Related Experiment Videos
[Informed well-considered consent ('informed consent'): an end or a means?]
R Schellings1, F Sturmans, A G Kessels
1Capaciteitsgroep Epidemiologie, Universiteit Maastricht.
Nederlands Tijdschrift Voor Geneeskunde
|June 16, 1999
Summary
Informed consent is crucial but can hinder epidemiological research. Alternative approvals by ethics committees can protect autonomy while enabling vital research using existing data.
Area of Science:
- Medical Ethics
- Epidemiology
- Research Regulations
Context:
- Post-WWII protective measures in medical care and research.
- Informed consent has become a standard, yet controversial, in experimental research.
- Absolute prerequisite for observational research threatens future epidemiological studies using existing data.
Purpose:
- To examine the tension between individual autonomy and general interests in research ethics.
- To explore the implications of strict informed consent requirements on epidemiological research.
- To discuss the applicability of informed consent in light of existing regulations and ethical principles.
Summary:
- Informed consent, while vital for self-protection and autonomy, is increasingly challenging for observational research, particularly studies using existing data.
- The Declaration of Helsinki and Dutch Law permit waiving individual informed consent under specific conditions, allowing for supervisory board or ethics committee approval.
- Insisting on informed consent when autonomy is already limited or addressed by other means may be counterproductive.
Impact:
- Highlights a potential conflict between stringent informed consent and the continuation of essential epidemiological research.
- Suggests a balanced approach, utilizing ethics committee oversight as an alternative to individual consent in certain research contexts.
- Emphasizes that informed consent is a means to an end (autonomy), not an absolute goal, and its rigid application can impede research progress.