A few ideas on the proposed federal rules on industry disclosure from Eric G. Campbell, Ph.D., and Darren E. Zinner, Ph.D. (From the Mongan Institute for Health Policy, Massachusetts General Hospital, Boston (E.G.C.); and the Heller School for Social Policy and Management, Brandeis University, Waltham, MA (D.E.Z.).
The proposals include lowering the disclosure threshold to $5,000; requiring disclosure to the investigator’s institution of all relationships, not just those that the investigator decides are related to a given grant; and requiring institutions to determine the relevance of relationships, to develop a management plan for all conflicts, and to share the results of these management plans with the NIH and the public through a public Web site.
The efficiency and effectiveness of the federal regulations could be enhanced in a few additional ways several of which are very similar to those proposed recently by the Institute of Medicine.
1. The disclosure threshold should be lowered to the level set by the ACA: $10 per gift or payment, or $100 per year, from a company.
2. A standardized federal reporting form should be developed, and all DHHS grantee institutions should be required to use it.
3. The NIH should fund research on the nature, extent, and consequences of the failure of faculty members to fully inform their institutions about industry ties; research findings should guide further government actions.
4. The DHHS should offer guidance to grantee institutions regarding the most problematic types of industry relationships, and the NIH should fund additional research into such questions.
5. Data on academic-industry relationships at the investigator and institutional levels should be made available, in a common format, on institutional Web sites.
6. If existing monies are not sufficient, additional funding should be provided to offset the additional costs associated with increased monitoring and reporting of industry relationships by academic institutions.