National Academies under fire for report on research participant rights

A report from the National Academies of Science, Engineering and Medicine is under fire from legal experts who contend that if its recommendations were followed, the rights of research participants would be at risk.

While the July report from the National Academies calls for sharing results and data with people who agree to participate in research studies, critics contend that the document calls for problematic changes to federal law that would effectively roll back important privacy protections.

“We believe the report creates major roadblocks to the return of data and results and would constrict participants’ existing rights of access,” write law professors Susan Wolf and Barbara Evans in an article published in the October 12 issue of Science.

Neither the National Academies nor Jeffrey Botkin, MD—associate vice president for research at the University of Utah and chair of the study committee that wrote the report—were immediately available for comment.

“True progress on return of results requires accepting participants’ established rights of access and respecting the value that participants place on broad access to their data and results,” added Wolf and Evans. “The next step is not to build barriers but to promote transparency."

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Wolf is the McKnight Presidential Professor of Law, Medicine and Public Policy and a professor of medicine at the University of Minnesota, while Evans is the Mary Ann and Lawrence E. Faust Professor of Law and Director of the Center for Biotechnology and Law at the University of Houston.

Although the National Academies report “proclaims support for the interests of research participants, endorses the importance of offering participants their individual-specific results, and advocates assessing the value of results from the standpoint of participants,” Wolf and Evans say the document's “announced commitment to participant-centered progress is undercut by its actual recommendations.”

In particular, they take the report to task for incorporating incorrect statements about the Clinical Laboratory Improvement Amendments—which are designed to ensure the quality of laboratory tests conducted for healthcare purposes—as well as overstating the degree to which research labs can be regulated under the CLIA statute.

In addition, Wolf and Evans charge that the report conflicts with existing federal privacy laws that protect research participants' access to their own data, including the HIPAA Privacy Rule, the Genetic Information Nondiscrimination Act and the Privacy Act.

They also criticize the report for recommending that an individual’s access to their data be restricted to the subset of data that meets certain quality standards. The problem with this approach, according to Wolf and Evans, is that only by seeing the personal data collected can an individual assess the privacy risks involved.

“The Academies’ report endorses the idea of participant access to results and data, but then builds daunting barriers,” conclude Wolf and Evans. “The report rejects established legal rights of access, two decades of consensus guidelines, and abundant data showing that participants benefit from access while incurring little risk. The report too often prefers paternalistic silence over partnership.”