Managing compliance risks. How to handle research involving human subjects.
Many Michigan hospitals and health systems conduct or participate in human subjects research, thus falling under the authority of complex federal rules and oversight. In recent years, the responsible federal agencies have vigorously enforced the rules related to human subjects protections, resulting in numerous on-site audits, suspensions of grants and research activity, and other disciplinary actions. Some hospitals have also faced private lawsuits from patients who claim they were harmed by the research or not adequately informed of its risks.
D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence / Q000592:standards*; D028744:Ethics Committees, Research; D019983:Guideline Adherence; D006739:Hospital Administration / Q000331:legislation & jurisprudence / Q000592:standards*; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D008824:Michigan; D012308:Risk Management / Q000458:organization & administration*