Does human specimen research always need consent? image

"Science Friday," PRI, July 24, 2016
Elizabeth Shockman, interviewing Holly Fernandez Lynch (Executive Director)

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What if the samples were left over from a doctor’s visit or a different study that you did consent to, and stripped of information that would identify you? 

According to proposed updates to ethics rules imposed by the US government, the answer to both questions is almost always no. Many advocate that you should be required to give explicit consent for the use of your specimens, especially as new medical developments are making it possible to link once-anonymous samples back to their donors.

However, under current rules, researchers can use human biological specimens leftover from blood drawn at the doctor’s office or leftover from previous research. But the US government is proposing an update to those rules. 

“What's being proposed to be changed now is saying, ‘It doesn't matter if those specimens have been de-identified. We're still going to require researchers to get your consent before using them,’” says Holly Fernandez Lynch, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School.  

Patient advocates support the proposed consent requirement, or even say it doesn’t go far enough in offering patients privacy or control over how their medical information is used.

“The good ... in proposing this rule change is people don't know how their specimens are being used and if we fail to tell them, we're going to lose trust in the research enterprise,” Lynch says. “We really ought to be telling people what we're doing with their specimen — so that's sort of the justification that's been put forth.” 

But not everyone thinks the new rules are a good idea. [...]

Read the article and listen to the full interview!

bioethics health law policy human subjects research human tissue privacy regulation research