Academic Medical Centers and Clinical Research

Crowell & Moring LLP provides counsel and representation on the specific and often technical legal issues facing academic medical centers and biomedical research. Apart from traditional reimbursement, commercial transaction and regulatory issues, we provide counsel and advice in matters including scientific integrity (e.g., misconduct, disqualification), research objectivity (e.g., financial conflicts of interest), human subjects and the Common Rule, FDA reporting obligations, the Shelby Amendment expansion of the Freedom of Information Act, animal welfare, inventorship and technology transfer, and the NIH grants process. We also deal with antitrust issues in collaborative activities among research centers. The firm's expertise and breadth of experience helps clients in addressing increased scrutiny directed at the conduct of medical research by the Recombinant DNA Advisory Committee, the FDA and the Office of Human Research Protection, particularly in determining whether the rights and health of human subjects in clinical trials are being safeguarded.

Our firm has represented universities, research centers, learned societies and individual researchers in over seventy civil cases and Departmental Appeals Board proceedings involving allegations of scientific misconduct or failure to comply with FDA rules. This includes our participation in many of the major cases in the field, including the David Baltimore and Thereza Imanishi-Kari, Robert Gallo, and Bernard Fisher matters.

Our attorneys also perform clinical research and scientific misconduct internal audits and investigations, defend research disqualification proceedings, and develop clinical research privacy compliance programs. We handle internal investigations of compliance with adverse effect reporting, informed consent, and recordkeeping requirements for human subjects research. We defended a lead investigator in an FDA disqualification hearing and represented a major teaching university in resolution without sanction of a significant government investigation. One member of our attorney team currently serves on the Institutional Review Board of a major teaching university’s academic medical center.

Where possible, we work to prevent the imposition of burdensome new federal regulations or burdensome administrative requirements on our academic medical center clients. We also help craft specific policies for research institution in compliance with evolving privacy regulations, and work with clients to ensure compliance with the Anti-Kickback Act and Stark law regulations as they apply to academic medical centers. Crowell & Moring also provides antitrust guidance for academic medical centers concerning managed care centers of excellence networks, protocols for clinical trial administration and reporting, and business and clinical affiliations with community hospitals and medical practices.