(Story updated at 12:48 p.m. ET)
Patient privacy advocates are not pleased with the Obama administration's decision to release a final rule that lifts a burden on scientists working with human subjects.
The revised Common Rule, as it's known, dials back a proposal requiring researchers to get written consent from patients before using any biospecimens obtained during medical procedures. The HHS issued the proposal in 2015. The draft drew more than 2,100 comments, mostly negative.
A change to the final rule, according to an HHS statement, “does not require that consent be obtained in order to conduct such research.”
Federal regulators had suggested obtaining patient consent during every step of research in order to avoid situations where a patient initially gave consent but then learned his or her specimen later was used without their knowledge. Researchers argued tracking patients would slow down their work.
Small hospitals and clinics said the change would likely prevent them from providing samples to researchers because of the cost and technology needed.
But now, “In general, researchers can continue to use such biospecimens in the way they are currently using them,” said Dr. Jerry Menikoff, director of the HHS Office for Human Protections. “We are very hopeful that these changes and all the others that reduce unnecessary administrative burdens will be beneficial to both researchers and research participants.”
A quick scan of the new Common Rule worries privacy advocate Twila Braise.
“I don't think they have protected the rights of people whose biospecimens have been taken,” she said.
The changes to the Common Rule go into effect next year. The likelihood of them actually being practiced, however, is remote. Last year, Republicans in Congress asked the administration to not release a final rule.
The Obama administration is using its last few days in office to address a number of data privacy issues. Last week, HHS released another final rule, amending and easing consent requirements in 42 CFR Part 2, the privacy rule covering the disclosure of healthcare records of patients in federally funded drug and alcohol abuse treatment programs.
Braise, a nurse and the president and co-founder of the not-for-profit Citizens' Council for Health Freedom, battled public health officials in her home state of Minnesota and forced them to halt the use of blood samples taken from newborns at birth for secondary research without parental consent. Privacy advocates in other states joined the fray.
That led to a consent provision in 2014 that required providers get parental consent before the DNA taken from their infants at birth for public health screening can be used for federally funded research.
HHS' proposed rule contained a provision that would have extended the consent requirement to research that was not federally funded, but the requirement was removed in the final rule.
The final rule also talks about de-identified biospecimens, but Braise's group, as have other genetic and privacy experts, question whether, in the coming era of precision medicine, if DNA can be deidentified and remain clinically useful.
“By the look of it, they don't consider biospecimens as human subjects, even if we're in the era of DNA,” Braise said.
A number of research projects, including Vice President Joe Biden's cancer moonshot and the White House's Precision Medicine Initiative depend on biospecimens to advance therapies.
