In August, the National Institutes of Health (NIH) sought input on proposed changes to its Guidelines for Human Stem Cell Research that would permit certain human-animal chimera research. NIH also sought feedback on a proposed steering committee to provide programmatic input and ensure compliance with NIH guidelines and policies on human-animal chimera research.
Initially issued in July 2009 to ensure NIH-funded stem cell research activities remained ethically responsible, scientifically worthy, and in accordance with applicable laws, the Guidelines for Human Stem Cell Research originally permitted scientists to explore research in which human pluripotent cells were introduced into early stage embryos of non-human vertebrate animals. Questions and concerns about such human-animal chimera experiments led NIH to issue a funding moratorium for such work on September 23, 2015, granting the agency time to assess the state of the science and address animal welfare concerns associated with this line of scientific inquiry.
The proposed changes to the NIH Guidelines acknowledge the challenges associated with human-animal chimera research while allowing preliminary exploration of the potential opportunities for science. Specifically, the revisions clarify that only research in which human pluripotent stem cells are introduced into non-human primate embryos after the blastocyst stage is eligible for funding. The updated Guidelines also maintain the funding ban on breeding animals in which the introduction of human cells may contribute to the germ line.
In its submitted comments, FASEB commended NIH for its efforts to balance exciting research opportunities with ethical concerns and expressed support for the proposed changes to Guidelines for Human Stem Cell Research. In addition, the Federation suggested that NIH provide a fact sheet or flow chart demonstrating the interactions between the reviews of research proposals by study sections, Councils, and the proposed steering committee to ensure that applicants understand which aspects of a proposal are being assessed at each stage of review.