Qualitative Research: Ethical Considerations

  • Anna-Maija PietiläEmail author
  • Sanna-Maria Nurmi
  • Arja Halkoaho
  • Helvi Kyngäs


Ethical aspects include perspectives of subject protection and conducting research based on ethical standards. This chapter aims to highlight the ethical aspects of qualitative research, with particular emphasis on content analysis. The chapter begins by presenting four ethical principles—autonomy, non-maleficence, beneficence, and justice—that were first brought to attention by Beauchamp and Childress (Principles of biomedical ethics. Oxford University Press, New York, 2013). These principles form the basis for the protection of the subject in qualitative research. Next, Shamoon and Resnik’s (Responsible conduct of research. Oxford University Press, New York, 2015) principles for responsible research conduct are described. The ethical framework presented by Emanuel et al. (J Infect Dis 189:930–937, 2000; JAMA 283:2701–2711, 2004), which includes eight ethical requirements, is then introduced, and later used to explore the ethical aspects of content analysis based on an example of qualitative research. The chapter concludes by discussing several challenges that researchers may face when applying content analysis to qualitative research.


Research ethics Ethical principles Ethical framework Qualitative research Content analysis 


  1. 1.
    Shamoo AE, Resnik D. Responsible conduct of research. 3rd ed. New York: Oxford University Press; 2015.Google Scholar
  2. 2.
    Mustajoki H, Mustajoki AS. A new approach to research ethics: using grounded dialogue to strengthen research communities. New York: Routledge; 2017.Google Scholar
  3. 3.
    Øye C, Sørensen NØ, Glasdam S. Qualitative research ethics on the spot. Nurs Ethics. 2016;23:455–64.CrossRefGoogle Scholar
  4. 4.
    Launis V. Ihminen kliinisen lääketieteellisen tutkimuksen kohteena. In: Keränen T, Pasternack A, editors. Kliinisen tutkimuksen etiikka. Helsinki: Kustannus oy Duodecim; 2015.Google Scholar
  5. 5.
    Heale R, Shorten A. Ethical context of nursing research. Evid Based Nurs. 2017;20:7.CrossRefGoogle Scholar
  6. 6.
    Beauchamp TL, Childress JF. Principles of biomedical ethics. New York: Oxford University Press; 2013.Google Scholar
  7. 7.
    Emanuel EJ, Wendler D. An ethical framework for biomedical research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The Oxford textbook of clinical research ethics. New York: Oxford university press; 2008. p. 123–35.Google Scholar
  8. 8.
    Finnish Advisory Board on Research Integrity. Responsible conduct on research and procedures for handling allegiations of misconduct in Finland. Helsinki. 2012. Accessed 14 Jan 2018.
  9. 9.
    Townsend A, Cox SM, Li LC. Qualitative research ethics: enhancing evidence-based practice in physical therapy. Phys Ther. 2010;90:615–28.CrossRefGoogle Scholar
  10. 10.
    Fallon RH. Two senses of autonomy. Stanford Law Rev. 1994;46:875–905.CrossRefGoogle Scholar
  11. 11.
    Secker B. The appearance of kant’s deontology in contemporary kantianism: concepts of patient autonomy in bioethics. J Med Philos. 1999;24:43–66.CrossRefGoogle Scholar
  12. 12.
    Halkoaho A, Pietilä A-M, Ebbesen M, et al. Cultural aspects related to informed consent in health research. Nurs Ethics. 2016;23:698–712.CrossRefGoogle Scholar
  13. 13.
    Brock DW. Philosophical justifications of informed consent in research. In: Emanuel EJ, Grady C, Crouch RA, Lie RK, Miller FG, Wendler D, editors. The oxford textbook of clinical research ethics. New York: Oxford University Press; 2008. p. 606–12.Google Scholar
  14. 14.
    Jefford M, Moore R. Improvement of informed consent and the quality of consent documents. Lancet Oncol. 2008;9:485–93.CrossRefGoogle Scholar
  15. 15.
    Biggs JS, Marchesi A. Information for consent: too long and too hard to read. Res Ethics. 2015;11:133–41.CrossRefGoogle Scholar
  16. 16.
    Ennis L, Wykes T. Sense and readability: participant information sheets for research studies. Br J Psychiatry J Ment Sci. 2016;208:189–94.CrossRefGoogle Scholar
  17. 17.
    Smith CA, Fogarty S. A survey of study participants’ understanding of informed consent to participate in a randomised controlled trial of acupuncture. BMC Complement Altern Med. 2015;16:10. Scholar
  18. 18.
    Tam NT, Huy NT, Thoa LTB, et al. Participants’ understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis. Bull World Health Organ. 2015;93:186–98.CrossRefPubMedPubMedCentralGoogle Scholar
  19. 19.
