationships, being able to consult is part of your University capability,” Castleberry said. “But it’s expected if you’re going to engage in consulting that you present it as a conflict of interest.”

While initial changes will only impact researchers engaged in health studies, greater changes could take shape next fall when the University looks at the entire conflict of interest policy, which includes all University professors, Martin said. The University-wide policy has not been adjusted in six years.

The University has until August to make the ordered changes to its policy governing financial and family-based conflicts of interest, which include lowering the minimum disclosure value from $10,000 down to $5,000, adding online training for medical researchers and setting up an internal database for public access to conflict of interest cases. Martin said the group would not create a public website to publish conflict of interest information out of privacy concerns, but the University must hand over records of cases within five days of a request.

The new policy will also force professors to disclose travel costs that a company covers.

“If Pfizer pays a faculty member to give a speech in Tahiti, even though they didn’t get compensation for it, the fact that they got the trip to Tahiti would now be something they have to report,” Martin said. “The [conflict of interest] training will help inform them of that.”

The current conflict of interest policy, which was last updated in 2004, establishes a “flexible, not rigid approach,” according to the document, and sets the monetary limit that researchers have to disclose as a conflict of interest at $10,000. Martin expects the examination to produce a broader policy that’s firmer with less room for error.

Under the current policy, Martin said the University collects about 1,500 conflict of interest forms from professors to compile into an annual report. About 50 of the most serious conflict of interest cases are reviewed by the Board of Trustees annually in a February report, Martin said, about half of which are conflicts in research.

Martin said department heads and deans take an active approach in snuffing out potential cases of conflict of interest “because the worst thing in the world is that you don’t want one of these to come back and end up on the front page of The Washington Post.”

The NIH doled out about $53.4 million, or 38 percent, of the University’s research expenditures in 2011. GW’s entire portfolio of federally funded medical research, which is also drawn from agencies like the Food and Drug Administration and the Centers for Disease Control and Prevention, stands at $199 million as of last month.

“The government is looking for greater transparency and accountability about what’s been done with public funds. It’s taxpayer money put forward,” said Melissa Goldstein, a health policy professor who specializes in ethics and sits on the committee drawing up the new policy.

Paula Lantz, the chair of the department of health policy who also sits on the policy’s review committee, said the new policies would boost the University’s research transparency.

“We want to make sure that we’re satisfied that GW’s at the forefront of this transparency and accountability idea, because it’s not just actual conflicts of interest that worry the public – it’s also not great to have an appearance,” he said. “That can be just as damning, even if it’s not necessarily fair.”

To help keep faculty honest, researchers will have to submit conflict of interest forms continuously as they receive new grants and start new projects, Martin said, instead of the current format of annual reports.

Former Provost and Vice President for Health Affairs John “Skip” Williams faced conflict of interest accusations in a 2009 Washington Post article from sources who questioned his position on the board of directors for United Health Services, which owns GW Hospital. Williams stepped down from the board of directors that year. He retired from the University in December and was granted professor emeritus status by the Board of Trustees.

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