Review Process
In general, the compliance considerations for the review of human pluripotent stem cell research concern, the science, cell line derivation, cell line provenance, and potential funding restrictions (hESC only).
Types of HPSCRO Review
For human embryonic stem cell (hESC) and/or human induced pluripotent stem cell (iPSC) research applications, U-M utilizes two possible review methods.
Convened Committee Review
Your HPSCRO application qualifies for review at a convened committee meeting when it involves:
- Procurement of and research with hESC lines not on the NIH Registry or with restricted NIH Registry lines
- Animal research other than standard tumor or teratoma assays to prove pluripotency of the cells
- Plans to derive hESC
- Introduction of iPSC, hESC, or hESC derivitives to humans
- Plans to allow animals involved in hESC or iPSC research to breed
- Other types of work not specifically covered under an expedited review process and/or that is judged by the Committee as requiring a full committee review.
HPSCRO Approval Date
The HPSCRO approval date is the date the Committee reviewed and approved your application. This date appears on your Record of Approved Project and in the Committee’s notification letter of approval.
You are expected to enter this date in eResearch for any subsequent proposal applications (PAFs), IRB applications (HUMs), Material Transfer Agreements (MTAs/UFAs), IBC applications, etc. if the research activity concerns human pluripotent stem cell research.
The approval letter also lists the conditions under which you are required to amend your approval
Expedited Review
Expedited reviews are conducted online (via email) with the full committee. Your HPSCRO application is eligible for an expedited review process when it involves:
- In vitro or in vivo hESC research with unrestricted NIH Registry lines
- In vivo iPSC research where the work consists of standard tumor assays (e.g., subcutaneous tumor-forming assay), or teratoma assay to prove pluripotency of the cells.
- Other types of work, per Committee judgement
Expedited does not mean a “faster” or an “emergency” review. The difference between the types of reviews is one of format for the HPSCRO Committee. All reviews of eligible applications, amendments, and renewals are initiated on or for determination on the posted meeting date for the month.
Review Decisions
The following lists the potential review determinations of the HPSCRO Committee:
Approved
the application has been approved as submitted. The approval date is the date of the Committee review.
Approved with Contingencies
the application has been approved, contingent on submission of specified changes to the application, informed consent document(s) and/or other supporting materials (e.g., MTA required). Final approval status is granted when HPSCRO has reviewed and approved all requested changes. The date of contingent approval is the date of the Committee review. This date will not change upon final approval.
Tabled
HPSCRO needs additional information from the investigator before an accurate assessment of the application can be made. The principal investigator must submit the requested additional information before HPSCRO will consider the application for further review.
Disapproved
the application does not meet HPSCRO criteria, and it is unlikely that it may be modified to do so. HPSCRO notifies the principal investigator of the disapproval in writing, including a statement of the reasons for its decision and providing the opportunity for the investigator to respond to the HPSCRO Committee in person or in writing.
Questions?
For questions regarding application, amendments, U-M guidelines and more, email HPSCROquestions@umich.edu or call (734) 764-7545.
Related Information
Check the NIH Registry for a list of unrestricted hESC lines