Researchers' Conflict Of Interest Rules Tightened Up By US Authorities

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Clinical Trials / Drug Trials
Article Date: 23 Aug 2011 - 20:00 PDT


US authorities have lowered the amount of money that constitutes a financial conflict and expanded the required disclosures for medical researchers. In order to manage, identify and ultimately avoid researchers' financial conflicts of interest, the US Department of Health and Human Services (HHS) has issued an updated Final Rule. The HHS and NIH (National Institutes of Health), which also contributed to the updated rule, say the 1995 regulations have been revised to "update and enhance the objectivity and integrity of the research process."

The 1995 regulation placed the responsibility of checking for a researcher's financial conflicts of interest on the universities where they worked. With the updated rule, researchers will have to disclose their conflict of interest to their institutions (universities), and the institutions then have to inform the NIH that it is being reduced, eliminated or managed. The researchers will now have to provide details on the value and nature of the conflict, and explain why it is a conflict and what impact it may have on research.

HHS Secretary Kathleen Sebelius, said:

"The medical research conducted and funded by the federal government has long been the gold standard of scientific investigation. Our financial conflict of interest rules must keep up with the times if we are to maintain our leadership role in the global scientific community."

SFI (significant financial interest) has a new definition that has been added to the rules. Other changes include the extent of a researcher's disclosure, the data given to the federal grant-awarding agency, what information is made available to the public, and the researcher's training.

E.G., the updated regulations:

• Researchers must disclose to their institutions all their SFIs associated with their institutional duties
• The threshold at which an SFI needs to be disclosed will drop from $10,000 to $5,000.
• Institutions will need to inform the federal grant-awarding agency regarding any extra information on identified financial conflicts of interest, and what is being done about it.
• Identified SFIs held by senior or key personnel must be openly disclosed to the public*.
• Researchers must have completed their training related to the regulations and the financial conflict of interest policy of their institution.

* Institutions will not have to disclose conflict of interest information online. They will keep the information offline and only provide it when requested. This is a change from the proposed rules announced last year.

NIH Director Dr. Francis S. Collins, said:

"The NIH is committed to safeguarding the public's trust in federally supported research that is conducted with the highest scientific and ethical standards. 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."

HHS added:

"The regulations will be implemented no later than 365 calendar days after publication of the final rule in the Federal Register."

The NIH said that approximately 2,000 organizations that receive public health science funding annually and about 40,000 researchers that take part in funded research and have an SFI will be affected.

Click here (PDF) for more details on the major changes to the regulations.

Written by Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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