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Responsible Research: A Systems Approach to Protecting Research Participants
sions. Undoubtedly, within the confines of academic settings there are likely to be many instances for which the assignment of responsibilities would remain constant, and template forms could be standardized accordingly.
An example of one such template is included in this appendix to illustrate the committee’s conception of such a document. This example is oriented toward clinical trials, and it presents several case scenarios to demonstrate the variety of partnerships that are possible within this one research domain. Because it is not possible to include all possible collaborative arrangements among clinical investigators, private industry, and federal or private funding sources, these scenarios attempt to embrace a range of illustrative potential collaborative relationships.
When an HRPPP is assembled to review and monitor any given protocol, accountability for the required participant protection functions must be clear. An individual representing the research organization must meet with the Principal Investigator (PI) or sponsor to identify all organizations potentially participating in study conduct that may play a role in the protection of research participants. Responsibilities for tasks ranging from protocol review to ongoing monitoring should be assigned before study initiation, and for every project conducted, an official with overall responsibility for the participant protection program should be identified. The template presented in this appendix is provided as an example of an internal tool that can be utilized by a program in establishing a hierarchy of accountability. Research organizations may or may not choose to make such documents available for public review (i.e., by participants already enrolled or considering enrollment in a study), although the document may also serve as a useful communication tool for external as well as internal purposes.
It should be emphasized that these templates are not intended to become an example of documentation without function. The potential utility of this tool lies in its explicit delineation of responsibilities in a consistent format that is accessible to all elements within a particular HRPPP. It also provides an instrument that may be useful to safety monitoring, auditing, and even HRPPP accreditation activities.
CASE SCENARIO #1 – A SINGLE-SITE, INVESTIGATOR-INITIATED, FEDERALLY FUNDED STUDY
A clinical investigator on the faculty of the Medical University of America (MUA—the sample academic institution in this case scenario) receives funding from a federal agency (e.g., the National Institutes of Health [NIH]) to conduct a single-site study (at MUA) evaluating a new indication