One committee suggestion for ensuring that accountability within any approved human research study is clearly articulated is the use of a document that explicitly defines the roles and responsibilities of all relevant parties at various stages of a protocol’s development. Such a document could be very useful to the IRB and others in the program as a tool for confirming that the necessary protection elements are in place within an HRPPP for a specific protocol. One template that could be adapted to address the protection needs within individual protocols is presented in Appendix C, along with several case scenarios developed to illustrate how this template might be used to establish protocol-specific accountability plans.
Within an organization such as an academic institution, the roles and responsibilities would likely remain the same for most single-site investigator-initiated trials, with the specific protection-related tasks determined by the degree of risk posed and protocol methodology. In contrast, the roles and responsibilities in large multicenter trials involving both private industry and academic institutions may vary widely from study to study. Again, the composition of the program for any protocol may be distributed among different elements or organizations as long as all parties clearly understand and meet their respective protection obligations.
A key to assuring accountability throughout the conduct of human research is efficient and frequent communication among all components of the protection program. This process is particularly critical when program components are geographically dispersed (i.e., multisite studies). HRPPPs will benefit from improved electronic linkages that will expedite communication and facilitate a “seamless” system of protections. For example, an electronic version of the template presented in Appendix C could be used to track the completion of tasks by each component of the HRPPP for a particular research study.
Two fundamental assumptions should underlie the interactions among program elements: 1) sound research is necessary for improvement of the human condition and 2) all research must be conducted in an ethical manner. Communication between the organizations sponsoring, reviewing, and conducting human research and the overseeing regulatory agencies provides the primary framework within which protections are provided.5 Thus, programs should establish mechanisms for ensuring that effective communication occurs between all entities. Just as individual program components are accountable to the senior leadership of research organizations, the overall program is accountable to the appropriate federal oversight office(s). Based upon their research portfolios, educational institutions may be ac-