This research project completes a census of research materials used in human embryonic stem cell (hESC) research. The census is based on (1) exclusive material transfer agreement (MTA) data from two major U.S. stem cell banks and (2) an exhaustive catalog of publications reporting findings of research that uses or derives pluripotent cell cultures. This dataset covers the entire life of hESC research, leveraging three naturally occurring, "quasi-experimental" comparisons to examine the effects policy shifts, technological developments, and alternative funding regimes have on scientific practices and outcomes. The researchers also conduct systematic interviews with active stem cell scientists that explore scientists' decisions about what cell lines to use, how to access them and how both decisions are shaped by the historical, technical and regulatory pressures. The project's expansion of comprehensive archival data on the research materials with theoretically sampled interviews provides timely, systematic data to policymakers working to revise federal rules for hESC funding. These data also enable longer-term academic analyses that treat hESC research as a "laboratory" for developing the science of science and innovation policy.
Intellectual merit: Previous research has found that there is a bottleneck between the cell bank and the laboratory bench that prevents even the relatively limited number of cell lines that can be federally supported from being extensively used. The PIs have a number of hypotheses about why this may be so. The bottleneck might depend on existing federal rules. An alternative possibility is a variety of scientific and technical factors. Yet another is fragmented state-level regimes: in extreme cases state law bans any research using materials derived from human embryos. But the bottlenecks might also be due to the way in which innovations are diffused: small initial differences (in accessibility, ease of use, or availability of technical complements such as known reagents and laboratory procedures) can lead to increasing returns for the selection of particular materials and eventually to lock-in on a dominant but often sub-par technological standard for a field.
The quasi-experimental comparisons made possible by these changes permit a unique opportunity to systematically analyze the effects different funding regimes, changing policy prescriptions, and technological changes have on scientific practices and outcomes as well as the growth trajectory of this new field. The results shed insights into the key social and institutional features related to the development of new scientific fields.
Broader impacts. Findings from this project provide evidence that can be used to assist policymakers by documenting patterns of use and availability for cell lines, the prevalence of different methods for their creation, and the types of research in which they are used. The research facilitates the development of sustainable, efficacious policies to enable broad access to and use of genetically diverse, ethically responsible cell cultures.
