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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
ELEMENTS OF AN ACCREDITATION PROCESS
At the beginning of the 20th century, a private voluntary accreditation system lifted American medical education out of mediocrity. In the early 1900s, the quality and content of medical education were wildly variable. Harvard University, the University of Pennsylvania, and The Johns Hopkins University had instituted formal curricula and linked medicine to science, but “the ports of entry into medicine were wide open, and the unwelcome passed through in great numbers “ (Starr, 1982, p. 116). The American Medical Association (AMA) appointed individuals from esteemed medical schools to the Council on Medical Education, and these individuals began to grade medical schools. A 1910 report by Abraham Flexner went a step further, arguing that the strategy for improving the system of medical education was by elevating schools to the Hopkins standard, and “the AMA Council effectively became a national accreditation agency for medical schools, as an increasing number of states adopted its judgments of unacceptable institutions” (Starr, 1982, p. 121).
Since then accreditation programs have been used to enhance quality in many different contexts. The improvement of care for laboratory animals involved in research has been widely attributed to the joint action of federal law, particularly the Animal Welfare Act of 1966, and the private accreditation system through AAALAC. Private accreditation has become pervasive in higher education and professional schools, hospitals and health care facilities, and managed care organizations. More recently, a long-standing and rigid regulatory framework for opioid treatment programs has begun to shift to a more flexible, clinically oriented accreditation process, even though it is still formally under federal regulation. An accreditation process is now proposed for HRPPPs.
The models described above have in common several elements that are expected to be part of emerging programs for accreditation of HRPPPs:
a national organization that can mediate the accreditation process;
an application process and set of threshold criteria by which organizations are eligible to apply for accreditation;
a process of self-evaluation;
an external evaluation process, including site visits by external accreditors;
an appeals process for accreditation determinations;
a repeat cycle of self-evaluation and external evaluation; and
a set of standards by which HRPPPs can be measured.
The central focus of this report and the following chapter is accreditation standards, the benchmarks by which accreditation programs measure achievement. Standards are only part of a process, however. This chapter describes the accreditation process for which standards are a tool.