U.S. Eyes Changes in Rules for Research on Humans

For the first time in years, the federal rules protecting the human subjects of federally funded scientific research projects may be changing.

Officials with the Department of Health and Human services have issued a proposal they said is intended to keep up with technological change as well as to reflect the Obama administration’s call to weed out unnecessary regulation.

Since 1991, 15 federal agencies have followed what is known as the Common Rule, which covers topics such as informed consent by research subjects and the institutional review boards that oversee research at universities and hospitals.

Under the proposed changes, the Common Rule would cover all research at institutions that get money from the 15 federal agencies, even studies paid for by other sources such as drug companies. As a result, the rules would apply to nearly all the biomedical experiments not already covered.

Among the proposed changes is allowing that a single institutional review board oversee a study with participants at multiple locations, rather than mandating that a board at each location endorse a trial. In addition, the rules aim to make it easier to do surveys or other social science research where risks to participants is considered minimal.

Some of the changes, however, would add regulation.

According to The Washington Post, the rules call for a single website that would track all adverse events from clinical studies — a change that might increase the chance of catching rare and severe complications more quickly.

Another possible change would require that volunteers in studies who donate blood, DNA or tissue give consent before samples are used in further research. The aim is to protect the anonymity of test subjects.

“This acknowledges that with today’s technology that biospecimens are inherently identifiable,” said Kathy Hudson, a deputy director at the National Institutes of Health.

The rules changes are at a preliminary stage. As The New York Times noted, the government has asked for public comment over the next 60 days. After that, specific rules will be developed that also will be sent out for comment.

LILLY FOWLER

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