ABSTRACT Background: The doctrine of informed consent (IC) exists to protect individuals from exploitation or harm. This study into IC was carried out to investigate how different researchers perceived the process whereby researchers obtained consent. It also examined researchers’ perspectives on what constituted IC, and how different settings influenced the process. Methods: The study recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the (...) United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Although the concept and application of the doctrine of IC should have been the same, irrespective of where the research was carried out, the process of obtaining it had to be different. The setting had to be taken into consideration and the autonomy of the subject had to be respected at all times. In areas of high illiteracy, and where understanding of the subject was likely to be a problem, there was an added responsibility placed on the researcher to devise innovative ways of carrying out the study, taking into consideration the peculiarities of the environment. Conclusion: The ethical issues for IC were the same, irrespective of where the research was conducted. However, because the backgrounds, setting, and knowledge of populations differed, there was the need to be similarly sensitive in obtaining consent. The problems of obtaining genuine IC were not limited to developing countries. (shrink)

ABSTRACT Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in (...) the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (shrink)

Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries.Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public health in the United (...) Kingdom. A purposive, snowballing approach was used to identify interviewees.Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries.Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (shrink)