Informed consent in international research: The rationale for different approaches

American Journal of Tropical Medicine and Hygiene

Volumn 83, Issue 4, 2010, Pages 743-747

  Krogstad, Donald J ^a   Diop, Samba ^b   Diallo, Amadou ^b   Mzayek, Fawaz ^c   Keating, Joseph ^a   Koita, Ousmane A ^b   Touré, Yéya T ^d  

^a TULANE UNIVERSITY   (United States)

^b UNIVERSITY OF BAMAKO   (Mali)

^c UNIVERSITY OF MEMPHIS   (United States)

^d UNIVERSITY OF BAMAKO   (Mali)

Author keywords

[No Author keywords available]

Indexed keywords

AMERICAN INDIAN; BIOINFORMATICS; COMMUNITY; DECISION MAKING; DEVELOPED COUNTRY; DEVELOPING COUNTRY; DOCUMENTATION; ESKIMO; ETHICS; EXPERIENCE; GENOMICS; HEALTH CARE UTILIZATION; HOUSEHOLD; HUMAN; INFORMED CONSENT; INSTITUTIONAL REVIEW; JUVENILE; MARRIAGE; MEDICAL CARE; MOLECULAR BIOLOGY; OCCUPATION; PARENT; PERSONAL AUTONOMY; PERSONNEL MANAGEMENT; POPULATION; PROFESSIONAL SECRECY; PUBLICATION; RANDOMIZATION; READING; REFUSAL TO PARTICIPATE; RESEARCH; RESOURCE ALLOCATION; REVIEW; TRAFFIC AND TRANSPORT; TRANSPLANTATION; ARTICLE; CONFLICT OF INTEREST; CULTURAL ANTHROPOLOGY; FEMALE; INFORMATION PROCESSING; INTERNATIONAL COOPERATION; LANGUAGE; MALE; PROFESSIONAL STANDARD; RESEARCH ETHICS;

CONFLICT OF INTEREST; CULTURE; DECISION MAKING; DEVELOPED COUNTRIES; DEVELOPING COUNTRIES; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; FEMALE; FOCUS GROUPS; HUMANS; INFORMED CONSENT; INTERNATIONAL COOPERATION; LANGUAGE; MALE;

EID: 79958028262     PISSN: 00029637     EISSN: None     Source Type: Journal    
DOI: 10.4269/ajtmh.2010.10-0014     Document Type: Review

References (43)

1. Shalala D, 2000. Protecting research subjects - what must be done. N Engl J Med 343: 808-810.
2. Spicer CM, 2000. Federal oversight and regulation of human subjects research - an update. Kennedy Inst Ethics J 10: 261-264.
3. Anonymous, 1998. Protection of human research subjects - HHS: notice of proposed rulemaking. Fed Regist 63: 27794-27804.
4. Faden RR, Beauchamp TL, eds., 1986. A History and Theory of Informed Consent. New York, NY : Oxford University Press, 3-330.
5. Tangwa GB, 2000. Moral agency, moral worth and the question of double standards in medical research in developing countries. Dev World Bioeth 1: 156-162.
6. Tangwa GB, 2000. The traditional African perception of a person: some implications for bioethics. Hastings Cent Rep 30: 39-43.
7. Barrett RJ, Parker DB, 2003. Rites of consent: negotiating research participation in diverse cultures. Monash Bioeth Rev 22: 9-26.
8. Benatar SF, 2002. Reflections and recommendations on research ethics in developing countries. Soc Sci Med 54: 1131-1141.
9. Bhutta ZA, 2002. Ethics in international health research: a perspective from the developing world. Bull World Health Organ 80: 114-120. (Pubitemid 34207740)
10. Sanchez S, Salazar G, Tijero M, Diaz S, 2001. Informed consent procedures: responsibilities of researchers in developing countries. Bioethics 15: 398-412. (Pubitemid 33019862)
11. Enwonwu CO, Falkler WA Jr, Idigbe EO, Afolabi BM, Ibrahim M, Onwujekwe D, Savage O, Meeks VI, 1999. Pathogenesis of cancrum oris (noma): confounding interactions of malnutrition with infection. Am J Trop Med Hyg 60: 223-232. (Pubitemid 29107106)
12. Lavery JV, Grady C, Wahl ER, Emanuel EJ, 2007. Ethical Issues in International Biomedical Research. New York, NY: Oxford University Press, 263-294.
13. Haworth L, 1986. The concept of autonomy. Haworth L, ed. Autonomy: An Essay in Philosophical Psychology and Ethics. New Haven, CT: Yale University Press, 1-46.
14. Dworkin G, 1988. The Theory and Practice of Autonomy. Cambridge, UK : Cambridge University Press, 3-120.
15. Dalla-Vorgia P, Lascaratos J, Skiadas P, Garanis-Papadatos T, 2001. Is consent in medicine a concept only of modern times? J Med Ethics 27: 59-61.
16. Horner J, 2003. Morality, ethics, and law: introductory concepts. Semin Speech Lang 24: 263-274. (Pubitemid 38028771)
17. Majumdar SK, 1996. Aristotle's ethical theory and modern health care. Bull Indian Inst Hist Med Hyderabad 26: 75-80.
18. Brema TA, 1999. Proposed revisions to the Declaration of Helsinki. N Engl J Med 341: 527-531.
19. Knippenberg R, Alihonou E, Soucat A, Oyegbite K, Calivis M, Hopwood I, Niimi R, Diallo MP, Conde M, Ofosu-Amaah S, 1997. Implementation of the Bamako Initiative: strategies in Benin and Guinea. Int J Health Plann Manage 12 (Suppl 1): S29-S47. (Pubitemid 27326348)
20. Das PK, 1991. Community participation in vector borne disease control: facts and fancies. Ann Soc Belg Med Trop 71 (Suppl 1): 233-242.
21. Uzochukwu BS, Onwujekwe OE, Akpala CO, 2002. Effect of the Bamako Initiative drug-revolving fund on the availability and rational use of essential drugs in primary care facilities in southeast Nigeria. Health Policy Plan 17: 378-383. (Pubitemid 35477381)
22. Soucat A, Gandaho T, Levy-Bruhl D, de Bethune X, Alihonou E, Ortiz C, Gbedonou P, Adovohekpe P, Camara O, Ndiaye JM, Dieng B, Knippenberg R, 1997. Health seeking behaviour and household health expenditures in Benin and Guinea: the equity implications of the Bamako Initiative. Int J Health Plann Manage 12 (Suppl 1): S137-S163. (Pubitemid 27326352)
23. Oguz NY, 2003. Research ethics committees in developing countries and informed consent: with special reference to Turkey. J Lab Clin Med 141: 292-296. (Pubitemid 36578097)
24. Willerson JT, Kereiakes DJ, 2003. Clinical research and future improvement in clinical care: the Health Insurance Portability and Accountability Act (HIPAA) and future difficulties but optimism for the way forward. Circulation 108: 919-920. (Pubitemid 37048217)
25. Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC, 2001. Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst 93: 139-147. (Pubitemid 32111992)
26. Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW, 2002. Comprehension during informed consent in a lessdeveloped country. Lancet 360: 1301-1302. (Pubitemid 35284623)
27. Angell M, 2000. Investigators' responsibilities for human subjects in developing countries. N Engl J Med 342: 967-969. (Pubitemid 30177058)
28. Macfarlane S, Racelis M, Muli-Musiime F, 2000. Public health in developing countries. Lancet 356: 841-846.
29. Truog RD, 1996. Is "informed right of refusal" the same as "informed consent?" J Clin Ethics 7: 87-89. (Pubitemid 126704206)
30. van Bogaert L-J, 2006. Rights and duties to non-consenting patients: informed refusal in the developing world. Dev World Bioeth 6: 13-22.
31. Featherstone K, Donovan JL, 1998. Random allocation or allocation at random: patients' perspectives of participation in a randomised controlled trial. BMJ 317: 1177-1180. (Pubitemid 28488505)
32. Llewellyn-Thomas HA, McGreal MJ, Thiel EC, Fine S, Erlichman C, 1991. Patients' willingness to enter clinical trials: measuring the association with perceived benefit and preference for decision participation. Soc Sci Med 32: 35-42.
33. Taylor KM, Kelner M, 1987. Informed consent: the physicians' perspective. Soc Sci Med 24: 135-143. (Pubitemid 17228442)
34. Macpherson CC, 2001. Ethics committees. Research ethics: beyond the guidelines. Dev World Bioeth 1: 57-68.
35. Arda B, 2000. Evaluation of research ethics committees in Turkey. J Med Ethics 26: 459-461.
36. Sollitto S, Hoffman S, Mehlman M, Lederman RJ, Youngner SJ, Lederman MM, 2003. Intrinsic conflicts of interest in clinical research: a need for disclosure. Kennedy Inst Ethics J 13: 83-91. (Pubitemid 37130488)
37. Morin K, Rakatansky H, Riddick FA Jr, Morse LJ, O'Bannon JM 3rd, Goldrich MS, Ray P, Weiss M, Sade RM, Spillman MA, 2002. Managing conflicts of interest in the conduct of clinical trials. J Am Med Assoc 287: 78-84. (Pubitemid 34251679)
38. LeVine RA, Dexter E, Velasco P, LeVine S, Joshi AR, Stuebing KW, Tapia-Uribe FM, 1994. Maternal literacy and health care in three countries: a preliminary report. Health Transit Rev 4: 186-191.
39. Macklin R, 2000. Informed consent for research: international perspectives. J Am Med Womens Assoc 55: 290-293.
40. Doumbo OK, Krogstad DJ, 1998. Doctoral training of African scientists. Am J Trop Med Hyg 58: 127-132. (Pubitemid 28096214)
41. McPherson CC, 2001. Research ethics: beyond the guidelines. Dev World Bioeth 1: 57-68.
42. Minnies D, Hawkridge T, Hannekom W, Ehrlich R, London L, Hussey G, 2008. Evaluation of the quality of informed consent in a vaccine field trial in a developing country. BMC Med Ethics 9: 15.
43. Krosin MT, Klitzman R, Levin B, Cheng J, Ranney ML, 2006. Problems in comprehension of informed consent in rural and periurban Mali, West Africa. Clin Trials 3: 306-313. (Pubitemid 44098068)