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Geoffrey Lomax, "Considerations for the Use of Bio-Specimens in Induced Pluripotent Stem (iPS) Cell Research"

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From the event "Specimen Science: Ethics and Policy Implications," held at Harvard Law School on November 16, 2015.

This event is a collaboration between The Center for Child Health and Policy at Case Western Reserve University and University Hospitals Rainbow Babies & Children’s Hospital; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; the Multi-Regional Clinical Trials Center of Harvard and Brigham and Women's Hospital; and Harvard Catalyst | The Harvard Clinical and Translational Science Center. It is supported by funding from the National Human Genome Research Institute and the Oswald DeN. Cammann Fund at Harvard University.

For more information, visit our website at http://petrieflom.law.harvard.edu/events/details/specimen-science-ethics-and-policy

Published in: Healthcare
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Geoffrey Lomax, "Considerations for the Use of Bio-Specimens in Induced Pluripotent Stem (iPS) Cell Research"

  1. 1. Senior Officer California Institute for Regenerative Medicine DATE GOES HERE Considerations for the Use of Bio- Specimens in Induced Pluripotent Stem (iPS) Cell Research Specimen Science: Ethics and Policy Implications Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Cambridge MA November 16, 2015 Geoffrey Lomax Dr. PH
  2. 2. Specimen Science: Considerations for Induced Pluripotent Stem Cells (iPSCs) • The value of iPSCs for addressing patients unmet medical needs • Considerations for the collection and management of bio-specimens and derived cell lines: o Donor re-contact / return of research finding o Withdrawal from research o Sensitive uses of cells
  3. 3. Our Mission Accelerating stem cell treatments to patients with unmet medical needs. MISSION
  4. 4. iPSCs Tools for Addressing Patients Unmet Medical Needs Heart cells Brain cells Gut cells Liver cells Insulin-producing cells Skin Cells Reprogram Blood hiPSC
  5. 5. iPSCs Tools for Disease Modeling and Drug Discovery Sick brain cellsNeurodegenerative disease Model disease Clinical trial Patients OH O O O Drug development hiPSC Drug Screen Repository Candidate drug
  6. 6. CIRM iPSC Banking Initiative Seven Tissue Collection ProgramsAcross Four Universities: One hiPSC Derivation Site: Repositoryand Distribution:
  7. 7. Donor Re-contact / Return of Research Findings Criteria for return of results in genomic studies not satisfied: • Genetic Instability: iPS cells have demonstrated significant genetic variability upon reprogramming and subsequent culture. • Validation Criteria: Protocols do not exist to harmonize results from research laboratories utilizing iPS cell lines with clinical (Clinical Laboratory ImprovementAmendments (CLIA)-approved) laboratories necessary to validate findings. • EtiologicComplexity: Genetically complex conditions, such as neurological and heart disease, result from a poorly understood confluence of pleiotropic gene effects.
  8. 8. Donor Re-contact / Return of Research Findings But we do suggest: In the future, we may want to contact you to (1) obtain additional samples or updates on your health or (2) inform you about significant new findings that may impact you, or (3) to get your permission for research not covered in this consent form. Donor consents to re-contact
  9. 9. Withdraw From Research Donorsare informed:  Primaryspecimens (skin blood) may be de-identified OR destroyed  The code linking the iPSC line to the donor can be removed  Once derived the iPSC line cannot be withdrawn
  10. 10. Sensitive Uses of iPSCs  Separate donor approval required for gamete or embryo research
  11. 11. Educational Materials Supplement Donor Consent
  12. 12. Use of Existing Bio specimens in iPSC Derivation
  13. 13. Senior Officer California Institute for Regenerative Medicine DATE GOES HERE Considerations for the Use of Bio- Specimens in Induced Pluripotent Stem (iPS) Cell Research Specimen Science: Ethics and Policy Implications Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Cambridge MA November 16, 2015 Geoffrey Lomax Dr. PH

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