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  • IRB: ETHICS & HUMAN RESEARCH

The Presidential Bioethics Commission’s Database of Human Subjects Research

In its recent report, Moral Science: Protecting Participants in Human Subjects Research, the U.S. Presidential Commission for the Study of Bioethical Issues highlighted a blind spot regarding human subjects research supported by the federal government: there is no readily available, comprehensive listing of such research. Nor are there lists of studies supported by individual federal departments and agencies that, together, provide a complete picture of federally supported research with humans.1

Faced with a presidential 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,”2 the commission recognized the need to collect systematic data to define the scope and volume of “scientific studies supported by the Federal Government.” Without such data, any assessment of the extent to which research participants are protected would be incomplete at best and biased at worst.

The Commission’s Data Collection and Database

The commission collected five years (FY06–FY10) of project-level data from the 18 federal departments/agencies that have adopted the Common Rule and are thus likely to conduct research with human subjects.3 Project-level data included study title, number and location of sites, number of research participants, and funding information. The commission developed a uniform tool for data submission and analyzed the data to present the most complete picture available of the landscape of U.S. government-supported human subjects research.

The commission described its methods and analyses of these data in the Moral Science report. And, on March 15, 2013, the commission posted the full database.4 The database, which comprises more than 250,000 project entries, can be downloaded along with a data dictionary that defines the data fields and distinguishes information provided by departments and agencies from commission-derived information (i.e., obtained in the course of data cleaning and analyses).

What is unique about this database is its breadth of coverage of the types of research supported across the U.S. government. Although ClinicalTrials.gov collects detailed information about clinical trials, it does not extend to other types of research with humans—for example, social, behavioral, and economic research. ClinicalTrials.gov also does not collect funding information.5 Moreover, department/agency-specific systems, like the Department of Energy’s Human Subjects Research Database,6 only provide a partial picture of the government’s human research portfolio. Although in some ways the commission’s database is not as detailed as ClinicalTrials.gov or the Human Subjects Research Database, it exclusively covers research projects supported by agencies such as the Department of Education and Department of Justice that are not captured fully in existing databases.

The Commission’s Analyses and Possibilities for Future Research

Assisted in its empirical work by the Empirical Advisory Group (comprising commission members and outside experts), in Moral Science the commission describes summary information that played a key role in helping to meet the presidential charge. For example, information is provided about temporal trends in the number of projects, locations of projects, and extramural funding amounts.7The commission found that the federal government supports tens of thousands of human subjects research projects every year; indeed, it supported over 55,000 projects in 2010 alone. The Department of Health and Human Services (HHS) supported the most projects, and, within HHS, the National Institutes of Health supported the most projects of any operating division. In addition to HHS, the Department of Veterans Affairs, Department of Defense, National Science Foundation, and Department of Education comprised the top five human research supporters (by number of projects) in 2010. And, as indicated by the varied agencies supporting human subjects research, these projects go well beyond biomedical research and into fields such as education and engineering.8

The commission, however, only scratched the surface of this rich database and did not have time to undertake additional analyses that promise to provide important information. For instance, it would be informative to review text fields (e.g., study title and abstract) to determine more finely the type of research undertaken in each project or whether vulnerable populations were involved. Similarly, a comparison of the database to existing databases like ClinicalTrials.gov could yield an enhanced understanding of the relationships between federally supported clinical research and clinical research not supported by federal departments and agencies. Moreover, with limited time to respond to the presidential charge, the commission did not undertake additional empirical research to assess directly the adequacy of human subjects protections—for example, by conducting stakeholder interviews or site visits for a subset of federally supported projects. Nonetheless, the database provides a solid starting point from which to understand and assess the ethics of research with human subjects.While it provides robust data for review and analysis, the database is static and will not be updated by the commission. The commission nonetheless recognized the importance of ongoing public access to similar data to enhance transparency and improve government accountability. In Moral Science, it recommended that federal departments and agencies assume responsibility for the task. Specifically, the commission recommended that departments and agencies either develop or improve their own systems for tracking human research projects or use existing trans-agency systems to make available a core set of project-level data. The commission also recommended that the Office for Human Research Protections or another central organizing agency maintain a Web-based portal linking to each department or agency system.9 This recommendation complements other recent efforts to increase public access to government information and research data.10

Some departments/agencies already have tracking systems in place, while others are taking steps to respond to the commission’s recommendation.11Nevertheless, centralized access to basic data aboutallfederally supported human research is still several steps away: each department or agency must adopt an electronic system to collect basic project-level data; it must make these data publicly available; and a central organizing agency must develop a Web-based portal linking to each department or agency’s system. Until the commission’s recommendation is fully realized, its database can provide a stepping-stone for considerable new insights into the landscape of federally supported research and suggest roads for further understanding the systems in place to protect research participants.

Disclosure

Jeremy Sugarman served as a Senior Advisor to the Presidential Commission for the Study of Bioethical Issues during the data collection described in this manuscript.

Michelle Groman, JD,is Associate Director at the Presidential Commission for the Study of Bioethical Issues, Washington, DC, andJeremy Sugarman, MD, MPH, MA,is Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Institute of Bioethics, Department of Medicine, and Department of Health Policy and Management, Johns Hopkins University, Baltimore, MD.

References

1. Presidential Commission for the Study of Bioethical Issues.Moral Science: Protecting Participants in Human Subjects Research. Washington, DC: Presidential Commission for the Study of Bioethical Issues, 2011, http://bioethics.gov/cms/sites/default/files/Moral%20Science %20June%202012.pdf.

2. Memorandum from President Barack Obama to Dr. Amy Gutmann, Chair, Presidential Commission for the Study of Bioethical Issues. November 24, 2010,http://bioethics.gov/cms/sites/default/files/news/Human-Subjects-Protection-Letter-from-President-Obama-11.24.10.pdf.

3. Code of Federal Regulations. Protection of Human Subjects. 45 CFR 46, Subpart A; see ref. 1, Presidential Commission for the Study of Bioethical Issues 2011.

4. March 15, 2013,http://www.bioethics.gov/cms/node/756.

5. Food and Drug Administration Amendments Act of 2007, sec. 801, 42 USC 282(j). 2007.

6.http://www.orau.gov/hsrdreport.

7. See ref. 1, Presidential Commission for the Study of Bioethical Issues 2011.

8. See ref. 1, Presidential Commission for the Study of Bioethical Issues 2011.

9. See ref. 1, Presidential Commission for the Study of Bioethical Issues 2011.

10. Memorandum from President Barack Obama to Heads of Executive Departments and Agencies. January 21, 2009,http://www.whitehouse.gov/the_press_office/Transparency_and _Open_Government/; see ref. 1, Presidential Commission for the Study of Bioethical Issues 2011.

11. Drummond K. Military plans mega-database to track human studies.ForbesAugust 13, 2012,http://www.forbes.com/sites/katiedrummond/2012/08/13/military-human-studies/.