Skip to main content

Genomics, Ethics, and Compliance

  • Chapter
  • First Online:
Personalized, Evolutionary, and Ecological Dermatology

Abstract

Genomics offers unprecedented opportunity to personalize medical care. Pharmacogenomics may help identify the best treatments for patients. These advances raise new ethical issues to consider. These issues also interface with the critically important issue of patient adherence and compliance to treatment. This chapter begins with a review of the history of ethics and especially its relationship to research in medicine, and this is followed by a discussion of genomics and the ethical issues it elucidates, as well as compliance in medicine and the associated ethical implications. The chapter is concluded with a commentary regarding this rather contemporary movement of pharmacogenomics, which embodies both ethics and compliance and is pertinent to the field of dermatology.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 159.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 109.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Freyhofer HH. The Nuremberg Medical Trial. New York: Peter Lang Publishing; 2004. p. 10–11.

    Google Scholar 

  2. Gillon R. Medical oaths, declarations, and codes. Br Med J (Clin Res Ed). 1985;290(6476):1194–5.

    Article  CAS  Google Scholar 

  3. Carlson R, Boyd KM, Webb DJ. The revision of the Declaration of Helsinki: past, present and future. Br J Clin Pharmacol. 2004;57(6):695–713.

    Article  PubMed  PubMed Central  Google Scholar 

  4. U.S. Department of Health and Human Services. The Belmont report. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. Accessed 2015 June.

  5. Brody BA. The Ethics of Biomedical Research: An International Perspective. New York: Oxford University Press; 1998. p. 36.

    Google Scholar 

  6. Shuster E. Fifty years later: the significance of the Nuremberg code. N Engl J Med. 1997;337:1436–40.

    Article  CAS  PubMed  Google Scholar 

  7. Gillon R. Medical oaths, declarations, and codes. Br Med J (Clin Res Ed). 1985;290(6476):1194–5.

    Article  CAS  Google Scholar 

  8. Frewer A. Human rights from the Nuremberg doctors trial to the Geneva declaration. Persons and institutions in medical ethics and history. Med Health Care Philos. 2010;13(3):259–68.

    Article  PubMed  Google Scholar 

  9. Williams JR. The Declaration of Helsinki and public health. Bulletin of the World Health Organization. 2008;86(8):650–2.

    Google Scholar 

  10. Holt GR. Declaration of Helsinki-the world’s document of conscience and responsibility. South Med J. 2014;107(7):407.

    Article  PubMed  Google Scholar 

  11. Parsa-Parsi RW, Ellis R, Wiesing U. Fifty years at the forefront of ethical guidance: the world medical association declaration of Helsinki. South Med J. 2014;107(7):405–6.

    Article  PubMed  Google Scholar 

  12. Mandal J, Acharya S, Parija SC. Ethics in human research. Trop Parasitol. 2011;1(1):2–3.

    Article  PubMed  PubMed Central  Google Scholar 

  13. Breault JL. Protecting human research subjects: the past defines the future. Ochsner J. 2006;6(1):15–20.

    PubMed  PubMed Central  Google Scholar 

  14. Fischer BA. A summary of important documents in the field of research ethics. Schizophr Bull. 2006;32(1):69–80.

    Article  PubMed  Google Scholar 

  15. Beauchamp TL. The Belmont report. The Oxford textbook of clinical research ethics. New York: Oxford University Press; 2011. p. 149–155.

    Google Scholar 

  16. Vollmer SH, Howard G. Statistical power, the Belmont report, and the ethics of clinical trials. Sci Eng Ethics. 2010;16(4):675–91.

    Article  PubMed  Google Scholar 

  17. About us. Council for International Organizations of Medical Sciences. http://www.cioms.ch/index.php/2012-06-07-19-16-08/about-us. Accessed 2015 June.

  18. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva. 2002. http://www.cioms.ch/publications/layout_guide2002.pdf. Accessed 2015 June.

  19. Stewart A, Karmali M, Zimmern R. GRaPH Int: a International Network for Public Health Genomics. In: Knoppers BA, editor. Genomics and public health: legal and socio-ethical perspectives. Leiden: Martinus Nijhoff; 2006. p. 260.

    Google Scholar 

  20. Caulfield T, McGuire AL, Cho M, Buchanan JA, Burgess MM, Danilczyk U, et al. Research ethics recommendations for whole-genome research: consensus statement. PLoS Biol. 2008;6(3):e73.

    Article  PubMed  PubMed Central  Google Scholar 

  21. Ayuso C, Millan JM, Mancheno M, Dal-Re R. Informed consent for whole-genome sequencing studies in the clinical setting. Proposed recommendations on essential content and process. Eur J Hum Genet. 2013;21(10):1054–9.

    Article  PubMed  PubMed Central  Google Scholar 

  22. Holm S. Withdrawing from research: a rethink in the context of research biobanks. Health Care Anal. 2011;19(3):269–81.

    Article  PubMed  Google Scholar 

  23. Boddington P. Ethical challenges in genomics research: a guide to understanding ethics in context. New York: Springer; 2012. p. 91.

    Book  Google Scholar 

  24. Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet. 2012;13:415–31.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  25. Kaye J, Boddington P, de Vries J, Hawkins N, Melham K. Ethical implications of the use of whole genome methods in medical research. Eur J Hum Genet. 2010;18(4):398–403.

