UCSF Stem Cell Research - Frequently Asked Questions

Research on existing human embryonic stem cell lines may be conducted with Federal support if the cell lines meet the US President’s criteria, which he announced on August 9, 2001 . All such human stem cell lines are on the NIH Human Embryonic Stem Cell Registry.

What is the Registry?

The NIH Human Embryonic Stem Cell Registry is a listing of stem cell lines that meet the eligibility criteria for Federally funded research that are currently available for shipping.

What type of research on HESC is not allowed to use Federal funding?

Research involving the derivation of new stem cells from human embryos, the use of human embryonic stem cells that are not listed on the NIH Human Embryonic Stem Cell Registry, or the use of derivatives of non-registry stem cells may not be conducted with Federal funds.

What is a stem cell derivative?

Derivatives are cells derived from and DNA, RNA, proteins, and any other products secreted by or extracted from human embryonic stem cells. They do not include data obtained from stem cell research, which are treated separately in the protocols.

How can researchers obtain approval to perform hESC research that is ineligible for federal funding?

The same process must be followed for all stem cell research (embryonic/adult; eligible/ineligible). Parallel to submitting a Grant Application, a researcher must complete a copy of the “ UCSF Human Stem Cell Research Supplement” and the “Request Approval for Use of Equipment in Non-Registry hESC Activity” and return to Associate Vice Chancellor Research, Box 0407 . [Copies are available at http://www.research.ucsf.edu/SC/index.asp] This form requires information on space and equipment proposed for use in the research project

Note: To facilitate easy review, Office of Research will forward the forms to all the appropriate units and provide the PI with the final outcome.

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Are there restrictions on which laboratory space can be used for ineligible hESC research?

Yes. Laboratory space can be used for ineligible hESC research unless it has been built or renovated with federal funds. To determine if federal funds have been used in the construction of the laboratory space, please complete the “UCSF Human Stem Cell Research Supplement” and return to Associate Vice Chancellor Research, Box 0407 .

If federal funds have been used in the construction of the laboratory space, the space can be used for ineligible HESC if the terms of the grant that funded the construction have expired (usually the terms require using the space for a particular function for 20 years). See Space Not Allowed for Non-Registry Human Embryonic Stem Cell Research.

May researchers use laboratories that receive federal funding to conduct ineligible hESC research?

Yes. With School approval, researchers may use laboratories that receive federal funding to conduct ineligible hESC research. They must, however, keep track of the personnel time, materials, purchased services, commodities, and, in some cases, equipment usage, associated with ineligible hESC research in order to allow for allocation of costs between allowable and unallowable activities.

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Can researchers use biological materials or derivatives from federally funded research, including both hESC and non-hESC research, in ineligible research?

Biological materials or derivatives from federally funded research, including, for example, antibodies, plasmids, and other vectors, are usable in ineligible research on the same terms as derivatives from non-federally funded hESC research. Such materials may be used if the costs are not charged to the federal government, and provided that the federal grant does not prohibit use of the materials for non-federal purposes.

May researchers use covered equipment originally acquired for use in a federal project to conduct ineligible hESC research?

Maybe, depending on the source of funding used to purchase the covered equipment and who holds title to the equipment. Covered equipment is defined as all tangible personal property used in HESC activity with an expected useful life of more than one year and an acquisition cost of $5,000 or more.

To use equipment in ineligible HESC research, researchers must seek approval from the Capital Asset Management unit which will employ the following guidelines to permit use of the equipment:

If no federal funds were used to acquire the equipment and UCSF holds title it, then researchers may use the equipment without restriction.
If federal funds were used to acquire the equipment but the segment of the grant or contract has been completed (defined by submission of the Final Status Report) and the title has been transferred to UCSF, then researchers may use the equipment without restriction.
If the federal government holds title to the equipment, the equipment may not be used for ineligible hESC research, unless:
- UCSF obtains, and the School(s) confirms in writing, the approval of the appropriate federal agency, which may in some cases involve a rental agreement with the federal agency; or
- UCSF purchases the equipment from the federal government and has documentation of such transaction, including title transfer.

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May researchers use expendable materials and supplies purchased for general laboratory use to conduct ineligible hESC research?

Yes, but researchers must keep account of how much of the general supply is being used for federally funded projects so that the federal government pays no more than its share of the total materials and commodities costs. In the case of reusable goods, researchers may proportion the cost allocable to the federal government by estimating, through reasonable allocation methods consistent with School policies, what proportion of the good is used for federal projects relative to its use for unallowable projects.

Expendable materials and supplies are used to refer broadly to non-equipment materials such as laboratory and office supplies, chemicals, test tubes, tissue culture materials, purchased services including equipment repair and preventive maintenance contracts, commercial software, other durable goods, etc. with expected useful life of one year or less.

What about California law?

A California law effective January 1, 2003 requires Institutional Review Board (IRB) approval for any research involving derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation. The law specifically makes such research legal in California, and also legalizes donation of embryonic or cadaveric fetal tissue for research purposes. See also: California Embryonic Stem Cell Guidelines, California Policy on HESC Research, and California Stem Cell Research & Cures Bond Act of 2004.

