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[Exception to informed consent in research: when is this possible in Chile?]
Carol Zúñiga1, Jessica Zúñiga-Hernández2
1Facultad de Ciencias de la Salud, Universidad Autónoma de Chile, Talca, Chile.
Revista Medica De Chile
|December 21, 2019
Summary
Waivers to informed consent in Chilean research are ethically complex. Current Chilean law lacks exceptions, but Ethics Committees may permit them, necessitating legal and scientific review.
Area of Science:
- Bioethics
- Medical Law
- Research Ethics
Background:
- Informed consent is a cornerstone of ethical research.
- Exceptions to informed consent can impact study feasibility and success.
- The ethical and legal landscape of informed consent waivers in Chile requires clarification.
Purpose of the Study:
- To delineate the current status of informed consent exceptions in Chilean research.
- To identify existing ethical-legal guidelines in Chile regarding research consent waivers.
Main Methods:
- A systematic review of English and Spanish articles from indexed journals was conducted.
- Documents meeting specific inclusion criteria were selected for analysis.
Main Results:
- Limited information exists on informed consent waivers in research.
- Chilean legislation does not explicitly include exceptions to informed consent.
- Ethical guidelines in Chile align with the Declaration of Helsinki, suggesting potential for committee-approved exceptions.
Conclusions:
- Chilean research ethics align with international standards, but legal frameworks for consent waivers are absent.
- Ethics Committees may authorize exceptions to informed consent, guided by international ethical principles.
- Further evaluation of legal and scientific perspectives on informed consent exceptions in Chilean research is essential.
