Information of two kinds can better guide decisions about improving HRPPPs in general and the role of accreditation in particular. First, a research program is needed both to establish the current baseline (current practices in human research) and to study ways in which that baseline might be improved. Second, the committee believes that an evaluation process that is independent of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the National Committee for Quality Assurance (NCQA), and any other accreditation bodies that may emerge will be necessary. The committee recommends that federal agencies with a track record of evaluating HRPPPs, such as the U.S. Department of Health and Human Services (DHHS), monitor the accreditation pilot programs.
Recommendation 10: Begin Collecting Data and Assessing Impacts of Accreditation Now
DHHS should commission studies to gather baseline data on the current system of protections for human participants in the research that it oversees and to assess whether the system is improving over time.
Baseline data are needed on the following:
a taxonomy of research institutions: the number of institutions conducting research with human participants and the number of studies of different types (e.g., clinical trials, surveys, student projects, and behavioral studies) approved by their HRPPPs;
a taxonomy of IRBs: the number of IRBs and what fraction of them are primarily devoted to studies of particular types;
a taxonomy of studies with humans: the number and distribution of investigations with humans under way by type of study, for example, clinical trials of various stages, observational studies, cross-sectional and longitudinal surveys, and social science experiments;
the number of people involved in research and, among them, how many are involved in research with more than minimal risk;
the fraction of studies with more than minimal risk that have formal safety monitoring boards and how (and how well) those boards operate;
the type and number of inquiries, investigations, and sanctions by the Food and Drug Administration and the Office for Human Research Protections; and
the type and number of serious or unanticipated adverse events attributable to research.
DHHS should also commission studies of how the databases for existing clinical trials and other research resources could be used to assess how well the system of research protections is operating and, specifically, whether accredita-