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Public Health Ethics Advance Access originally published online on January 28, 2009
Public Health Ethics 2009 2(1):37-44; doi:10.1093/phe/phn040
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© The Author 2009. Published by Oxford University Press. Available online at www.phe.oxfordjournals.org

Comprehension and Recall of Informed Consent among Participating Families in a Birth Cohort Study on Diarrhoeal Disease

Rajiv Sarkar

Christian Medical College, Vellore, India

Edward Wilson Grandin

Tufts University

Beryl Primrose Gladstone

Christian Medical College, Vellore, India

Jayaprakash Muliyil

Christian Medical College, Vellore, India

Gagandeep Kang*

Christian Medical College, Vellore, India

* Corresponding author: Department of Gastrointestinal Sciences, Christian Medical College, Vellore 632 004, Tamil Nadu, India. Tel.: +91 416 228 2052; Fax: +91 416 223 2035; Email: gkang{at}cmcvellore.ac.in


  Abstract

Comprehension and recall of informed consent was assessed after the study closure in the parents/guardians of a birth cohort of children participating in an intensive three-year diarrhoeal surveillance. A structured questionnaire was administered by field workers who had not participated in the study's follow-up protocol. Of 368 respondents, 329 (89.4 per cent) stated that the study was adequately explained during enrolment, but only 159 (43.2 per cent) could recall that it was on diarrhoea. Nearly half (45.9 per cent) of the respondents stated that they would not have participated if free medical treatment was not provided, although the free medical clinic was not offered at enrolment. Spousal approval (82.9 per cent) was the most important factor in the decision to participate. In the multivariate analysis, maternal education was associated with increased awareness about the disease under study: mothers without any formal education had the lowest awareness (OR = 3.47, 95 per cent CI = 1.60–7.51). Despite a high compliance with the study protocol, retention of understanding about the research study was low over a long period of time. Although the local government provides free healthcare in the study area, respondents cited free healthcare as an important reason for participation, highlighting the need for true health equity before meaningful informed consent can be obtained.


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