Managing Incidental Genomic Findings in Clinical Trials: Fulfillment of the Principle of Justice

1. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) Belmont report: ethical principles and guidelines for the protection of human subjects of research. Fed Regist 44: 23192–23197.

2. Dresser R (2011) The role of patient advocates and public representatives in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, et al. The Oxford textbook of clinical research ethics. Oxford: Oxford University Press pp. 231–241.

3. MestanKK, IlkhanoffL, MouliS, LinS (2011) Genomic sequencing in clinical trials. J Trans Med 9: 222.

4. WolfSM, LawrenzFP, NelsonCA, KahnJP, ChoMK, et al. (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36: 219–248.

5. GreenRC, BergJS, GrodyWW, KaliaSS, KorfBR, et al. (2013) ACMG recommendations for reporting of incidental findings in clinical exome and genome sequencing. Genet Med 15: 565–574.

6. American College of Medical Genetics and Genomics (2013) Incidental findings in clinical genomics: a clarification. Genet Med 15: 664–666.

7. WolfSM, AnnasGJ, EliasS (2013) Patient autonomy and incidental findings in clinical genomics. Science 340: 1049–1050.

8. McGuireA, JoffeS, KoenigBA, BieseckerBB, McCulloughLB, et al. (2013) Ethics and genomic incidental findings. Science 340: 1047–1048.

9. TownsendA, AdamS, BirchPH, FriedmanJM (2013) Paternalism and the ACMG recommendations on genomic incidental findings: patients seen but not heard. Genet Med 15: 751–752.

10. HoltzmanNA (2013) ACMG recommendations on incidental findings are flawed scientifically and ethically. Genet Med 15: 750–751.

11. KlitzmanR, AppelbaumPS, ChungW (2013) Return of secondary genomic findings vs patient autonomy. JAMA 310: 369–370.

12. RossLF, RothsteinMA, ClaytonEW (2013) Mandatory extended searches in all genome sequencing. JAMA 310: 367–368.

13. Presidental Commission for the Study of Bioethical Issues (2013) Commission plans next project: ethical implications of incidental findings. Available: http://bioethics.gov/node/819. Accessed 17 December 2013

14. National Human Genome Research Institute (2012) NHGRI funds return of results studies, forms expert consortium. Available: http://www.genome.gov/27545526. Accessed 17 December 2013.

15. SimonR, RoychowdhuryS (2013) Implementing personalized cancer genomics in clinical trials. Nat Rev Drug Discov 12: 358–369.

16. RichardsonHS, BelskyL (2004) The ancillary-care responsibilities of medical researchers. An ethical framework for thinking about the clinical care that researchers owe their subjects. Hastings Cent Rep 34: 25–33.

17. Richardson HS (2013) Moral entanglements: the ancillary-care obligations of medical researchers. Oxford: Oxford University Press.

18. GliwaC, BerkmanBE (2013) Do researchers have an obligation to actively look for genetic incidental findings? Am J Bioeth 13: 32–42.

19. FacioFM, EidemH, FisherT, BrooksS, LinnA, et al. (2013) Intentions to receive individual results from whole-genome sequencing among participants in the ClinSeq study. Eur J Hum Genet 21: 261–265.

20. Council for International Organizations of Medical Sciences (2002) International ethical guidelines for biomedical research involving human subjects. Available: http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed 17 December 2013.

21. ClaytonEW, HagaS, KuszlerP, BaneE, ShutskeK, et al. (2013) Managing incidental genomic findings: legal obligations of clinicians. Genet Med 15: 624–629.

22. PriceWN (2013) Legal implications of an ethical duty to search for genetic incidental findings. Am J Bioeth 13: 48–49.

23. CaliffRM, ZarinDA, KramerJM, ShermanRE, AberleLH, et al. (2012) Characteristics of clinical trials registered in ClinicalTrials.gov, 2007–2010. JAMA 307: 1838–1847.

24. AllyseM, MichieM (2013) Not-so-incidental findings: the ACMG recommendations on the reporting of incidental findings in clinical whole genome and whole exome sequencing. Trends Biotechnol 31: 439–441.

25. BurkeW, AntommariaAHM, BennettR, BotkinJ, ClaytonEW, et al. (2013) Recommendations for returning genomic incidental findings? We need to talk. Genet Med 15: 854–859.

26. RossLF, SaalHM, DavidKL, AndersonRR (2013) American Academy of Pediatrics, American College of Medical Genetics and Genomics (2013) Technical report: ethical and policy issues in genetic testing and screening of children. Genet Med 15: 234–245.

27. DresslerLG, SmolekS, PonsaranR, MarkeyJM, StarksH, et al. (2012) IRB perspectives on the return of individual results from genomic research. Genet Med 14: 215–222.

28. (2011) Title 42—the public health and welfare. United States Code, section 263(a). Available: http://www.gpo.gov/fdsys/pkg/USCODE-2011-title42/pdf/USCODE-2011-title42-chap6A-subchapII-partF-subpart2-sec263a.pdf. Accessed 17 December 2013.

29. National Cancer Institute (2013) BRCA1 and BRCA2: cancer risk and genetic testing. Available: http://www.cancer.gov/cancertopics/factsheet/risk/brca. Accessed 17 December 2013.

30. JamesCA, CalkinsH (2013) Update on arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C). Curr Treat Options Cardiovasc Med 15: 476–487.

31. National Human Genome Research Institute (2013) Learning about familial hypercholesterolemia. Available: http://www.genome.gov/25520184. Accessed 17 December 2013.