The Healthcare Research & Academic Institutions Group delivers a comprehensive array of support to the research and administrations of universities, academic medical centers, hospitals, physician groups, and other research sites. We also provide assistance to academic research organizations, site management organizations, and related research service providers. We suggest and offer our expert advice and assistance in every aspect of the research cycle, including the creation of research-related policies, negotiation of sponsored research agreements, mediation and arbitration of research affiliation agreements with academic partners and collaborating research sites. Some of these agreements include Clinical Trial Agreements, CMO/CRO agreements, API and Formula transfer agreements, Co-Dev/Collaboration agreements and many more.
We counsel our clients on all areas of subjects of research and compliance law. We understand fully the uses of research materials; research on products regulated by the U.S. Food and Drug Administration (FDA), compliance with requirements for research sponsored by the U.S. Department of Health and Human Services (including the National Institutes of Health (NIH) and the Centers for Disease Control). Also the ever changing principles related to clinical trials transparency with respect to FDA clinical trials registration, improvement of research plans and support structures for global research projects. We also work closely with clients on issues specific to “bench” or “laboratory” science, as they relate to the research context and the return of information to participants, and frontier challenges.
We interact with relevant U.S. federal agencies (e.g., the Office for Human Research Protections, the FDA, the Office for Civil Rights, and the Office of Research Integrity) to acquire informal and formal guidance related to specific questions, as well as in conjunction with for-cause or not-for-cause investigations or audits.
Composed of attorneys from the firm’s Healthcare Group, the Healthcare Research & Academic Institutions Group is familiar to dealing with matters at the juncture of healthcare law and research, including compliance with the evolving requirements of U.S. privacy laws for example, HIPAA and HITECH, and foreign privacy laws. We are adept with U.S. and foreign transparency requirements; fraud and abuse laws; Medicare secondary payer rules and the National Coverage Determination for Routine Costs in Clinical Trials.
We also have expertise in the FDA regulatory requirements such as the restrictions on the promotion of pharmaceutical products and medical devices, the requirements to bring FDA-regulated products to market, the treatment use of investigational products under expanded access protocols and in the context of humanitarian use devices, and special rules regarding the use of human cells, tissues, and cellular and tissue-based products. We assist clients in understanding institutional overhead cost principles of the U.S. Public Health Service and Office of Management and Budget as well as laws applicable to sensitive information, such as genetic, substance abuse, and mental health information.
We have vast knowledge and applied experience with developing compliance programs. We represent pharmaceutical manufacturers, academic medical centers and a pharmaceutical service company in connection with federal and state False Claims Act investigations and court actions.
Recent demonstrative assignments that members of the Healthcare Research & Academic Institutions Group have handled include: