and expected conduct (see Recommendation 2.4). The sponsor also shares some responsibility for ensuring that the research organization it engages employs only qualified personnel and has the resources to conduct the study. The stimulation of a high-quality research culture is one area in which the committee believes that developing accreditation programs may offer a significant contribution by focusing an organization’s attention on QI and specific resource needs.10 The committee suggests in Chapter 6 that adding a standard within accreditation programs directed at establishing and identifying accountability for specific protection functions would facilitate performance improvement within accredited protection programs (see Recommendation 6.3).

Provide Sufficient Resources

Protection programs should have the dedicated financial and nonfinancial resources needed to implement and sustain a sufficiently robust system of protection, including adequate space, equipment, and personnel, in addition to an appropriate annual budget. Research organizations, sponsors, and investigators agree that funds should be allocated for investigators and staff and to cover the out-of-pocket costs of research, but no satisfactory agreement has been reached regarding how to fund specific protection activities.

Unfortunately, few published data quantify the costs of ethics review and other protection activities (such as safety monitoring); thus, it is difficult to determine reasonable funding levels for offices or the individuals involved in the process.

Adequate resources are essential for the protection of research participants and are a real part of the cost of doing research. Therefore, to assure successful protection programs, public and private research sponsors and research organizations should partner to develop benchmark guidelines for critical functions and to provide the necessary funding sources (see Recommendation 2.3).

Refocus Institutional Review Board Mission on Ethical Review of Protocols

As the demands on the research oversight system have grown, so has the reliance upon IRBs to accomplish all protection tasks. This is a disser-

10  

Accreditation efforts have been undertaken by AAHRPP and NCQA. The progress and potential contributions of accreditation programs are discussed in Chapter 6.



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