获得签署知情同意并不是一个保证参与者真正理解了提出研究和Crigger et al。(2001)解释说,研究发展中国家的人口可能存在的伦理挑战,因为他们可能没有足够的知识研究意义,甚至当他们这样做,很多没有人会注意到。
Obtaining a signed informed consent is not a guarantee that the participant has truly understood the proposed research and Crigger et al. (2001) explains that research conducted on populations in developing nations might present an ethical challenge because they might not have sufficient knowledge of the research implications and even when they do, a lot goes unnoticed.
Providing adequate and comprehensible information remains the principle pre-requisite of the informed consent process and all study-related procedures should be presented in a language understood by the participant thus enabling him/her to fully comprehend the design, risks and potential benefits of the clinical study. Hence the subjects might be unable to assimilate the study information.
Since the research will be conducted in a focus group, the thought of discussing such personal details with other participants may be an ethical challenge. This is because most traditional norms and culture in Africa condemn the discussing of such issues in public. Hence, it is suggested that requesting or insisting on condom use may be regarded as a violation of their cultural norms and practices due to different cultural dynamics pertaining to sex, since condoms are considered to be associated with unfaithfulness, promiscuity and extra-marital affairs
Mystakidou (2009) mentions that women consenting for research are subject to their husband’s control, religious coercion or social hierarchies which are conditions under which free informed consent is not feasible to obtain and that women are more prone to discrimination from their partners, families and community members.