The National Institutes of Health is being pressured to play a greater role in eliminating financial conflicts of interest among academic researchers.

In a report released Nov. 19, the HHS Office of Inspector General noted that nearly half of institutions that receive NIH grants do not require researchers to provide specific amounts of equity or compensation on their financial disclosure forms and 90 percent rely on researchers' discretion as to whether their financial interests should be reported. Further, OIG said institutions rarely reduce or eliminate conflicts of interest.

The OIG recommended that NIH collect details on the nature of all reported conflicts and how they are managed, reduced or eliminated and require grantee institutions to obtain information on all significant financial interests held by researchers.

This is the second study OIG has conducted on the topic. It issued similar recommendations in a January 2008 report.

OIG conducted the current study at the request of Congress. Sen. Chuck Grassley, R-Iowa, has launched several investigations to expose the financial ties between the pharmaceutical industry and researchers and doctors, and legislation he developed to require company disclosure of company payments to medical professionals is included as part of health care reform legislation (¹ "The Pink Sheet," Oct. 12, 2009).

High-Profile Cases Spur OIG Report

The OIG report, "How Grantees Manage Financial Conflicts of Interest in Research Funded by the National Institutes of Health," noted that recent inquiries by the Senate Finance Committee have led to investigations of financial conflicts of interest among NIH-funded researchers. It said that to date, nine cases have been made public by committee staff.

OIG notes that one of these researchers, Charles Nemeroff of Emory University, failed to disclose that he received $2.4 million from pharmaceutical companies over a seven-year period. NIH subsequently suspended a $9 million grant to Emory and Nemeroff stepped down as chair of the Department of Psychiatry and Behavioral Sciences. Emory conducted its own investigation and found that Nemeroff had received $800,000 from GlaxoSmithKline, the largest single payer, for more than 250 speaking engagements from January 2000 to January 2006.

The day before OIG released its report, Grassley announced that he had sent letters to leading medical schools requesting their policies on ghostwriting. He likened industry's use of articles and research papers ghostwritten by faculty to plagiarism.

NIH is the latest target of inquiries over academic conflicts of interests. The OIG report puts the onus on NIH to be more proactive in policing conflicts of interest among its grant recipients. It notes that 80 percent of NIH's $29.5 billion in fiscal year 2008 was distributed to more than 325,000 researchers at more than 3,000 universities, medical schools and other research institutions.

"With so much funding at stake, the question of research integrity becomes crucial because of the appearance or existence of conflicts by recipients of these grants," OIG states. "It is vital to public health and safety that this research not be biased by researchers' conflicts."

Equity Ownership Is Most Frequent Conflict

OIG collected information from 41 grantee institutions that reported conflicts to NIH in fiscal year 2006. Of the 225 conflict-of-interest reports they submitted to NIH, OIG analyzed 184. It found that the most common type of financial conflict was researchers having equity ownership in companies that could significantly affect their grant research. Grantee institutions provided specific equity amounts for 56 researchers. Six of these researchers had equity valued at more than $100,000 and 13 had equity ownership of 50 percent or more.

The second most common type of conflict was researchers inventing or developing technology or intellectual property related to or used as part of the grant research. Other conflicts included researchers consulting or holding positions with outside companies. Seven researchers received at least $50,000 in royalty payments or for their services.

OIG said the most common method grantee institutions used to manage conflicts was disclosing the conflict in publications and presentations and the second was ensuring there were protections to prevent researchers from putting inappropriate pressure on other staff working on the grant.

Among other recommendations, OIG advised NIH to develop guidance on methods to verify researchers' financial interests. It also recommended that the agency ensure that grantee institutions are taking appropriate actions against researchers who do not follow reporting procedures.

NIH Director Francis Collins responded to OIG's draft report in an August letter. He said many of the recommendations cannot be implemented because NIH is bound by the current regulation on federal financial conflict of interest. In May NIH issued an advance notice of proposed rulemaking to get public comments as to whether the agency needed to modify the regulation.

Collins noted that NIH has discretion to request relevant information to evaluate compliance. However, he said, "should NIH request this additional information from grantees with such frequency that the request amounts to a 'de facto' requirement to submit additional information to the agency, it could be argued that the practice constitutes a rule, which would need to be issued consistent with notice and comment procedures."

In its report, OIG stated that it believes the current regulation allows NIH to take a more proactive role in overseeing grantee institutions. And it recommends that NIH amend its regulations where necessary to enhance its oversight of financial conflicts of interest.

NIH must submit a final management decision, including any action plan, to OIG within 60 days. It must state whether it concurs with OIG's recommendations and the steps it will take to implement them.

- Brenda Sandburg ( ² b.sandburg@elsevier.com )

Conflicts of Interest By Academics Should Be Better Policed By NIH, OIG Says

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