HPSCRO Application Process

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.