“Making the method of disclosure optional hurts public access,” Grassley said 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. According to figures supplied by the National Institutes of Health, in fiscal 2010, government funding of research that is subject to conflict of interest disclosure regulation totaled more than $25.1 billion—81% of the NIH's total $30.8 billion budget for that year.
The new rule features regulations proposed last year and also includes “major changes” to regulations concerning disclosure, public reporting and researcher training, according to an HHS news release. A summary on the NIH 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 organization 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 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.
Wolfe said the only possible reason for such a provision would be “to keep people in the dark,” and added how it also contradicts statements made by Collins in an essay he co-wrote titled “Managing Financial Conflict of Interest in Biomedical Research” that was published in the May 24, 2010 edition of the Journal of the American Medical Association.
“The public may not always understand the intricacies of rigorous science, but most individuals quickly grasp the concept of bias,” Collins wrote. “Plain and simple, Americans do not want financial conflicts of interest to influence the federally funded research they hope will yield better ways to fight disease and improve health.”
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.
Grassley began investigating university disclosure of researchers' outside financial interests in 2007, and he noted instances where prominent psychiatry professors at Emory, Harvard and Stanford universities who were conducting NIH-funded research failed to disclose their financial interests.
“Emory, as other schools, is committed to ensuring the integrity of our research,” a university spokeswoman said in an e-mail. “We are examining and revising our policies and procedures to ensure compliance with the new regulations.”
Stanford and Harvard officials declined to comment.