Scope of SCRO Review
The SCRO must review:
- All research funded by the Regenerative Medicine Research Fund, including those that do not use human embryonic stem cells;
- All stem cell research involving human embryonic stem cells and their derivatives;
- All stem cell research involving human gametes and human embryos;
- iPS cell research involving implantation of human cells into pre-natal animals or the central nervous systems of post-natal animals, and iPS research involving the generation of human embryos or other totipotent cells.
This applies to research at all schools, colleges, campuses, and research arms of the University of Connecticut regardless of the source of funding.
Stem cell research using human embryonic stem cells, human gametes, or human embryos may not begin and external funds will not be released until SCRO approval is granted.
- The SCRO does not replace or duplicate the oversight of Institutional Biosafety Committee (IBC) and Animal Care and Use Committee (IACUC), or alter the scope of review of these committees. Protocols that normally require IBC and IACUC approval continue to require these approvals. Investigators have the responsibility of submitting the required documents to the relevant oversight committees.
- SCRO has the final sign-off on stem cell protocol approvals. Final SCRO approval will not be given until the SCRO receives documentation of all required IBC and IACUC approvals.
- Parallel review with SCRO and the IBC or IACUC is permitted. Investigators may submit their protocol applications to the SCRO while IBC or IACUC approval is pending or after it is granted.
- IBC: All protocols using recombinant DNA or hazardous biological materials must be approved by the University of Connecticut Biosafety Committee(s) at the campus(es) where the research will be conducted.
- IACUC: All protocols using animals must be approved by the University of Connecticut IACUC(s) at the campus(es) where the research will be conducted.
- The SCRO does not replace or duplicate the oversight of the IRB or alter the scope of IRB review. Protocols that would normally require IRB approval continue to require IRB approval. Investigators have the responsibility of submitting the required documents to the relevant committees.
- SCRO has the final sign-off on stem-cell protocol approvals and will not give final approval until it receives documentation of all required IRB approvals.
- Because oversight issues of the IRB and the SCRO are intertwined, it is recommended that the IRB and SCRO reviews occur in parallel. Investigators should submit a copy of their IRB application to the SCRO along with their SCRO 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.
Final SCRO approval will not be given until the SCRO receives documentation of all other required protocol approvals from the IBC, IACUC, and IRB, as well as a copy of the MTA for any hESC lines or derivatives. To facilitate and expedite the review process, the review of protocols by the SCRO and other oversight committees may occur in parallel.
State Group grant proposals are composed of several related but relatively autonomous separate projects. A separate SCRO protocol application should be submitted to the SCRO for each component project, along with the required supporting documentation for that project (e.g. IBC, IACUC, IRB approvals and a copy of MTAs.)
A separate application for each component project should also be submitted as required to the IBC, IACUC, and IRB.
If any component of the research project is conducted at an institution other than the University of Connecticut, SCRO 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 Application Form. The application should clearly indicate which aspects of the research will occur at each site. Final SCRO approval of the project will not be given until documentation of all required approvals are received.
Investigators who plan to use nonhuman animal tissues or cells supplied from another researcher or institution for the creation of chimeras should provide the SCRO with documentation that these materials were obtained with IACUC oversight at the relevant institution.
Transfer of already donated human somatic cells, gametes, or nonembryonic stem cells to University of Connecticut Researchers
Investigators who plan to use already derived hESC lines that have not been pre-approved by the University of Connecticut SCRO 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 and IRB.
- A copy of the MTA (or as soon as it is available)
- SCRO approval will be valid for one year from the date of approval, but the SCRO reserves the right to review research more frequently.
- Any changes in research activities or additions of hES cell lines must be approved prior to implementation.
- Submission of an SCRO or iPS renewal form is recommended 60 days prior to the date when approval expires.