Cultural aspects related to informed consent in health research: A systematic review

Nursing Ethics

Volumn 23, Issue 6, 2016, Pages 698-712

  Halkoaho, Arja ^a   Pietilä, Anna Maija ^b   Ebbesen, Mette ^c   Karki, Suyen ^b   Kangasniemi, Mari ^b  

^a KUOPIO UNIVERSITY HOSPITAL   (Finland)

^b UNIVERSITY OF EASTERN FINLAND   (Finland)

^c AARHUS UNIVERSITY   (Denmark)

Author keywords

Autonomy; cultural; informed consent; research ethics; systematic review

Indexed keywords

AWARENESS; CINAHL; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; MEDLINE; RESEARCH ETHICS; SCOPUS; SYSTEMATIC REVIEW; CULTURAL COMPETENCE; CULTURAL DIVERSITY; CULTURAL FACTOR; ETHICS; METHODOLOGY; PATIENT SELECTION; QUALITATIVE RESEARCH;

BIOMEDICAL RESEARCH; CROSS-CULTURAL COMPARISON; CULTURAL CHARACTERISTICS; CULTURAL COMPETENCY; CULTURAL DIVERSITY; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; PATIENT SELECTION; QUALITATIVE RESEARCH; RESEARCH DESIGN;

EID: 84987746826     PISSN: 09697330     EISSN: 14770989     Source Type: Journal    
DOI: 10.1177/0969733015579312     Document Type: Review

References (65)

