Approval by a University of Connecticut IBC, IACUC and/or IRB and Coordination with the SCRO Committee
- 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.
- 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.
- 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 University of Connecticut Institutional Biosafety Committee(s) at the campus(es) where the research will be conducted.
IACUC: All use of animals must be approved by the University of Connecticut 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. Investigators should submit a copy of their IRB application to the SCRO Committee along with their SCRO Committee application.
A University of Connecticut 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 University of Connecticut researchers;
- Receiving and coding for human biological materials with personal donor identifiers;
- Implanting stem cells into human subjects.
Approval must be obtained from the IRB(s) at the campus(es) where the research will occur.
Sequence of Protocol Submissions to Institutional Research Oversight Committees.
Final SCRO Committee approval will not be given until the SCRO Committee receives documentation of all other required protocol approvals from the IBC, IACUC, and IRB, as well as a copy of the material transfer agreement (MTA) for any hESC lines or derivatives being used. SCRO Committee approval is contingent upon all other relevant approvals being current.
Collaborations with Researchers at Other Institutions
If any component of the research project is conducted at an institution other than the University of Connecticut, SCRO Committee must receive documentation that the relevant approvals (IBC, IACUC, or IRB) have been obtained at the institution where the research is conducted.
Investigators should identify all collaborating sites on the SCRO Committee Application Form. The application should clearly indicate which aspects of the research will occur at each site. Final SCRO Committee approval of the project will not be given until documentation of all required approvals are received.
Transfer of hESC lines to University of Connecticut Investigators
Investigators who plan to use hESC lines that have not been pre-approved by the University of Connecticut SCRO Committee must provide documentation of their provenance and their ethical derivation. This documentation includes:
- 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 University of Connecticut SCRO Committee and IRB.
- A copy of the MTA (or as soon as it is available)