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University of Balamand > Academics > Research > Seminars > Michel Daher

Ethics in Human Subjects Research

Wednesday March 7, 2007 from 11:00 to 12:00 at Jacobo Auditorium

SUBMITTED BY: Dr. Michel Daher
Saint George’s Faculty of Postgraduate Medical Education
University of Balamand

ABSTRACT: Medical research can be defined simply as the application of the scientific method to medicine. Medical research involving human subjects raises complex ethical, legal and social issues. The ethical and scientific standards for carrying out biomedical research on human subjects have been developed and established in international guidelines, including the Declaration of Helsinki, the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, and the WHO Guidelines for Good Clinical Practice. Compliance with these guidelines helps to ensure that the dignity, rights, safety, and well-being of research participants are promoted and that the results of the investigations are credible.

The ethical conduct of research rests on 3 guiding principles: respect for persons, beneficence, and justice:
  • Respect for persons underlies the duty to obtain informed consent from study participants. The principle of respect for autonomy dictates that potential subjects be given the opportunity to choose whether to participate in research, and their choice should be an informed one. Patients who may become subjects should understand that they are being asked to participate in research, which of the proposed interventions are part of standard therapy, and which are necessary for research purposes.
  • Beneficence demands a favourable balance between the potential benefits and harms of participation.
  • Justice requires that vulnerable people not be exploited and that eligible candidates who may benefit from participation not be excluded without good cause.
Studies must be designed in a way that ensures the validity of findings and must address questions of sufficient importance to justify the risks of participation. Investigators sometimes find that their obligations with respect to a research project come into conflict with their obligations to individual patients.

Researchers have a responsibility to inform themselves about the ethical, legal and policy standards that govern their activities. When difficulties arise, they should consult the existing literature and seek the advice of experts in research ethics.
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