Ethical and institutional review board issues.

IRBs provide an important role in the protection of research subjects/patients. Research investigators have an inherent potential conflict of interest as health care professionals; as physicians, they are dedicated to promoting the welfare of individual patients, whereas as researchers, they seek knowledge that can be generalized and is applicable to persons other than the individual patient under study. The second goal may be in conflict with the first. IRBs have the paramount responsibility of protecting the rights and welfare of human research subjects. Although the IRB system is not perfect, conscientious IRBs reassure the public that the rights and welfare of human subjects are seriously considered by people who do not have a vested interest in the outcome of the research. By exercising their responsibilities, IRBs promote the protection of human subjects. IRB approval provides a significant affirmation of the scientific and ethical qualities of research, and therefore offers important validation to research and research investigators. IRBs, acting in accordance with the guiding principles of the Belmont Report and within the regulatory guidelines of 45.CFR.46, are intended to provide balance between society's interest in advancing scientific knowledge and the mandate to protect the rights and welfare of human subjects.