Considering Actionability at the Participant's Research Setting Level for Anticipatable Incidental Findings from Clinical Research

Wolf S. M. Lawrenz F. P. Nelson C. A. Kahn J. P. Cho M. K. Clayton E. W. Fletcher J. G. Georgieff M. K. Hammerschmidt D. Hudson K. Illes J. Kapur V. Keane M. A. Koenig B. A. Leroy B. S. McFarland E. G. Paradise J. Parker L. S. Terry S. F. Van Ness B. Wilfond B. S. , “Managing Incidental Findings in Human Subjects Research: Analysis and Recommendations,” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 219–248.

Presidential Commission for the Study of Bioethical Issues, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (Washington, D.C.: Presidential Commission, 2013).

See Wolf 2008, supra note 1; Wolf S. M. Crock B. N. Van Ness B. Lawrenz F. Kahn J. P. Beskow L. M. Cho M. K. Christman M. F. Green R. C. Hall R. Illes J. Keane M. Knoppers B. M. Koenig B. A. Kohane I. S. Leroy B. Maschke K. J. McGeveran W. Ossorio P. Parker L. S. Petersen G. M. Richardson H. S. Scott J. A. Terry S. F. Wilfond B. S. Wolf W. A. , “Managing Incidental Findings and Research Results in Genomic Research Involving Biobanks and Archived Data Sets,” Genetics in Medicine 14, no. 4 (2012): 361–384; National Institute of Biomedical Imaging and Bioengineering, supra note 1; GenomeWeb Staff Reporter, “Incidental Findings from Sequencing Studies Should Be Returned, Say Genetics Specialists,” GenomeWeb Daily News (2012), available at <http://www.genomeweb.com/sequencing/incidental-findings-sequencing-studies-should-be-returned-say-genetics-specialists> (last visited September 3, 2015); Green R. C. Berg J. S. Berry G. T. Biesecker L. G. Dimmock D. P. Evans J. P. Grody W. W. Hegde M. R. Kalia S. Korf B. R. Krantz I. McGuire A. L. Miller D. T. Murray M. F. Nussbaum R. L. Plon S. E. Rehm H. L. Jacob H. J. , “Exploring Concordance and Discordance for Return of Incidental Findings from Clinical Sequencing,” Genetics in Medicine 14, no. 4 (2012): 405–410; Green R. C. Berg J. S. Grody W. W. Kalia S. S. Korf B. R. Martin C. L. McGuire A. L. Nussbaum R. L. O'Daniel J. M. Ormond K. E. Rehm H. L. Watson M. S. Williams M. S. Biesecker L. G. , “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574; Gliwa C. Berkman B. E. , “Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?” American Journal of Bioethics 13, no. 2 (2013): 32–42; Zawati M. H. Van Ness B. Knoppers B. M. , “Incidental Findings in Genomic Research: A Review of International Norms,” GenEdit 9, no. 1 (2011): 8; Knoppers B. M. Avard D. Senecal K. Zawati M. H. , “Return of Whole-Genome Sequencing Results in Paediatric Research: A Statement of the P3G International Paediatrics Platform,” European Journal of Human Genetics 22, no. 1 (2014): 3–5; Knoppers B. M. Deschenes M. Zawati M. H. Tasse A. M. , “Population Studies: Return of Research Results and Incidental Findings Policy Statement,” European Journal of Human Genetics 21, no. 3 (2013): 245–247; Presidential Commission, 2013, supra note 2; Parker L. S. , “The Future of Incidental Findings: Should They Be Viewed as Benefits?” Journal of Law, Medicine & Ethics 36, no. 2 (2008): 341–351.

See Wolf , supra note 1; Wolf , supra note 3; Id. (GenomeWeb Staff Reporter); Id. ( Green 2012); Id ( Green 2013); McGuire A. L. Joffe S. Koenig B. A. Biesecker B. B. McCullough L. B. Blumenthal-Barby J. S. Caulfield T. Terry S. F. Green R. C. , “Point-Counterpoint. Ethics and Genomic Incidental Findings,” Science 340, no. 6136 (2013): 1047–1048; Zawati M. H. Knoppers B. M. , “International Normative Perspectives on the Return of Individual Research Results and Incidental Findings in Genomic Biobanks,” Genetics in Medicine 14, no. 4 (2012): 484–489; Wolf S. M. , “The Past, Present, and Future of the Debate over Return of Research Results and Incidental Findings,” Genetics in Medicine 14, no. 4 (2012): 355–357; Vayena E. Tasioulas J. , “Genetic Incidental Findings: Autonomy Regained?” Genetics in Medicine 15, no. 11 (2013): 868–870; Driessnack M. Daack-Hirsch S. Downing N. Hanish A. Shah L. L. Alasagheirin M. Simon C. M. Williams J. K. , “The Disclosure of Incidental Genomic Findings: An ‘Ethically Important Moment’ in Pediatric Research and Practice,” Journal of Community Genetics 4, no. 4 (2013): 435–444; Presidential Commission, 2013, supra note 2; Couzin-Frankel J. , “Genome Sequencing. Return of Unexpected DNA Results Urged,” Science 339, no. 6127 (2013): 1507–1508; Price W. N. 2nd. , “Legal Implications of an Ethical Duty to Search for Genetic Incidental Findings,” American Journal of Bioethics 13, no. 2 (2013): 48–49; Ulrich M. , “The Duty to Rescue in Genomic Research,” American Journal of Bioethics 13, no. 2 (2013): 50–51; Ross K. M. Reiff M. , “A Perspective from Clinical Providers and Patients: Researchers' Duty to Actively Look for Genetic Incidental Findings,” American Journal of Bioethics 13, no. 2 (2013): 56–58.

