Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

INTRODUCTION, BACKGROUND, AND DEFINITIONS 35 What Is a Human Research Participant Protection Program? The current framework for HRPPPs grew out of research conducted by a single investigator at a single institution that could assign protocol review to a single IRB. With the expansion of the scope and scale of research and particularly the expansion of privately funded research, a growing fraction of research falls outside this research institution framework. If the research design comes from a central sponsor—whether it is an agency gathering statistical data on the national population, an NIH institute, or a private firm testing a drug or a device—the participants in a trial may be drawn from dozens or even hundreds of places. In addition, the study may involve many research institutions and go outside traditional research sites into clinics and community hospitals or even (as in the case of surveys) into the general population. The power of each individual institution and its associated IRBs is limited to that institution. Under the current system, each IRB makes a separate and distinct determination that results in approval, disapproval, or modification of a research study. Collectively, the IRB rulings for the same protocol may result in disparate or even contradictory findings. The committee's first task was to make recommendations about accreditation standards for “human research participant protection programs,” a term by implication (tautologically) defined to be the unit of accreditation. As discussed in Chapter 3, the proposed NCQA and PRIM&R standards essentially assume the unit of accreditation to be • VA facilities to be accredited by NCQA; or • research institutions that conduct biomedical research and that have one or more IRBs. This committee uses the term to embrace a set of functions and institutions somewhat wider than those contemplated in the draft standards to include boards that monitor the safety of clinical trials or that report serious and unexpected adverse events that arise from research and also to include research organizations not configured as academic research institutions (Figure 1-1). The key components of HRPPPs are • the organizational units responsible for designing, overseeing, and conducting research (which, for some research, includes research sponsors); • the IRB reviewing that research; • the investigators carrying out the research; • monitoring bodies (including data safety and monitoring boards; ombudsman programs; data collection centers; and reporting mechanisms for adverse events, complaints, and concerns); and • the participants involved in the research. The term HRPPP and the various contexts in which it applies are further discussed below in an effort to clarify the scope of the committee's findings and recommendations.