Regulatory Knowledge Support: What’s Next?

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Regulatory Knowledge Support: What’s Next?

  1. 1. Regulatory Knowledge Support: What next?<br />Bernard Lo, M.D., Deborah Grady, M.D., Peter St. Wecker, Ph.D.<br />July 28, 2011<br />
  2. 2. Things we’ve done<br />RKS consultations<br />Marlene Berro<br />Contracts and Grants<br />Erik Lium<br />IRB electronic submissions<br />John Heldens<br />
  3. 3. Things we’re still doing<br />Multi-site IRB review<br />Alan Venook<br />John Heldens<br />Lisa Denny<br />
  4. 4.
  5. 5. Things we’d like to do<br />Revamp regulatory training<br />Responsible conduct of research online<br />CHR training on line?<br />
  6. 6.
  7. 7. Things we’d like to do<br />Process mapping for research<br />Identify steps in research process<br />Remove those that don’t add value<br />Aim for simultaneous (parallel) processes<br />Human Relations?<br />
  8. 8.
  9. 9. Things we’d like to do<br />Proposed revisions to regulations for human subjects research<br />One IRB reviews multisite studies<br />Minimal risk research excused from IRB review<br />Improving consent process<br />Simplify, shorten consent forms<br />Assess comprehension of participant<br />
  10. 10. Things we’d like to do<br />Proposed revisions to regulations for human subjects research<br />Consent for biospecimens for future research<br />Data security standards<br />
  11. 11. ANPRM poses 70 questions:How can CTSI help?<br />Open forum<br />Responses from<br />UCOP<br />CTSI national program<br />Professional societies<br />Community partners<br />

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