search. For example, does an IRB have sufficient expertise in child health to review the kinds of pediatric research protocols that come before it? Is sufficient expertise in child health present on the safety monitoring boards that monitor injuries and other adverse events that occur during the course of a study? Are information systems organized to report separately on protocols involving children?

The recent report Integrity in Scientific Research observed that the research environment, like any system, includes both “variables and constants” and that “the most unpredictable and influential variable” is the individual investigator (IOM/NRC, 2002, p. 26). Each investigator’s professional integrity is shaped by his or her education, culture, and ethical upbringing and is, inevitably, unique. This means that “the constants” operating in behalf of ethical conduct must come from the institutions and larger systems within which investigators work.

One advantage of considering human research protections in a systems framework of shared responsibilities is that it reduces the temptation to focus too narrowly on discrete individuals and organizations and, thereby, to underrate or ignore the diverse forces that powerfully shape their behavior. Figure 1.1 depicts, in highly simplified form, a program of human research protections operating within a larger social, economic, and political environment and a surrounding ethical culture and climate.

As shown in Figure 1.1, a significant system component is a human research participants protection program. A program in this sense is not a discrete IRB but, rather, a variable mix of individuals, organizational units, and organizations (see the discussions in IOM, 2001 and 2003a). The core functions of such a human research participants protection program include review of research protocols for ethical and scientific soundness, monitoring of participant safety appropriate to the risk presented by individual studies, ethical interactions between investigators and research participants, and arrangements for assessing compliance with rules and policies and improving program performance.

The specific components or modules of a human research protection program may differ depending on the characteristics of a particular study (e.g., the setting or the risks to participants), its sponsorship, and other factors. A program consists of the collection of organizational structures, policies, and procedures that apply to a particular research protocol or group of protocols. Thus, a program may include a body appointed to monitor data related to research participant safety if a study presents appreciable risk to participants, but such a body will not be part of a minimal risk study. (See discussion in Chapter 3 of data and safety monitoring boards and data monitoring committees.)

For complex multicenter clinical trials, the human research protection program may involve multiple research organizations, IRBs, research teams,



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