NIH Changes Ground Rules for Biotech

The nation's most significant source of funding for life science research, the National Institutes of Health, announced two sweeping changes last week that could dramatically alter biotechnology commercialization. The first policy change addresses known and potential conflicts of interest by NIH employees, while the second encourages all NIH-funded research to be released publicly within 12 months of final publication.

Issues of Ethics

Over the past year, NIH has been addressing the ethics issues raised by the outside consulting activities of several of its employees. Under the new rules, all NIH employees are prohibited from engaging in certain outside employment with: 1) substantially affected organizations, including pharmaceutical and biotechnology companies; 2) supported research institutions, including NIH grantees; 3) health care providers and insurers; and 4) related trade, professional or similar associations. Investments in organizations substantially affected by NIH, such as the biotechnology and pharmaceutical industries, also are not allowed for those employees who are required to file public and confidential financial disclosure reports and are restricted for other staff.

Effective immediately, this interim final regulation remains in effect unless changed by subsequent regulations. The Department of Health & Human Services (HHS) intends to evaluate certain provisions in the rule, including those regarding outside activities and financial holdings, within the next year.

During this period, HHS also will complete a review of existing outside activities that is presently ongoing, develop and test more effective oversight systems, overhaul its administrative capabilities for the management of its ethics program, implement improved training and evaluate the impact of this regulation. NIH scientists will continue to be able to conduct academic activities such as teaching courses at universities, writing general textbooks, performing scientific journal reviews, participating in scientific meetings and providing general lectures to physicians and scientists at continuing professional education and similar events, as well as practicing medicine as appropriate, provided that the activities are otherwise in accordance with existing law and adhere strictly to the conditions specified in the new rules.

For further information, see NIH Conflict of Interest Information and Resources: http://www.nih.gov/about/ethics_COI.htm

Public Release of Research Results

A Feb. 1 policy change from NIH is to accelerate the public's access to published articles resulting from NIH-funded research. The policy calls on scientists to release to the public manuscripts from research supported by NIH as soon as possible, and within 12 months of final publication.

These peer-reviewed, NIH-funded research publications will be available in a Web-based archive to be managed by the National Library of Medicine (NLM), a component of NIH. The online archive will increase the public's access to health-related publications at a time when demand for such information is on a steady rise.

"While this new policy is voluntary, we are strongly encouraging all NIH-supported researchers to release their published manuscripts as soon as possible for the benefit of the public," said NIH Director Elias  Zerhouni, M.D. "Scientists have a right to see the results of their work disseminated as quickly and broadly as possible, and NIH is committed to helping our scientists exercise this right. We urge publishers to work closely with authors in implementing this policy."

Zerhouni added, "NIH recognizes the importance of preserving quality peer review and the viability of a diversity of publishing models. Nevertheless, we expect that only in limited cases will authors deem it necessary to select the longest delay period."

Beginning May 2, 2005, the policy requests that NIH-funded scientists submit an electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported in whole or in part by NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

The policy gives authors the flexibility to designate a specific time frame for public release ­ ranging from immediate public access after final publication to a 12 month delay ­ when they submit their manuscripts to NIH.

Additional information on the new policy and related documents, including a "Questions and Answers" fact sheet, is available at: http://www.nih.gov/about/publicaccess/index.htm