Research in the hospital setting on human subjects. Protecting the patient and the institution.

A hospital's institutional review board is charged with the responsibility of fully protecting the rights of research subjects. In doing so, the board establishes that research protocols are based on sound scientific principles, that benefits to research subjects outweigh the risks, and that the subject's consent is informed and not coerced. Although it has been argued that risk management has no role in the activities of such boards, the literature indicates that risk management and quality assurance principles apply to all areas of the institution, including the activities of the board. The institution must ensure that its researchers and board members are as fully protected as possible from civil and criminal liability and that the integrity of those conducting the research is established and maintained. The institution must also provide sufficient support for the board to conduct its reviews and educate the research community and board members on current and evolving laws and regulations governing human research. Risk prevention and quality assurance strategies should recognize the rights of the research subject as paramount while protecting the institution, its researchers, and the community served.