From Bank to Bench to Breakthrough: Selection, Access, and Use of Human Stem Cell Research Methods

该研究项目完成了人类胚胎干细胞（hESC）研究中使用的研究材料的普查。该普查基于（1）来自美国两个主要干细胞库的独家材料转移协议（MTA）数据和（2）报告使用或衍生多能细胞培养物的研究结果的详尽出版物目录。该数据集涵盖了hESC研究的整个生命周期，利用三个自然发生的“准实验”比较来研究政策转变，技术发展和替代资金制度对科学实践和成果的影响。研究人员还对活跃的干细胞科学家进行了系统的采访，探讨了科学家关于使用什么细胞系，如何获得它们以及这两种决定如何受到历史，技术和监管压力的影响的决定。该项目扩大了关于研究材料的综合档案数据，并进行了理论上的抽样采访，为致力于修订联邦hESC资助规则的政策制定者提供了及时、系统的数据。这些数据也使长期的学术分析，把hESC研究作为一个“实验室”，发展科学和创新政策的科学。智力优点：以前的研究发现，细胞库和实验室工作台之间存在瓶颈，即使是联邦政府支持的数量相对有限的细胞系也无法广泛使用。 对于为什么会这样，PI有许多假设。 瓶颈可能取决于现有的联邦规则。 另一种可能性是各种科学和技术因素。另一个是支离破碎的州级制度：在极端情况下，州法律禁止任何使用人类胚胎材料的研究。 但瓶颈也可能是由于创新的传播方式：小初始差异（在可访问性，易用性，或技术补充的可用性，如已知的试剂和实验室程序）可以导致选择特定材料的回报增加，并最终锁定在一个领域的主导但往往低于标准的技术标准上。这些变化使实验性比较成为可能，从而提供了一个独特的机会，可以系统地分析不同的供资制度、不断变化的政策规定和技术变革对科学实践和成果以及这一新领域的增长轨迹的影响。 研究结果揭示了与新科学领域发展相关的关键社会和制度特征。该项目的研究结果提供了证据，可用于通过记录细胞系的使用和可用性模式、不同创建方法的流行程度以及使用它们的研究类型来帮助政策制定者。 该研究促进了可持续的，有效的政策的发展，使广泛获得和使用遗传多样性，道德上负责任的细胞培养。

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.