Understanding ‘anticipatory governance’

STS scholar David Guston defines, clarifies, and responds to critiques of “anticipatory governance.” Anticipatory governance is one framework that has gained currency within STS for thinking about how to build the necessary social capacity to govern emerging technologies. The term originated in policy and environmental management scholarship, but it was adapted and developed by Guston and his collaborators at the Center for Nanotechnology in Society at Arizona State University (CNS-ASU).

Summary statement of the Asilomar conference on recombinant DNA molecules.

Several of the molecular biologists who gathered at the Asilomar Conference Grounds reported back on the conference shortly after its conclusion. They stated their general agreement that the voluntary moratorium called for the previous year need not continue. The researchers laid out the criteria for responsible research, focusing on managing risks (which remained largely unknown) with technical forms of containment rather than limits on risky research.

The recombinant DNA controversy: twenty years later.

Paul Berg, one of the scientists behind the original call for a voluntary moratorium on recombinant DNA research, and Maxine Singer, another molecular biologist and fellow Asilomar organizer, reflect on the legacy of Asilomar 20 years after the conference. They identify Asilomar “the beginning of an exceptional era for science and for the public discussion of science policy—one that continues unabated to this day.” They note the universal observance of the voluntary moratorium as evidence of its success.

Potential Biohazards of Recombinant DNA Molecules

A committee of prominent genetic researchers writing on behalf of the Assembly of Life Sciences and the National Research Council (NRC) call for action to address concerns around recombinant DNA. This action includes “voluntarily deferring” several types of scientific experimentation, generally involving the dissemination of potentially harmful plasmids. They also include the formation of an advisory committee to oversee experiments and develop guidelines and procedures for potentially hazardous research.

Self-organization of the in vitro attached human embryo

In this study led by Ali Brivanlou of Rockefeller University, scientists report the development of an in vitro “attachment platform”: a system that allows the study of the post-implantation development phase of the human embryo. In this arrangement, human blastocysts self-organize to display key events of development that occur in vivo. This novel method builds upon a previous study reported in mice.

HEW Support of Research Involving Human In Vitro Fertilization and Embryo Transfer: Report and Conclusions

This U.S. government report is widely acknowledged to contain (on pages 106-107) the first imposition of a two-week limit on culturing human embryos. It reads "The Ethics Advisory Board finds that it is acceptable from an ethical standpoint to undertake research involving human in vitro fertilization and embryo transfer provided that . . .

Agricultural Biotechnology: The U.S.-EU Dispute

In a US Congressional Research Service report, Charles Hanrahan recounts a dispute between the United States (along with Argentina and Canada) and the EU over the subject of genetically modified crops. The EU had kept a de facto moratorium on the import of genetically engineered foodstuffs, which the US argued was in violation of World Trade Organization rules and was causing economic harm to the United States both directly and through the global influence of EU policy.

Notice Announcing the Removal of the Funding Pause for Gain-of-Function Research Projects

This brief notice announced to researchers and the public that the funding moratorium on gain-of-function research instituted in 2014 would be lifted. This announcement came after the U.S. Government conducted a risk/benefit analysis on such research. Based on this analysis, the Department of Health and Human Services (HHS) established a new framework for the review of dual-use gain-of-function research with potential pandemic pathogens (PPPs). In effect, the U.S.

US suspends risky disease research

Science writer Sara Reardon discusses the announcement from the White House Office of Science and Technology Policy (OSTP) that it would be instituting a forced moratorium on gain-of-function research on influenza, SARS, and MERS viruses. Reardon notes the mixed reception within the scientific community, with some praising the decision as an opportunity for deliberation of the research’s risks and others characterizing the decision as an overreaction.

US biologists adopt cloning moratorium

A brief Nature news item documents the adoption of a voluntary five-year moratorium on human cloning by the Federation of American Societies for Experimental Biology (FASEB). The moratorium made a point of distinguishing human cloning intended for implantation from human cloning for research in vitro prohibiting the former while permitting the latter. Some scientists argued that this move was intended to assuage public concerns about human cloning and preempt legislative bans that could affect in vitro research, claims that FASEB officials denied.

Human Embryo Research: Lessons from History

LeRoy Walters, Georgetown bioethicist and one of the authors of the report of the Ethics Advisory Board report on in vitro fertilization (IVF), reflects on the trajectory that federal policy on human embryo followed in the decades after the report’s publication. Walters argues that different presidential administrations in the United States have ignored the ethics of embryo research and have generally lacked decisive action, for which the United Kingdom set a model example.

U.S. Government Gain-of-Function Deliberative Process and Research Funding Pause on Selected Gain-of-Function Research Involving Influenza, MERS, and SARS Viruses - October 17, 2014

In 2014, the White House Office of Science and Technology Policy (OSTP) made the decision to pause funding on certain types of gain-of-function research. Gain-of-function research alters pathogenic organisms to test the ability of pathogens to acquire additional virulence. OSTP decided that the biosafety and biosecurity risks of such experiments were too great and decided to impose a moratorium on new federal funding for such research focused on pathogens with high pandemic potential: influenza, MERS, and SARS viruses.

NIH supports call for moratorium on clinical uses of germline gene editing

At the same time Lander et al. published their call for a voluntary moratorium on heritable human germline editing, two leaders of the US National Institutes of Health (NIH) voiced their support. In this brief Nature correspondence on behalf of NIH, Wolinetz, the acting Chief of Staff, and Collins, the Director, also voice support for a process of “substantive debate” and allow that this may result in a ban of human germline editing in the future. The authors also note that NIH is presently prohibited from supporting research on human germline gene editing.

New Beginnings

In Experiments in Democracy, Observatory Co-Director Ben Hurlbut traces a history of the American debates, forms of reasoning, norms, and institutional struggles that have faced the moral status of the human embryo and justified its use for research purposes. In the first chapter, he examines the ethics and politics of reproductive rights and research in the US, from the mid-1960s to 1980.

A Voluntary Moratorium

Sheldon Krimsky details the events surrounding the 1974 call for a voluntary moratorium that produced the following year’s Asilomar Conference on Recombinant DNA. Krimsky explains the roels that Paul Berg and David Baltimore came to play in publishing the initial call and some of the uncertainties and disputes within the research community that produced it.