1. WMA. WMA Declaration of Helsinki—ethical principles for medical research involving human subjects, http://www.wma.net/en/30publications/10policies/b3/ (2013, accessed 20 March 2014).
2. Veerus P, Lexchin J, Hemminki E. Legislative regulation and ethical governance of medical research in different European Union countries. J Med Ethics 2014; 40: 409–413.
3. Haugen HM. Inclusive and relevant language: the use of the concepts of autonomy, dignity and vulnerability in different contexts. Med Health Care Philos 2010; 13: 203–213.
4. Jordan MC. Bioethics and “human dignity.” J Med Philos 2010; 35: 180–196.
5. Beauchamp TL, Childress JF., Principles of biomedical ethics. 7th ed. Oxford University Press, New York, USA, 2013.
6. Rendtorff J, Kemp P., Basic ethical principles in European bioethics and biolaw: autonomy, dignity, integrity and vulnerability. Centre for Ethics and Law, Copenhagen, Denmark, 2000.
7. Andrews MM, Boyle JS. Transcultural concepts in nursing care. 2nd ed. Philadelphia, PA: J. B. Lippincott Company, 1995.
8. Leininger MM. Transcultural nursing. Concepts, theories, research and practices. 2nd ed. New York: McGraw-Hill, 1995.
9. Bhutta ZA. Ethics in international health research: a perspective from the developing world. Bull World Health Organ 2002; 80: 114–120.
10. Olsen DP, Wang H, Pang S. Informed consent practices of Chinese nurse researchers. Nurs Ethics 2010; 17: 179–187.
11. Mandava A, Pace C, Campbell B. The quality of informed consent: mapping the landscape. A review of empirical data from developing and developed countries. J Med Ethics 2012; 38: 356–365.
12. Glickman SW, Ndubuizu A, Weinfurt KP. Perspective: the case for research justice: inclusion of patients with limited English proficiency in clinical research. Acad Med 2011; 86: 389–393.
13. Penn C, Evans M. Recommendations for communication to enhance informed consent and enrolment at multilingual research sites. Afr J AIDS Res 2009; 8: 285–294.
14. Penn C, Evans M. Assessing the impact of a modified informed consent process in a South African HIV/AIDS research trial. Patient Educ Couns 2010; 80: 191–199.
15. Watermeyer J, Penn C. “They take positive people”: an investigation of communication in the IC process of an HIV/AIDS vaccine trial in South Africa. Crit Inq Lang Stud 2008; 5: 81–208.
16. Essack Z, Koen J, Slack C. Civil society perspectives on negative biomedical HIV prevention trial results and implications for future trials. AIDS Care 2012; 24: 1249–1254.
17. Lindegger G, Richter LM. HIV vaccine trials: critical issues in informed consent. S Afr J Sci 2000; 96: 313–317.
18. Moodley K, Pather M, Myer L. Informed consent and participant perceptions of influenza vaccine trials in South Africa. J Med Ethics 2005; 31: 727–732.
19. Sarojini N, Anjali S, Ashalata S. Findings from a visit to Bhadrachalam: HPV vaccine demonstration project site in Andhra Pradesh. Report, Sama—Resource Group for Women and Health, New Delhi, India, 3 2010.
20. Slack C, Lindegger G, Vardas E. Ethical issues in HIV vaccine trials in South Africa. S Afr J Sci 2000; 96: 291–295.
21. World Health Organization (WHO). Standards and operational guidance for ethics review of health-related research with human participants, http://whqlibdoc.who.int/publications/2011/9789241502948_eng.pdf (2011, accessed 26 March 2015).
22. UNESCO. Report of the International Bioethics Committee of UNESCO (IBC) on consent, http://unesdoc.unesco.org/images/0017/001781/178124e.pdf (2008, accessed 26 March 2015).
23. Newton SK, Appiah-Poku J. The perspectives of researchers on obtaining informed consent in developing countries. Dev World Bioeth 2007; 7: 19–24.
24. Beauchamp TL. Informed consent: its history, meaning, and present challenges. Camb Q Healthc Ethics 2011; 20: 515–523.
25. Dickersin K, Scherer R, Lefebvre C. Identifying relevant studies for systematic reviews. BMJ 1994; 309: 1286–1291.
26. Chen H, Kramer EJ, Chen T. Engaging Asian Americans for mental health research: challenges and solutions. J Immigr Health 2005; 7: 109–116.
27. Dein S, Bhui K. Issues concerning informed consent for medical research among non-westernized ethnic minority patients in the UK. J R Soc Med 2005; 98: 354–356.
28. Hamilton LA, Aliyu MH, Lyons PD. African-American community attitudes and perceptions toward schizophrenia and medical research: an exploratory study. J Natl Med Assoc 2006; 98: 18–27.
29. Herring P, Montgomery S, Yancey AK. Understanding the challenges in recruiting blacks to a longitudinal cohort study: the Adventist health study. Ethn Dis 2004; 14: 423–430.
30. Karwalajtys TL, Redwood-Campbell LJ, Fowler NC. Conducting qualitative research on cervical cancer screening among diverse groups of immigrant women: research reflections: challenges and solutions. Can Fam Physician 2010; 56: e130–e135.
31. Kerkorian D, Traube DE, McKay MM. Understanding the African American research experience (KAARE): implications for HIV prevention. Soc Work Ment Health 2007; 5: 295–312.
