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CITI ESCRO Module Update May 21, 2009

CITI ESCRO Module Update May 21, 2009. Gwenn Oki Mina Busch Jeff Cooper Iekuni Ichikawa Ko Momotoni Ernest Prentice. Audience. IRB Members and Staff ESCRO Committee Members Investigators. Learning Objectives. MODULE 1

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CITI ESCRO Module Update May 21, 2009

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  1. CITI ESCRO ModuleUpdateMay 21, 2009 Gwenn Oki Mina Busch Jeff Cooper Iekuni Ichikawa Ko Momotoni Ernest Prentice

  2. Audience • IRB Members and Staff • ESCRO Committee Members • Investigators

  3. Learning Objectives MODULE 1 • Provide the historical background and the basic science associated with human embryonic stem cell research. • Define terms related to stem cell research. (Add table that compares and contrast different cell types.) • Decribe the methods of hESC derivation and use. MODULE 2 (After ~July 7, 2009) • Describe the history of federal regulation of hESC derivation and use • Address final NIH requirements on human stem cell research • Articulate the basic issues and considerations for IRB and ESCRO committee reviews.

  4. Developing Module 2After July 7, 2009 • Draft NIH Guidelines for hESC research issued April 23, 2009. • Comment period closed May 26, 2009. • NIH has received approximately 9,000 comments. • Final Guidelines are due by July 7, 2009.

  5. Developing Module 2After July 7, 2009 5. Current draft guidelines are highly restrictive, e.g., existent human embryos cannot be used to derive SCs with federal funds. 6. Once the SCs are derived then NIH funding can be used for research purposes with comprehensive documentation. • Some lawmakers favor more expansive guidelines and may attempt to overthrow the Dickey-Wicker amendment.

  6. Developing Module 2After July 7, 2009 8. The ESCRO Working Group and content author recommends waiting until after July 7 when more information about federal restrictions will be available. • It is logical to have a separate module on federal requirements, IRB and ESCRO review, and ethical considerations.

  7. Conclusion POST MODULE 1 • Establish objectives • Edit text • Edit quizzes and add feedback • Ready to go tomorrow

  8. Module 2 Development • From content experts--Edit current text on human subject research issues regarding human stem cell research. • Incorporate NIH draft guidelines on informed consent and documentation. • Add relevant guidelines from the Nat’l Academy of Science and the Int’l Society for Stem Cell Research (ISSCR). • Target date (July 1, 2009) for draft of IRB/ESCRO review considerations • Modify draft when final NIH guidance is issued.

  9. Thank you.

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