Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations

Susan M Wolf; Rebecca Branum; Barbara A Koenig; Gloria M Petersen; Susan A Berry; Laura M Beskow; Mary B Daly; Conrad V Fernandez; Robert C Green; Bonnie S LeRoy; Noralane M Lindor; P Pearl O'Rourke; Carmen Radecki Breitkopf; Mark A Rothstein; Brian Van Ness; Benjamin S Wilfond

doi:10.1111/jlme.12288

Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations

J Law Med Ethics. 2015 Fall;43(3):440-63. doi: 10.1111/jlme.12288.

Authors

Susan M Wolf¹, Rebecca Branum², Barbara A Koenig³, Gloria M Petersen⁴, Susan A Berry⁵, Laura M Beskow⁶, Mary B Daly⁷, Conrad V Fernandez⁸, Robert C Green⁹, Bonnie S LeRoy¹⁰, Noralane M Lindor¹¹, P Pearl O'Rourke¹², Carmen Radecki Breitkopf¹³, Mark A Rothstein¹⁴, Brian Van Ness¹⁵, Benjamin S Wilfond¹⁶

Affiliations

¹ McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; Professor of Medicine; Faculty member, Center for Bioethics; and Chair, Consortium on Law and Values in Health, Environment & the Life Sciences at the University of Minnesota. She is one of three Principal Investigators on NIH/NCI/NHGRI grant 1-R01-CA154517 on return of genomic results to family members, including after the death of the proband.
² Policy director at the Minnesota State College Student Association and previously served as a Research Associate at the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences.
³ Professor of Bioethics and Medical Anthropology based at the Institute for Health & Aging, University of California, San Francisco. Currently, she co-directs a Center of Excellence in ELSI Research focused on translational genomics, co-leads an NCI/NHGRI R01 on return of results in genomic biobanks, and directs the ELSI component of a U19 award focused on newborn screening in an era of whole genome analysis.
⁴ Professor of Epidemiology in the Department of Health Sciences Research at Mayo Clinic College of Medicine in Rochester, Minnesota. She earned her Master's degree in Anthropology from University of Oregon, and Ph.D. in Anthropology from UCLA. She is a Founding Fellow of the American College of Medical Genetics and Genomics.
⁵ Professor of Pediatrics & Genetics and Division Director for Genetics and Metabolism in the Department of Pediatrics, University of Minnesota. She is a member of the Minnesota Department of Health Newborn Screening Advisory Committee, the Society for Inherited Metabolic Disease, and the American Society of Human Genetics, and is a Fellow of the American Academy of Pediatrics and the American College of Medical Genetics.
⁶ Associate Professor at the Duke University School of Medicine and Duke Clinical Research Institute, where her work focuses on ethics and policy issues in biomedical research - particularly human subjects issues in large-scale genomic and translational research. She holds a B.S. in nutrition from Iowa State University, an M.P.H. with a concentration in health law from Boston University, and a Ph.D. in health policy and administration from the University of North Carolina at Chapel Hill.
⁷ Medical oncologist and epidemiologist who chairs the Department of Clinical Genetics at Fox Chase Cancer Center. Her research focuses on defining the best methods of communicating hereditary cancer risk information and on providing risk management strategies and coping skills to family members dealing with an increased risk for cancer.
⁸ Professor and Head of the Division of Pediatric Hematology/Oncology in the Department of Pediatrics, IWK Health Centre, Dalhousie University and is cross-appointed in Bioethics, Medicine, and Postgraduate Studies. He obtained his Hon. B.Sc. at the University of Western Ontario, his medical degree at McMaster University, specialist certification in Pediatrics as a Fellow of the Royal College of Physicians and Surgeons of Canada at Dalhousie University, and completed specialty training in Pediatric Hematology/Oncology at the University of British Columbia.
⁹ Medical geneticist and physician-scientist who directs the G2P Research Program in translational genomics and health outcomes in the Division of Genetics, Brigham and Women's Hospital and Harvard Medical School. He is also Associate Director for Research at Partners Personalized Medicine. Dr. Green leads and co-leads the MedSeq Project and the BabySeq Project respectively, two NIH-funded randomized trials designed to explore the medical, behavioral, and economic implications of integrating genome sequencing into the medical care of adults and newborns.
¹⁰ Professor and Director of the Graduate Program in Genetic Counseling, University of Minnesota. The primary focus of her work is on preparing graduate students to enter the profession of genetic counseling. Her research examines the ethical and social challenges associated with the genetic counseling profession. Prof. LeRoy served as the President of the American Board of Genetic Counseling from 2001-03.
¹¹ Professor of Medical Genetics in the Department of Health Sciences Research at Mayo Clinic in Scottsdale, Arizona. She received her Bachelor of Arts degree from the University of Minnesota, her doctorate of medicine from Mayo Medical School in Rochester, Minnesota, and did her residencies at Bowman Gray School of Medicine in Winston-Salem, North Carolina, and at Mayo Clinic in Rochester.
¹² Director of Human Research Affairs at Partners HealthCare in Boston, and Associate Professor of Pediatrics at Harvard Medical School. She received her B.A. from Yale University, and completed medical school at Dartmouth Medical School and the University of Minnesota Medical School.
¹³ Associate Professor of Health Services Research in the Department of Health Sciences Research at Mayo Clinic College of Medicine in Rochester, Minnesota. She earned her Master's and Doctoral degrees in Psychology from the State University of New York at Albany.
¹⁴ Herbert F. Boehl Chair of Law & Medicine and Director of the Institute for Bioethics, Health Policy & Law, University of Louisville School of Medicine. From 1999-2008, he served as Chair of the Subcommittee on Privacy and Confidentiality of the National Committee on Vital and Health Statistics, the statutory advisory committee to the Secretary of Health and Human Services on health information policy. He is past-President of the American Society of Law, Medicine & Ethics and serves as Public Health Ethics editor for the American Journal of Public Health.
¹⁵ Professor of Genetics, Cell Biology and Development at the University of Minnesota. He earned his doctorate in Biochemistry from the University of Minnesota, completed a postdoctoral fellowship at Fox Chase Cancer Center in Philadelphia, and has served as the Department Head and Director of the Institute of Human Genetics at the University of Minnesota.
¹⁶ Director of the Treuman Katz Center for Pediatric Bioethics, Seattle Children's Hospital; Professor and Chief of the Division of Bioethics; Professor, Pulmonary and Sleep Medicine, Department of Pediatrics; and Adjunct Professor, Department of Bioethics and Humanities, University of Washington School of Medicine. He is President of the Association of Bioethics Program Directors, Chair for the Clinical Research Ethics Consultation Working Group for the Clinical and Translational Science Awards program, and a member of the Bioethics and Legal Working Group of the Newborn Screening Translational Research Network.

Abstract

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Publication types

Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Child
Disclosure / ethics*
Disclosure / legislation & jurisprudence*
Family*
Genomics / ethics*
Genomics / legislation & jurisprudence*
Humans
Informed Consent
Research Subjects / legislation & jurisprudence*

Abstract

Publication types

MeSH terms

Grants and funding