Views of US researchers about informed consent in international collaborative research
Section snippets
Background and introduction
In recent decades, there has been widespread recognition of the importance of informed consent in medical care and in research. While there is general agreement about the need to respect dignity and autonomy of patients and subjects through the practice of informed consent, in-depth studies of the topic have revealed the subtlety and complexity of ways that people understand information and make decisions about important aspects of their health, including clinical care and research
Methods
The study was approved by the Committee for Human Research (CHR) of the Johns Hopkins School of Public Health. The study employed qualitative and quantitative methods (focus groups and written questionnaire). Respondents in focus groups gave written consent.
Results
Researchers working in developing countries described multiple issues in focus groups related to informed consent. Based on systematic coding of focus group data, researchers’ descriptions of informed consent in focus groups were organized into three paradigms: (1) the regulatory paradigm; (2) the community relationship paradigm and (3) the individual decision-making paradigm. [See Fig. 1(a–c)]. Each paradigm contains a distinct pattern of elements of the informed consent process, with some
Discussion
Researchers in focus groups described experiences and beliefs related to informed consent that we organized into three paradigms: regulatory, community, and individual. Researchers did not describe the paradigms in mutually exclusive terms, but did describe tensions among them. Quantitative data support the existence and relevance of all three paradigms.
In the regulatory paradigm, qualitative and quantitative data indicated researchers engage in numerous procedures relating to consent forms and
Disclaimer
The views expressed are those of the authors, reflecting their own personal research, and do not necessarily reflect the views or policies of the US National Institutes of Health, the Public Health Service, or the Department of Health and Human Services of the US Government.
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