Scholars Concerned By NIH Proposals

New regulations proposed by the National Institutes of Health (NIH) may affect funding for much of the biomedical research taking place at Harvard and other universities nationwide.

The proposed rules have sparked an instant controversy among researchers here, particularly because they may have implications for the University's Medical Science Partnership (MSP), a venture capital fund for marketing new technology that comes out of Medical School research.

MSP, a highly controversial plan announced by Harvard last fall, is the first such University attempt to market professors' research while ensuring a percentage of the profits for itself.

"Of course MSP is following very closely the formulation of the new regulations," said Andre LaMotte, managing general partner for MSP.

Med School administrators held a meeting yesterday to determine the effects the new restrictions on the MSP, according to an official who spoke on condition of anonymity. "They are discussing what this whole thing means to the MSP now," said the source.

"It is not for MSP to make policy," said LaMotte. "We are waiting for Harvard and NIH to formulate policies and we will follow them."

The Med School established a committee approximately seven months ago to look into revising their conflict of interest policy, said the source. "The Med School is undergoing a soul-searching process," the school official said.

In part, that "soul-searching" process is the result of several controversies which have rocked Harvard's prestigious Med School over the past year--including the revelations that Dr. Shervert H. Frazier, former head of psychiatry at the Harvard-affiliated McLean Hospital, plagiarized an article he had written early in his career.

In current form, the NIH proposals are designed to control conflicts of interest between industry and academic researchers by requiring researchers to disclose financial interests and outside professional activities, said Dr. M. Janet Newburgh of NIH's Office of Extramural Research.

The new rules would prohibit researchers with NIH funding from holding stock in a company that would be affected by their research, said Newburgh. Federally-funded researchers would also be prevented from sharing information before publication with any company that has an interest in the results of their research.

But Newburgh said the proposed rules have not yet been formally approved and are still subject to change. "These are simply draft guidelines, and the rules will be affected very much by public comments," Newburgh said.

The new proposals place the burden of monitoring and disciplining researchers on universities, said Newburgh. "The NIH would step in only if it determined the university was not doing the job," she said.

Violations of the regulations could lead to a cutoff of all or some of NIH funding, Newburgh said.

NIH gave out a total of 30,531 awards worth more than $5.5 billion during fiscal year 1988, said James D. Tucker, a computer systems analyst with NIH's Division of Research Grants.

Harvard received a total of 452 awards worthmore than $97 million from NIH for fiscal year1988. Harvard ranked 7th out of 1668 universitiesreceiving awards from NIH, said Tucker.

Professors doing research with NIH fundingexpressed concern yesterday over the prohibitiveclauses in the new proposals.

"The first several points, those dealing withavoiding equity interest, are a good thing," saidAssociate Professor of Biological Chemistry andMolecular Pharmacology Don M. Coen. "But the pointof sharing information with companies is a littlesticky--it needs to be spelled out."

Coen said he thought some collaboration betweencorporate research staffs and academic scientistswas beneficial. "The restrictions on sharing couldbe counter-productive to public interest," hesaid