Do Researchers Have an Obligation to Actively Look for Genetic Incidental Findings?

American Journal of Bioethics

Volumn 13, Issue 2, 2013, Pages 32-42

  Gliwa, Catherine ^a   Berkman, Benjamin E ^b  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

^b NATIONAL HUMAN GENOME RESEARCH INSTITUTE   (United States)

Author keywords

genetic research; genetics (clinical); human subjects research; research ethics

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; BENEFICENCE; CONFLICT; CONFLICT OF INTEREST; ETHICS; FORECASTING; GENETICS; HEALTH CARE PLANNING; HUMAN; HUMAN GENOME; HUMAN RELATION; INCIDENTAL FINDING; INTERPERSONAL COMMUNICATION; MORALITY; PERSONNEL; RESEARCH ETHICS; SOCIAL BEHAVIOR; WORKLOAD;

ACCESS TO INFORMATION; BENEFICENCE; CONFLICT (PSYCHOLOGY); CONFLICT OF INTEREST; ETHICS, RESEARCH; FORECASTING; GENETIC RESEARCH; GENOME, HUMAN; HEALTH RESOURCES; HUMANS; INCIDENTAL FINDINGS; MORAL OBLIGATIONS; RESEARCH PERSONNEL; RESEARCHER-SUBJECT RELATIONS; SOCIAL RESPONSIBILITY; TRUTH DISCLOSURE; WORKLOAD;

EID: 84873884799     PISSN: 15265161     EISSN: 15360075     Source Type: Journal    
DOI: 10.1080/15265161.2012.754062     Document Type: Article

References (42)

