Ethics & Regulatory Subcommittee

MISSION: Ensure that RCMI CC activities meet and exceed standards for regulatory compliance, placing particular emphasis upon meeting federal requirements and addressing privacy issues for health and research-related electronic records at the clinical sites.

The Ethics & Regulatory subcommittee is focused on moving the IRB harmonization efforts for the Network’s 18 RCMI sites, and will continue to implement information sharing opportunities that address compliance areas including IACUC, Biosafety and Research Integrity.

Recent activities

• Implementing IRB Harmonization that will expedite the approval and implementation of multi-site research studies
• Developing RCMI CC IRB Standard Operating Produce (SOP)
• Devising plan to test authorization agreements using the Small Grants Awards Project
• Implemented RCMI CC IRB Café (Compliance Café) webinar series to expand understanding of compliance issues

Abstract : Establishment of IRB Reciprocity in a Multi-Center Translational Research Network. Junko Nishitani, PhD; Zoe H. Hammatt, JD, Mphil; John C. Smith, MSW, CIM, CIP; Brenda J. Klement, PhD; Stephen O. Sodeke, PhD, MA, accepted for display as a poster at PRIM&R’s 2013 Advancing Ethical Research Conference, November 7-9, Boston, MA.