Emory is one of the first research universities in the country to implement a process to address institutional conflicts of interest in research, complimenting an existing policy focused on individual researchers that has been in place for several years.

The new policy, approved by the Board of Trustees in September, will deal with situations in which Emory has significant direct or indirect financial or other interest in a product or process being developed by researchers associated with the University.

“We’re one of the leaders; as far as I know we’re the first major research university to put an institutional conflict of interest policy into place,” said interim Provost Woody Hunter.

Discussions about the need for Emory to create such a policy began three years ago in the wake of the death of an 18-year-old participant in an experimental gene-therapy trial at Pennsylvania University, which led to the suspension of clinical trials at Penn’s Institute for Human Gene Therapy and an FDA investigation. It was subsequently found that institutional conflicts of interest may have existed between the pharmaceutical company Genovo—which Penn partly owned and which had exclusive rights to discoveries made at the gene therapy institute—and the researchers involved in the project.

In October 2001, the Association of American Universities (AAU) issued a report on individual and institutional financial conflict of interest that basically suggested institutions develop a process for identifying and managing such conflicts, but the AAU did not specify how such a process would look or function. A group at Emory tackled the tough job of creating that process.

“This new policy is not in response to any specific problem at Emory,” said Frank Stout,
vice president for research. “It began with discussions between [Executive Vice President for Health Affairs] Mike Johns and [former Provost] Rebecca Chopp, and from expressions of concern and interest from many of the deans and faculty. It’s been developed over the last nine months with input from many people.”

The new policy calls for the creation of a standing External Review Committee (ERC) composed of individuals drawn from academia, industry and government, and who are not dependent on Emory in any way, either financially or otherwise. The ERC will receive referrals from Emory officers and existing conflict of interest committees, requesting that a particular study be analyzed for possible institutional conflicts of interest and for recommendations for controlling such conflicts, once identifed.

The ERC will report to Emory’s trustees at least annually and also will review and comment on all policies and procedures that relate to conflicts of interest, both individual and institutional.

Stout said the policy became effective upon board approval. He is working with Hunter to identify a trustee member for the ERC and will soon ask deans to recommend potential members. Stout said he hopes to have the ERC in place by early 2003.