IRB: Waiver of Informed Consent on Human Clinical Investigations
June 26, 2023
Remitted an actionable request to the FDA and HHS to outlining our organizations questions and concerns regarding the "IRB: Waiver of Informed Consent on Human Clinical Investigations" that was issued in July of 2017.
We requested the FDA to add this regulatory change to the Federal Register in order to collect public commentary (post fact) and revise accordingly.
Informed Consent is a basic human right. Engaging in human clinical trials without the partipants' knowledge or consent is a violation of the Belmont Agreement and an abuse of human rights.
Pharmaceutical Supply Chain
June 12, 2023
Sent request for the creation of a federal committee to review issues related to accessing opioid-based medications due to supply chain or public-health policy changes and to make recommendations to address the gaps and inconsistencies in federal polices that are causing public harms.
Correspondence - White House - Office of Public Engagement
May 23, 2023
Letter of Inquiry - Oversight and Accountability Committee
May 3, 2023
Sent a formal letter of inquiry to the Oversight and Accountability Committee Chairman James Comer regarding the NIH-HEAL Initiative's Hemodialysis Opioid Prescription Effort
Submission of Formal Commentary to the CDC
July 16, 2021
Submitted formal commentary to the CDC Board of Scientific Counselors for the National Center for Injury Prevention and Control regarding their initial "Observations of the Opioid Workgroup" - 2016 CDC Guideline for Prescribing Opioids.
May 6, 2021
Submitted an appropriations request to the House Subcommittee on Labor, Health & Human Services, and Education requesting allocation of funding for an Oversight Committee with additional funding allocation to perform studies assessing and evaluating the impact recent healthcare changes are having on the public's health and well-being.
Addressing the Tri-Crisis
December 10, 2020
Sent a copy of Addressing the Tri-Crisis to the Biden/Harris Administration. This document outlines goals and recommendations that we would like to see the administration take within the first 100 days of office.