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Working with Human Tissues for Translational Cancer Research

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Beyond the informed consent procedure: continuing consent in human research.

Mary-Rose Mueller¹, Susan Instone

¹Hahn School of Nursing and Health Science, University of San Diego, San Diego, CA 92110, USA. mmueller@sandiego.edu

Ciencia & Saude Coletiva

|September 25, 2008

Summary

Informed consent in hepatitis C trials is a continuing process, not a one-time event. Researchers re-consented subjects for protocol changes, with one participant withdrawing.

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Area of Science:

Clinical Research Ethics
Medical Anthropology
Public Health Policy

Background:

Informed consent is recommended as an ongoing process, not a single event.
Understanding the practical application of continuing informed consent in clinical trials is limited.
Hepatitis C clinical trials present complex scenarios for consent due to protocol changes and patient health status.

Purpose of the Study:

To explore the practical implementation of continuing informed consent in hepatitis C clinical trials.
To analyze how researchers and human subjects navigate consent processes during trial conduct.
To evaluate a proposed typology of continuing consent against observed practices.

Main Methods:

Ethnographic field study methodology.
Observation of researcher and human subject interactions during clinical trial conduct.
Analysis framed by a proposed typology of continuing consent.

Main Results:

Re-consent for major protocol revisions was the most frequent practice observed.
One subject withdrew consent, despite eligibility, highlighting participant autonomy.
Implied consent, through subject cooperation, emerged as an unclassified practice.

Conclusions:

Observed continuing consent practices partially aligned with existing typologies.
Implied consent through adherence to protocols represents a significant, undocumented aspect of the process.
Further research is needed to refine understanding and guidelines for continuing informed consent in clinical research.