Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Additional Resources for IRBs


Comment: A few commenters recommended that HHS work to provide additional resources to IRBs to assist them in meeting their new responsibilities.

Response: This recommendation is beyond our statutory authority under HIPAA, and therefore, cannot be addressed by the final rule. However, we fully agree that steps should be taken to moderate the workload of IRBs and to ensure adequate resources for their activities. Through the Office for Human Research Protections, the Department is committed to working with institutions and IRBs to identify efficient ways to optimize utilization of resources, and is committed to developing guidelines for appropriate staffing and workload levels for IRBs.