1. 23andMe. 2012a. Terms of service. 23andMe. Available at: https://www.23andme.com/about/tos (accessed August 16, 2012)
2. 23andMe. 2012b. Exome 80x: Pilot program. 23andMe. Available at: https://www.23andme.com/exome (accessed August 16, 2012)
3. American College of Medical Genetics and Genomics. 2012. Policy statement: Points to consider in the clinical application of genomic sequencing. Available at: http://www.acmg.net/StaticContent/PPG/Clinical_Application_of_Genomic_Sequencing.pdf
4. American College of Medical Genetics Board of Directors. 2004. ACMG statement on direct-to-consumer genetic testing. Genetics in Medicine, 6(1): 60
5. Ashley, E. A., Butte, A. J.Wheeler, M. T. 2010. Clinical assessment incorporating a personal genome. Lancet, 375(9725): 1525-1535.
6. Belsky, L. and Richardson, H. S. 2004. Medical researchers' ancillary clinical care responsibilities. British Medical Journal, 328(7454): 1494-1496.
7. Berg, J. S., Khoury, M. J. and Evans, J. P. 2011. Deploying whole genome sequencing in clinical practice and public health: Meeting the challenge one bin at a time. Genetics in Medicine, 13(6): 499-504.
8. Biesecker, L. G. 2012. Opportunities and challenges for the integration of massively parallel genomic sequencing into clinical practice: Lessons from the ClinSeq project. Genetics in Medicine, 14(4): 393-398.
9. Bookman, E. B., Langehorne, A. A.Eckfeldt, J. H. 2006. Reporting genetic results in research studies: Summary and recommendations of an NHLBI working group. American Journal of Medical Genetics Part A, 140(10): 1033-1040.
10. Bredenoord, A. L., Kroes, H. Y., Cuppen, E., Parker, M. and van Delden, J. J. 2011. Disclosure of individual genetic data to research participants: The debate reconsidered. Trends in Genetics, 27(2): 41-7.
11. Brunham, L. R. and Hayden, M. R. 2012. Medicine. Whole-genome sequencing: The new standard of care?. Science, 336(6085): 1112-1113.
12. Burke, W., Tarini, B., Press, N. A. and Evans, J. P. 2011. Genetic screening. Epidemiologic Reviews, 33(1): 148-164.
13. Cassa, C. A., Savage, S. K., Taylor, P. L., Green, R. C., McGuire, A. L. and Mandl, K. D. 2012. Disclosing pathogenic genetic variants to research participants: Quantifying an emerging ethical responsibility. Genome Research, 22(3): 421-428.
14. Cho, M. K. 2008. Understanding incidental findings in the context of genetics and genomics. Journal of Law, Medicine and Ethics, 36(2): 280-285.
15. Clayton, E. W. 2008. Incidental findings in genetics research using archived DNA. Journal of Law, Medicine and Ethics, 36(2): 286-291.
16. Council for International Organizations of Medical Sciences andWorld Health Organization. 2002. International ethical guidelines for biomedical research involving human subjects, Geneva, Switzerland: CIOMS. Available at: http://www.cioms.ch/publications/layout_guide2002.pdf
17. Dickert, N., DeRiemer, K.Duffy, P. E. 2007. Ancillary-care responsibilities in observational research: Two cases, two issues. Lancet, 369(9564): 874-877.
18. Fabsitz, R. R., McGuire, A.Sharp, R. R. 2010. Ethical and practical guidelines for reporting genetic research results to study participants: Updated guidelines from an NHLBI working group. Circulation: Cardiovascular Genetics, 3(6): 574-580.
19. Green, E. D. and Guyer, M. S. 2011. Charting a course for genomic medicine from base pairs to bedside. Nature, 470(7333): 204-213.
20. Green, R. C., Berg, J. S.Berry, G. T. 2012. Exploring concordance and discordance for return of incidental findings from clinical sequencing. Genetics in Medicine, 14(4): 405-410.
21. Hayden, E. C. 2012. Geneticists debate what to tell patients about clinical genome sequences. News blog. Nature, March 16. Available at:http://blogs.nature.com/news/2012/03/geneticists-debate-what-to-tell-patients-about-clincial-genome-sequences.html
22. Institute of Medicine, Board on Health Science Policy. 2012. Integrating large-scale genomic information into clinical practice: Workshop summary, Edited by: Olsen, rapporteurs S., Beachy, S. H., Giammaria, C. F. and Berger, A. C. Washington, DC: National Academies Press.
23. Joffe, S. and Miller, F. G. 2008. Bench to bedside: Mapping the moral terrain of clinical research. Hastings Center Report, 38(2): 30-42.
24. Knoppers, B. M., Joly, Y., Simard, J. and Durocher, F. 2006. The emergence of an ethical duty to disclose genetic research results: International perspectives. European Journal of Human Genetics, 14(11): 1170-1178.
25. Kohane, I. S., Hsing, M. and Kong, S. W. 2012. Taxonomizing, sizing, and overcoming the incidentalome. Genetics in Medicine, 14(4): 399-404.
26. McGuire, A. L., Basford, M.Dressler, L. G. 2011. Ethical and practical challenges of sharing data from genome-wide association studies: The eMERGE Consortium experience. Genome Research, 21(7): 1001-1007.
27. Miller, F. A., Christensen, R., Giacomini, M. and Robert, J. S. 2008. Duty to disclose what? Querying the putative obligation to return research results to participants. Journal of Medical Ethics, 34(3): 210-213.
28. Miller, F. G., Mello, M. M. and Joffe, S. 2008. Incidental findings in human subjects research: What do investigators owe research participants?. Journal of Law, Medicine and Ethics, 36(2): 271-279.
29. National Human Genome Research Institute. 2012. Clinical sequencing exploratory research. National Human Genome Research Institute. Available at: http://www.genome.gov/27546194 (accessed August 16, 2012)
30. Parker, L. S. 2008. The future of incidental findings: Should they be viewed as benefits?. Journal of Law, Medicine and Ethics, 36(2): 341-213.
31. Participants in 2006 Georgetown University Workshop on Ancillary-Care Obligations of Medical Researchers Working in Developing Countries. 2008. The ancillary-care obligations of medical researchers working in developing countries. PLoS Medicine, 5(5): e90
32. Pollack, A. 2011. "DNA sequencing caught in deluge of data". In New York Times November 30. Available at:http://www.nytimes.com/2011/12/01/business/dna-sequencing-caught-in-deluge-of-data.html
33. Ravitsky, V. and Wilfond, B. S. 2006. Disclosing individual genetic results to research participants. American Journal of Bioethics, 6(6): 8-17.
34. Resnik, D. B. 2009. The clinical investigator-subject relationship: A contextual approach. Philosophy, Ethics and Humanities in Medicine, 4: 16
35. Richardson, H. S. 2008. Incidental findings and ancillary-care obligations. Journal of Law, Medicine and Ethics, 36(2): 256-270.
36. Richardson, H. S. and Belsky, L. 2004. The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Center Report, 34(1): 25-33.
37. Stitziel, N. O., Kiezun, A. and Sunyaev, S. 2011. Computational and statistical approaches to analyzing variants identified by exome sequencing. Genome Biology, 12(9): 227
38. Tabor, H. K., Berkman, B. E., Hull, S. C. and Bamshad, M. J. 2011. Genomics really gets personal: How exome and whole genome sequencing challenge the ethical framework of human genetics research. American Journal of Medical Genetics Part A, 155(12): 2916-2924.
39. Van Ness, B. 2008. Genomic research and incidental findings. Journal of Law, Medicine and Ethics, 36(2): 292-297.
40. Wolf, S. M., Crock, B. N.Van Ness, B. 2012. Managing incidental findings and research results in genomic research involving biobanks and archived data sets. Genetics in Medicine, 14(4): 361-384.
41. Wolf, S. M., Lawrenz, F. P.Nelson, C. A. 2008. Managing incidental findings in human subjects research: analysis and recommendations. Journal of Law, Medicine and Ethics, 36(2): 219-248.
42. World Medical Association. 2008. Declaration of Helsinki: Ethical principles for medical research involving human subjects Available at: http://www.wma.net/en/30publications/10policies/b3/index.html