Informed consent, anticipatory regulation and ethnographic practice

Area of Science:

• Health Services Research
• Medical Ethics
• Sociology of Health

Background:

• Informed consent is a cornerstone of ethical research involving human participants.
• Current ethical review practices often model themselves on clinical or biomedical research paradigms.
• Ethnographic research in health care settings presents unique methodological and ethical considerations.

Purpose of the Study:

• To critically examine the application of informed consent principles to ethnographic health care research.
• To challenge the adequacy of current bureaucratic ethical review systems for ethnographic studies.
• To propose alternative regulatory models that better accommodate the nature of ethnographic inquiry.

Main Methods:

• Analysis of the principles and practices of informed consent in research.
• Comparison of ethnographic research methodologies with those of clinical and biomedical research.
• Critique of existing ethical review regimes in North America and elsewhere.

Main Results:

• Current ethical review frameworks, designed for clinical research, are ill-suited for ethnographic research.
• Key differences in ethnographic research—such as extended fieldwork, emergent designs, and unique risk profiles—make standard informed consent procedures difficult to apply.
• Existing regulatory regimes may inadvertently hinder valuable ethnographic contributions to health care improvement.

Conclusions:

• The identification of informed consent with rigid, bureaucratic practices threatens ethnographic research's potential.
• Alternative professional models of regulation, focusing on education, training, and mutual accountability, are necessary.
• Developing tailored ethical oversight is crucial for supporting ethnographic research that enhances health care efficiency, equity, and humanity.