Oduro AR, Aborigo RA, Amugsi D, Anto F, Anyorigiya T, Atuguba F, Hodgson A, Koram KA Understanding and Retention of informed consent process among Parents in a Rural Northern Ghana. [JOURNAL ARTICLE] BMC Med Ethics 2008 Jun 19; 9(1):12.
ABSTRACT: INTRODUCTION: The individual informed consent model remains critical to the ethical conduct and regulation of research involving human beings especially in less endowed areas. Parental informed consent process in a rural setting of Ghana was studied to describe comprehension and retention among parents as part of the evaluation of the existing informed consent practices. METHODS: The study involved 270 female parents who gave witnessed informed consent for their children to participate in a prospective cohort study from June 2005 to May 2006 that evaluated immune correlates of protection against childhood malaria in northern Ghana. A semi-structured questionnaire with questions based on the main themes of the individual model informed consent form was used in the evaluation. Parents whose children participated in the original cohort study were interviewed to determine their comprehension and retention of the process and elicited ways on how to improve upon the existing informed consent practices in the area. RESULTS: Baseline characteristics were; average parenatal age 33.3 years (range 18-62), married women (91.9%), christians (71.9%), farmers (62.2%) and no formal education (53.7%). Only 3% of respondents had ever taken part in a research compared with about 54% who had at least one relation ever take part in a research as a participant. The results showed that over 90% of parents interviewed knew their children were involved in a research work that was not related to medical care. About 66% said the study procedures were explained thoroughly to them. Approximately, 70% recalled the study involved direct benefits compared with 20% for direct study risks. Though about 95% (259/270) understood study participation was completely voluntary, only 21% (57/270) recalled they could withdraw from the study without giving reasons. Reasons given by parents for allowing their children to take part in the research were free medical care (36.5%), better medical care (18.8%), general benefits (29.4%), contribution to the research work in the area (8.8%) and benefit to the local community (1.8%). Parental suggestions for improving the inform consent procedure included; devoting more time for explanations (46.9%), use of the local languages (15.9%) and obtaining consent at homes (10.3%). CONCLUSION: Significant but varied comprehension of the informed consent process exists among parents who participate in research activities in northern Ghana and it appears the existing practices are fairly effective in informing research participants in the study area.
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