New guidelines put focus on research conflicts of interest
Timely disclosure required
Conflicts of interest (COI) have been an important priority for IRBs and research institutions for decades. Now with the revised federal regulations on the subject, research institutions should revise and update their COI policies and procedures or they might find themselves in noncompliance with the Department of Health and Human Services (HHS).
"It is a very important and pressing focus for everybody involved in research and research administration," says John R. Baumann, PhD, executive director, research ethics, education, and policy, office of research administration, Indiana University in both Bloomington and Indianapolis, IN.
"Since the federal government issued a new set of guidelines that go into effect next August, everyone is reviewing and revising their conflict of interest policies, procedures, processes, and education," he adds.
Research institutions have the next eight months to meet all the regulatory requirements of the revised conflicts of interest regulations. The final rule, signed by HHS Secretary Kathleen Sebelius and National Institutes of Health Director Francis S. Collins, was published in the Federal Register on Aug. 25, 2011. The new regulations are in effect as of Sept. 26, 2011, and will have a final compliance date of Aug. 24, 2012.
"Within the new regulations are modifications of existing rules and an introduction of some new types of rules," Baumann says.
There are several steps where potential conflicts of interest can be identified, including an annual disclosure in which faculty and staff submit their annual disclosure of conflicts of interest that might be related to their university's role and disclosures that take place whenever a researcher applies for IRB review or applies for a federal grant or contract, he explains.
The HHS revisions to COI regulations retain the basic principle that each research institution has a responsibility to promote objectivity and make sure that any financial interest of anyone involved in the research does not introduce bias, Baumann says.
"One of the changes is that HHS lowered the dollar threshold such that a significant financial interest went from $10,000 to $5,000 now," he explains. "Many human subjects protection offices, however, have a $1 threshold."
For instance, Indiana University currently has a $10,000 threshold for general COI, and a $1 threshold for disclosing any research involving human subjects, he notes.
Another change is that more activities are reported now than were when HHS previously published COI regulations in 1995.
DHHS also changed guidelines for education about financial COI related to research.
Previously, Indiana University had published and disseminated its COI policy, but the institution was not required to document completion of education on the policy. Now all institutions will need to document that researchers have completed COI education, and their education must be updated every four years, he says.
"This is required of everyone involved in federal research, including investigators and key individuals responsible for the design, conduct, and reporting of research," Baumann says. "The IRB requires disclosure of financial interests."
IRB members who are engaged in research also have to report any conflicts of interest with regard to any study reviewed by the IRB, he notes.
"IRB members who have a conflict with any such study are required to recuse themselves," Baumann adds.
Another important change is that HHS will require research institutions to make specific conflicts of interest available to anyone who requests the information within five days of the inquiry.
"It would be, conceivably, difficult to respond to all requests within five days, and you can't prioritize those requests," Baumann says. "So we are exploring what is our best option for this, and some universities like us are considering having a public website available that would identify all financial conflicts of interest related to research."
While some researchers might object to his level of disclosure, others would view it as little different from making a disclosure at a conference before giving a presentation, he notes.
"We believe that engaging in research should be a transparent process, and since there are federal regulations with regard to conflicts of interest, we'll follow them," Baumann says.
Conflicts of interest (COI) have been an important priority for IRBs and research institutions for decades.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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