New conflict of interest disclosure rules favor drug companies, puts onus on us to determine who is paid to write what?


NIH completes its conflict of interest policies.

Plan tightens rules but scales back call for public disclosure of financial conflicts of interest.

Heidi Ledford

Francis Collins, director of the NIH, claims that stricter financial conflict laws will increase public confidence. Abel Dolgin

The US National Institutes of Health (NIH) released a financial conflict-of-interest policy today after more than two years of deliberation-interest policy that would impose stricter reporting obligations on institutions and investigators receiving federal funding.

But the guideline also backs off from a suggested requirement that organizations disclose such conflicts on websites that are open to the public. In accordance with the final regulation, organizations can choose not to keep a public website providing they make the data accessible upon request within five business days of receiving an inquiry.

According to NIH director Francis Collins, the updated standards are meant to bolster oversight of conflicts of interest and maintain public trust in the face of expanding ties between academics and industry. He stated, “We’re hopeful that the findings will further increase public confidence in the scientific method and the findings of NIH-funded research.”

Since investigations led by Senator Charles Grassley (Republican, Iowa) revealed researchers who had failed to disclose millions of dollars in funding, the NIH has been under pressure to tighten regulations on financial conflicts of interest of income from companies with a stake in their research.

The final policy reduces the $10,000 threshold at which an investigator’s financial interest must be declared to $5,000 in accordance with the draft regulations issued in May 2010. Prior regulations, established in 1995, only required institutions to disclose a financial conflict of interest involving an investigator and whether it was being managed, reduced, or eliminated. Institutions are now required to describe how they are resolving the conflict. But disclosure of those management plans is still optional.

aiming for public trust

The draft guidelines unveiled in May also included a suggestion that institutions be required to disclose financial conflicts on a website that is open to the public. The White House Office of Management and Budget put pressure on the NIH to drop that requirement earlier this month, according to a report in Nature News (see Conflict disclosure plan dropped). President Barack Obama charged the office in January with assessing and reducing the cost of new rules. The National Institutes of Health (NIH) projects that the new regulations will be 25% more expensive overall and that it will cost $350,000 to implement the public disclosure requirements at 2,000 institutions.

Ned Feder, a staff scientist at the Project on Government Oversight in Washington, DC, claims that without the website requirement, the public’s trust may suffer. need a submission in order A “barrier” prevents people from retrieving the data, he claims. It is truly unfortunate.

However, Carrie Wolinetz, associate vice president for federal relations at the Association of American Universities in Washington, DC, says the increased flexibility will be welcomed by the universities. According to her, many universities expressed worry about the additional costs associated with creating and maintaining the websites and questioned whether it would be beneficial to the general public.


Without any context or explanation of what the information actually meant, she says, “it would just be information up on the website.” “I believe the new rule’s flexibility is a good compromise.”

Sheldon Krimsky, an ethicist at Tufts University in Boston, Massachusetts, is worried about how the regulations permit institutions to appoint a representative to assess whether an investigator’s financial interests present a conflict of interest. According to Krimsky, the designated official might be reasoning, “Well, I know this person, and he’s not going to let money affect the outcome of his research.” It’s raising the bar too high, I think.



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