. "2 A Systematic Approach to Human Research Participant Protection Programs." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
late research conducted within their borders that has not been regulated by the federal government. To avoid confusion, the committee encourages the states to do so in a manner that is consistent with the existing federal regulations and with the recommendations and approach offered in this report. The Maryland statute adopted in 2002 provides one such model for this approach (An Act Concerning Human Subject Research—Institutional Review Boards. House Bill 917. General Assembly of Maryland. 2002).3
DEFINING PROTECTION PROGRAMS
Appropriate protection that incorporates the necessary safeguards can most effectively be provided through a program of systematic and complementary functions within which discrete roles and respective accountability are clearly articulated. By definition, “a system is a set of interdependent elements interacting to achieve a common aim…” (Reason, 1990). The critical factor in the effectiveness of any given system lies in how the discrete elements are brought together to achieve their common aim (IOM, 2001b)—in this context, the protection of research participants. Therefore, the form the program assumes is less important than the functions it performs. However, each entity that conducts human research should have a defined set of processes and procedures that are appropriate to its research portfolio. In some cases, this may involve the utilization of an independent IRB or Contract Research Organization, while in other cases, all oversight activities would be performed by “in-house” entities. Regardless of the specific program configurations, the system should be developed to maximize participant protection and minimize unproductive administrative activities and excessive costs.
In its first report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (IOM, 2001a), the committee adopted the term “HRPPP” to embrace a set of functions somewhat broader than is represented in the customary emphasis on the Institutional Review Board (IRB). In that report, the key components of the program were defined as follows:
the participants involved in the research;
the investigators carrying out the research;
the review boards responsible for reviewing the scientific and ethical integrity of the research;
In addition to the Maryland statute, New York, Virginia, and California have extended some level of research participant protection requirements to the private sector at the state level (Schwartz, 2001).