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Ethics of clinical trials
1Department of Obstetrics and Gynecology, Yale University School of Medicine, New Haven, Connecticut 06520-8063, USA.
Seminars in Reproductive Endocrinology
|May 1, 1996
Summary
Clinical trials involve human experimentation, necessitating strict ethical guidelines to protect patient rights. Outside interests can conflict with patient well-being, requiring informed consent and physician adherence to moral principles.
Area of Science:
- Medical ethics
- Clinical research methodology
- Patient advocacy
Background:
- Clinical trials are a form of human experimentation with a history of ethical concerns.
- The doctor-patient relationship in clinical trials is complicated by external interests beyond patient health.
- Evolving healthcare delivery models introduce new complexities to clinical trial ethics.
Purpose of the Study:
- To highlight the ethical considerations unique to modern clinical trials.
- To emphasize the importance of protecting patient interests amidst external influences.
- To discuss the ethical underpinnings of informed consent and patient rights in research.
Main Methods:
- Review of historical ethical principles in human experimentation.
- Analysis of the doctor-patient relationship in the context of clinical trials.
- Application of Kantian moral theory and the Hippocratic Oath to clinical trial ethics.
Main Results:
- Clinical trials introduce external interests that can challenge the therapeutic alliance.
- Physician's duty to uphold patient rights is paramount, forming the basis of informed consent.
- Randomization in clinical trials is ethically permissible under conditions of equipoise.
Conclusions:
- Ethical vigilance is crucial in clinical trials due to inherent human experimentation.
- Protecting patient interests requires adherence to moral principles and robust informed consent processes.
- The integration of external interests necessitates ongoing ethical evaluation in clinical research.