UNDERSTANDING
2.9 STUDIES CONDUCTED IN DEVELOPING COUNTRIES TO ASSESS TRIAL PARTICIPANTS’ UNDERSTANDING
With the increasing amount of research being conducted in developing countries, it becomes imperative for research around ethical standards and practices to be conducted in these contexts. In this section, studies conducted in developing countries outside Africa and those dealing with developing countries in general, are reviewed.
In a study of HIV-1 transmission in Haiti, participants were required to pass an oral examination on the contents of the consent form with a passing score of 12 out of 15 (80 percent) before enrolment. Fitzgerald, Marotte, Verdier, Johnson, and Pape (2002) conducted a small study involving 35 individuals to compare two methods of disclosing information.
Fifteen individuals were given information during a single meeting with a physician, and 30 other volunteers were given information by a counselor during three meetings. Three of the 15 (20 percent) got high scores of 80 percent and above, compared to 24 of the 30 (80 percent).
The findings suggest that interactive and flexible methods of disseminating information,
including the repetition and reinforcement of the information during various sessions, may lead to improvements in recall. The authors recommended that formal assessment of research participants' comprehension of provided information should be considered as a routine step in the informed consent process in HIV prevention research among illiterate populations.
In a pilot qualitative study to learn how participants in international clinical trials define research and why they choose to enrol in research, Kass, Maman and Atkinson (2005) interviewed 26 participants from three developing countries who were participating in six different international studies. The participants were referred to the authors by study staff. The study revealed that participants generally understood the purpose of the clinical trials that they had chosen to participate in. However, respondents generally did not understand randomisation and treatment allocation. The authors found that most of the participants had agreed to join the clinical trials so as to access better quality medical care. A significant number of the
respondents were not aware that they could withdraw from the study at any time. The authors recommended that formative research should guide the development of messages to be disclosed to participants so that the messages are relevant and meaningful within the specific communities in which the research is conducted. It is possible that the referral of participants by the study staff could present a selection bias, as study staff may only have referred those participants that they were confident would answer the questions correctly.
In a study conducted in Peru to examine challenges in obtaining informed consent among indigenous peoples, Creed-Kanashiro, Ore, Scurrah, Gil and Penny (2005) reported the complexities of obtaining informed consent among individuals that live in close-knit societies and the need to involve significant others in the informed consent process. They note that, while this may be a noble gesture, it may inadvertently lead to an individual agreeing to participate in research as a result of pressure from others and not as a result of understanding
about the research aims and procedures. The authors discuss the role of verbal consent in illiterate populations, where written documents may not be very meaningful. They also discuss the importance of formatting and presenting information in a way that is meaningful to a specific target audience, and recommend that, in international trials, investigators at specific sites should take positive steps to adapt generic informed consent documents and information so that these become more meaningful at their specific site.
Dawson and Kass (2005) conducted a study with US researchers doing research in developing countries to investigate the ethical issues they confronted during informed consent as well as in conducting their research. Findings revealed that researchers’ experiences and beliefs about informed consent could be categorized into three categories: regulatory, community and individual. US researchers were mainly interested in fulfilling regulatory requirements that are emphasised by IRBs, while at the same time trying their best to fulfill the expectations of the communities, and also individual information requirements. Researchers described community influence on individual decision making but stressed the need for comprehension and voluntary decision making at individual level. About 52 percent of the researchers stated that the legal language in their informed consent documents was meaningless to participants, and 23 percent believed that the informed consent focused too much on the individual while ignoring the individuals’ social context. About 54 percent of the researchers believed that participants did not understand placebos. The authors recommended that more studies to look at how culture and community affect individual decision making need to be conducted.
In a study conducted in Thailand to assess the quality of information provided during the informed consent process, Pace et al. (2005) interviewed 141 individuals immediately after they had consented to participate in a randomised HIV study in Bangkok. The survey looked specifically at individuals’ experiences with the informed consent process, their understanding
of the information provided, and the voluntary nature of their decisions. The authors note that in Thai culture it is common for individuals to defer to the authority of healthcare
professionals. The informed consent in the HIV study was divided into two parts: a group discussion led by trained study nurses, followed by individual interviews. The Thai language protocol was read through page by page, followed by questions and discussion. The instrument that was used consisted of 67 multiple-choice questions designed to elicit information on the individuals’ experience with informed consent as well as their comprehension of the
information disclosed to them.
About 98 percent of study participants reported having read the informed consent document adequately and 77 percent found the form to be moderately easy to understand (Pace et al., 2005). About 21percent of the respondents found the discussion to be more useful than the informed consent form. All respondents except for one reported that they felt well or moderately informed and yet, only 31 percent were aware that only half of the study participants would receive the test drug. One-third of the respondents were aware of the randomisation procedure. Eighty-eight percent (88%) of respondents identified the test drug as an experimental therapy for HIV, while nine percent identified it as routine treatment. About 56 percent believed that their own chance of developing AIDS might decrease. This finding presented some evidence of therapeutic misconception. Some study participants indicated that they had some issues they had not understood but that they did not ask questions as they could not find the best way of asking the questions. This finding suggests that researchers should not take silence on the part of potential research participants as a sign of understanding as it may be a sign of confusion (Pace et al., 2005).
Hyder and Wali (2006) conducted a survey of developing country researchers involved in human subjects research. They distributed a questionnaire with 169 questions to the
researchers. They found that about 40 percent of the researchers did not use written consent in their most recent studies. Eighty-four percent of respondents acknowledged that measures of understanding should be incorporated into informed consent processes. The majority of respondents recommended that regulations should allow for some flexibility in the methods that are used in documenting informed consent. These findings suggest that researchers from limited resource settings have an interest in ensuring that trial participants’ decisions to participate are based on adequate information.
A study was conducted in India to assess comprehension and recall of informed consent after the closure of a birth cohort study on diarrhoea (Sarkar, Grandin, Gladstone, Muliyil & Kang, 2009). In this study, a structured questionnaire was administered to 368 respondents. About 329 of these reported that the study had been adequately explained to them. However, only 43,5 percent of respondents could recall that the study was on diarrhoea. About 46 percent of the respondents stated that they would not have joined the study if it was not for free medical care which was offered at enrolment. The authors concluded that, in a typical rural Indian setting, medical doctors are respected as authority figures and this could have led to some individuals agreeing to join the research so as to please the researchers. The authors found that, despite high levels of compliance with the protocol, retention of study information was low over a long period of time such as one year. The finding relating to free medical care is very important, especially in limited resource settings, and demonstrates the influence of contextual factors in the making of decisions to participate in research.
The current has reviewed some studies assessing trial participants in the context of developing countries outside Africa. Factors such as illiteracy, culture and limited resources are critical in one’s decision to enroll in research. The next section is devoted to studies conducted in African countries.