Less than a year after its release, the Commission’s report, Moral Science: Protecting Participants in Human Subjects Research, is having a noteworthy impact in the research community. Recently, stakeholders have taken concrete steps to implement two of the Commission’s recommendations, namely, those concerning accountability through public access and promoting community engagement.
As part of its thorough review of current research protections in 2011, the Commission sought basic data about government-supported human subjects research from eighteen federal agencies. The Commission quickly learned, however, that agency systems to track human subjects research vary widely – some agencies could readily provide the requested information, while others took several months to provide sometimes incomplete responses. Informed by this experience, the Commission recommended that federal agencies make publicly available basic data about human subjects research projects to improve accountability in federally supported research.
In August, the Department of Defense took action toward accomplishing that goal. The Department announced that it is developing a unified web-based system to track all of its human subjects research projects. It cited the Commission’s Moral Science report and noted that this new database will help alleviate much of the difficulty the Department faced in preparing its response to the Commission’s data request. Although this database is currently being designed as an internal system, the Department has left open the possibility of making it public (http://www.forbes.com/sites/katiedrummond/2012/08/13/military-human-studies/).
The Commission also recognized the role of community engagement in furthering the protection and ethical treatment of research participants. The Commission pointed to the UNAIDS/AVAC Good Participatory Practice Guidelines as a promising framework for community engagement practices. These guidelines, however, were developed specifically for HIV-prevention research, and the Commission recommended that they be further evaluated and specified to provide a standardized framework applicable to human subjects research more broadly. One such specification recently occurred. A working group of the Critical Path to TB Drug Regimens initiative adapted the Good Participatory Practice Guidelines to tuberculosis drug trials (http://cptrinitiative.org/2012/10/01/launch-of-the-good-participatory-practice-guidelines-for-tb-drug-trials/).
We continue to monitor responses to the Moral Science report with interest. In its final point in the report the Commission recommended that the government respond directly to the Commission’s recommendations, either with changes to the status quo or reasons for maintaining it.