Arent Fox represents sponsors, contract research organizations, site management organizations, and clinical trial sites, including hospitals and academic medical centers, in clinical trial contracting and compliance.
Arent Fox also represents clients when presenting to institutional review boards (IRBs) for permission to commence research, as well as following discovery that research may have occurred without appropriate permissions. We further advise clients regarding multiple aspects of IRB operations and compliance, including preparation and review of policies and procedures, and issues related to bioethics.
Arent Fox attorneys have conducted investigations on behalf of clients relating to potential research misconduct. As a result of our broad-based health care industry experience, we also understand and advise regarding issues that may overlap with research misconduct, including scope of practice and medical staff issues. As enforcement actions increase, we offer our clients the benefit of such broad-based experience and knowledge related to clinical trials and compliance to assist them in avoiding problems, ensuring they are appropriately protected when problems arise, and resolving and defending enforcement actions.