Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research
- PMID:25346543
- PMCID: PMC4207216
Finding Fault? Exploring Legal Duties to Return Incidental Findings in Genomic Research
Abstract
The use of whole-genome sequencing in biomedical research is expected to produce dramatic advances in human health. The increasing use of this powerful, data-rich new technology in research, however, will inevitably give rise to incidental findings (IFs)-findings with individual health or reproductive significance that are beyond the aims of the particular research-and the related questions of whether and to what extent researchers have an ethical obligation to return IFs. Many have concluded that researchers have an ethical obligation to return some findings in some circumstances but have provided vague or context-dependent approaches to determining which IFs must be returned and when. As a result, researchers have started returning IFs inconsistently, giving rise to concerns about legal liability in circumstances in which notification could have potentially prevented injury. Although it is clear that ethical guidance should not be automatically codified as law and that crafting ethical obligations around legal duties can be inappropriate, the ethical debate should not proceed unaware of the potential legal ramifications of advancing and implementing an ethical obligation to return IFs. This Article assesses the legal claims that could be brought for a researcher's failure to return IFs. The potential for researchers to be held liable in tort is still uncertain and turns largely on a number of factors-including customary practice and guidance documents-that are still in flux. Unlike medical care, which has a well-defined duty into which evolving scientific knowledge about genetics and genomics can readily be incorporated, a researcher's duty to return IFs is less well defined, making it difficult to determine at the outset whether and when legal liability will attach. This Article advocates for a clearer, ethically sound standard of requiring that researchers disclose in the informed consent document which approach to offering IFs will be taken. This approach enables participants to know at the outset which findings, if any, will be returned, allows researchers to ascertain when their failure to appropriately return incidental findings will give rise to liability, and enables courts to make determinations that will produce more consistent legal guidance.
Similar articles
- To disclose, or not to disclose? Perspectives of clinical genomics professionals toward returning incidental findings from genomic research.AlFayyad I, Al-Tannir M, Abu-Shaheen A, AlGhamdi S.AlFayyad I, et al.BMC Med Ethics. 2021 Jul 27;22(1):101. doi: 10.1186/s12910-021-00670-y.BMC Med Ethics. 2021.PMID:34315465Free PMC article.
- Incidental Findings in Study Participants: What Is the Researcher's Obligation?Schaare D, Ward LD, Boccuto L.Schaare D, et al.Genes (Basel). 2022 Sep 22;13(10):1702. doi: 10.3390/genes13101702.Genes (Basel). 2022.PMID:36292587Free PMC article.
- Can I be sued for that? Liability risk and the disclosure of clinically significant genetic research findings.McGuire AL, Knoppers BM, Zawati MH, Clayton EW.McGuire AL, et al.Genome Res. 2014 May;24(5):719-23. doi: 10.1101/gr.170514.113. Epub 2014 Mar 27.Genome Res. 2014.PMID:24676095Free PMC article.
- A Framework to Ethically Approach Incidental Findings in Genetic Research.Beshir L.Beshir L.EJIFCC. 2020 Nov 20;31(4):302-309. eCollection 2020 Nov.EJIFCC. 2020.PMID:33376470Free PMC article.Review.
- Managing "incidental findings" in biobank research: Recommendations of the Taiwan biobank.Lin JC, Hsiao WW, Fan CT.Lin JC, et al.Comput Struct Biotechnol J. 2019 Aug 2;17:1135-1142. doi: 10.1016/j.csbj.2019.07.006. eCollection 2019.Comput Struct Biotechnol J. 2019.PMID:31462969Free PMC article.Review.
Cited by
- The Responsibility to Recontact Research Participants after Reinterpretation of Genetic and Genomic Research Results.Bombard Y, Brothers KB, Fitzgerald-Butt S, Garrison NA, Jamal L, James CA, Jarvik GP, McCormick JB, Nelson TN, Ormond KE, Rehm HL, Richer J, Souzeau E, Vassy JL, Wagner JK, Levy HP.Bombard Y, et al.Am J Hum Genet. 2019 Apr 4;104(4):578-595. doi: 10.1016/j.ajhg.2019.02.025.Am J Hum Genet. 2019.PMID:30951675Free PMC article.
- A systematic approach to the disclosure of genomic findings in clinical practice and research: a proposed framework with colored matrix and decision-making pathways.Matsui K, Yamamoto K, Tashiro S, Ibuki T.Matsui K, et al.BMC Med Ethics. 2021 Dec 25;22(1):168. doi: 10.1186/s12910-021-00738-9.BMC Med Ethics. 2021.PMID:34953504Free PMC article.
- Institutional review board perspectives on obligations to disclose genetic incidental findings to research participants.Gliwa C, Yurkiewicz IR, Lehmann LS, Hull SC, Jones N, Berkman BE.Gliwa C, et al.Genet Med. 2016 Jul;18(7):705-11. doi: 10.1038/gim.2015.149. Epub 2015 Nov 19.Genet Med. 2016.PMID:26583685Free PMC article.
- Possible barriers for genetic counselors returning actionable genetic research results across state lines.Roberts MC, Wood EM, Gaieski JB, Bradbury AR.Roberts MC, et al.Genet Med. 2017 Nov;19(11):1202-1204. doi: 10.1038/gim.2017.34. Epub 2017 Apr 20.Genet Med. 2017.PMID:28425980No abstract available.
- Returning incidentally discovered Hepatitis C RNA-seq results to COPDGene study participants.Silverman EK, Kim AY, Make BJ, Regan EA, Morrow JD, Hersh CP, O'Brien J, Crapo JD, Hansel NN, Criner G, Flenaugh EL, Conrad D, Casaburi R, Bowler RP, Hanania NA, Barr RG, Bhatt SP, Sciurba FC, Anzueto A, Han MK, McEvoy CE, Comellas AP, DeMeo DL, Rosiello R, Curtis JL, Uchida T, Wilson C, O'Rourke PP.Silverman EK, et al.NPJ Genom Med. 2023 Oct 31;8(1):36. doi: 10.1038/s41525-023-00379-4.NPJ Genom Med. 2023.PMID:37903807Free PMC article.
References
See, e.g. , Collins Francis S, Morgan Michael, Patrinos Aristides. The Human Genome Project: Lessons from Large-Scale Biology. Sci. 2003;300:286, 287.
See International Consortium Completes Human Genome Project. Nat’l Human Genome Res Inst. 2003 Apr 14;http://www.genome.gov/11006929 .
See, e.g. , Donley Greer, Hull Sara Chandros, Berkman Benjamin E. Hastings Center Rep. Jul-Aug. 2012. Prenatal Whole Genome Sequencing: Just Because We Can, Should We? p. 28.p. 28.p. 31.
See, e.g. , Collins Francis S, Green Eric D, Guttmacher Alan E, Guyer Mark S. A Vision for the Future of Genomics Research. Nature. 2003;422:835, 836.Morozova Olena, Marra Marco A. Applications of Next-Generation Sequencing Technologies in Functional Genomics. Genomics. 2008;92:255, 257–58.Tran Ben, et al. Cancer Genomics: Technology, Discovery, and Translation. J Clinical Oncology. 2012;30:647, 647.
“Incidental findings” can also be called “secondary findings” or “incidentalomes.”
Related information
Grants and funding
LinkOut - more resources
Full Text Sources
Research Materials