In order to respond to President Obama’s November 24, 2010 charge “to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government,” the Commission recognized that a critical first step would be to define and understand the landscape of “scientific studies supported by the Federal Government.” Finding no comprehensive publicly available source for this information, the Commission asked the 18 federal departments and agencies that have adopted the Common Rule—and therefore were likely to support scientific studies with human subjects—to provide basic project-level data for department/agency-supported human subjects research in Fiscal Year 2006 to Fiscal Year 2010.
These data, which include study title, number and location of sites, number of subjects, and funding information, were compiled into the Commission’s Research Project Database, and analyzed as part of its Human Subjects Research Landscape Project.
Posted here is the Commission’s analysis dataset, which incorporates minimal data cleaning as detailed in “Appendix II: Human Subjects Research Landscape Project Methods.” Also posted is a data dictionary that defines the dataset’s fields. The data are available in two formats: Microsoft Access and .CSV. The Access file contains the same information as the three .CSV files.
As detailed in the Methods, department/agency-reported information in the dataset was not independently audited or verified. Moreover, the dataset is static; no additional data will be added to it.
For further information, and to read the Human Subjects Research Landscape Project Methods, please see “Appendix I: Human Subjects Research Landscape Project: Scope and Volume of Federally Supported Human Subjects Research” and “Appendix II: Human Subjects Research Landscape Project Methods.”
In order to learn more about how the Human Subjects Research Landscape Project – Analysis Dataset is being used, we would appreciate if those using the data would send a brief email to email@example.com about you, your affiliation, the focus of your analyses, and what products you have developed or anticipate developing, for example, teaching materials or journal articles. Commission staff may follow up with you as opportunities for dialogue and possible collaborations arise. Thank you.
- Download the Data Dictionary.
- Download the dataset as an Access file.
- Download the dataset as a CSV file (3 tables): study record, site record, other federal funding record.