Incidental Findings in Genetics Research Using Archived DNA

Overview

Journal J Law Med Ethics

Publisher Cambridge University Press

Specialties Forensic Sciences
General Medicine
Health Services
Medical Ethics

Date 2008 Jun 13

PMID 18547196

Citations 36

Authors

Ellen Wright Clayton

Affiliations

Soon will be listed here.

Abstract

Despite calls by some commentators for disclosing incidental findings in genetics research, several factors weigh in favor of caution. The technology of genetics has the power to uncover a vast array of information. The most potent argument for restraint in disclosure is that much research is pursued without consent so that the individual participant may not know that research is being conducted at all. Often the work is done by investigators and at institutions with which the person has no prior contact. Past practice is also relevant; genetics researchers historically have chosen not to disclose incidental findings, of which misattributed paternity and pleiotropic alleles such as ApoE have been the most common. Many people choose not to have genetic tests when given a choice. It may be desirable to discuss the topic of incidental findings when consent for research is obtained, but given the risk of unwanted surprise when there has been no prior discussion, the potential utility of incidental findings should be very high before they are even offered to individuals.

Citing Articles

Algorithmic identification of persons with dementia for research recruitment: ethical considerations.

London A, Karlawish J, Largent E, Hey S, McCarthy E Inform Health Soc Care. 2024; 49(1):28-41.

PMID: 38196387 PMC: 11001531. DOI: 10.1080/17538157.2023.2299881.

Do Clinicians Have a Duty to Participate in Pragmatic Clinical Trials?.

Garland A, Morain S, Sugarman J Am J Bioeth. 2022; 23(8):22-32.

PMID: 36449269 PMC: 10355327. DOI: 10.1080/15265161.2022.2146784.

Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.

Morain S, Largent E Am J Bioeth. 2022; 23(8):10-21.

PMID: 35435790 PMC: 9576818. DOI: 10.1080/15265161.2022.2063435.

Ethics and Collateral Findings in Pragmatic Clinical Trials.

Morain S, Weinfurt K, Bollinger J, Geller G, Mathews D, Sugarman J Am J Bioeth. 2020; 20(1):6-18.

PMID: 31896322 PMC: 7027922. DOI: 10.1080/15265161.2020.1689031.

A Belmont Reboot: Building a Normative Foundation for Human Research in the 21st Century.

Brothers K, Rivera S, Cadigan R, Sharp R, Goldenberg A J Law Med Ethics. 2019; 47(1):165-172.

PMID: 30994072 PMC: 6587582. DOI: 10.1177/1073110519840497.

References

Biesecker B, Ishibe N, Hadley D, Giambarresi T, Kase R, Lerman C . Psychosocial factors predicting BRCA1/BRCA2 testing decisions in members of hereditary breast and ovarian cancer families. Am J Med Genet. 2000; 93(4):257-63. DOI: 10.1002/1096-8628(20000814)93:4<257::aid-ajmg1>3.0.co;2-8. View

Pullman D, Hodgkinson K . Genetic knowledge and moral responsibility: ambiguity at the interface of genetic research and clinical practice. Clin Genet. 2006; 69(3):199-203. DOI: 10.1111/j.1399-0004.2006.00581.x. View

Foster C, Evans D, Eeles R, Eccles D, Ashley S, Brooks L . Non-uptake of predictive genetic testing for BRCA1/2 among relatives of known carriers: attributes, cancer worry, and barriers to testing in a multicenter clinical cohort. Genet Test. 2004; 8(1):23-9. DOI: 10.1089/109065704323016003. View

Pulley J, Brace M, Bernard G, Masys D . Attitudes and perceptions of patients towards methods of establishing a DNA biobank. Cell Tissue Bank. 2007; 9(1):55-65. DOI: 10.1007/s10561-007-9051-2. View

Scheuner M . Genetic evaluation for coronary artery disease. Genet Med. 2003; 5(4):269-85. DOI: 10.1097/01.GIM.0000079364.98247.26. View

Shalowitz D, Miller F . Disclosing individual results of clinical research: implications of respect for participants. JAMA. 2005; 294(6):737-40. DOI: 10.1001/jama.294.6.737. View

. Genome-wide association study of 14,000 cases of seven common diseases and 3,000 shared controls. Nature. 2007; 447(7145):661-78. PMC: 2719288. DOI: 10.1038/nature05911. View

Friedman Ross L . Disclosing misattributed paternity. Bioethics. 1996; 10(2):114-30. DOI: 10.1111/j.1467-8519.1996.tb00111.x. View

Pesudovs K, Luscombe C, Coster D . Recall from informed consent counselling for cataract surgery. J Law Med. 2006; 13(4):496-504. View

10.

DeCamp M, Sugarman J . Ethics in population-based genetic research. Account Res. 2004; 11(1):1-26. DOI: 10.1080/08989620490280221. View

11.

Turney L . The incidental discovery of nonpaternity through genetic carrier screening: an exploration of lay attitudes. Qual Health Res. 2005; 15(5):620-34. DOI: 10.1177/1049732304273880. View

12.

Pollitt R . Introducing new screens: why are we all doing different things?. J Inherit Metab Dis. 2007; 30(4):423-9. DOI: 10.1007/s10545-007-0647-2. View

13.

Weir R, Horton J . DNA banking and informed consent -- part 1. IRB. 1995; 17(4):1-4. View

14.

Roberts J, Barber M, Brown T, Cupples L, Farrer L, LaRusse S . Who seeks genetic susceptibility testing for Alzheimer's disease? Findings from a multisite, randomized clinical trial. Genet Med. 2004; 6(4):197-203. DOI: 10.1097/01.gim.0000132688.55591.77. View

15.

Kohane I, Mandl K, Taylor P, Holm I, Nigrin D, Kunkel L . Medicine. Reestablishing the researcher-patient compact. Science. 2007; 316(5826):836-7. DOI: 10.1126/science.1135489. View

16.

Alexander D, van Dyck P . A vision of the future of newborn screening. Pediatrics. 2006; 117(5 Pt 2):S350-4. DOI: 10.1542/peds.2005-2633O. View

17.

Beskow L, Burke W, Merz J, Barr P, Terry S, Penchaszadeh V . Informed consent for population-based research involving genetics. JAMA. 2001; 286(18):2315-21. DOI: 10.1001/jama.286.18.2315. View

18.

Pelias M . Research in human genetics: the tension between doing no harm and personal autonomy. Clin Genet. 2004; 67(1):1-5. DOI: 10.1111/j.1399-0004.2004.00324.x. View

19.

Bookman E, Langehorne A, Eckfeldt J, Glass K, Jarvik G, Klag M . Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. Am J Med Genet A. 2006; 140(10):1033-40. PMC: 2556074. DOI: 10.1002/ajmg.a.31195. View

20.

Wertz D, Fletcher J . Ethics and medical genetics in the United States: a national survey. Am J Med Genet. 1988; 29(4):815-27. DOI: 10.1002/ajmg.1320290411. View