program is functioning adequately. The only mechanisms currently available for assessing such compliance include compliance assurances issued by DHHS and several other federal departments, site inspections of IRBs conducted by FDA, other types of site inspections for participant protection, and institutional audits. Some institutions have taken steps to establish ongoing mechanisms for assessing investigator and/or IRB compliance with regulations.11 However, institutions vary considerably in their efforts and abilities to monitor investigator compliance, from those that have no monitoring programs to those that conduct random audits. Assessing the performance of investigators and all program entities is an important part of protecting research participants and should be considered a serious responsibility of each protection program.

SUMMARY

A number of core systematic and complementary functions are essential to the protection of research participants and can be provided through a protection program that ensures that the research is conducted ethically. The entity within the protection program that carries out each function may vary according to the specifics of the protocol, but it is essential that some component within the established program have the clearly delineated responsibility for each core function in every study. To accomplish these essential functions, those at the highest levels of organizations that participate in human research should ensure that explicit lines of authority and responsibility are established and that a culture of ethics is pervasive throughout the organization. In addition, the research organization should ensure that those conducting and overseeing research with humans have the appropriate ethical and regulatory knowledge and that continuing education programs and consultative services are available to supplement basic education. Sponsors are obligated to effectively partner with research organizations to provide adequate resources for all elements of protection programs. Protection programs should be structured so that information regarding their general operations and specific protocol-related activities is accessible in a format useful to the public and, in particular, to current and potential research participants. In addition, research organizations and sponsors should ensure that all functions are carried out by responsible parties in order to fully protect research participants.

11  

Albany Medical Center; University of California, San Diego; University of Pennsylvania; University of Texas Medical Branch; and the Fred Hutchinson Cancer Research Center have such quality assurance procedures in place.



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