Washington

US clinical researchers and their institutions received a stern warning last week: improve voluntary management of financial conflicts of interest, or face strict federal regulation.

That warning, from Greg Koski, currently professor of anaesthesiology at Massachusetts General Hospital in Boston, provides a preview of how he will run the Office for Human Research Protections (OHRP) when he takes up his new post on 5 September.

Ever since Donna Shalala, secretary of the Department of Health and Human Services, announced last summer that she would place the office, then under the jurisdiction of the National Institutes of Health (NIH), directly under her authority, researchers have been speculating over whether the new supervision would be looser or tighter.

Koski provided some hints at an NIH conference on financial conflicts of interest. Before his address, at the end of the two-day meeting in Bethesda, Maryland, many researchers had spoken in favour of greater ‘guidance’ — a euphemism for non-binding policy suggestions.

But Koski hinted that stricter measures might be on the way if this failed to work. “If guidance is not effective, then rules, regulations and laws will follow,” he said.

Such measures may already be on the cards. Koski said that conflicts of interest in clinical research have become “pervasive”. Physicians routinely get bonuses for encouraging their patients to become research subjects; academic researchers involved with clinical trials are often rewarded with equity in biotech companies; and paid consultancies by pharmaceutical companies to biomedical faculty members are on the rise.

Koski said he would avoid offering specific policy proposals to address those trends until he starts the job. But he sketched out a few ideas. For example, he suggested that universities might need new committees to adjudicate on conflicts of interest, as current institutional review boards (IRBs) could not be the “sole protector” against them.

And while several researchers spoke of the need for clinical scientists, universities and members of IRBs to make their financial interests public, Koski said that such measures are only a starting point. “Disclosure is not enough,” he declared.

Several institutions detailed their approaches after being praised at the meeting by Ruth Kirschstein, NIH acting director, for representing ‘best practices’ in managing conflict of interest. Washington University in St Louis, for example, has strict rules: if a researcher has stock in a company, that company cannot fund the researcher's work.

Johns Hopkins University Medical School in Baltimore, Maryland, has, in addition to an IRB, a conflict-of-interest panel that rules whether a researcher should put stock in a company that has interests in his or her research into escrow, or sell it off.

Both schools also scrutinize their own stock, and examine how their intellectual property could affect the perception of clinical trials. Any intellectual property owned by the university — such as a research tool used to perform an experiment — has to be described in the informed-consent forms that a patient must sign before entering a clinical trial.

Speakers pointed out that the appearance of conflict of interest is as important as evidence of wrongdoing. A perceived conflict of interest dogged James Wilson, director of the University of Pennsylvania Institute of Human Gene Therapy in Philadelphia, after the death of Jesse Gelsinger in a gene-therapy clinical trial last autumn.

Wilson had a large interest in a biotech company that produced viral vectors used for therapeutic gene delivery. Although an outside investigation found no wrongdoing, it concluded that Wilson's holdings caused an appearance of a financial conflict of interest (see Nature 405, 497; 2000). The university ended clinical trials conducted through the institute after the investigation.

Koski says the Pennsylvania incident galvanized interest in research conflicts of interest. Demands are already being heard in Congress, for example, for investigators to be required to give more detailed financial information on informed-consent forms.

Opinions were mixed about the need for more federal regulations governing conflicts of interest. Michele Russell-Einhorn, director of regulatory affairs at OHRP, speaking for a group of scientists who met during the conference to discuss possible ways to manage them, said that “there is a consensus that there should not be regulations”.

But Abbey Meyers, president of the National Organization for Rare Disorders, said that patient groups such as her own would like to see more protection against conflicts of interest. Regulation, rather than voluntary compliance, is the best way to ensure this, she said.