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STANDARDS FOR ACCREDITATION 71 RELATION OF THE STANDARDS TO THE EXISTING REGULATORY REQUIREMENTS Recommendation 6: Base Standards on Existing Regulations Accreditation standards should start from federal regulations for the protection of human research participants but should augment those regulations. The process should be iterative and continual, with evolution of both accreditation standards and the operations of accredited organizations, creating incentives for accredited organizations to improve. Institutions that receive federal funds, that hold an assurance from OHRP, or that seek FDA approval must comply with the Common Rule or parallel FDA regulations. Therefore, it is important that any standards be considered in relation to the regulatory requirements; that is, are they consistent, supplemental, or contradictory? Many commentators at the committee's public forum, as well as committee members themselves, expressed concern that new standards for accreditation could impose another layer of bureaucracy on a system that is already sagging under the weight of paperwork, but would add little to the protection of human research participants (AAPP, 2001; Cornblath, 2001; Oakes, 2001). Three issues to be considered in this context: (1) If the standards are identical to federal regulatory standards, both the institution and the accreditor are performing redundant tasks (presumably largely paperwork, assuming that the institution is already in compliance with the federal regulations) unless some simple means is found for the certification of compliance; (2) If the standards are inconsistent with federal regulations, confusion is likely to result; (3) If the standards are more demanding than federal regulations, a question must be raised: are the additional expectations likely to strengthen protections at a reasonable cost? Accreditation standards should start from the base of regulations governing research with humans. These regulations, in turn, are based on a set of principles for the ethical conduct of research (see Recommendation 4). By the use of standards that emphasize processes of continuous quality improvement instead of an exclusive focus on regulatory compliance (see below), the way may be open to the development of future standards that center on HRPPP performance, in addition to the current focus on documentation. For example, an HRPPP that demonstrates that it can ensure informed consent because it has data showing that participants understand the protocols in which they are enrolled, could begin to supplant or augment paper audits of signed informed-consent forms. This strategy therefore has the potential to introduce the desired flexibility and focus on outcomes into the oversight system. Furthermore, this goal that standards continuously evolve supports the committee's recommendation (Recommendation 2) that HRPPP accreditation bodies be nongovernmental organizations, as the
