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

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. 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. Our Mission
Accelerating stem cell
treatments to patients with
unmet medical needs.
MISSION

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. 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. CIRM iPSC Banking Initiative
Seven Tissue Collection ProgramsAcross Four Universities:
One hiPSC
Derivation Site:
Repositoryand Distribution:

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. 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. 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. Sensitive Uses of iPSCs
 Separate donor approval required for gamete or embryo
research

11. Educational Materials Supplement Donor
Consent

12. Use of Existing Bio specimens in iPSC
Derivation

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