Obama administration dials back patient consent restrictions on Common Rule

The Obama administration is using its last few days in office to address a number of data privacy issues, most recently releasing 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. 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. 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.” 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.

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