Susan M. Wolf, Frances P. Lawrenz, Charles A. Nelson, Jeffrey P. Kahn, Mildred K. Cho, Ellen Wright Clayton, Joel G. Fletcher, Michael K. Georgieff, Dale Hammerschmidt, Kathy Hudson, Judy Illes, Vivek Kapur, Moira A. Keane, Barbara A. Koenig, Bonnie S. LeRoy, Elizabeth G. McFarland, Jordan Paradise, Lisa S. Parker, Sharon F. Terry, Brian Van Ness & Benjamin S. Wilfond
Journal of Law, Medicine and Ethics 36 (2):219-248 (2008)
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Abstract |
No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed
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DOI | 10.1111/j.1748-720X.2008.00266.x |
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References found in this work BETA
False Hopes and Best Data: Consent to Research and the Therapeutic Misconception.Paul S. Appelbaum, Loren H. Roth, Charles W. Lidz, Paul Benson & William Winslade - 1987 - Hastings Center Report 17 (2):20-24.
The Ancillary‐Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking About the Clinical Care That Researchers Owe Their Subjects.Henry S. Richardson & Leah Belsky - 2004 - Hastings Center Report 34 (1):25-33.
Disclosing Individual Genetic Results to Research Participants.Vardit Ravitsky & Benjamin S. Wilfond - 2006 - American Journal of Bioethics 6 (6):8 – 17.
Informing Study Participants of Research Results: An Ethical Imperative.Conrad V. Fernandez, Eric Kodish & Charles Weijer - 2003 - IRB: Ethics & Human Research 25 (3):12.
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Citations of this work BETA
The Emergence of Clinical Research Ethics Consultation: Insights From a National Collaborative.Kathryn M. Porter, Marion Danis, Holly A. Taylor, Mildred K. Cho & Benjamin S. Wilfond - 2018 - American Journal of Bioethics 18 (1):39-45.
Ethics and Collateral Findings in Pragmatic Clinical Trials.Stephanie R. Morain, Kevin Weinfurt, Juli Bollinger, Gail Geller, Debra J. H. Mathews & Jeremy Sugarman - 2020 - American Journal of Bioethics 20 (1):6-18.
How Can Law and Policy Advance Quality in Genomic Analysis and Interpretation for Clinical Care?Barbara J. Evans, Gail Javitt, Ralph Hall, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan & Ellen Wright Clayton - 2020 - Journal of Law, Medicine and Ethics 48 (1):44-68.
Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?Catherine Gliwa & Benjamin E. Berkman - 2013 - American Journal of Bioethics 13 (2):32-42.
Incidental Findings in Human Subjects Research: What Do Investigators Owe Research Participants?Franklin G. Miller, Michelle M. Mello & Steven Joffe - 2008 - Journal of Law, Medicine and Ethics 36 (2):271-279.
View all 104 citations / Add more citations
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