nisms can ensure participants' safety in ongoing research; (5) the steps that research institutions and their leadership can take to cultivate a culture that puts the safety and interests of research participants foremost; and (6) mechanisms by which research institutions and, where applicable, research sponsors can be held accountable for ensuring sufficient funding, structural support, and professional rewards for HRPPPs.

The NCQA standards, if improved as recommended, could also be used —by NCQA, AAHRPP, or other accreditation organizations—as the basis for the development of accreditation standards for non-VA research organizations.

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 FDA 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 accreditation is having measurable impacts (e.g., by comparing accredited and nonaccredited institutions or by comparing institutions before and after accreditation).

Other studies are needed to bolster the nascent literature on how well research participants understand the studies that they join, which risks matter most



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