Comments on FDA Guidance Regarding IRB Waiver of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects September 22, 2017
Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding an Unethical Clinical Trial Involving Heart Attack Patients August 1, 2017
Letter to the OHRP Regarding Major Ethical and Regulatory Lapses in the Conduct of the SUPPORT Trial June 14, 2017