    Falagas ME, Korbila IP, Giannopoulou KP, et al. Informed consent: how much and what do patients understand? Am J Surg. 2009;198:420–35.CrossRefGoogle Scholar
  20. 20.
    Paris A, Deygas B, Cornu C, et al. Improved informed consent documents for biomedical research do not increase patients’ understanding but reduce enrolment: a study in real settings. Br J Clin Pharmacol. 2015;80:1010–20.CrossRefPubMedPubMedCentralGoogle Scholar
  21. 21.
    Nishimura A, Carey J, Erwin PJ, et al. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. BMC Med Ethics. 2013;14(1):28. Scholar
  22. 22.
    Halkoaho A, Vähäkangas K, Häggman-Laitila A, et al. Views of midwives about ethical aspects of participation in placental perfusion studies. Midwifery. 2012;28:131–7.CrossRefGoogle Scholar
  23. 23.
    Nurmi S-M, Kangasniemi M, Halkoaho A, et al. What enables ethically conducted clinical research in hospitals? Views of the administrative staff. Clin Ethics. 2016;11:166–75.CrossRefGoogle Scholar
  24. 24.
    Leino-Kilpi H, Välimäki M, Dassen T, et al. Privacy: a review of the literature. Int J Nurs Stud. 2001;38:663–71.CrossRefGoogle Scholar
  25. 25.
    Kaye J. The tension between data sharing and the protection of privacy in genomics research. Annu Rev Genomics Hum Genet. 2012;13:415–31.CrossRefPubMedPubMedCentralGoogle Scholar
  26. 26.
    Elliot M, Mackey E, O’Hara K, et al. The Anonymisation decision-making framework. Manchester: UKAN; 2016. Accessed 24 Apr 2018.Google Scholar
  27. 27.
    Nurmi S-M, Kangasniemi M, Halkoaho A, et al. Privacy of clinical research subjects: an integrative literature review. J Empir Res Hum Res Ethics. 2019;14:33–48.CrossRefGoogle Scholar
  28. 28.
    Ministry of Education and Culture. Open science and research leads to surprising discoveries and creative insights. 2014. Accessed 3 Dec 2017.
  29. 29.
    Rumbold JMM, Pierscionek BK. A critique of the regulation of data science in healthcare research in the European Union. BMC Med Ethics. 2017;18(1):27. Scholar
  30. 30.
    The European Parliamanet and European Council. General Data Protection Regulation. 2016. Accessed 3 Dec 2017.
  31. 31.
  32. 32.
    Decker SE, Naugle AE, Carter-Visscher R, et al. Ethical issues in research on sensitive topics: participants’ experiences of distress and benefit. J Empir Res Hum Res Ethics. 2011;6:55–64.CrossRefGoogle Scholar
  33. 33.
    Tilburt J, Ford JG, Howerton MW, et al. Applying justice in clinical trials for diverse populations. Clin Trials. 2007;4:264–9.CrossRefGoogle Scholar
  34. 34.
    Rogers J, Kelly UA. Feminist intersectionality: bringing social justice to health disparities research. Nurs Ethics. 2011;18:397–407.CrossRefGoogle Scholar
  35. 35.
    Rawls J. A theory of justice. Cambridge: Harvard University Press; 1971.Google Scholar
  36. 36.
    Shaw D, Satalkar P. Researchers’ interpretations of research integrity: a qualitative study. Account Res. 2018;25:79–93.CrossRefGoogle Scholar
  37. 37.
    Nurmi S-M, Halkoaho A, Kangasniemi M, et al. Collaborative partnership and the social value of clinical research: a qualitative secondary analysis. BMC Med Ethics. 2017;18:57. Scholar
  38. 38.
    Nurmi S-M, Pietilä A-M, Kangasniemi M, et al. Nurse leaders’ perceptions of the ethical recruitment of study subjects in clinical research. J Nurs Manag. 2015;23:1020–8.CrossRefPubMedPubMedCentralGoogle Scholar
  39. 39.
    Resnik DB. The ethics of science: an introduction. London: Routledge; 2005. Scholar
  40. 40.
    Resnik DB. Scientific research and the public trust. Sci Eng Ethics. 2011;17:399–409.CrossRefGoogle Scholar
  41. 41.
    Emanuel EJ, Wendler D, Killen J, et al. What makes clinical research in developing countries ethical? The benchmarks of ethical research. J Infect Dis. 2004;189:930–7.CrossRefGoogle Scholar
  42. 42.
    Emanuel EJ, Wendler D, Grady C, et al. What makes clinical research ethical? JAMA. 2000;283:2701–11.CrossRefGoogle Scholar
  43. 43.
    Tsoka-Gwegweni JM, Wassenaar DR. Using the Emanuel et al. Framework to assess ethical issues raised by a biomedical research ethics Committee in South Africa. J Empir Res Hum Res Ethics. 2014;9:36–45.CrossRefGoogle Scholar
  44. 44.
    Heaton J. Reworking qualitative data. London: SAGE; 2004.CrossRefGoogle Scholar
  45. 45.
    Heimer CA, Petty J. Bureaucratic ethics: IRBs and the legal regulation of human subjects research. Annu Rev Law Soc Sci. 2010;6:601–26.CrossRefGoogle Scholar
  46. 46.
    Pollock K. Procedure versus process: ethical paradigms and the conduct of qualitative research. BMC Med Ethics. 2012;13:25.CrossRefPubMedPubMedCentralGoogle Scholar
