and recommendations regarding the need to compensate participants for research-related injury, a topic that has been discussed at the national level for decades but never adequately addressed in practice. This chapter also highlights the need for continuous quality improvement (CQI), a critical means for ensuring that the various Human Research Participant Protection Program (HRPPP) functions are performing at optimal levels, and the potential of accreditation programs.


Quality improvement (QI) in the context of health care involves individuals working together to improve systems and processes with the intent of securing the best possible outcomes. A catch phrase used in the quality field is, “If you always do what you always did, you will always get what you always got.” The premise, of course, is that standing pat is not a viable strategy when better performance is demanded. “Zero defects” may be a reasonable description of public expectations of protection programs, but it is far from a reality in current practice, in perception or in fact. Formal, systematic QI methods are widely used in the health care system and are at the heart of health care accreditation. One of the promises of accrediting protection programs previously highlighted by this committee is the much greater visibility of and attention to QI in participant protection efforts. Programs seeking accreditation will have to learn and implement this management approach.

However, even in the absence of accreditation preparation, programs can and should work on CQI of their program. Elements of CQI include the following:

  • identifying standards for the program,

  • benchmarking performance against that of leading programs,

  • searching for best practices to accomplish program functions and processes,

  • adapting identified best practices to the individual institution’s or sponsor’s situation,

  • performing self-assessments to determine the degree to which these processes are being successfully implemented,

  • using continuous improvement techniques to further refine the best practices, and

  • disseminating these refinements to aid other programs in the research community through journal articles and other channels.

Best practice in this context should not connote a belief that no further performance gains are possible—or expected. This term is used in QI to

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