32. Lillington L, Johnson I, Chlebowski R. African-American women’s perspectives on research participation. MED AM 2000; 1: 20–25.
33. Yick AG. Role of culture and context: ethical issues in research with Asian Americans and immigrants in intimate violence. J Fam Violence 2007; 22: 277–285.
34. Krosin MT, Klitzman R, Levin B. Problems in comprehension of informed consent in rural and peri-urban Mali, West Africa. Clin Trials 2006; 3: 306–313.
35. Macklin R. Informed consent for research: international perspectives. J Am Med Womens Assoc 2000; 55: 290–293.
36. Mfutso-Bengo J, Masiye F, Molyneux M. Why do people refuse to take part in biomedical research studies? Evidence from a resource-poor area. Malawi Med J 2008; 20: 57–63.
37. Upvall M, Hashwani S. Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan. Int Nurs Rev 2001; 48: 188–192.
38. Marshall PA, Adebamowo CA, Adeyemo AA. Voluntary participation and informed consent international genetic research. Am J Public Health 2006; 96: 1989–1995.
39. Crigger NJ, Holcomb L, Weiss J. Fundamentalism, multiculturalism and problems of conducting research with populations in developing nations. Nurs Ethics 2001; 8: 459–468.
40. Pletsch PK, Doerr B, Irwin D. Focus group interviews: a method for creating partnerships with African-American women in the design of research informed consent. J Natl Black Nurses Assoc 2001; 12: 42–47.
41. Phipps E, Harris D, Brown N. Investigation of ethnic differences in willingness to enroll in a rehabilitation research registry: a study of the Northeast Cognitive Rehabilitation Research Network. Am J Phys Med Rehabil 2004; 83: 875–883.
42. McCabe M, Morgan F, Curley H. The informed consent process in a cross-cultural setting: is the process achieving the intended result? Ethn Dis 2005; 15: 300–304.
43. Barata PC, Gucciardi E, Ahmad F. Cross-cultural perspectives on research participation and informed consent. Soc Sci Med 2006; 62: 479–490.
44. Calderón JL, Baker RS, Fabrega H. An ethno-medical perspective on research participation: a qualitative pilot study. MedGenMed 2006; 8: 23.
45. Campbell CL. Respect for persons. J Hosp Palliat Nurs 2007; 9: 74–78.
46. Rivera R, Borasky D, Rice R. Informed consent: an international researchers’ perspective. Am J Public Health 2007; 97: 25–30.
47. Shaibu S. Ethical and cultural considerations in informed consent in Botswana. Nurs Ethics 2007; 14: 503–509.
48. Calamaro CJ. Culture competence in research: research design and subject recruitment. J Pediatr Health Care 2008; 22: 329–332.
49. Lloyd CE, Johnson MRD, Mughal S. Securing recruitment and obtaining informed consent in minority ethnic groups in the UK. BMC Health Serv Res 2008; 8: 68.
50. Ojeda L, Flores LY, Meza R. Culturally competent qualitative research with Latino immigrants. Hispanic J Behav Sci 2011; 33: 184–203.
51. Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects, http://www.cioms.ch/index.php/printable-publications?task=view&id=48&catid=57 (2002, accessed 26 March 2015).
52. Medical Research Act. Medical research Act No. 488/1999, http://www.finlex.fi/fi/laki/kaannokset/1999/en19990488.pdf (2014, accessed 15 April 2014).
53. Ndebele P. The Declaration of Helsinki, 50 years later. JAMA 2013; 310: 2145–2146.
54. Taljaard M, Weijer C, Grimshaw JM. The Ottawa Statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. BMJ 2013; 346: f2838.
55. Prainsack B, Buyx A. A solidarity-based approach to the governance of research biobanks. Med Law Rev 2013; 21: 71–91.
56. European Commission. Structural change in research institutions: enhancing excellence, gender equality and efficiency in research and innovation, http://ec.europa.eu/research/science-society/document_library/pdf_06/structural-changes-final-report_en.pdf (2012, accessed 26 March 2015).
57. Vallely A, Lees S, Shagi C. How informed is consent in vulnerable populations? Experience using a continuous consent process during the MDP301 vaginal microbicide trial in Mwanza, Tanzania. BMC Med Ethics 2010; 11: 10.
58. Verastegui EL. Consenting of the vulnerable: the informed consent procedure in advanced cancer patients in Mexico. BMC Med Ethics 2006; 7: e13.
59. Rid A, Emanuel EJ, Wendler D. Evaluating the risks of clinical research. JAMA 2010; 304: 1472–1479.
60. Wendler D. How to enroll participants in research ethically. JAMA 2011; 305: 1587–1588.
61. Benatar SR. Reflections and recommendations on research ethics in developing countries. Soc Sci Med 2002; 54: 1131–1141.
62. Pang T. Commentary on “reflections and recommendations on research ethics in developing countries” by S.R. Benatar. Soc Sci Med 2002; 54: 1145–1148.
63. Doumbo OK. Global voices of science. It takes a village: medical research and ethics in Mali. Science 2005; 307: 679–681.
64. Guerrier G, Sicard D, Bray PT. Informed consent: cultural differences. Nature 2012; 483: 36.
65. Whittemore R, Knafl K. The integrative review: updated methodology. J Adv Nurs 2005; 52: 546–553.