Frequently Asked Questions -
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1. What types of human stem cell research requires review/approval by the hSCRO? hSCRO review/approval is in addition to other required research approvals (e.g. IACUC/IRB/IBC). There are 8 categories of human stem cell research requiring hSCRO review. Categories 1-4 qualify for Administrative Review (Registration) and Categories 5-8 require review by the full hSCRO Committee. The specific descriptions of the categories of human stem cell research requiring review may be found on Page 3 of the hSCRO application http://www.rcco.pitt.edu/hscro/forms/hSCROApplication.doc 2. What are the current restrictions for human stem cell research at the University of Pittsburgh? The current restrictions for human stem cell research at the University of Pittsburg arise from University policies as well as federal and state regulations and may be found on Page 3 of the hSCRO policies: http://www.rcco.pitt.edu/hscro/Policies.htm 3. Who initiates the review process? Investigators should be aware of the University’s hSCRO policies (http://www.rcco.pitt.edu/hscro) and initiate the review process.
hSCRO approval is in addition to other required research approvals. 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. 4. How are protocols reviewed? There are two types of hSCRO review: Administrative review by the hSCRO Chair or his/her designee (Registration) and hSCRO Committee review. The type of review required depends on the nature of the research. The hSCRO Committee is notified of all protocols that have received administrative review/approval.
5. Who is on the hSCRO Committee? The composition of the hSCRO Committee is outlined in the hSCRO Policies and Procedures. The policies state that the voting membership of the hSCRO Committee must include at least one representative from the public (not affiliated with the University) as well as University faculty or staff with expertise in the following areas:
• Assisted reproduction
• Developmental biology
• Molecular biology
• Stem cell research
• Legal & ethical issues in human embryonic stem cell research
In addition to the voting members of the committee outlined above, there are also ex-officio (non-voting) members that include individuals from:
• Legal counsel from the University of Pittsburgh and UPMC
• Representatives of the Office of Research
• Representatives of the Research Conduct and Compliance Office (RCCO) 6. Does research involving adult stem cells require hSCRO review/approval? Yes, protocols involving human adult stem cell research must be submitted for hSCRO review/approval. These protocols often qualify for Administrative review by the hSCRO Office. 7. Does research involving iPS cells need hSCRO review/approval? Yes, research involving iPS cells require review/approval by the hSCRO. 8. Does research involving stem cells derived from placental or fetal tissue require hSCRO review/approval? Yes, protocols of this nature must be submitted to the hSCRO Office and many of these protocols will qualify for administrative review. As Pennsylvania has certain restrictions for the use of fetal tissue derived from an induced abortion, protocols will be reviewed by the hSCRO for compliance with the Pennsylvania Abortion Control Act. 9. Why does the hSCRO Committee want to review non embryonic stem cell research? The hSCRO Committee is to serve as a resource for the University’s research community and to ensure that alternatives to human embryonic stem cell research have been evaluated. By being aware of the scope of human stem cell research conducted at the University of Pittsburgh, the hSCRO Committee is better able to perform this function. 10. Is there an hSCRO annual review process? Yes, 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 of the annual review by the hSCRO Office approximately 60 days prior to the one year anniversary of registration/approval. Failure to complete the annual review form by the one year anniversary date will result in the termination of the hSCRO approval. 11. What information needs to be submitted to the hSCRO Office? The 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 & detailed hSCRO application form
Other required supporting documentation (when applicable): - University agreement for the transfer of research materials to/from an outside entity
- Evidence of prior scientific review
- IACUC approval letter or proposed IACUC protocol
- IRB approval letter or proposed IRB protocol/consent
- IBC/rDNA approval letter
- External sponsor’s clinical protocol/investigator’s brochure
- Outside oversight committee approval
- UPMC CTO approval letter
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