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HHS Unveils Plan to Tighten Human Subjects Rules

After 20 years, it's time for an overhaul. That was the message today from the U.S. Department of Health and Human Services (HHS), which wants to beef up protections for people participating in research. New recommendations include requiring that people give explicit consent about the use of their or their child's blood and tissues in research, and that certain privately funded studies abide by federal guidelines protecting human subjects.

Right now, HHS is soliciting comments on its ideas, part of a months-long process. It's focused on what's called the "Common Rule," which governs the ethics of federally funded and some privately funded research involving humans. Officials point out that the Common Rule hasn't been updated since 1991, and in that time, lots has changed. Disciplines such as genomics and social sciences are more active, there's increasing interest in using the Internet for human subjects research, tissue banks are expanding rapidly, and research projects are often spread across dozens or even hundreds of sites rather than concentrated in one place as they used to be. "These changes in the research landscape have raised questions regarding the effectiveness of the current regulatory framework," Howard Koh, assistant secretary for health at HHS, said at a press conference today.

HHS has a number of suggestions. Some are logistical: having just one institutional review board oversee a study, no matter how large it is, rather than require that each university outpost have its own IRB running interference for that study. HHS also wants to streamline informed consent forms, which have gotten more and more unwieldy but aren't necessarily any easier to understand, said Kathy Hudson, deputy director for science outreach and policy at the National Institutes of Health, also speaking at the press conference.

HHS also hopes to change how biospecimens are handled, something that's become a huge area of interest and controversy. These days, specimens like blood, skin, or cancer tissue collected for one study may be stored indefinitely and used in dozens of others, often without the original donor having any idea. HHS says that donors should give explicit permission for this kind of research, which they're generally not doing now. Researchers have said that permission isn't necessary in part because the specimens are stripped of identifiers. Although that's technically true, "with today's technology, biospecimens are inherently identifiable," Hudson said, referring mainly to DNA testing. That's one reason HHS wants the rule amended. Hudson said the proposal, if implemented, would also apply to newborn blood spots; they're collected right after a baby's birth to test for various diseases but also often banked and studied, without, in many cases, the parents' consent.

Finally, HHS wants to broaden the Common Rule to cover more types of research. Right now it governs federally funded research, as well as some industry-funded work that is vetted by the U.S. Food and Drug Administration. But there are still gaps, and the new proposal states that at any university that gets any federal funding—which, practically speaking, means all of them—researchers' work will fall under the Common Rule whether or not it's government supported.

HHS is open for comments, and instructions on how to submit them are here.