Clinical and TranslationalScience Institute / CTSIat the University of California, San Francisco

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?

• 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

Things we’d like to do

• Proposed revisions to regulations for human subjects research– Consent for biospecimens for future research– Data security standards

• Open forum

• Responses from– UCOP– CTSI national program– Professional societies– Community partners

ANPRM poses 70 questions:How can CTSI help?