Scientists Raise Concerns About Revisions to Human Research Regulations; The Scientist, February 19, 2019

Katarina Zimmer, The Scientist; Scientists Raise Concerns About Revisions to Human Research Regulations

"When Henrietta Lacks visited the Johns Hopkins Medical Center in the 1950s to be treated for cervical cancer, she had no idea that some of her cancer cells would be used to create one of the most scientifically valuable and financially profitable cell lines that is used in labs today. Nor was she asked for permission.

Lacks’s experience has become nationally acknowledged as a shameful episode in the history of biomedical research in the US—particularly after the publication of a popular book about Lacks and her family—and forced the scientific community to consider how to conduct ethical research with human samples. The case was one of the reasons for a heated debate during a recent, six-year-long process of revising the Common Rule, a package of regulations adopted in the 1990s intended to ensure that all federally funded research conducted on human subjects is done ethically.

The revisions, enacted last month, are an attempt to strike a better balance between patients’ need for privacy and the benefits of using their tissue for research. In a paper published January 31 in JAMA Oncology, a group of clinicians and ethicists from the University of Michigan and the University of Pennsylvania argue that the revisions could have unintended consequences for research with various types of biospecimens, and propose that regulators should consider them differently when creating research protections."