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[Clinical trials in developing countries: who should define ethics?].

F Béréterbide¹, F Hirsch

¹Faculté de médecine, Département de recherche éthique, Université Paris-Sud-XI, France.

Bulletin De La Societe De Pathologie Exotique (1990)

|June 12, 2008

Summary

This summary is machine-generated.

Conducting clinical trials in developing nations presents ethical challenges, particularly regarding informed consent and access to care. Local ethics committees are crucial for navigating these dilemmas, rather than relying solely on international guidelines.

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Area of Science:

Global Health
Bioethics
Clinical Research

Context:

Clinical trials in developing countries face significant implementation hurdles compared to developed nations.
The accessibility of medical care through trial participation complicates the principle of informed consent.
A potential
double ethical standard
arises if these challenges are ignored.

Purpose:

To analyze the ethical complexities of conducting clinical trials in developing countries.
To question the adequacy of current international guidelines and the role of informed consent in these contexts.
To highlight the underrepresentation of local ethics committees in the decision-making process.

Summary:

The implementation of clinical trials in developing countries is fraught with difficulties, raising concerns about a potential
double ethical standard
and the integrity of informed consent when trials offer access to medical care.
While international organizations and guidelines are prominent, the theoretical justification for restricting or halting trials is weak.
The analysis emphasizes the critical, yet often absent, role of local ethics committees as the most legitimate partners in addressing these ethical dilemmas.

Impact:

Underscores the necessity of strengthening local ethics committees in developing countries for ethical clinical trial oversight.
Advocates for a more nuanced approach to international research ethics that respects local contexts and autonomy.
Suggests that effective ethical review requires greater engagement with and empowerment of local ethical bodies, rather than a one-size-fits-all international standard.