One of the truisms of science policy is that developments are often reactive, in response to external events or breakthrough leaps forward in science and technology. Thoughtful, deliberative policymaking on emerging fields of science and biotechnologies is challenging, particularly since unpredictability is inherent in the very nature of scientific discover. Simply put, the wheels of science often turn faster than the wheels of policy.
Today, NIH published a notice in the NIH Guide for Grants and Contracts announcing the agency would “not fund research in which human pluripotent cells are introduced into non-human vertebrate animal pre-gastrulation stage embryos” while we consider a possible policy revision in this area. As described in the Guide notice, this is an exciting area of science that is rapidly progressing, but in which ethical and animal welfare considerations might merit additional guidance to move forward. This is a unique opportunity to take a deep breath, look at the state of the science, and think about current policies and consider whether any additional policies are needed to promote the responsible conduct of this promising science.
Of course, thinking about the ethical considerations related to the formation of these types of animal-human chimeras is not new. In 2005, the National Academies Guidelines for Research on Human Embryonic Stem Cells urged caution for experiments in which human embryonic stem cells were introduced into non-human embryos, suggesting both restrictions and additional consideration might be necessary. NIH adopted several of those provisions in the 2009 NIH Guidelines for Human Stem Cell Research. While the Academies report pre-dated the discovery of the ability to create induced pluripotent stem cells, the ethical considerations raised remain resonant. Advances in cellular technologies and gene editing present opportunities to address interesting scientific questions and propel progress in regenerative medicine. They also illustrate that the time is ripe to proactively consider whether additional ethical considerations should be put into place to guide the science moving forward.
Moving forward, NIH will bring together experts in the field to discuss the state of the science: what are the aims of research involving early stage chimeras and what are the advances on the horizon? This discussion will help serve as a foundation to consider policy needs going forward. In other words, thoughtful, deliberative policymaking at its best.