Ethical issues in health care institutions. Lesson five: Research ethics

Well-constructed research protocols provide the mechanism to examine new clinical practices and new approaches to the provision of health care services which can be evaluated in a systematic manner. In order to be consistent with the underlying ethical duties of health care providers, the principle of respect for persons requires fully informed consent of those subjects who can act autonomously. If the subjects have diminished autonomy, special precautions must be taken to protect their interests and welfare if they are to take part in research projects which may be of benefit to them. Research, if it is to be consistent with duties of beneficence, must be directed toward the best interests of the subject. Careful attention must be paid to the assessment of potential benefits and risks, so that the balance of benefit to risk is a favorable one. Considerations of fairness prevent us from inequitably distributing the benefits and risks, thus subjecting the most disadvantaged groups in society to further disadvantage. The requirement for prospective review of research protocols by an IRB is important in protecting the rights, health and welfare of people who take part in research.