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Scientists want to do research on your tissues without asking you first

And the Feds want to stop them

(NCI-Frederick / Wikimedia Commons)

Right now, tissues belonging to millions of Americans are being used in scientific research without patients' consent. That's because a rule designed long before genetic analysis was able to reidentify samples makes it legal to do so. If that makes you uncomfortable, then you have until tomorrow night to let the US government know.

Currently, scientists are allowed to use leftover tissues from blood tests, surgeries, and biopsies for research without patients' permission if the patient’s identity is removed. But now that genetic testing has made it possible to link tissues back to their donors, the US government wants to change that. That's why federal regulators have proposed a number of revisions to the Federal Policy for Protection of Human Subjects — a policy that regulates research on humans as well as on their tissues and genes. Among these changes is a proposal that would require that scientists obtain consent for research on biospecimens, regardless of whether the tissues are anonymous or not.

Requiring informed consent could limit "the diversity of patient populations."

The proposed changes are controversial. Involving donors in research might help scientists get better information about the tissues they're working on. Requiring consent might also give donors more control over the ways their tissues are used. Finally, a new consent rule might prevent nasty surprises for donors should their tissues ever be reidentified using genetic analysis. "All research should be done in total transparency, with informed consent, and a reasonable measure of control given to participants," Lauren Wendelken, who identified herself as a former clinical biomedical researcher, wrote in the comments tied to the proposal. But some researchers say that the new rule would lead to a burdensome increase in the amount of work involved in obtaining tissues. Scientists also worry that they won’t get as many tissues if donors have the option of saying no.

"Requiring informed consent would add considerable time and expense to anticipated studies, potentially limiting the diversity of patient populations and the types of pathogens observed," the Infectious Diseases Society of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society wrote in a comment. "This change from current requirements would have a chilling effect on many types of research that rely on the use of stored biospecimens."

Scientists’ concerns that patients might not want to participate may be unfounded. "People have told me by the thousands, and numerous public opinion studies find the same: they want to know if their biospecimens are used in research, and they want to be asked first," Rebecca Skloot, author of The Immortal Life of Henrietta Lacks, wrote in a New York Times opinion piece last month. Most will probably say "yes" because people understand the importance of scientific research, she says. "They just don’t want to find out later."

People "want to know if their biospecimens are used in research."

The new rule would only apply to new samples, which means the millions of anonymous biospecimens currently housed in US labs would still be fair game. Still, a change like that could affect scientific research for decades to come. Without biospecimens, numerous advances in diseases such as cancer and diabetes would not have been possible. But the original rules were written before concerns over genetic privacy became mainstream.

The government has posted a summary of the proposal, as well as a series of videos that explain the changes. The changes are open for public comment until tomorrow, January 6th, at 11:59PM.