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New rules on trial subjects omit consent requirement, aiding test development

A final regulation on the ethical treatment of individuals participating in federally funded research is most noteworthy for what it does not include: a provision that would have mandated researchers to obtain subjects' consent before using their "non-identifiable" samples for purposes other than the trials.

Such biospecimens are used in the development of diagnostic tests and genetics research and often consist of leftover samples from clinical research. The samples would have their identifiers removed and would no longer be traceable to the subject they were collected from, according to Ropes & Gray attorney David Peloquin.

"While some research happens at academic medical centers that may have had the resources to collect the consent of each patient, a lot of research today is happening at community hospitals, in physician practices, in clinical laboratories and other settings where it may not have been possible to obtain a consent from every patient," Peloquin said.

The 126-page final rule contains a number of other modifications from the draft regulation issued in 2015. It does not expand the scope of the regulation to include clinical trials that are not federally funded, and also omits criteria that would have made it harder to obtain a waiver of informed consent for research involving identifiable biospecimens, according to a brief written by Ropes & Gray.

The regulations also require that informed consent begins with a “concise and focused presentation of the key information” so that potential subjects can understand the pros and cons of participation.

The rules, which had not been reformed since 1991, are also known as the "common rule" because they apply to several agencies that conduct research in the social and biological sciences. Although the U.S. Department of Health and Human Services is covered by the rule, one of its agencies, the FDA, is not.

But the 21st Century Cures Act calls for harmonization of the common rule and the regulations governing FDA research within three years, Peloquin said.

"By having a final rule, it puts the agencies on a path of moving toward that harmonization," he said. "That has been a frustration of the regulated community, in that they have two sets of regulations to follow, and while they're similar, there are certain differences that can sometimes add to administrative burden and review."

The final regulations were published in the Federal Register on Jan. 19 as one of the last acts of the Obama administration.

"It's something they had been working on for almost six years, and I think they wanted to finalize it at the end of the administration," he said. "Clinical research is one area that does appear to garner bipartisan support."