The NIH has published a notice in the Federal Register saying it has begun the formal process of writing regulations to govern how institutions ensure their researchers aren’t biased by payments from outside companies.
“The increased interaction between government and the private sector in meeting common public-health goals, and recent public scrutiny, have raised the question of whether a more rigorous approach to investigator disclosure, management of conflicts, and federal oversight is required,” the NIH said in the notice.
The NIH itself may be part of the problem. An audit report last year by the inspector general of the Department of Health and Human Services — the NIH’s parent agency — said that hundreds of financial conflicts of interest among university researchers were simply not being investigated by the NIH.
Agency leaders, in their promise of new regulations, make specific mention of their interest in a set of recommendations issued in February 2008 by the Association of American Medical Colleges and the Association of American Universities.
Those recommendations include requiring that investigators conducting research on human subjects report to their institution all outside financial interests related to their professional responsibilities.
The NIH notice also raises the possibility of requiring institutions with 50 or more employees to form independent conflict-of-interest committees, and requiring that all grantee institutions submit “conflict-management plans.”
The agency will take public comments on such ideas through July 7. —Paul Basken