The SCRO Committee does not replace the oversight of the Institutional Biosafety Committee (IBC), Animal Care and Use Committee (IACUC) or Institutional Review Board (IRB), or alter the scope of review of these committees. Protocols that normally require IBC, IACUC and/or IRB approval continue to require these approvals. Investigators have the responsibility of submitting the required documents to the relevant oversight committees. If any component of the research project is conducted at an institution other than UConn, the SCRO Committee must receive documentation that the relevant approvals (IBC, IACUC, or IRB) have been obtained at the institution where the research is conducted.
The SCRO Committee has the final sign-off on stem cell protocol approvals. Final SCRO Committee approval will not be given until the SCRO Committee receives documentation of all required IBC, IACUC and IRB approvals. Continued SCRO approval is contingent upon all other relevant approvals being current. Parallel review with the SCRO Committee and the IRB, IBC or IACUC is permitted. Investigators may submit their protocol applications to the SCRO Committee while IRB, IBC or IACUC approval is pending or after it is granted.
- IBC: All use of recombinant DNA or hazardous biological materials (human cells) must be approved by the Institutional Biosafety Committee(s) at the campus(es) where the research will be conducted.
- IACUC: All use of animals must be approved by the IACUC(s) at the campus(es) where the research will be conducted.
- IRB: Because oversight issues of the IRB and the SCRO Committee are intertwined, it is recommended that the IRB and SCRO Committee reviews occur in parallel. Approval must be obtained from the IRB(s) at the campus(es) where the research will occur. Investigators should submit a copy of their IRB application to the SCRO Committee along with their SCRO Committee application. A UConn IRB must review and approve stem cell research protocols for:
- Informed consent for the donation of human embryos, gametes, or somatic cells from human subjects to UConn researchers;
- Receiving and coding for human biological materials with personal donor identifiers;
- Implanting stem cells into human subjects.
Documentation for acquired cells
All stem cell projects are required to have proper documentation for the hESC and hiPSC lines that faculty plan to use before the SCRO Committee can provide final approval.
- Cells derived at another institution or outside UConn require an executed Material Transfer Agreement (MTA).
- Cells coming from the UConn Stem Cell Core facility but developed and owned elsewhere such as the WiCell Stem Cell Bank lines that are banked at the Core require a shortened Materials Transfer Agreement (MTA) known as a Short Letter Agreement (SLA). The procedures for obtaining these cells and the required documentation are detailed on the Core website: https://health.uconn.edu/stem-cell-core/services/distribution-of-human-pluripotent-stem-cell-lines/.
- Investigators who plan to use hESC/iPSC lines that have not been previously approved by the UConn SCRO Committee must provide documentation of their provenance and their ethical derivation. This documentation includes:
- A copy of the fully executed Material Transfer Agreement (MTA)
- Evidence of IRB approval at the relevant institution
- Documentation of the informed consent process in sufficient detail to allow for evaluation of conformity with State of Connecticut Regulations, National Academy of Science Guidelines, and standards of the UConn SCRO Committee and IRB.