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09/24/2015

Modernizing Human Subjects Research Protections: Informed Consent for Genetic Research

This is the third installment of a new blog series—Modernizing Human Subject Research Protections—taking a closer look at the recent notice of proposed rulemaking (NPRM) that suggests revisions to the Common Rule governing federally funded human subjects research. The NPRM draws on the work of the Bioethics Commission, and its ethical underpinnings mirror the analysis used by the Commission in many of its reports.

In its 2012 report, Privacy and Progress in Whole Genome Sequencing, the Bioethics Commission examined the ethics of large-scale genetic research, and made recommendations about how to reconcile the drive to compile large data sets with the imperative to protect the security of donors’ data. Privacy and Progress examined the informed consent process in depth, explaining that informed consent can be more difficult to obtain for genetic research than for other kinds of studies. First, rather than presenting a risk of physical harm, genetic research can involve informational and privacy risks that can be harder to quantify. And second, much of the genetic research that is currently conducted uses samples and data that were collected for other purposes, such as during a clinical encounter or previous research.

Despite these challenges, the Commission emphasized the importance of obtaining fully informed consent from all participants. Being asked to provide informed consent about the use of their data, the Commission argued, conveys respect to participants, separate and apart from their interest in preventing the unauthorized use or disclosure of their data. In other words—there is value to informed consent in and of itself, as it respects autonomy and personhood.

The NPRM reiterates this ethical analysis as a justification for strengthening informed consent for research using biospecimens, even when identifying data are not included. In emphasizing the importance of prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample was derived, the NPRM cites to the ethical analysis and recommendations in Privacy and Progress. The Bioethics Commission is pleased that its work has proven useful in the proposed revisions of human subjects research regulations as they evolve to keep pace with modern advances in science and technology.

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