- DEA will not reschedule marijuana unless the FDA determines the drug has a medical use.
- DEA’s new research policy will hopefully facilitate future necessary medical research.
Clinical Trials, Research & IRBs
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.
Last week, bipartisan legislation was introduced in the US Senate and the House of Representatives to amend the Controlled Substances Act and ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana.
Federal regulations require institutions and institutional review boards (IRB) that are responsible for review and oversight of human subject research to prepare and maintain adequate documentation of IRB activities, including minutes of IRB meetings. On November 5, 2015, the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) announced the availability of draft guidance regarding IRB minutes (Draft Guidance). (See 80 Fed. Reg.
ABOUT ARENT FOX LLP
Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.