Minal M. Caron
Associate
Minal Caron joined Ropes & Gray in 2014 as an associate in the health care group. Minal advises academic medical centers, hospitals, universities, pharmaceutical manufacturers, and other health care organizations regarding a broad range of regulatory, compliance, financing, and transactional issues. He regularly represents both academic and industry clients in the area of clinical research.
Prior to joining the firm, Minal served as a law clerk to Chief Judge John A. Woodcock, Jr., U.S. District Court for the District of Maine. During law school, Minal worked as a judicial intern for Judge Kermit Lipez, U.S. Court of Appeals for the First Circuit, and received the Harvard Law School Paul C. Weiler Scholar Award for excellence in Sports Law.
Experience
- Advised multiple research institutions and industry sponsors regarding a broad range of research policy and compliance issues, including human subjects protection and informed consent, and the drafting of research protocols, central Institutional Review Board agreements, and internal policies relating to research misconduct and good clinical practices (GCPs).
- Advised multiple health care and research institutions in connection with internal investigations involving allegations of research misconduct.
- Advised a large pharmaceutical manufacturer in government inquiry into compliance with clinical trial registration and results reporting requirements.
- Advised a leading hospital in conducting internal investigations regarding controlled substances prescribing practices.
- Advised multiple health care clients in connection with the resolution of federal False Claims Act qui tam actions.
- Advised multiple health care providers in preparing and submitting self-disclosures of overpayments to Medicare Administrative Contractors and various state Medicaid programs.
- Advised a university regarding evaluation and negotiation of potential “spin-off” transactions for its controlled teaching hospital with both for-profit and non-profit potential acquirers.
- Advised several health care and university organizations on corporate finance matters, including tax-exempt and taxable public offerings and bank direct purchases.
Publications
- Co-author, “The Evolving Regulatory Landscape for Clinical Trials in India,” Food and Drug Law Institute’s Food and Drug Law Journal (December 2018)
- Co-author, “Drawing A Road Map For Nationwide Health Info Sharing,” Law360 (February 15, 2018)
- Co-author, “Agency Guidance Limits May Shift Health Care Enforcement,” Law360 (February 9, 2018)
- Co-author, “SACHRP Releases Guidance on Broad Consent Under Revised Common Rule,” Bloomberg BNA’s Life Sciences Law & Industry Report (September 15, 2017)
- Co-author, “New Frontiers in AMC Funding: Mission Support Alternatives Post-Halifax,” Member Briefing, American Health Lawyers Association (AHLA) AMCs and Teaching Hospitals Practice Group (May 2017)
- Co-author, “Investigating Allegations of Research Fraud: Finality and Implementation of an Institution’s Findings in Research Misconduct Cases,” Bloomberg BNA Medical Research Law & Policy Report (July 6, 2016)
- Co-Author, “Indian Ministry of Health and Family Welfare Amends Informed Consent Rules,” Bloomberg BNA Medical Research Law & Policy Report (October 21, 2015)
- Co-author, “India’s Proposed Amendments to the Drug and Cosmetics Act: Compensation for Injuries to Clinical Trial participants and the Criminalization of Clinical Research,” Bloomberg BNA Life Sciences Law & Industry Report (January 23, 2015)