Id. ( Wolf 2008); Id. ( Wolf 2012); see National Institute of Biomedical Imaging and Bioengineering, “NIBIB Points to Consider for Investigators: Incidental Findings in Imaging Research,” (2011), available at <http://www.nibib.nih.gov/Research/Resources/PointsToConsider> (last visited September 3, 2015); GenomeWeb Staff Reporter, supra note 3; Green , supra note 3; Id. ( McGuire ); Gliwa Berkman , supra note 3; Zawaati , supra note 3; Knoppers , 2014, supra note 3; Presidential Commission, 2013, supra note 2; Parker , supra note 3.

See Knoppers , 2014, supra note 3.

Protection of Human Subjects, “Belmont Report: Notice of Report for Public Comment,” Federal Register 44, no. 76 (1979): 23191–23197.

See Wolf , 2008, supra note 1.

The Participants in The 2001 Conference on Ethical Aspects of Research in Developing Countries, “Moral Standards for Research in Developing Countries: From ‘Reasonable Availability’ to ‘Fair Benefits,”’ Hastings Center Report 34, no. 3 (2004): 17–27.

Ortiz A. A. Ehler L. , “Individual Research Results and Anticipatable Incidental Findings in HIV Research with Vulnerable Populations: Actionability at the Participant's Level,” Poster presented at International Aids Society—AIDS 2014, Melbourne, Australia, 2014.

See Moral Standards for Research in Developing Countries, supra note 12; Zusevics K. , “Ancillary Care, Genomics, and the Need and Opportunity for Community-Based Participatory Research,” American Journal of Bioethics 13, no. 2 (2013): 54–56.

Id. (Moral Standards for Research in Developing Countries).

See Zusevics , supra note 12; Parker , supra note 3.

See Moral Standards for Research in Developing Countries, supra note 12; See Presidential Commission, 2013, supra note 2; National Bioethics Advisory Commission (NBCA), Ethical and Policy Issues in International Research: Clinical Trials in Developing Countries: Report and Recommendations of the National Bioethics Advisory Commission no. 145 (Rockville, MD: NBAC, 2001); Protection of Human Subjects, supra note 7.

See Presidential Commission, 2013, supra note 2.

See Green , 2013, supra note 3; Id. (Presidential Commission 2013); Ulrich M. , “Resource Restraints: Rethinking Disclosure of Individual Genomic Findings,” Michigan State University Journal of Medicine and Law 17 (2012): 127; Ulrich , supra note 4; Ross Reiff , supra note 4.

See GenomeWeb Staff Reporter, supra note 3; Green , 2013 supra note 3; Vayena Tasioulas , supra note 4; Zusevics , supra note 12; Ross Reiff , supra note 4.

Studies, GENEVA (Gene-Environment Association), “Geneva Statement on Incidental Findings,” available at <http://www.ncbi.nlm.nih.gov/projects/gap/cgi-bin/GetPdf.cgi?document_name=GENEVA_Statement_on_Incidental_Findings.pdf> (last visited September 10, 2015); Presidential Commission, 2013, supra note 2; Biesecker L. G. , “The Nirvana Fallacy and the Return of Results,” American Journal of Bioethics 13, no. 2 (2013): 43–44; Id. ( Borgelt ); Price, supra note 4; Ulrich , supra note 7; Anastasova V. Blasimme A. Julia S. Cambon-Thomsen A. , “Genomic Incidental Findings: Reducing the Burden to Be Fair,” American Journal of Bioethics 13, no. 2 (2013): 52–54; Ross Reiff , supra note 4.

Rothstein M. A. , “Tiered Disclosure Options Promote the Autonomy and Well-Being of Research Subjects,” American Journal of Bioethics 6, no. 6 (2006): 20–21; author reply W10–2.

McGuire A. L. Beskow L. M. , “Informed Consent in Genomics and Genetic Research,” Annual Review Genomics and Human Genetics 11 (2010): 361–381; Bookman E. B. Langehorne A. A. Eckfeldt J. H. Glass K. C. Jarvik G. P. Klag M. Koski G. Motulsky A. Wilfond B. Manolio T. A. Fabsitz R. R. Luepker R. V. , “Reporting Genetic Results in Research Studies: Summary and Recommendations of an NHLBI Working Group,” American Journal of Medicine and Genetics A 140, no. 10 (2006): 1033–1040.

See NIBIB, supra note 5.

American College of Medical, Genetics and Genomics, “Incidental Findings in Clinical Genomics: A Clarification,” Genetics in Medicine 15, no. 8 (2013): 664–666; Presidential Commission, 2013, supra note 2.

See Stein , supra note 1; Stein R. , “Scientists See Upside and Downside of Sequencing Their Own Genes,” edited by Stein Rob , Morning Edition, NPR, 2012.

Helgesson G. , “Autonomy, the Right Not to Know to Know Personal Research Results: What Rights Are There, and Who Should Decide about Exceptions?” Journal of Law, Medicine & Ethics 42, no. 1 (2014): 28–37.

See Wolf , 2012, supra note 1.

Ortiz A. A. Ehler L. , “Considering Incidental Findings (IFs) in HIV Research: A Must in Today's Environment,” document presented at “Advancing Ethical Research, Public Responsibility in Medicine and Research (PRIM&R)” Boston, Massachusetts 2013.

Garrett J. R. , “Reframing the Ethical Debate Regarding Incidental Findings in Genetic Research,” American Journal of Bioethics 13, no. 2 (2013): 44–46.