Michael C. Roach
Michael has been serving clients in the healthcare industry as a consultant and attorney for 30 years. He focuses his practice on clinical research billing compliance, human-subject protection regulatory compliance, negotiation of clinical trial agreements on behalf of research sites with pharmaceutical companies and device manufacturers, and health information privacy.
Michael worked in operational roles in the healthcare industry for several years before returning to law school and starting his career as an attorney and consultant. He was the administrator for the Department of Rehabilitation Medicine at the Medical College of Virginia at Virginia Commonwealth University; worked as a program evaluator on an NCI grant in the Department of Medical Oncology at the Mayo Clinic in Rochester, and was an operations analyst at Henry Ford Hospital in Detroit.
Michael has extensive experience assisting health care entities and business associates as they address issues related to health information privacy and security, especially with regard to the
HIPAA Privacy Rule and HIPAA Security Rule, and he has frequently presented at conferences on these topics.
He also focuses much of his practice on clinical research programs, assisting sites with program structural assessment and re-design, clinical trial agreement negotiation, and compliance with human research protection regulations. In addition to his work with Arete, Michael is a partner in the Chicago based law firm, Meade Roach & Annulis, LLP.
Served as Interim Director of Human Research Protections Program for a major university and as Interim Research Compliance Officer for a large multidisciplinary physician practice
Served as Interim Chief Compliance Officer for the health campus of a major West Coast university
Served as Interim Privacy Officer for a large metropolitan Department of Public Health, a major multi-hospital health system, and a nationally recognized children’s hospital
Assisted with investigation and settlement discussions with the DHHS OIG and Local U.S. Attorneys of clinical trial billing issues for large research institutions
Assisted multiple research sites and principal investigators with responses to FDA form 483 fillings and warning letters
JD cum laude,
University of Richmond
MS in Sociology, University of
Illinois – Champaign
MHSA, University of Michigan
School of Public Health
(received U.S. Public Health
Licensed to practice law Virginia
Certified in Healthcare Research Compliance (CHRC)
Certified IRB Professional (CIP)