. "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
tion services. Because of the many competing demands on all parties involved (i.e., those developing the protocols as well as those reviewing them), these educational programs should be efficient as well as effective.
It should be noted, however, that the effectiveness of Continuing Medical Education programs has been in question (Davis, et al., 1995; Davis and Taylor-Vaisey, 1997; Thomson O’Brien, et al, 2002), and that although education is important, other program elements also are essential in ensuring that participants are protected and research is conducted ethically. Ideally, the cumulative effect of a comprehensive education program and the inculcation of an ethically sound research culture will enhance the performance of all parties involved in human research, thereby improving the protection participants receive.
An evolving core body of knowledge and best practices that focuses on ethical considerations, contextual concepts and issues, applicable regulations, and case law should be established. OHRP, in consultation with other federal agencies, should pursue efforts to facilitate the development and dissemination of this knowledge and best practices. The pertinent content for education programs at the various levels of the HRPPP is discussed below.
Organizational Leadership. Consistent with Recommendation 2.2 regarding ultimate accountability for human research protections, those within the administrative structure who have oversight responsibility for program functions should be knowledgeable about the ethical tenets underlying an effective program. Box 2.2 describes the type of information that those who oversee program activities should have and suggests that appropriate professional organizations work together to develop the relevant curriculum.
Investigators. Research investigations that enroll participants require a specialized knowledge base that goes beyond that provided through traditional scientific training. Research investigators and key personnel should be versed in the ethical foundations underlying research participant protection, the regulatory requirements for carrying out such research (including confidentiality issues), the relevant research administration and management skills (Phelps, 2001), and, as applicable, GCP and medical ethics. Failure to understand the complexities of conducting research with humans may lead to serious errors in the implementation of a study that would compromise the safety of the participant(s) and/or the integrity of the data and its subsequent interpretation, possibly exposing participants to unnecessary risks, however minimal the risks may have been.
Until recently, few research investigators have received formal education in the human participant protection issues underlying the theory, de-