U.S. amends human research rules

By Dr. Ananya Mandal, MDJul 24 2011

The U.S. Government has proposed major changes in the rules covering research involving human subjects. Officials believe this would strengthen protections while reducing red tape that can impede studies. The experts cited vastly altered research climate as reasons for these recommendations. New features include genomics studies using patients’ DNA samples, the use of the Internet and a growing reliance on studies that take place at many sites at once. The new rules cover topics like the informed consent that research participants must provide and the institutional review boards that oversee research at universities and hospitals.

A single institutional review board would oversee studies that take place at multiple sites. Right now, the institutional review board at each location generally must endorse a trial, which can lead to long delays. Donors of blood, DNA or tissue samples would be asked to give consent before those samples could be used in subsequent research. Now, if the identity of the donor cannot be determined, samples can often be used for further research without permission. Informed consent would be sought in these cases.

The change would expand the rules’ coverage to all studies conducted at institutions that receive money from any of the 15 federal agencies that have adopted the Common Rule. While that would encompass more medical research, it was not clear whether trials financed by drug companies and conducted at individual physicians’ offices would be covered.

“These are the first substantial changes that have been made to the rules governing human subjects in decades, so this is really quite a historic moment,” Kathy Hudson, a deputy director of the National Institutes of Health, said.

Initially drawn up by the Department of Health and Human Services in the 1970s and ’80s, the system was adopted by 14 other federal agencies and departments in 1991 and became known as the Common Rule. But some experts said it had become too cumbersome.

“It’s a terrible drag on getting good research done,” said Dr. Robert J. Levine, a professor of medicine and a bioethicist at Yale who headed the university’s institutional review board for 31 years. He said Sunday that while he had not thoroughly reviewed the government’s lengthy proposal, he was encouraged by what he had seen.

The process of making the changes is still in progress but the officials have described possible changes and asked for public comment over the next 60 days; after that, specific rules will be formulated and again sent out for comment. The government said its proposal was consistent with President Obama’s executive order in January calling on agencies to weed out unnecessary regulations. But some of the proposed changes would add regulation.