Comments on the FDA’s Proposed Rule for Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations February 13, 2019
Testimony Before the FDA’s Obstetrics and Gynecology Devices Panel Regarding Surgical Mesh for Transvaginal Repair of Pelvic Organ Prolapse February 12, 2019
Letter to the Vanderbilt University Medical Center IRB Chairs Regarding Sepsis Clinical Trial Funded by NIH August 29, 2018
Letter to OHRP Calling for a Halt to Unethical, Reckless Sepsis Clinical Trial Funded by NIH August 28, 2018
Follow-up Letter to the FDA and OHRP Regarding Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation July 30, 2018
Letter to the Association for the Accreditation of Human Research Protection Programs Regarding the Hennepin County Medical Center’s Human Subjects Protection Program July 26, 2018
Letter to the FDA and OHRP Calling for Investigations of Unethical High-Risk Clinical Trials That Tested Ketamine for Management of Agitation July 25, 2018
Follow-up Complaint Letter to the OHRP and the VA Office of Research Oversight Regarding a Potentially Unethical Clinical Trial Involving Heart Attack Patients July 5, 2018