Department of Health and Human Services cracks down on research rules

The Department of Health and Human Services tightened the guidelines governing federally funded medical research this month as part of an ongoing effort to reduce conflicts of interest in the medical field.

The new rules ­– championed by the Obama administration – will keep researchers, scientists and physicians who receive federal funds on a tighter fiscal leash by mandating that any payments from drug companies over $5,000 be reported to the government. The existing limit stands at $10,000.

When the new guidelines begin next year, researchers must report all financial interests that could impact the design or conduct of their research. Meanwhile, the researchers’ institutions must report specifics of the conflict to the National Institute of Health, including travel reimbursements, consulting fees, gifts and descriptions of how conflicts relate to their NIH-funded studies.

The guidelines also toughen the rules on what is considered a significant financial conflict of interest, especially for studies involving relatives of researchers or studies related to the researcher’s academic responsibilities at the institution.

Research institutions currently have the option to disclose conflict-of-interest financial relationships online for public access, but they will only be required to disclose such information upon request.

“NIH’s goal here is not to discourage relationships between academic researchers and the private sector,” Director Francis Collins told reporters last Tuesday in a conference call about the announcement. “But we do want to make sure those relationships are subjected to close scrutiny.”

The new guidelines will affect more than 40,000 federally funded researchers who also receive payment or stock from drug and medical-device companies. Anne Hirshfield, the associate vice president for health research at GW, did not make available the number of federally funded researchers GW employs, but said the new guidelines would have a limited effect on the University.

Hirshfield said she believes the tighter guidelines are beneficial to the overall medical community.

“They clarify and expand institutional obligations to assure objectivity in research and they increase public access to information about conflict of interest and its management,” she said.

Federal resources paid for approximately 74 percent of research in the School of Medicine and Health Sciences in 2011 – all of which could be affected when the regulations are instituted in 2012.

While the new guidelines could increase transparency, Hirshfield said the paperwork required to now legally report all private-sector partnerships could hold researchers back from their work.

“I am concerned, however, that the mechanisms needed to collect and report this information will substantially increase administrative burden on our faculty and staff,” she said.

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