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October 30, 2019

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NIH Human Fetal Tissue Research Policy

IDSA has become increasingly involved in federal discussions regarding recent changes to human fetal tissue research policy, sharing our concerns about the dangers these changes pose to important research and patient care. Historically, there has been bipartisan support of human fetal tissue research with the recognition that it serves an important and necessary scientific purpose. HFT research has been conducted in the United States since the 1930s and funded by the National Institutes of Health since the 1950s.

Following the termination of a Food and Drug Administration contract involving fetal tissue and a subsequent audit of federally funded research in this space, the U.S. Department of Health and Human Services released a statement in June on forthcoming changes to existing HFT research policy. NIH released Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research, effective September 25. Among the many restrictive changes to funding HFT research in the policy is the establishment of an NIH Ethics Advisory Board whose composition must include not only “at least one” theologian, but also restricts scientists with relevant research expertise to no more than half of the EAB membership.

IDSA and HIVMA submitted a joint letter to HHS Secretary Alex Azar II and NIH Director Dr. Francis Collins detailing our concerns with the NIH policy as it impacts patient care and ID/HIV research. Our societies have also joined other medical and research organizations on multiple congressional and research coalition letters. We are concerned that this policy will create substantial barriers to important biomedical research, jeopardize the integrity of the peer review process, and create an unnecessarily cumbersome and bureaucratic process for reviewing crucial research. It also upends the existing legal and ethical frameworks for HFT research, which have provided rigorous and appropriate oversight for decades and allowed important biomedical research to progress.

NIH Principal Deputy Director Lawrence Tabak, DDS, PhD, responded to IDSA and HIVMA, sharing his appreciation for our comments and outlined the process by which the EAB will be determined. We will continue to work with NIH and concerned stakeholders to maintain access to critical HFT research and advocate for gold standard evidence-based review.

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