Bioethics Blogs

Modernizing Human Subjects Research Protections: Changing the Landscape of Biospecimen Research

In this fourth post in a new blog series, we zoom in on changes to the Common Rule—proposed in the notice of proposed rulemaking (NPRM) released earlier this month—that would alter oversight processes for biospecimen research.

In its current form, the Common Rule contains a regulatory gap, recognized throughout the Bioethics Commission’s work. Today, when biospecimens are collected for research purposes, their collection and associated analyses is considered human subjects research and are subject to IRB oversight, informed consent, and other protections required by the Common Rule. However, when biospecimens are collected for clinical purposes, but subsequently used for research, that research is not considered human subjects research under the Common Rule if they are stripped of traditional identifiers. The NPRM proposes changing that.

Over the past 3 years, technology has advanced rapidly, such that it is now possible to identify the donors of biospecimens, even when samples are stripped of traditionally recognized identifiers. As a result, the deidentification process no longer sufficiently protects biospecimen donors from privacy and security risks. In Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission urged that informed consent be obtained for any and all genetic research, regardless of where or why the data were obtained. The NPRM echoes this suggestion, by proposing that the use of biospecimens in research, whether obtained in the context of a study, in the clinic, or any other setting, be considered human subjects research under the Common Rule.

The NPRM strikes a balance for this subsequent data use, allowing for broad initial consent for future research when data are collected for a non-research purpose—a path forward that is both practical and ethically sound, as recognized by the Bioethics Commission in Privacy and Progress.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.