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Stem Cell Research Oversight Committee (SCRO) & Human Fetal Tissue Review 

General Information 

The Office of the IRB Administration (OIA) administers the SCRO review process. California state law and California Institute of Regenerative Medicine (CIRM) regulations require that a SCRO committee oversee all human stem cell research undertaken by UC San Diego faculty, staff, and students that involve covered stem cells. The role of the UC San Diego SCRO is to ensure that research using human embryonic stem cells (hESC), human induced pluripotent stem cells (iPSC), or human fetal tissue work that is not human subjects research is well-justified and that inappropriate and/or unethical research is not conducted. 

UCSD has entered into an agreement with the Scripps Research Institute to have the UC San Diego SCRO program provide this oversight for Scripps.

SCRO oversight complements but does not replace other institutionally required approvals for compliance with federal and state regulations as well as local policies and requirements(e.g.,  Institutional Animal Care and Use Committee (IACUC), Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), etc.). 

Determining if SCRO Review is Required 

Stem Cells: Not all stem cell research falls under SCRO oversight.  

  • If your project is funded by CIRM and the materials involve a culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential, SCRO review is required. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin.  
  • If your project is not funded by CIRM but involves a culture-derived, human pluripotent stem cell population derived from an embryo or product of SCNT that is capable of: (1) sustained propagation in culture; and (2) self-renewal to produce daughter cells with equivalent developmental potential tissue of origin, SCRO review is required.

Human Fetal Tissue: All use of human fetal tissue will require either a SCRO or an IRB review. If your work does NOT involve interacting with the donor to obtain the tissue, AND the materials do not include information that could individually identify the donor, SCRO review is required. Otherwise, submit for IRB review.  

SCRO review is required, do I still need to submit an IRB application for my project? 

Some stem cell research may require either or both IRB and SCRO reviews.  There can also be cases where the stem cell research does not need a SCRO review, but does need an IRB review. This will depend on if your study is determined to involve human subjects research. To determine if IRB review is required, review the OIA’s page Determining if IRB Review is Required or email irb@ucsd.edu 

If your project does require both an IRB and SCRO review, follow the instructions in the IRB Quick Sheet – Steps to Submitting a New SCRO with IRB Application.  

SCRO review is required, how do I submit a SCRO application in Kuali? 

If SCRO review is required, a SCRO application must be submitted in Kuali IRB. Please review the IRB Quick Sheet – Steps to Submitting a New SCRO-Only Application. 

What documents do I need to submit for a new SCRO-only Application? 

SCRO Non-Interventional Protocol  

What documents do I need to submit for a new SCRO with an IRB Application?  

Biomedical Interventional Protocol  

OR 

Biomedical Non-Interventional Protocol (For observational studies only) 

Is continuing review/renewal (annual review) required for SCRO studies? 

This will depend on several factors. Please review your approval letter which will specify. This can be found in the Activity Log tab on the top bar of your Kuali IRB application, where you should search for the blue hyperlinked “Correspondence Generated.”. 

General Resources 

Contacts 

SCRO Inquiries: IRB@ucsd.edu | 858-246-4777