Frequently Asked Questions
What types of human stem cell research requires review/approval by the hSCRO?
- Why does the hSCRO want to review non-embryonic stem cell research?
- What are the current restrictions for human stem cell research at the University of Pittsburgh?
Who is on the hSCRO Committee?
Who initiates the review process?
- What information should be submitted to the hSCRO Office?
How are protocols reviewed?
Is there an hSCRO annual review process?
1. What types of human stem cell research requires review/approval by the hSCRO?
2. Why does the hSCRO want to review non-embryonic stem cell research?
hSCRO review/approval is required for all embryonic stem cell research and certain types of non-embryonic stem cell research and is in addition to other required University research approvals (e.g. IACUC, IRB). Examples of non-embryonic stem cells that require review are:
- A clinical trial (human subjects) where the administration of stem cells is considered to be experimental
- Transplantation of any type of human stem cell into an animal
- Transplantation of cells that originated from human IPS cells or ES cells
The specific descriptions of the human stem cell research requiring hSCRO review may be found on Page 3 of the hSCRO application http://www.rcco.pitt.edu/hscro/forms/hSCROApplication.doc.
3. What are the restrictions for human stem cell research at the University of Pittsburgh?
As there may be potential ethical concerns with any pluripotent stem cell research, the hSCRO Committee’s purview includes oversight of both embryonic and certain types of non-embryonic stem cell research. The hSCRO Committee’s specialized expertise and knowledge of the broad scope of human stem cell research being conducted at the University of Pittsburgh allows the Committee to serve as a valuable resource.
4. Who is on the hSCRO Committee?
The restrictions for human stem cell research at the University of Pittsburgh arise from federal and state regulations as well as University policies. Only hES cell lines included on the NIH Human Embryonic Stem Cell Registry are eligible for use at the University of Pittsburgh. The derivation of human embryonic stem cell lines is prohibited at the University of Pittsburgh. A complete listing of restrictions and may be found on Page 8 of the hSCRO policies: http://www.rcco.pitt.edu/hscro/Policies.htm
5. Who initiates the review process?
The voting membership of the hSCRO Committee includes individuals with expertise in stem cell research, developmental biology, molecular biology, assisted reproduction, ethics and law, as well as members of the public who are not affiliated with the University. Non-voting members include representatives from legal counsel for the University of Pittsburgh and UPMC, representatives of the University’s Office of Research, and the Research Conduct and Compliance Office (RCCO).
6. What information should be submitted to the hSCRO Office?
Investigators should be aware of the University’s hSCRO policies (http://www.rcco.pitt.edu/hscro) and submit an hSCRO application for review. For new projects, the investigator may initiate all of the required approval processes (e.g. hSCRO, IACUC, IBC, IRB) in parallel, following the submission guidelines of each oversight office.
7. How are protocols reviewed?
The complete hSCRO submission process is outlined in the policies and procedures. The review of hSCRO applications will be facilitated if the following information is submitted to the hSCRO Office:
- A complete and detailed hSCRO Application
Other required supporting documentation (when applicable):
External IRB approval letter if the protocol is processed through the UPMC OSPARS Office. Sponsor clinical protocols should not be forwarded to the hSCRO Office if the contract is through the UPMC OSPARS Office.
- IACUC approval letter(s) or proposed supporting IACUC protocol(s)
- IBC approval letter
- University of Pittsburgh IRB approval letter or proposed University of Pittsburgh IRB protocol/consent
- External sponsor’s clinical protocol/investigator’s brochure if Pitt is the IRB of record
8. Is there an hSCRO annual review process?
There are two levels of hSCRO review: Administrative review by the hSCRO Chair (Registration) and hSCRO Committee review. The type of review required depends on the nature of the research. To determine the level of review required, please refer to Page 3 of the hSCRO application http://www.rcco.pitt.edu/hscro/forms/hSCROApplication.doc
Yes, to verify the current status of the project and to ensure no changes have inadvertently taken place in the research activity that may require further review by the hSCRO, all approved protocols will be required to undergo an abbreviated annual hSCRO review. Investigators will be notified by e-mail of the annual review by the hSCRO Office approximately 60 days prior to the one year anniversary of initial approval. An e-mail response is required from the PI. Failure to respond to the annual review by the one year anniversary date may result in the termination of the hSCRO approval. Projects that remain as inactive status upon annual review for three years will be closed by the hSCRO Office, and investigators will be required to submit a new protocol to resume work on the project.