Elsevier

Social Science & Medicine

Volume 61, Issue 6, September 2005, Pages 1211-1222
Social Science & Medicine

Views of US researchers about informed consent in international collaborative research

https://doi.org/10.1016/j.socscimed.2005.02.004Get rights and content

Abstract

Informed consent poses challenges in all settings. Challenges may be particularly great in international collaborative research, where cultural perspectives may differ, and where education levels and language may be barriers to participant understanding. We conducted a written survey and focus groups with US health researchers doing research in developing countries, asking about informed consent and other ethical issues in their research. We present here both qualitative and quantitative data relevant to informed consent. Qualitative data revealed that researchers’ experiences and beliefs about informed consent fell into three paradigms: regulatory, community, and individual. The regulatory paradigm refers to researchers’ views and practices relating to informed consent requirements of institutional review boards and other oversight bodies. The community paradigm refers to researchers’ approach to the content and methodology of informed consent in the context of long-term relationships between research teams and study communities. Researchers emphasized the importance of these relationships for creating and maintaining communication fundamental to the informed consent process. Finally, the individual paradigm refers to researchers’ views about individual participants’ understanding and decision-making process regarding research. Researchers described community-level influences on participants’ decision-making, but stressed the need for individual comprehension and voluntary participation. While these paradigms are distinct, they also are intertwined. Quantitative data supported the existence of these three paradigms in respondents’ characterization of informed consent. Researchers frequently stated that legal language on the consent forms was meaningless (52%). Forty-four percent of researchers had consulted with community leaders, and 23% believed the consent process focuses too much on the individual, rather than on family or community. Most researchers (82%) reported that the consent process was an important means of educating participants about the study. Fifty-four percent of researchers believed participants did not understand placebos. Further research is needed to understand how culture and relationships affect research participation, and to provide information and dialogue among researchers, oversight bodies and community representatives about appropriate ways to approach informed consent in international 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.

References (21)

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