HHS is drawing strong reactions to its updated final rule (PDF) aimed at "providing a framework for identifying, managing and ultimately avoiding" financial conflicts of interest among scientists conducting government-funded research.
Criticism, praise for updated HHS disclosure rule
In particular, Sen. Chuck Grassley (R-Iowa) is condemning a provision that makes the public Internet posting of financial conflicts optional. Under the provision, when individuals conducting federally funded research have a significant financial interest in the research, their institutions can put that information on a publicly accessible website or wait until someone requests financial disclosure information and then disclose it in writing within five business days.
"Making the method of disclosure optional hurts public access," said Grassley, who ranked No. 47 this year on Modern Healthcare's 100 Most Influential People in Healthcare list, in a news release. "An institution that doesn't want to disclose information readily will be able to opt for the written request, knowing that requiring a request in writing is a barrier. … This is a missed opportunity to inject transparency where it's really needed. With less public scrutiny than we could have had, we'll lose a valuable layer of oversight."
The rule applies to any institution applying for or receiving an HHS public health service grant and takes effect Aug. 24, 2012.
It includes regulations proposed last year. Also, according to an HHS news release, it includes "major changes" to regulations concerning disclosure, public reporting and researcher training. A summary on the National Institutes of Health website lists new changes such as lowering the threshold for disclosure of payment for services or equity interests to $5,000 from $10,000; requiring travel-expense reimbursement disclosure; and requiring the disclosure of the name of the entity with which the researcher has a financial conflict of interest, the nature the conflict and the value of the interest.
The NIH "is committed to safeguarding the public's trust in federally supported research that is conducted with the highest scientific and ethical standards," National Institutes of Health Director Dr. Francis Collins said in the HHS news release. "Strengthening key provisions of the regulations with added transparency will send a clear message that NIH is committed to promoting objectivity in the research it funds."
Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, said he was troubled by Collins' statement in light of the optional public-posting provision.
"That's hypocrisy," Wolfe said in an interview, adding that "to preserve the public trust," the public needs to be fully informed.
The Association of American Medical Colleges gave the updated rule a positive reception.
"Today's final rule from the NIH is an important step forward on the path to strengthening the integrity of biomedical research through enhanced requirements for disclosure and transparency," Dr. Darrell Kirch, AAMC president and CEO, said in a news release. Kirch ranked No. 95 on Modern Healthcare's 2011 Top 100 Most Influential People in Healthcare list.
The updated rule notes that the purpose of the original 1995 regulations was to protect against bias in the design, conduct or reporting of any HHS-funded research as a result of financial conflicts of interest.
It also states, "The growing complexity of biomedical and behavioral research; the increased interaction among government, research institutions and the private sector in attaining common public health goals while meeting public expectations for research integrity; as well as increased public scrutiny, all have raised questions as to whether a more rigorous approach to investigator disclosure, institutional management of financial conflicts and federal oversight is required."
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