NCHR Written Comment to NIH on Post-Trial Needs and Informed Consent for Research Participants Receiving Investigational Implantable Devices

May 22, 2026, NCHR submitted comments to NIH on their draft of resources needed for investigational implantable device trials, emphasizing the need for better planning to make sure that patients understand the medical and financial risks of having an experimental implant that may be found to be neither safe nor effective. Patients volunteering for clinical trials of implanted devices deserve to know the risks and be protected from long-term device-related risks and medical care.

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NCHR Written Comment to AHRQ on Improving the Management of Menopausal Symptoms in Perimenopausal and Early Postmenopausal Women

May 13, 2026, NCHR submitted comments in response to AHRQ’s request for feedback on its research protocol that will inform the NIH Pathways to Prevention Workshop on Improving the Management of Menopausal Symptoms. NCHR urged AHRQ to include all relevant studies rather than exclude foundational evidence through publication date cutoffs. We are especially concerned at the exclusion of long-term Women’s Health Initiative (WHI) findings, and to provide unbiased, easy-to-understand information about the risks and benefits of different menopause treatments.

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NCHR Written Comment to FDA on the Plausible Mechanism Framework for Developing Individualized Therapies for Genetic Conditions

April 27, 2026: NCHR raises concerns about the FDA’s proposed plausible mechanism framework for therapies targeting rare and genetic diseases, warning that reliance on such very limited evidence makes it difficult or impossible to make informed choices based on safety and effectiveness, and means even more very high costing unproven drugs, which patients will pay for directly or through health insurance.

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