vided through the indirect rate attached to the direct costs of research. Due to the infrastructure nature of HRPPP activities, officials claim that they have already paid for this review, as it is a cost that transcends individual projects. However, not all research projects involve humans, and even in the case of human research, the extent of the review and ongoing monitoring will vary widely according to the risks presented by a specific protocol. Consequently, the costs per project are discrete.
In response to this argument regarding indirect cost recovery, academic institutions counter that the limited overhead funds available for facilities and administrative costs must be used to meet a number of competing needs. This is especially challenging for academic medical centers in the current era of managed care, in which payments for patient care have markedly diminished, restricting their ability to subsidize research programs at past levels. However, the committee asserts that because sufficient resources are fundamental to implementing a robust participant protection program, providing the needed funds is a real cost of doing research.
Private foundations, which frequently provide much lower indirect costs than federal grants, should also provide money for HRPPP review within their yearly project budgets. Ethics review of investigator-initiated protocols that receive only internal funding should be paid for by the academic department or the institution supporting the research. If an organization cannot provide the resources for the protections, it should not conduct the research.
Payment schemes can be determined by attempting to calculate the actual cost of the time and effort involved in the review process or by agreeing to a fixed percentage of directly expended research dollars. In either event, a robust quality assurance process should determine whether the amounts committed are sufficient to accomplish the required tasks (see Chapter 6). Institutional funding might come from a variety of sources. IRBs could charge for their services, as many already do (IRB teleconference8). Overhead funds allocated through industry grants and federal indirect costs could include a specific percentage designated for such activities.
The committee commends NIH for beginning to address this fundamental need through its Request for Applications to support one-time infrastructure building activities and its ongoing grant mechanisms in research ethics, informed consent, and clinical research education programs (NIH, 2001; NIH, 2002b,c). This most recent initiative is soliciting creative solutions to improve HRPPP infrastructure, such as better methods for ongoing monitoring of adverse events or better software systems for tracking clinical trials within a program, that will benefit protection efforts across the
See Appendix A, “Methods,” for more information.