Clinical Research: Pathways for Risk Management and Patient Safety

​The competitive market for medical innovation has drawn community hospitals into patient recruitment for clinical trials. Clinical trials carry different risk, safety, and liability exposures than the provision of clinical care. The role of the hospital risk manager is circumscribed with regard to oversight of the conduct of clinical trials. Speaking at the American Society for Healthcare Risk Management annual conference in Anaheim, California, Ruth Ison, MDiv, STM, patient safety analyst/consultant at ECRI Institute PSO, said that although risk managers are not directly responsible for identifying and managing liability risk and patient safety in regard to human subject research in their facilities, they should become familiar with the breadth of research activities conducted in their facilities and the research management structure, including the institutional review board (IRB), medical executive leadership for research, research policies, and contractual arrangements. Among the significant differences in the regulatory environments of acute care and of clinical research are informed consent and the informed consent process. Approving the informed consent document for human subject research is the responsibility of the IRB; nevertheless, hospitals have been held liable for failure to provide informed consent that meets federal regulatory requirements, said Madelyn Quattrone, JD, senior risk management analyst at ECRI Institute. The IRB chair and administrators and hospital legal counsel can help risk managers understand the federal regulatory requirements of clinical research and can be helpful partners in identifying potential facility liability exposures in risk mitigation planning.