July 26, 2002

Dear Colleagues,

Ensuring adherence to the highest standards of research integrity is a top priority at the School of Medicine. Because conflicts of interest have the potential to undermine the objectivity, safety, and credibility of research, it is essential that we have robust policies and procedures for addressing conflicts of interest. The School was a pioneer when it adopted a policy on conflict of interest ten years ago. However, with the rapid growth in our research portfolio and the number and complexity of faculty relationships with industry during the last decade, it was time to re-examine our conflict of interest policy.

A committee under the leadership of Randall Reed developed a new conflict of interest policy, which was approved by the Advisory Board of the Medical Faculty in June. Other members of the committee were George Bigelow, Henry Brem, Curt Civin, Chi Dang, Ruth Faden, Estelle Fishbein, John Gearhart, and Julie Gottlieb. Over the course of a year, the committee carefully considered how to institute optimal protection of human research subjects while promoting the translation of basic research to the bedside and recognizing the University’s obligations to transfer technology to the commercial arena.

The new policy sets forth in detail the requirements for reporting and compliance, describes review and management processes, and sets forth appeal mechanisms and sanctions for failure to comply. It differs from prior policy and practice in two key respects: it covers all individuals participating in research, and it addresses human subjects research as a special category of activity. For human subjects research, the policy mandates prohibition of certain arrangements, and approval of petitions for exceptions from the stated prohibitions only with careful management. It places the authority for imposing restrictions on human subjects research on the IRB. A subsequent announcement will describe the new relationship between the Committee on Conflict of Interest and the IRBs.

The new conflict of interest policy is available at http://www.hopkinsmedicine.org/research/policies_conflict.html. Frequently Asked Questions are posted at http://www.hopkinsmedicine.org/research/faq_on_coi.html. Specific questions can be addressed to the Office of Policy Coordination.

I urge you to become familiar with this important policy.

Sincerely,

Edward D. Miller, M.D.

Dean of the Medical Faculty
CEO/Johns Hopkins Medicine