Educational FAQs
Q: My research involves hematopoietic stem cell transplant protocols; do I need to submit a SCRO protocol?
A: Yes, the California Health and Safety code requires that research involving human adult stem cells be reviewed by a stem cell research oversight panel. If the topic of the research is hematapoietic stem cell transplant, Administrative SCRO Review is required. If the topic of research is therapy adjunct to standard-of-care stem cell transplantation, SCRO Review is NOT required.
Q. My research involves cancer stem cells; do I need to submit a SCRO Protocol?
A. Yes, the California Health and Safety code requires that research involving human adult stem cells be reviewed by a stem cell research oversight panel. In isolation of cancer stem cells, it is difficult to distinguish between normal stem cells and cancer stem cells; at this time an Administrative SCRO review is required.
Q. My research involves progenitor cells; do I need to submit a SCRO Protocol?
A. Yes, the California Health and Safety code requires that research involving human adult stem cells be reviewed by a stem cell research oversight panel.
Note: research involving neural progenitor cells that are introduced into animals requires SCRO review (even if not they are not called “stem cells”). Committed progenitor cells, not stem cells, do not require review. If the research is described in any document as using or pertaining to “stem cells”, a SCRO Review will be required.
Q. My research involves mesenchymal cells; do I need to submit a SCRO Protocol?
A. Yes, the California Health and Safety code requires that research involving human adult stem cells be reviewed by a stem cell research oversight panel; at this time an Administrative SCRO review is required
Q: Does my research require IRB and SCRO review or only SCRO?
A: If your research involves human subjects or tissue(s) procured from human subjects, who have not undergone human subjects review elsewhere, your research protocol must be reviewed by the IRB and SCRO.
If your research involves human tissue(s) procured elsewhere (eg: Advanced Biosciences Research, Inc., or a tissue bank or repository) and the human subject(s) involved has/have been consented elsewhere, your research will be reviewed by SCRO only.
Q: If my research requires both IRB and SCRO review, how long will this process take and how will that work?
A: When your research involves both human subjects and stem cell research, please submit research protocols within Human Subject eProtocol and Stem Cell eProtocol. The SCRO and IRB Managers will work together so that review and approval is completed concomitantly.
Q: My research involves animal embryonic stem cells; do I need to submit a SCRO protocol?
A: No, the SCRO panel reviews research involving only human stem cells. Your research does require APLAC review.
Q: Where can I find state and CIRM regulations?
A: State Health and Safety Codes can be found here (see Division 106, Part 5, Chapter 3, Articles 1, 2):
http://www.leginfo.ca.gov/cgi-bin/calawquery?codesection=hsc&codebody=&hits=20
CIRM regulations can be found here: http://www.cirm.ca.gov/reg/default.asp
Q: What is the difference between ORA and SCRO?
A: ORA is the Office of Research Administration; their role is to manage the administrative processes related to Stanford’s sponsored research and capital equipment. ORA is responsible for service centers, research compliance, and the development and negotiation of fringe benefit and F&A rates. ORA oversees the management of federal funding of registered or non-registered human embryonic stem cells.
SCRO is Stem Cell Research Oversight and is managed within the Research Compliance Office. The SCRO Panel meets monthly to review protocols that require full Panel review.
Q: What will be reviewed in my protocol?
A: Protocols involving stem cells will be reviewed based on the type of stem cell being used (eg: adult stem cells, neural progenitor cells, registered human embryonic stem cells). Projects involving pluripotent stem cells will be evaluated on their scientific merit, the ethics of stem cell derivation and use, and community concerns.
Q: What are the different levels of review for stem cell research protocols?
A: SCRO staff reviews protocols submitted in Stem Cell eProtocol and using a Review Process decision tree, assigns the protocol to the appropriate level of review: 1) Administrative, 2) Designated, 3) Full.
Q: My research involves introducing human stem cells into animals; what review will be required?
A: Your research will require both SCRO and APLAC review.
Q: My research involves both CIRM and gift/NIH/internal department funds, how will that affect reporting requirements that need to be satisfied for my research?
A: When stem cell research is funded by both CIRM and other funding sources, the Stem Cell Research Oversight Office will be required to report specific information to the State of California about your research. As currently proposed (and subject to change until finalized), these reporting requirements would include, but would not be limited to, descriptions and updates of the research, cell type(s), use of human oocytes and/or gametes, number of female IVF patients/clients, SCNT, parthenogenesis, induced pluripotency, clinical trials, and unanticipated events or noncompliance and institutional response. These reports need to be made or updated annually. When funding is solely from CIRM, SCRO is not required to report information to the state, and CIRM provides oversight to the research.