Frequently Asked Questions (FAQs)
Federal Restrictions and Stem Cell Lines
Storage of Stem Cells
- Does UCSD have guidelines for stem cell research?
All research or teaching use with hESCs must be compliant with the “UCSD Guidelines for Human Embryonic Stem Cell Research.” The guidelines can be found at http://escro.ucsd.edu/UCSD_guidelines.html.
- What research has to be reviewed?
Projects involving the use of hESCs, both federally and non-federally approved lines, as defined in the guidelines, require the review and approval of the ESCRO Committee prior to initiation of research or teaching.
- What other relevant committees must review hESC research?
Before you can begin research or teaching use with human embryonic stem cells, you must have approval from:
- UCSD Human Research Protections Program/
Institutional Review Board (IRB)
(858) 657-5100, http://irb.ucsd.edu
- Institutional Biosafety Committee/
Environmental Health and Safety (EH&S)
(858) 534-3660, http://www-ehs.ucsd.edu
- What other reviews are required for hESC research?
Other reviews may be required depending on the sources of funding, the sources of materials, and what is actually planned. Information summarizing these reviews can be found at http://escro.ucsd.edu/approvals.html.
- Is adult or tissue-specific human stem cell research exempt from requirements for ESCRO Committee review?
Yes, unless the project includes stem cells as defined in the UCSD Guidelines for Human Embryonic Stem Cell Research:
“…culture-derived, human pluripotent stem cell population that is capable of: 1) sustained propagation in culture; and 2) self-renewal to produce daughter cells with equivalent developmental potential. ‘Pluripotent’ means capable of differentiation into mesoderm, ectoderm, and endoderm. This definition includes both embryonic and non-embryonic human stem cell lines regardless of the tissue of origin.”
For example, this means that research on human hematopoietic stem cells would not normally be subject to ESCRO review, although it is still subject to review by the Human Research Protections Program, http://irb.ucsd.edu.
- What procedures are necessary for transferring hESCs to or from other institutions for the purpose of stem cell research?
Receipt of hESC materials will require a Material Transfer Agreement (MTA) or other written acknowledgement or by purchase. For MTA requirements, contact:
Any transfer of UCSD generated or modified hESC materials off campus will normally require an MTA or license agreement. For these requirements, contact Office of Technology Transfer and Intellectual Property Services (TechTIPS), (858) 534-5815, http://invent.ucsd.edu
- Where can I find a list of federally-approved stem cell lines?
The National Institutes of Health maintains the NIH Human Embryonic Stem Cell Registry at http://stemcells.nih.gov/research/registry. A table for converting provider codes to NIH codes can be found at: http://escro.ucsd.edu/NIH_codes.html
- May I use federal funds (e.g., NIH) to study cells or molecules that are derived from stem cell lines that are not federally approved?
It is prohibited to use federal funds for research involving stem cell lines that are not included on the NIH registry of federally approved stem cell lines. If your research project includes or will include any use of biological products of human embryonic stem cell lines that are not on the federal registry, then you are required to consult with the UCSD ESCRO Committee (858-455-5050, email@example.com) to determine whether or not federal funds can be used for your project. UCSD Guidelines for separation of federal funds for hESC research can be found at: http://escro.ucsd.edu/separatingcosts.html.
- What are the steps for research project review by the ESCRO Committee?
Instructions can be found at Submit Protocol.
- What is the deadline for submitting a research project for review by the ESCRO Committee?
For review of a protocol by the ESCRO Committee at its meeting normally scheduled for the last Thursday of the month, the deadline for submission of a protocol is the 3rd Wednesday of the month.
- What is the purpose of ESCRO Committee Review?
The ESCRO Committee is responsible for ethical and scientific review, approval, and disapproval of human embryonic stem cell research projects.
- What does the ESCRO Committee look for in its scientific review?
The ESCRO Committee does not conduct a full scientific review as might be expected for a grant review board, but ethical research must also be scientifically defensible. With this in mind, the ESCRO Committee typically considers the following questions in reviewing protocols:
- What is the central question or hypothesis to be addressed?
- Why is this important?
- Why can this question not be reasonably addressed in another way (e.g., with non-human cells)?
- If existing stem cell lines will be used, what is the rationale for using those particular lines?
- If new stem cell lines are to be derived, what is the rationale for doing so?
- Has this work been done previously? And, if so, why is it important that it be repeated?
- Does this research team have experience (years or publications) with the necessary methods?
- If members of the research team do not yet have the necessary expertise, how will they be trained?
- When do I need to renew my protocol approval?
ESCRO protocol approvals are for one year from the date of review.
Renewal: To avoid a lapse in approval, a renewal application must be submitted prior to expiration of the current approval. Any project that has expired before a renewal application has been submitted will be considered closed.
- What if I do not renew my protocol approval before it expires?
Under California regulations, if project approval has expired, then work on the project must be stopped until a new protocol has been reviewed and approved.
- What if I make changes to my project before I renew it?
Any changes to the research plan or in project personnel, funding source, or space since the last approval, must be submitted for review by the ESCRO Committee.
Storage of Stem Cells
- What additional requirements must be met for storing stem cells in a location different from the one in which they are to be used?
Before storing or moving cells to any other location, UCSD investigators should check the provisions of any Material Transfer Agreements, purchase agreements, or other documents that govern their responsibilities for control of the stem cells. Typically, these agreements require the investigator to ensure that the cells will remain under her or his control. In all cases, the storage location(s) must be noted on the ESCRO Standard Application Form. If the cells are proposed to be stored at any location other than on the UCSD campus, then the storage location will be approvable only if the space is explicitly rented by and under the control of the investigator. All storage arrangements are approvable only if no funding restrictions are violated. Any proposed exceptions to these requirements should be addressed for review by the Office of the Vice Chancellor for Research.
- What additional requirements must be met for storing stem cells at UCSD on behalf of another institution or an investigator at another institution?
Before storing or moving cells to any other location, the non-UCSD investigators should check, or ask his/her institution to check, the provisions of any Material Transfer Agreements, purchase agreements, or other documents that govern their responsibilities for control of the stem cells. Typically, these agreements require the investigator to ensure that the cells will remain under her or his control. If a non-UCSD investigator or another institution then wishes UCSD or a UCSD investigator to store stem cells, both UCSD and the other institution would need to determine whether it was appropriate to enter into an inter-institutional agreement outlining the extent of mutual responsibility. Also, a new or amendment protocol would need to be submitted by the UCSD investigator for review and approval by the UCSD ESCRO Committee. The protocol should indicate that the purpose of the request is for storage of cells only, but the provenance of the stem cell lines should also be documented sufficiently so that the ESCRO Committee can ensure that the cells meet the standards expected for any stem cell research project at UCSD.
- Where can I find more information about stem cells and stem cell research?
- Where can I find more information about possible ethics training options?