Correspondence

Obtaining Informed Consent in Bangladesh

N Engl J Med 2001; 344:460-461February 8, 2001

Article

To the Editor:

Informed consent is essential for research involving human subjects. However, little is known about whether researchers manage to communicate to potential study participants the required information as outlined in the Helsinki Declaration.1 The potential participants in a developing country may be illiterate and may have limited experience with medical care and research. The researchers' communication skills are particularly important in such situations.2 Only a few empirical studies have addressed this issue.3

We studied informed consent among pregnant women participating in a community-based study of iron supplementation. The study was conducted in rural Bangladesh in 1998 and involved 105 women. Informed consent was obtained after the study had been explained in detail to the women during their first visit to an antenatal care center. Field assistants unaffiliated with the study of iron supplementation collected the data regarding informed consent, using a structured questionnaire. About two thirds of the study women were illiterate, and three fourths were from households with insufficient land for subsistence farming.

The information we elicited on the adequacy of informed consent varied. Although most women were informed about the objectives of the study, many of them did not understand that they were free to decline to participate (Table 1Table 1Rates of Positive Responses to Questions Related to the Comprehensibility and Adequacy of Information Given to 105 Potential Study Participants in Bangladesh.). Even fewer women understood that they might choose to leave the study. About half believed that participation was part of ordinary, routine health care. Eighty-seven percent indicated that they participated because they believed that doing so might carry such great advantages, primarily in terms of medical treatment for themselves or improved health for their babies, that it was difficult to say no.

These results are discouraging. The problem is not limited to developing countries, however; there have been similar experiences in Sweden, for example. Of 42 Swedish women participating in a gynecologic clinical trial, 17 did not know that they were free to withdraw from participation, and 4 women got the impression that a surgical diagnostic procedure, performed only for the purposes of research, was part of routine care.4 But in settings with limited health care facilities, the reality may be that participation in medical research offers an opportunity to have access to services that are not otherwise readily available. The vulnerability of potential research subjects demands that researchers take seriously their responsibility to ensure the rights of the participants.

Niels Lynöe, M.D., Ph.D.
Ziauddin Hyder, M.B., B.S.
Umeå University, 901 87 Umeå, Sweden

Mustaque Chowdhury, Ph.D.
Bangladesh Rural Advancement Committee, 1212 Dhaka, Bangladesh

Lotta Ekström, Ph.D.
Umeå University, 901 87 Umeå, Sweden

4 References

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Citing Articles (13)

Citing Articles

1. 1

   A. Arora, S. Rajagopalan, N. Shafiq, P. Pandhi, A. Bhalla, D.P. Dhibar, S. Malhotra. (2011) Development of tool for the assessment of comprehension of informed consent form in healthy volunteers participating in first-in-human studies. Contemporary Clinical Trials 32:6, 814-817
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2. 2

   Aisha Y. Malik. (2011) Physician-Researchers’ Experiences of the Consent Process in the Sociocultural Context of a Developing Country. AJOB Primary Research 2:3, 38-46
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3. 3

   , Amy L. Corneli, James R. Sorenson, Margaret E. Bentley, Gail E. Henderson, J. Michael Bowling, Jacqueline Nkhoma, Agnes Moses, Cynthia Zulu, James Chilima, Yusuf Ahmed, Charles M. Heilig, Denise J. Jamieson, Charles Horst. (2011) Improving Participant Understanding of Informed Consent in an HIV-Prevention Clinical Trial: A Comparison of Methods. AIDS and Behavior
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   Niveditha Devasenapathy, Kavita Singh, Dorairaj Prabhakaran. (2009) Conduct of clinical trials in developing countries: a perspective. Current Opinion in Cardiology 24:4, 295-300
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   Amy L. Corneli, Margaret E. Bentley, James R. Sorenson, Gail E. Henderson, Charles van der Horst, Agnes Moses, Jacqueline Nkhoma, Lyson Tenthani, Yusuf Ahmed, Charles M. Heilig, Denise J. Jamieson. (2006) Using Formative Research to Develop A Context-Specific Approach to Informed Consent for Clinical Trials. Journal of Empirical Research on Human Research Ethics 1:4, 45-60
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   P. A. Marshall, C. A. Adebamowo, A. A. Adeyemo, T. O. Ogundiran, M. Vekich, T. Strenski, J. Zhou, T. E. Prewitt, R. S. Cooper, C. N. Rotimi. (2006) Voluntary Participation and Informed Consent to International Genetic Research. American Journal of Public Health 96:11, 1989-1995
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   EDITH VALDEZ-MARTINEZ, BERNARDO TURNBULL, JUAN GARDUNO-ESPINOSA, JOHN D.H. PORTER. (2006) DESCRIPTIVE ETHICS: A QUALITATIVE STUDY OF LOCAL RESEARCH ETHICS COMMITTEES IN MEXICO. Developing World Bioethics 6:2, 95-105
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8. 8

   Patricia A. Marshall. (2006) Informed Consent in International Health Research. Journal of Empirical Research on Human Research Ethics 1:1, 25-42
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   C. Pace, A. Talisuna, D. Wendler, F. Maiso, F. Wabwire-Mangen, N. Bakyaita, E. Okiria, E. S. Garrett-Mayer, E. Emanuel, C. Grady. (2005) Quality of Parental Consent in a Ugandan Malaria Study. American Journal of Public Health 95:7, 1184-1189
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    C.S. Molyneux, N. Peshu, K. Marsh. (2004) Understanding of informed consent in a low-income setting: three case studies from the Kenyan coast. Social Science & Medicine 59:12, 2547-2559
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11. 11

    Koumavi Didier Ekouevi, Renaud Becquet, Ida Viho, Laurence Bequet, Fran??ois Dabis, Val??riane Leroy. (2004) Obtaining informed consent from HIV-infected pregnant women, Abidjan, C??te d'Ivoire. AIDS 18:10, 1486-1488
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    Wendy K. Mariner. (2003) Taking Informed Consent Seriously in Global HIV Vaccine Research. JAIDS Journal of Acquired Immune Deficiency Syndromes 32:2, 117-123
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13. 13

    Daniel W Fitzgerald, Cecile Marotte, Rose Irene Verdier, Warren D Johnson, Jean William Pape. (2002) Comprehension during informed consent in a less-developed country. The Lancet 360:9342, 1301-1302
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