The letter, addressed to Acting Secretary Norris Cochran of the Department of Health and Human Services, urges the withdrawal of the proposed rule (RIN 0991-AC-15) concerning increased safeguards and integrity requirements for extramural research involving human fetal tissue (HFT). Representing a broad coalition of scientific, medical, and patient organizations, the signatories argue that the rule would impede essential biomedical research and delay the development of treatments and vaccines for serious diseases such as COVID-19, ALS, spinal cord injury, Parkinson’s disease, and others. They emphasize that HFT is a critical and, in many cases, irreplaceable resource for advancing medical science, supporting the development of therapies and understanding infectious diseases.
The letter critiques the proposed rule on several grounds: it would restrict federal funding for HFT procurement, raising institutional research costs during a period of financial strain caused by the pandemic; it would impose unnecessary procedural barriers to tissue donation and procurement, despite comprehensive informed consent processes already being in place; and it lacks a sound ethical rationale, given the existing robust oversight and legal requirements that govern HFT research. The authors contend that these new restrictions are unwarranted and would ultimately hinder public health progress. They call on the agency not only to withdraw this particular rule but also to revoke related restrictive policies established in 2019, reaffirming their commitment to evidence-based research and expressing their desire to collaborate in support of effective, ethically sound biomedical research.
