As part of the CTSA initiative, NIH has identified “increased regulatory burdens,” as one of five key “barriers that can delay the development of new interventions for patients in need.” Federal and (to a lesser extent) state governments shape every aspect of health sciences innovation, from the provision of research funding with innumerable strings attached, to providing intellectual property incentives, to the protection of human subjects and preservation of privacy, to the complicated reimbursement systems that define the market once an innovation reaches the clinic, and ultimately to the liability regime for products and prescribers.
The AZiCATS Regulatory Science Consultative Service (RSCS) is a novel concierge service that provides rapid solutions to specific legal, compliance and regulatory challenges to advancing clinical and translational research. In partnership with the UA James E. Rogers College of Law, the RSCS provides services to the health sciences research community at the University of Arizona, the AZiCATS CTSA regional hub, and the national CTSA network. College of Law faculty and RSCS fellows are available to provide forward-thinking legal analyses in areas including: health care law, drug and device law and regulations (e.g., FDA IND/IDE), compliance (e.g., Office of Inspector General audit, evaluation, and investigation activities), administrative law, contracts, bioethics, IP and technology commercialization, and information privacy (e.g., HIPAA, FERPA, HITECH, etc.).
Christopher Robertson, JD, PhD
Associate Dean for Research and Innovation
Associate Professor, James E. Rogers College of Law, University of Arizona