‘Problems in Comprehension of Informed Consent in Rural and Peri-urban Mali, West Africa’

San Francisco Orthopedic Program at St. Mary's Medical Center, San Francisco, CA, USA.
Clinical Trials (Impact Factor: 1.93). 02/2006; 3(3):306-13. DOI: 10.1191/1740774506cn150oa
Source: PubMed


Clinical trials undertaken by industrialized nations in undeveloped nations pose several critical ethical dilemmas. One key potential problem concerns misunderstandings of the consent process by participants. Though other reports have begun to explore this area, needs remain to identify specific areas of misunderstanding.
To identify deficits in comprehension during consent processes in Mali, West Africa.
After obtaining informed consent for participation for a malaria vaccine trial being conducted in two West African villages, we administered to participants a nine-item questionnaire testing their understanding of information relevant for their consent. After testing their ability to understand a multiple choice format, 78 of 100 subjects were administered the questionnaire in one village and 85 of 100 in the other.
Participants had difficulty comprehending several concepts relevant to informed consent: 90% of respondents did not understand withdrawal criterion, 93% did not understand the existence of study side effects, and 74% did not understand that they were enrolled in an investigation as opposed to receiving therapy. The response rate and percentage of correct answers was generally much higher in the village nearer an urban center than the more rural village. The percent of correct answers exceeded 50% for five questions in the urban village and for only two question in the more rural setting.
Potential limitations of this study are relating to translation, cultural differences in the notion of informed consent, staff differences between each village, the proportion who could not understand the survey instrument and the fact that the study explored participants' understanding of the consent process but did not observe the process itself.
This study illustrates potential areas of miscomprehension in the consent process in a developing country. The degree of miscomprehension found in this study appeared to be more than that found in similar studies conducted in industrialized nations. Despite efforts to obtain truly informed consent, several factors make it more challenging in the developing world. This research highlights the need for more comprehensive studies of consent in developing countries. Such studies may eventually aid investigators in identifying, targeting and addressing specific areas of miscomprehension and thereby improve the informed consent process in the developing world.

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Available from: Robert Klitzman, Mar 04, 2014
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    • "[1]–[5]. For example, participant comprehension may be compromised by a lack of education [6]–[8], difficulties in translating scientific terms [9], [10], and difficulties with processing large amounts of information in a time-limited setting [1], [11]. "
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    ABSTRACT: Verifying participant comprehension continues to be a difficult ethical and regulatory challenge for clinical research. An increasing number of articles assessing methods to improve comprehension have been published, but they use a wide range of outcome measures including open-ended, closed-ended, and self-perceived measures of comprehension. Systematic comparisons of different measures have rarely been reported. This study evaluated the likely direction of bias observed when using open-ended, closed-ended, and perceived ease of comprehension measures among women administered a mock informed consent process in Mwanza, Tanzania. Participants were randomized to either a closed-ended or an open-ended assessment of comprehension, administered the consent process for a hypothetical HIV prevention trial in Kiswahili, and then administered a comprehension assessment, per their randomization. They were then asked how easy or hard it was to understand each of the informed consent components measured in the comprehension assessment. Women in the closed-ended arm had significantly higher overall comprehension scores than in the open-ended arm. Perceived scores were significantly higher when compared to both open-ended and close-ended scores within arms but were similar between arms. Findings highlight the importance of comprehension assessments in complex clinical trials that go beyond asking participants if they understand or have any questions. They also indicate the need for continued exploration of objective measures of comprehension in international clinical research settings, so that points in need of clarification can be efficiently and effectively identified and addressed. Such measures would reduce burdens on both staff and participants that result from well-intentioned but potentially unnecessary time spent explaining in unwarranted detail things already understood.
    PLoS ONE 08/2014; 9(8):e105720. DOI:10.1371/journal.pone.0105720 · 3.23 Impact Factor
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    • "Most studies evaluating the quality of informed consent especially in developing countries have focused on informed consent practices in clinical research. These include previous studies from Nigeria [52], Uganda [53], South Africa [54] and Mali [55]. Most of these studies reported problems with comprehension and understanding of the informed consent process by patients including the right of withdrawal [52-55]. "
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    ABSTRACT: Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists scoring lowest, while internists, GPs and obstetricians/gynaecologists scored highest. Comparative ICAS scores showed that professional nurses scored significantly lower than doctors (p ≤ 0.001). This study shows that though doctors had general knowledge of informed consent requirements, execution in practice was inadequate, with deficiency in knowledge of basic local laws and regulations. Remedying identified deficiencies may require a 'corps' of interpreters in local hospitals to assist doctors in dealing with language difficulties, and continuing education in medical law and ethics to improve informed consent practices and overall quality of healthcare service delivery.
    BMC Medical Ethics 12/2013; 14 Suppl 1(Suppl 1):S3. DOI:10.1186/1472-6939-14-S1-S3 · 1.50 Impact Factor
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    • "The type of scientific trial, particularly whether randomization is done and whether it is done in clusters or by individual, may shape which consent processes best protect vulnerable subjects [20]. Moreover, in certain settings, individuals may be less likely to understand the research being conducted or their rights as participants [21,22], leading to concerns about the adequacy of standard informed consent practices. Illiteracy, lack of formal education and differing views of health and research complicate informed consent in all settings and may be particularly significant in resource-limited settings [21,23]. "
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    ABSTRACT: Background International collaborators face challenges in the design and implementation of ethical biomedical research. Evaluating community understanding of research and processes like informed consent may enable researchers to better protect research participants in a particular setting; however, there exist few studies examining community perspectives in health research, particularly in resource-limited settings, or strategies for engaging the community in research processes. Our goal was to inform ethical research practice in a biomedical research setting in western Kenya and similar resource-limited settings. Methods We sought to use mabaraza, traditional East African community assemblies, in a qualitative study to understand community perspectives on biomedical research and informed consent within a collaborative, multinational research network in western Kenya. Analyses included manual, progressive coding of transcripts from mabaraza to identify emerging central concepts. Results Our findings from two mabaraza with 108 community members revealed that, while participants understood some principles of biomedical research, they emphasized perceived benefits from participation in research over potential risks. Many community members equated health research with HIV testing or care, which may be explained in part by the setting of this particular study. In addition to valuing informed consent as understanding and accepting a role in research activities, participants endorsed an increased role for the community in making decisions about research participation, especially in the case of children, through a process of community consent. Conclusions Our study suggests that international biomedical research must account for community understanding of research and informed consent, particularly when involving children. Moreover, traditional community forums, such as mabaraza in East Africa, can be used effectively to gather these data and may serve as a forum to further engage communities in community consent and other aspects of research.
    BMC Medical Ethics 09/2012; 13(1):23. DOI:10.1186/1472-6939-13-23 · 1.50 Impact Factor
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