    Article  CAS  PubMed  Google Scholar 

  26. Lin Z, Owen AB, Altman RB. Genetics. Genomic research and human subject privacy. Science. 2004;305(5681):183.

    Article  CAS  PubMed  Google Scholar 

  27. Henderson GE, Wolf SM, Kuczynski KJ, Joffe S, Sharp RR, Parsons DW, et al. The challenge of informed consent and return of results in translational genomics: empirical analysis and recommendations. J Law Med Ethics. 2014;42(3):344–55.

    Article  PubMed  PubMed Central  Google Scholar 

  28. Clarke AJ. Managing the ethical challenges of next-generation sequencing in genomic medicine. Br Med Bull. 2014;111(1):17–30.

    Article  PubMed  Google Scholar 

  29. Christenhusz GM, Devriendt K, Dierickx K. To tell or not to tell? A systematic review of ethical reflections on incidental findings arising in genetics contexts. Eur J Hum Genet. 2013;21(3):248–55.

    Article  PubMed  Google Scholar 

  30. Klitzman R, Appelbaum PS, Fyer A, Martinez J, Buquez B, Wynn J, et al. Researchers’ views on return of incidental genomic research results: qualitative and quantitative findings. Genet Med. 2013;15(11):888–95.

    Article  PubMed  Google Scholar 

  31. Pinxten W, Howard HC. Ethical issues raised by whole genome sequencing. Best Pract Res Clin Gastroenterol. 2014;28(2):269–79.

    Article  PubMed  Google Scholar 

  32. Appelbaum PS, Anatchkova M, Albert K, Dunn LB, Lidz CW. Therapeutic misconception in research subjects: development and validation of a measure. Clin Trials. 2012;9(6):748–61.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Kermani F, Davies M. Patient compliance: sweetening the pill. Hampshire: Gower; 2006.

    Google Scholar 

  34. McDonald HP, Garg AX, Haynes RB. Interventions to enhance patient adherence to medication prescriptions. J Am Med Assoc. 2002;288(22):2868–79.

    Article  Google Scholar 

  35. Martin LR, Williams SL, Haskard KB, DiMatteo MR. The challenge of patient adherence. Ther Clin Risk Manag. 2005;1(3):189–99.

    PubMed  PubMed Central  Google Scholar 

  36. Giuffrida A, Torgerson DJ. Should we pay the patient? Review of financial incentives to enhance patient compliance. BMJ. 1997;315(7110):703–7.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  37. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane Database Syst Rev 2014;(11):CD000011.

    Google Scholar 

  38. Laugesen J, Hassanein K, Yuan Y. The impact of internet health information on patient compliance: a research model and empirical study. J Med Internet Res. 2015;17(6):e143.

    Article  PubMed  PubMed Central  Google Scholar 

  39. Zolnierek KBH, DiMatteo MR. Physician communication and patient adherence to treatment: a meta-analysis. Med Care. 2009;47(8):826–34.

    Article  PubMed  Google Scholar 

  40. Roter DL, Hall JA, Merisca R, Nordstrom B, Cretin D, Svarstad B. Effectiveness of interventions to improve patient compliance: a meta-analysis. Med Care. 1998;36(8):1138–61.

    Article  CAS  PubMed  Google Scholar 

  41. Dao R, Su S, Chung W. Recent advances of pharmacogenomics in severe cutaneous adverse reactions: immune and nonimmune mechanisms. Asia Pac Allergy. 2015;5(2):59–67. doi:10.5415/apallergy.2015.5.2.59.

    Article  PubMed  PubMed Central  Google Scholar 

  42. Chung W, Chang W, Lee Y, Wu Y, Yang C, Ho H, et al. Genetic variants associated with phenytoin-related severe cutaneous adverse reactions. J Am Med Assoc. 2014;312(5):525–34. doi:10.1001/jama.2014.7859.

    Article  Google Scholar 

  43. Guo Y, Sawalha AH, Lu Q. Epigenetics in the treatment of systemic lupus erythematosus: potential clinical application. Clin Immunol. 2014;155(1):79–90. doi:10.1016/j.clim.2014.​09.002.

    Google Scholar 

  44. Draelos ZD. Genomics: the future of cosmetic dermatology. J Cosmet Dermatol. 2010;​9:265–6.

    Article  PubMed  Google Scholar 

  45. Bernardini J. Ethical issues of compliance/adherence in the treatment of hypertension. Adv Chronic Kidney Dis. 2004;11(2):222–7.

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Steven R. Feldman MD, PhD .

Editor information

Editors and Affiliations

Rights and permissions

Reprints and permissions

Copyright information

© 2016 Springer International Publishing Switzerland

About this chapter

Cite this chapter

Faulks, S.W., Feldman, S.R. (2016). Genomics, Ethics, and Compliance. In: Norman, R. (eds) Personalized, Evolutionary, and Ecological Dermatology. Springer, Cham. https://doi.org/10.1007/978-3-319-41088-3_7

Download citation

  • DOI: https://doi.org/10.1007/978-3-319-41088-3_7

  • Published:

  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-319-41086-9

  • Online ISBN: 978-3-319-41088-3

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics