- Introduction
- Factors that Differ Between Developing and Developed Countries
- Decision-Making from the Perspective of Informed Consent
- Provision of Relevant Information to Potential Participants
- Incentives for Participation and Access to Care
- Complex Issues
- IRB Expertise and Challenges
- Potential Conflicts of Interest in Research and During IRB Review
- Conclusions and Summary
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
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.
-
10.
Sanchez S, Salazar G, Tijero M, Diaz S, 2001. Informed consent procedures: responsibilities of researchers in developing countries. Bioethics 15: 398–412.
-
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.
-
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.
-
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.
-
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 south-east Nigeria. Health Policy Plan 17: 378–383.
-
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.
-
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.
-
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.
-
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.
-
26.
Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW, 2002. Comprehension during informed consent in a less-developed country. Lancet 360: 1301–1302.
-
27.
Angell M, 2000. Investigators' responsibilities for human subjects in developing countries. N Engl J Med 342: 967–969.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1245 | 1012 | 100 |
| Full Text Views | 812 | 23 | 1 |
| PDF Downloads | 435 | 22 | 1 |
Informed Consent in International Research: The Rationale for Different Approaches
Donald J. Krogstad
Donald J. Krogstad
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Samba Diop
Samba Diop
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Amadou Diallo
Amadou Diallo
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Fawaz Mzayek
Fawaz Mzayek
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Joseph Keating
Joseph Keating
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Ousmane A. Koita
Ousmane A. Koita
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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Yéya T. Touré
Yéya T. Touré
Department of Tropical Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of International Health and Development, Tulane University Health Sciences Center, New Orleans, Louisiana; Department of Medicine, Tulane University Health Sciences Center, New Orleans, Louisiana; The Center for Infectious Diseases, Tulane University Health Sciences Center, New Orleans, Louisiana; The Malaria Research and Training Center, University of Bamako, Bamako, Mali; Faculties of Medicine, Pharmacy, Dentistry, and Science, University of Bamako, Bamako, Mali
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In developed countries, informed consent is based on the autonomy of the individual, a written description of the studies proposed, and previous experience of the participant with Western medicine. Consent is documented by the signature of the participant and supervised by institutional review boards (IRBs), which have conflicts of interest because they are also responsible for limiting institutional liability. In developing countries, the initial decision-making for informed consent is typically vested in the community rather than the individual, and illiteracy is common—limiting the value of written documents and signatures. The challenges in developing countries are exacerbated by the fact that persons at greatest risk of disease are often illiterate, have limited experience with Western medicine, and have limited understanding of the scientific rationale for the studies proposed. Given these differences, it is unrealistic to expect that consent strategies used in developed countries would be effective in such diverse settings.
Author Notes
Financial support: These studies were supported by grants from the National Institute of Allergy and Infectious Diseases (NIAID; Grants AI-074058 and AI 21536), Cooperative Agreement P50 AI 34969 from NIAID to the Mali-Tulane Tropical Medicine Research Center, grants from the United Nations Development Programme (UNDP)/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR; 94-0622 and 92-0751), and a New Initiatives in Malaria Research Award to D.J.K. from the Burroughs–Wellcome Fund.
Authors' addresses: Donald J. Krogstad, Department of Tropical Medicine and Center for Infectious Diseases, Tulane University, New Orleans, LA, E-mail: krogstad@tulane.edu. Samba Diop and Ousmane A. Koita, Department of Public Health, Faculties of Medicine, Pharmacy, and Dentistry, University of Bamako, Bamako, Mali, E-mails: saibd@icermali.org and okoita@icermali.org. Amadou Diallo, University of Bamako, Bamako, Mali, E-mail: amaddia2003@yahoo.fr. Fawaz Mzayek, Department of Epidemiology, University of Memphis, Memphis, TN, E-mail: fmzayek@memphis.edu. Joseph Keating, Department of International Health and Development, Tulane University, New Orleans, LA, E-mail: jkeating@tulane.edu. Yéya T. Touré, Faculty of Medicine, Pharmacy and Dentistry, University of Bamako, Bamako, Mali, E-mail: tourey@who.int.
- Introduction
- Factors that Differ Between Developing and Developed Countries
- Decision-Making from the Perspective of Informed Consent
- Provision of Relevant Information to Potential Participants
- Incentives for Participation and Access to Care
- Complex Issues
- IRB Expertise and Challenges
- Potential Conflicts of Interest in Research and During IRB Review
- Conclusions and Summary
ProCite
RefWorks
Reference Manager
BibTeX
Zotero
EndNote
-
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.
-
10.
Sanchez S, Salazar G, Tijero M, Diaz S, 2001. Informed consent procedures: responsibilities of researchers in developing countries. Bioethics 15: 398–412.
-
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.
-
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.
-
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.
-
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 south-east Nigeria. Health Policy Plan 17: 378–383.
-
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.
-
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.
-
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.
-
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.
-
26.
Fitzgerald DW, Marotte C, Verdier RI, Johnson WD Jr, Pape JW, 2002. Comprehension during informed consent in a less-developed country. Lancet 360: 1301–1302.
-
27.
Angell M, 2000. Investigators' responsibilities for human subjects in developing countries. N Engl J Med 342: 967–969.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
-
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.
| Past two years | Past Year | Past 30 Days | |
|---|---|---|---|
| Abstract Views | 1245 | 1012 | 100 |
| Full Text Views | 812 | 23 | 1 |
| PDF Downloads | 435 | 22 | 1 |