Regulatory Knowledge Support: What next? Bernard Lo, M.D., Deborah Grady, M.D., Peter St. Wecker, Ph.D. July 28, 2011
Things we’ve done RKS consultations Marlene Berro Contracts and Grants Erik Lium IRB electronic submissions John Heldens
Things we’re still doing Multi-site IRB review Alan Venook John Heldens Lisa Denny
Things we’d like to do Revamp regulatory training Responsible conduct of research online CHR training on line?
Things we’d like to do Process mapping for research Identify steps in research process Remove those that don’t add value Aim for simultaneous (parallel) processes Human Relations?
Things we’d like to do Proposed revisions to regulations for human subjects research One IRB reviews multisite studies Minimal risk research excused from IRB review Improving consent process Simplify, shorten consent forms Assess comprehension of participant
Things we’d like to do Proposed revisions to regulations for human subjects research Consent for biospecimens for future research Data security standards
ANPRM poses 70 questions:How can CTSI help? Open forum Responses from UCOP CTSI national program Professional societies Community partners