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September 26, 2011

Returning genetic results to study participants will be addressed nationally

The National Human Genome Research Institute (NHGRI) today, Monday, Sept. 26, awarded seven grants, totaling $5.7 million, aimed at untangling one of the knottiest ethical issues facing genomic researchers.

A consortium of experts in law, medicine, and bioethics will look at the issues of if, when, and how researchers should tell participants about their risk for diseases discovered during scientific studies of their genomes. A genome is all of the genetic material contained in a living thing, including its chromosomes, genes and DNA (deoxyribonucleic acid).

Among the grant recipients is Holly K. Tabor, assistant professor of pediatrics, Division of Bioethics, at the University of Washington. She will work with experts in clinical genetics, genomics, genetic counseling and biomedical informatics. They will compare traditional approaches for returning genetic results to research participants, such as through face-to-face sessions with genetic counselors, with a web-based tool. Based on her project findings, Tabor will help develop a framework, guidelines and proposed policies for returning genome sequencing results to research participants as part of the national expert consortium.

Tabor is a scholar at the Treuman Katz Center for Pediatric Bioethics at Seattle Childrens  as well as a researcher at the UWs Center for Genomics and Health Care Equality, the  Institute of Translational Health Sciences, and the Institute for Public Health Genetics.

In addition to Tabor, the consortium researchers receiving funding for these projects are:

Paul S. Appelbaum, professor of psychiatry, Medicine & Law and Director, Division of Law, Ethics, and Psychiatry, Department of Psychiatry, Columbia University, New York, N.Y.

Appelbaum will develop a menu of potential approaches for dealing with the challenges of informed consent that must be addressed before widespread efforts to return genomic research results are put into place

Wendy K. Chung, assistant professor of pediatrics, Department of Pharmacology, Columbia University, New York, N.Y.

Chung will investigate the preferences of participants who have enrolled in genomic research studies with respect to getting back incidental genetic results, as well as the potential psychosocial and behavioral consequences of receiving this information.  

Ellen Wright Clayton, professor of pediatrics and law, Vanderbilt University, Nashville, Tenn.

Clayton will identify criteria to guide decisions about returning individual research results to children who participate in genomic research. She will examine U.S. law and international guidelines about decision making for and by minors as the foundation for her study.

Jeremy R. Garrett, research associate, Childrens Mercy Bioethics Center, Kansas City, Mo.

Garrett will conduct philosophical research to analyze the claim that it is morally obligatory, or at least morally permissible, for genomic researchers who study samples in biorepositories to return individual research results participants.  
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Ingrid A. Holm, assistant professor of pediatrics, Childrens Hospital of Boston, Mass.

Holm will explore the extent to which research participants preferences can reliably guide the return of individual genomic research results and how these preference can be incorporated into a governance structure for a genetic research registry or biobank.

Michelle Huckaby Lewis, research scholar, Johns Hopkins University, Berman Institute of Bioethics, Baltimore, Md. and Genetics and Public Policy Center, Washington, D.C.

Lewis will conduct research to develop the normative and legal framework for considering if newborn screening programs are to be expanded and if efforts are to be made to offer to return results to parents for research conducted with dried blood spots. She will evaluate existing state policies on newborn screening and on biorepositories using dried blood samples, identify regulatory gaps, and develop recommendations for policymakers.