islands—the FDA has power to regulate curative genetic tools, NIH certainly
imposes controls through its control of funding streams, and so on, but we
must acknowledge that large gaps still exist.118
The flurry of meetings, “summits,” and other linked activities makes it
appear that wise scientists and academics are indeed sorting through the risks
and downsides of CRISPR. But many of the participants are scientists with
a long term interest in the success of CRISPR in enhancing their own research
success. Such ad hoc processes are just that, called into action briefly but
without the capacity of in-depth review or continuity.
B. Renewing the Power of Technology Assessment
Given the limits of self-regulation and the peculiar uncertainties attendant
upon research, a regulatory vacuum is undesirable. Some systematic means
of evaluating risks is necessary. I will develop five criteria for evaluating a
genetic tool such as CRISPR.119 First, a brake or governor is needed to slow
rapid development, whether through scientists’ own restraint or outside
pressures from government or professional organizations. A means to trigger
that “governor”—a method by which the expansion of research can be
checked in order to allow more careful evaluation of risks, benefits, and
future developments—will also be necessary. Public control through funding
agencies such as NIH certainly provides some regulatory controls and brakes
potentially hazardous research. However, most industrial research is not
touched by these funding streams, and as basic research is done either by
industry or through industrial-academic cooperation, any controls through
funding are weakened. It is also clear that federal funding decisions represent
the value judgments of the scientific community involved in the peer review
process, and the earlier rDNA controversy showed that the attitude of the
U.S. funding agencies became one of speeding up research, not waiting for
analysis of uncertain risks.120
Uncertainty in scientific research like CRISPR includes a range of risks—
from human germline modification effects to agricultural harms. We need
an institutional mechanism that can suspend or slow some kinds of research
while thorough study is undertaken as to the nature of the research risks and
modes of reduction, if any. What I earlier advocated with regard to rDNA
research is equally applicable to CRISPR varieties of research: we need “…a
more deliberate, explicit, and somewhat more pessimistic consideration of
the area of uncertainty as to potential hazards, triggered by some mechanism
118. Charo & Greely, supra note 116, at 14.
119. This discussion of criteria is heavily based on my earlier discussion in Governing
Science. Furrow, supra note 2.
120. See Wright, supra note 85, at 456 (explaining that the abandonment of early policies
exemplified the importance of industrial advancement and scientific achievement).
