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You can submit completed HPSCRO applications, amendments, or renewals by either:
Human pluripotent stem cell research may require additional compliance approvals for:
- Human subjects (IRB)
- Animal care and use (IACUC)
- Agreements to share/obtain stem cell lines (MTA)
Be prepared to list related approvals and supply supporting documentation for HPSCRO Committee review.
HPSCRO Application Criteria
The HPSCRO application is designed so that the investigator identifies, explains, and/or describes the:
- Type of cell line to be derived and/or obtained: human embryonic stem cell (hESC) or human induced pluripotent stem cell (iPSC)
- Cell source (e.g., skin tissue, blood, embryo) for derivation, if applicable
- Provider of the cell line (e.g., patient sample, bio-repository, research collaborator)
- Scientific objectives and rationale for the proposed experiments
- Federal funding restrictions, if applicable
- Related compliance requirements (e.g., proper informed consent, IACUC approval)
Overall HPSCRO Consideration - The Science
Provide a brief, but complete, description of the scientific objectives and experiments in the HPSCRO application. In particular the investigator should articulate a compelling rationale for or justification of:
- Using human pluripotent stem cells instead of non-human stem cells
- Using hESC and/or human iPSC instead of other types of stem cells
- Selecting a particular stem cell line(s) to be used
- Creating a new stem cell line, especially an embryonic stem cell line
- Creating or using more than one stem cell line
- Conducting hESC or iPSC research with animals (restrictions apply)
- Conducting hESC or iPSC research in humans (restrictions apply)
When Deriving hESC or iPSC lines at U-M
For derivation, appropriate informed consent for the donation of the embryo or somatic cells is the key factor. Always reference the IRB application (e.g., U-M HUM number or external IRB application) associated with the donation of the embryo or somatic cell on your HPSCRO application. This indicates provenance for the cell line. Overall human subject consent falls within the IRB purview and is addressed through the IRB review process. The HPSCRO Committee works with the IRB to review aspects applicable to the human pluripotent stem cell research.
For iPSC derivation, it is highly recommended to include in the IRB informed consent documentation certain template language that defines iPS cells and explains various concepts (e.g., confidentiality, storage and sharing of lines, etc.). See the HPSCRO iPSC Informed Consent Guidelines in Resources below for details.
When obtaining hESC or iPSC lines from outside U-M
Always reference the Material Transfer Agreement (MTA) associated with the incoming line or source material for derivation of the line on your HPSCRO application. The MTA can be initiated by U-M or by the external party (e.g., researcher, bio-repository, etc.). This indicates provenance for the cell line. For its review, the HPSCRO Committee may request a copy of the agreement and/or, in cases of hESC and/or iPSC derived external to U-M, a copy of the informed consent documentation.
Note: If you want to subsequently share cell lines obtained via an MTA, first verify that MTA conditions allow sharing, then it is recommended to complete a memorandum of understanding (MOU) between the parties sharing the line(s).
When there are hESC funding restrictions
Provide U-M funding information on the HPSCRO application if your human pluripotent stem cell research isn't eligible for federal funding.
- Federal funding is permissible for research with hESC lines on the NIH Registry.
- Federal funding is not allowed for hESC derivation or for research with non-registered hESC cell lines. See the HPSCRO hESC Funding Guidelines for information regarding salaries, laboratory space, lab supplies and equipment when deriving hESC or working with non-registered lines.