By Emily P. Walker, Washington Correspondent, MedPage Today
Published: May 24, 2010
WASHINGTON -- Researchers funded by the National Institutes of Health (NIH) would have to disclose more information about their financial ties to industry under a proposed new rule.
The move to shine light on the complex -- and often opaque -- interplay between academia, industry, and the government stems in part from recent pressure from members of Congress who charge that some government-funded researchers don't disclose the full extent of their financial connections to private companies.
The proposed NIH rule would lower the dollar threshold at which researchers must report conflicts of interest to their academic institutions and would require universities to develop plans on ways to manage or reduce such financial conflicts.
"Plain and simple, Americans do not want financial conflicts of interest to influence federally funded research they hope will yield better ways to fight disease and improve health," wrote NIH Director Francis Collins, MD, and Sally Rockey, PhD, in an editorial published online in the Journal of the American Medical Association (JAMA).
The editorial comes several days after the NIH posted its proposed rule in the federal register.
Current regulations governing financial disclosures (rules which date back 15 years) put most of the responsibility to disclose conflicts of interest on individual investigators funded by the Public Health Service of which the NIH is a part. The researcher is responsible for determining whether he or she has any financial relationships that might appear to be in conflict with the NIH and is expected to report those conflicts to his or her university. The university is then required to manage, reduce, or eliminate the conflict, and report it to the NIH.
Under the proposed new rule, researchers would report all financial interests related to their research -- not just those that might conflict with NIH-funded research, and the institution would then report specifics of the conflict to the NIH, including consulting fees, travel reimbursements, honoraria, and a description of how the conflicts relate to the researcher's NIH-funded research.
The proposed changes would:
* Lower the threshold at which a researcher's financial interests require full disclosure to $5,000 from $10,000.
* Require institutions to create a plan to manage all identified financial conflicts of interest, which might include reducing or eliminating the conflict. Institutions would need to report the key elements of their plan to the NIH.
* Require every Public Health Service-funded institution to post on a website information on all significant financial conflicts of interest.
* Require investigators to undergo financial conflict of interest training before engaging in Public Health Service-funded research, and every two years thereafter.
"If NIH-supported researchers fail to disclose the full extent of their financial interests, universities fail to comprehensively manage [financial conflicts of interest], or NIH fails to diligently oversee the entire system, public trust will be jeopardized in ways that may have far-reaching implications for the future of science," they wrote.
". . . for the good of the research enterprise and for our nation as a whole, it is imperative to take collective steps now to usher in a new era of clarity and transparency in the management of financial conflicts of interest," Collins and Rockey conclude.
The proposed rule is open for comment for 60 days, and the NIH will issue a final rule before the end of the year.
The authors reported no financial conflicts of interest.
Primary source: Journal of the American Medical Association
Source reference:
Collins F, Rockey S "Managing financial conflicts of interest in biomedical research" JAMA 2010; DOI:10.1001/jama.2010.774.
Published: May 24, 2010
WASHINGTON -- Researchers funded by the National Institutes of Health (NIH) would have to disclose more information about their financial ties to industry under a proposed new rule.
The move to shine light on the complex -- and often opaque -- interplay between academia, industry, and the government stems in part from recent pressure from members of Congress who charge that some government-funded researchers don't disclose the full extent of their financial connections to private companies.
The proposed NIH rule would lower the dollar threshold at which researchers must report conflicts of interest to their academic institutions and would require universities to develop plans on ways to manage or reduce such financial conflicts.
"Plain and simple, Americans do not want financial conflicts of interest to influence federally funded research they hope will yield better ways to fight disease and improve health," wrote NIH Director Francis Collins, MD, and Sally Rockey, PhD, in an editorial published online in the Journal of the American Medical Association (JAMA).
The editorial comes several days after the NIH posted its proposed rule in the federal register.
Current regulations governing financial disclosures (rules which date back 15 years) put most of the responsibility to disclose conflicts of interest on individual investigators funded by the Public Health Service of which the NIH is a part. The researcher is responsible for determining whether he or she has any financial relationships that might appear to be in conflict with the NIH and is expected to report those conflicts to his or her university. The university is then required to manage, reduce, or eliminate the conflict, and report it to the NIH.
Under the proposed new rule, researchers would report all financial interests related to their research -- not just those that might conflict with NIH-funded research, and the institution would then report specifics of the conflict to the NIH, including consulting fees, travel reimbursements, honoraria, and a description of how the conflicts relate to the researcher's NIH-funded research.
The proposed changes would:
* Lower the threshold at which a researcher's financial interests require full disclosure to $5,000 from $10,000.
* Require institutions to create a plan to manage all identified financial conflicts of interest, which might include reducing or eliminating the conflict. Institutions would need to report the key elements of their plan to the NIH.
* Require every Public Health Service-funded institution to post on a website information on all significant financial conflicts of interest.
* Require investigators to undergo financial conflict of interest training before engaging in Public Health Service-funded research, and every two years thereafter.
"If NIH-supported researchers fail to disclose the full extent of their financial interests, universities fail to comprehensively manage [financial conflicts of interest], or NIH fails to diligently oversee the entire system, public trust will be jeopardized in ways that may have far-reaching implications for the future of science," they wrote.
". . . for the good of the research enterprise and for our nation as a whole, it is imperative to take collective steps now to usher in a new era of clarity and transparency in the management of financial conflicts of interest," Collins and Rockey conclude.
The proposed rule is open for comment for 60 days, and the NIH will issue a final rule before the end of the year.
The authors reported no financial conflicts of interest.
Primary source: Journal of the American Medical Association
Source reference:
Collins F, Rockey S "Managing financial conflicts of interest in biomedical research" JAMA 2010; DOI:10.1001/jama.2010.774.
