1. What are the panel meeting dates & deadlines?
For a current schedule, refer to the Panel meeting dates & deadlines.
2. What is the IRB/SCRO Panel?
The
IRB/SCRO Panel responsible for overseeing the protection of human
participants in research and overseeing
scientific and ethical considerations for human stem cell research. The
IRB/SCRO Panel is a part of the Research Compliance Office and derives its
authority from the Office of the Vice Provost and Dean of Research. The Panel reviews both IRB protocols and SCRO
protocols. The IRB and SCRO review
follow separate processes, however, they may be
conducted concurrently.
3. Does research on human cancer stem cells require a SCRO
protocol?
The
IRB/SCRO Panel does not review protocols when research involves only human
cancer stem cells, unless it is required by the sponsor or if the Panel has
specific concerns about the research.
4. Do hematopoietic stem
cell transplants require a SCRO protocol?
Research
focusing on the characteristics of the stem cell itself requires SCRO
review. Research on treatment issues such as pre-transplant medications
or GVHD (Graft Vs Host Disease) does not require review.
5. Does research
involving other human stem cells, progenitor cells or mesenchymal cells require SCRO review?
You
will need to submit a SCRO protocol. However, much human adult stem cell research is eligible for a process
called Written Notification. Once you submit a SCRO protocol, the Panel
determines whether your research is eligible for Written Notification.
6. What is Written Notification?
Research
that is eligible for Written Notification will not be reviewed on an annual
basis, unless there is a change in the research that requires IRB/SCRO Panel
approval. Written Notification is an
SCRO review type whereby the Panel acknowledges that a researcher has submitted
his or her research aims. The Panel
determines whether the research meets the eligibility for written notification
under the regulations at 17 CCR § 100070 or the CDPH Guidelines for Human Stem
Cell Research, §5 (a)(3).
7. Does research
involving the derivation of induced pluripotent stem cells (iPSC)
require a SCRO review?
Research
with iPSCs may require SCRO review. We
encourage you to submit a SCRO protocol and/or contact IRB/SCRO staff if you have questions about whether a
review is required. Any iPSC work that involves
placing the cells or the derivatives of the cells into animals or humans will
require full convened Panel review.
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8. My research does not
involve stem cells at this time, but I am collecting tissues or samples that
may result in human pluripotent stem cells. Do I need to submit a SCRO
Protocol?
No, a
SCRO protocol is not necessary at this time; however, an IRB protocol is
required. We advise you to use informed consent
language (Word doc) that will permit you to use these samples
for stem cell research in the future.
9. My research involves using human embryonic stem cells
(hESC). What do I need to establish provenance?
For
Federally funded research, acceptable provenance is met by checking to see if
the hESC (human embryonic stem cell) line is listed on the NIH Registry. For research funded from sources other than
the Federal government, any of the following serves to establish acceptable
provenance of the cell line:
- listed on the NIH registry
- listed on CIRM registry
- deposited or approved by the United Kingdom Human
Fertilization and Embryology Authority
- approved by the Canadian National Stem Cell Oversight
Committee
- derived in accordance with Japanese Guidelines
- listed on the Stanford Stem Cell Matrix (excel doc)
10. My research involves iPSCs or their derivatives. What do I need to
establish provenance?
- Documentation that there are limitations to payments
made to individuals who are not tissue donors for CIRM funded research
- If CIRM-Funded and identifiable, establishing
provenance requires one of the following:
- IRB or IRB-equivalent approval letter for original
collection of the tissues, or
- Informed consent that allowes the somatic cells to be used for research, or
- Assurance from
the Principal Investigator or organization responsible for the collection of
somatic cells that all applicable laws were followed in the collection of the
tissue for research purposes.
11. Does my human stem cell research also require an IRB review?
IRB review is only required if human subjects are
involved. If you have questions about
whether human subjects are involved, we may ask that you fill out a short Determination of Human
Subjects Form, which will help us determine if IRB review is
necessary.
12. Which
organizations does the Stanford IRB/SCRO Panel serve?
The
Stanford IRB/SCRO Panel reviews research for Stanford and its affiliates. This
includes:
- Stanford University
- Stanford Hospital and Clinics (SHC)
- Lucile Packard Children’s Hospital at Stanford (LPCH)
- Veterans Affairs Palo Alto Health Care System (VAPAHCS)
- Palo Alto Veterans Institute for Research (PAVIR)
13. Who can I contact for more information?
|
IRB/SCRO Panel Manager/Associate:
Alison Holzer
Phone: (650) 725-5873
Lily Chaskelmann
Phone: (650) 736-2594
Email |
eProtocol Technical Support:
Submit a HelpSU ticket.
(Set the request category to Administrative
Applications and request type to eProtocol - Stem Cells)
eProtocol HelpDesk: (650) 724-8964 |
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14. Can Stanford human subject, animal subject or human stem cell studies be conducted at non-Stanford facilities?I'm working with fish larvae, do I need an APLAC approval?
Yes. Please click here to know what steps to follow
IRB - Human Subjects
APLAC - Laboratory Animal Care
APB - Biosafety (EH&S)
APRS - Radiological Safety (EH&S)