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The Health Care Research and Academic Institutions group at Dickinson Wright delivers a comprehensive array of support to universities, academic medical centers, hospitals, physician groups, and other research sites, including clinical research organizations.
Comprised of attorneys from the firm’s Health Care practice, the Health Care Research and Academic Institutions group is familiar with matters at the juncture of health care law and research, including compliance with U.S. privacy laws such as HIPAA and HITECH, and foreign privacy laws. Additionally, we are well versed in 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.
Advice and assistance through every stage of the research cycle, including the creation of policies, negotiation of clinical trial agreements, and development of research affiliation agreements with academic partners and collaborating research sites.
Counseling on animal and human subjects research compliance, including products regulated by the FDA and 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 CDC.
Assistance with relevant U.S. federal agencies, including 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.
Advice on FDA regulatory requirements such as the restrictions on the promotion of pharmaceutical products and medical devices; the requirements for bringing FDA-regulated products to market; the treatment of investigational products under expanded access protocols; and the context of humanitarian use devices and special rules regarding the use of human cells, tissues, and cellular and tissue-based products.
Assistance with the institutional overhead cost of the U.S. Public Health Service and Office of Management and Budget as well as laws applicable to sensitive health information, including genetic, substance abuse, and mental health information.
–Developed compliance programs for pharmaceutical manufactures and academic centers.
–Represented pharmaceutical manufacturers, academic medical centers and pharmaceutical service companies in connection with federal and state False Claims Act Counseled a private medical research institute on development and approval of multiple medical technologies, including biomaterials, personalized medicine and anti-aging technologies.
–Counseled a private foundation serving as a partnership intermediary with Federal laboratories, including master-level cooperative research and development agreements (CRADA’s).
–Created a clinical research contract and provided regulatory counsel to cardiac device company engaged in national, multi-site clinical research trial as well as a publicly-traded medical technology company conducting multi-site clinical research trial.