Navigating the research–clinical interface in genomic medicine: analysis from the CSER Consortium

Genetics in Medicine - Tập 20 - Trang 545-553 - 2018
Susan M. Wolf1, Laura M. Amendola2, Jonathan S. Berg3, Wendy K. Chung4, Ellen Wright Clayton5, Robert C. Green6, Julie Harris-Wai7, Gail E. Henderson8, Gail P. Jarvik2,9, Barbara A. Koenig10, Lisa Soleymani Lehmann11,12, Amy L. McGuire13, Pearl O'Rourke14, Carol Somkin15, Benjamin S. Wilfond16, Wylie Burke2,17
1Law School; Medical School; Consortium on Law and Values in Health, Environment & the Life Sciences, University of Minnesota, Minneapolis, Minnesota, USA;
2Medical Genetics, Department of Medicine, University of Washington, Seattle, Washington, USA;
3Departments of Genetics and Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA;
4Departments of Pediatrics and Medicine, Columbia University, New York, New York, USA;
5Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA;
6Genetics, Department of Medicine, Brigham and Women’s Hospital, Broad Institute and Harvard Medical School, Boston, Massachusetts, USA;
7Institute for Health and Aging, University of California–San Francisco; Division of Research, Kaiser Permanente Northern California, San Francisco, California, USA;
8Department of Social Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA;
9Department of Genome Sciences, University of Washington, Seattle, Washington, USA
10Program in Bioethics, Institute for Health and Aging, University of California–San Francisco, San Francisco, California, USA;
11Veterans Administration National Center for Ethics in Health Care, Washington, DC, USA;
12Harvard University, Cambridge Massachusetts USA
13Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas, USA
14Human Research Affairs, Partners HealthCare, Boston, Massachusetts, USA;
15Division of Research, Kaiser Permanente Northern California, Oakland, California, USA;
16Treuman Katz Center for Pediatric Bioethics, Seattle Children’s Hospital, Department of Pediatrics, University of Washington, Seattle, Washington, USA;
17Department of Bioethics and Humanities, University of Washington, Seattle, Washington, USA;

Tài liệu tham khảo

Wolf Green National Institutes of Health. RFA-HG-10-017: Clinical Sequencing Exploratory Research (U01). https://grants.nih.gov/grants/guide/rfa-files/RFA-HG-10-017.html. Accessed 12 March 2017. Berg Henderson Easter Largent Wolf Hall A, Alberg C, Luheshi L. PHG Foundation. Genomics and the boundary between research and clinical care and treatment. 2014. http://www.phgfoundation.org/briefing_notes/303/. Accessed 30 January 2017. Angrist National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report. 1979. https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html. Accessed 18 August 2017. Office for Human Research Protections (OHRP). Federal policy for the protection of human subjects (‘Common Rule’). 2016. https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/. Accessed 18 August 2017. US Department of Homeland Security, Department of Agriculture, Department of Energy, 2017, Federal policy for the protection of human subjects, Fed Regist, 82, 7149 Beauchamp Henderson Phimister Brody Burke Jarvik Berkman Lee Green Kalia Evans Kelley Faden Biesecker Richardson Kohane Holm Evans Manolio Marchant
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Genetics in Medicine

Tập 20

545-553

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