  47. 47.
    Löfström E. Students’ ethical awareness and conceptions of research ethics. Ethics Behav. 2012;22:349–61.CrossRefGoogle Scholar
  48. 48.
    McCormack WT, Garvan CW. Team-based learning instruction for responsible conduct of research positively impacts ethical decision-making. Account Res. 2014;21:34–49.CrossRefPubMedPubMedCentralGoogle Scholar
  49. 49.
    Todd EM, Torrence BS, Watts LL, et al. Effective practices in the delivery of research ethics education: a qualitative review of instructional methods. Account Res. 2017;24:297–321.CrossRefGoogle Scholar
  50. 50.
    Chen DT, Jones L, Gelberg L. Ethics of clinical research within a community-academic partnered participatory framework. Ethn Dis. 2006;16:118–35.Google Scholar
  51. 51.
    Kaiser K. Protecting respondent confidentiality in qualitative research. Qual Health Res. 2009;19:1632–41.CrossRefPubMedPubMedCentralGoogle Scholar
  52. 52.
    Sanjari M, Bahramnezhad F, Fomani FK, et al. Ethical challenges of researchers in qualitative studies: the necessity to develop a specific guideline. J Med Ethics Hist Med. 2014;7:14.PubMedPubMedCentralGoogle Scholar
  53. 53.
    Saunders B, Kitzinger J, Kitzinger C. Anonymising interview data: challenges and compromise in practice. Qual Res. 2015;15:616–32.CrossRefPubMedPubMedCentralGoogle Scholar
  54. 54.
    Burles MC, Bally JMG. Ethical, practical, and methodological considerations for unobtrusive qualitative research about personal narratives shared on the internet. Int J Qual Methods. 2018;17:160940691878820.CrossRefGoogle Scholar
  55. 55.
    Anuradha RB. Securing privacy for confidential databases using anonymization. Middle-East J Sci Res. 2012;12:1792–5.Google Scholar
  56. 56.
    Coppieters Y, Levêque A. Ethics, privacy and the legal framework governing medical data: opportunities or threats for biomedical and public health research? Arch Public Heal. 2013;71:1–4.CrossRefGoogle Scholar
  57. 57.
    De Lusignan S, Liyanage H, Di Iorio CT, et al. Using routinely collected health data for surveillance, quality improvement and research: framework and key questions to assess ethics, privacy and data access. J Innov Health Inform. 2016;22:426–32.CrossRefGoogle Scholar
  58. 58.
    Porsdam Mann S, Savulescu J, Sahakian BJ. Facilitating the ethical use of health data for the benefit of society: electronic health records, consent and the duty of easy rescue. Philos Trans R Soc A Math Phys Eng Sci. 2016;374:1–17.CrossRefGoogle Scholar
  59. 59.
    Frizzo-Barker J, Chow-White PA, Charters A, et al. Genomic big data and privacy: challenges and opportunities for precision medicine. Comput Support Coop Work. 2016;25:115–36.CrossRefGoogle Scholar
  60. 60.
    Tucker K, Branson J, Dilleen M, et al. Protecting patient privacy when sharing patient-level data from clinical trials. BMC Med Res Methodol. 2016;16:1–10.CrossRefGoogle Scholar
  61. 61.
    Rho MJ, Jang KS, Chung K-Y, et al. Comparison of knowledge, attitudes, and trust for the use of personal health information in clinical research. Multimed Tools Appl. 2015;74:2391–404.CrossRefGoogle Scholar
  62. 62.
    Grande D, Asch DA, Wan F, et al. Are patients with cancer less willing to share their health information? Privacy, sensitivity, and social purpose. J Oncol Pract. 2015;11:378–83.CrossRefPubMedPubMedCentralGoogle Scholar
  63. 63.
    Aitken M, de St Jorre J, Pagliari C, et al. Public responses to the sharing and linkage of health data for research purposes: a systematic review and thematic synthesis of qualitative studies. BMC Med Ethics. 2016;17(1):73. Scholar
  64. 64.
    Riordan F, Papoutsi C, Reed JE, et al. Patient and public attitudes towards informed consent models and levels of awareness of electronic health records in the UK. Int J Med Inform. 2015;84:237–47.CrossRefPubMedPubMedCentralGoogle Scholar
  65. 65.
    Mulligan DK, Koopman C, Doty N. Privacy is an essentially contested concept: a multi-dimensional analytic for mapping privacy. Philos Trans A Math Phys Eng Sci. 2016;374(2083):20160118. Scholar

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Anna-Maija Pietilä
    • 1
    Email author
  • Sanna-Maria Nurmi
    • 1
  • Arja Halkoaho
    • 1
    • 2
  • Helvi Kyngäs
    • 3
  1. 1.University of Eastern FinlandKuopioFinland
  2. 2.Tampere University of Applied SciencesTampereFinland
  3. 3.Research Unit of Nursing Science and Health Management, Oulu UniversityOuluFinland

Personalised recommendations