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COMMITTEE ON HUMAN RESEARCH REVIEW

Is there a need for Committee on Human Research (CHR) review of proposed research at UCSF if an investigator intends to work on Human Embryonic Stem Cells (HESC)?

Yes. The CHR is UCSF’s Institutional Review Board (IRB). California Law requires IRB approval for any research involving derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells from any source, including somatic cell nuclear transplantation. CHR review is needed even for uses of human stem cells that might be exempt from IRB review under Federal law.

If an investigator (at UCSF) receives human embryos or HESC from another investigator (or institution), what obligation does the receiving investigator have to ensure that the consent obtained by the sending institution is adequate?

It is important to respect donors’ wishes, whether they donate embryos no longer needed for assisted reproduction or donate the oocytes or sperm that are used to create the embryos.

Generally researchers are not expected to verify IRB review and adequate consent when they receive established, commercially available, de-identified cell lines. For almost all other human tissue received for research purposes, the researchers should receive written assurance from the source that the protocol for tissue collection received IRB review or formal exemption. At UCSF, investigators should request written assurance from the source that donors of embryos and/or germ cells used to create embryos specifically consented to use of the cells in the type of research being proposed.

Are all of the cell lines on the NIH Human Embryonic Stem Cell Registry de-identified?

Yes. However, because of California law, CHR review (usually Expedited review) is still required for research using registry cell lines.

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Can donors of embryos, oocytes, or sperm be contacted again to get additional information from them, to provide them with information, to discuss commercialization, or for other purposes?

Donors may be recontacted if, in the donation consent form, they have agreed to be recontacted. If researchers expect they may want to recontact donors, the initial consent form should describe the circumstances and purposes of recontact. Allowing recontact can be optional; there could be separate lines for subjects to initial to indicate whether or not they consent to possible recontact. It may be desirable to allow donors to specify whether or not they are willing to be contacted for specific purposes or in specific manners.

If researchers want to recontact donors but the consent form is silent about whether recontact is permissible, the researchers should seek IRB approval before trying to make contact. The researchers and the IRB must weigh the intrusion on the donors’ privacy against whatever personal or scientific benefit would come from the contact.

If the donation consent form says the researchers will not or may not recontact the donors, or if the consent form says all links between the donor’s identity and the donated material will be destroyed, or if the purpose or nature of the recontact exceeds what was agreed to in the consent form, no recontact should be attempted.

Exceptions to the above guidelines might occur in extraordinary circumstances where going against the terms of consent would lead to great benefit or prevent great harm. However, such exceptions would be extremely rare. Careful IRB review and approval would be necessary before proceeding. Even if the recontact seemed ethically justified, it might be prohibited by privacy laws.

If/when research progresses to the point of potential transplantation of HESC into humans, is there a change in the need for CHR involvement?

Yes. The human transplantation phase will require a separate CHR application and approval.

How can the donor(s)’ interests be protected? What should the consent form and process include?

For the purpose of obtaining embryos, oocytes, or sperm for the purpose of creating stem cell lines, review of the informed consent form must be thorough. The CHR must ensure that donors are told enough to make an informed decision and that any payment made to the donor is not excessive. Consent should be obtained from the couple or single woman who participate in assisted reproduction technology (ART) and from any oocyte or sperm donors (if different from the participants in ART). Donors should be asked to allow broad categories of research (e.g. creation of stem cell lines as opposed to infertility research) without making the consent form too restrictive and unnecessarily eliminating possible uses.

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ADDITIONAL REVIEWS

What other review of human embryonic stem cell (HESC) research is required at UCSF?

In some cases, the Human Gamete, Embryo, and Stem Cell Research Committee (GESCR) will also review studies. The CHR will coordinate with GESCR to determine which studies should receive additional review. GESCR has scientific and ethicist representation as well as community lay members and has an advisory role for the Executive Vice Chancellor and the CHR.

Does HESC work require additional or different occupational health and safety review, guidelines or programmatic oversight as compared to other human materials work?

The Biological Safety Committee should review the applications and determine if there are any specific safety issues.

What kinds of financial Conflict Of Interest (COI) issues might arise if the investigator is using Registry HESC lines?

Financial COI issues with HESC are not likely to arise at these early stages. However, if the studies yield potential therapeutic applications with the potential sponsor and COI issues may arise, these can be addressed during the contract negotiations.

With respect to Conflict of Interest Committee review, completion of the Form 700U is required for all sponsored projects – this includes research sponsored by the government, industry and non-profits. In addition, according the UC Office of the President guidelines, completion of the Form 700U was recently required for Material Transfer Agreements (MTA) as well.

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FUNDING AND ACCOUNTING

Separating Accounts

See REGULATORY ISSUES section above for more information.

Does UCSF separately account for research using HESC not on the NIH Human Embryonic Stem Cell Registry (“non-registry HESC”) as opposed to Federally funded research?

Yes. The Committee on Human Research application and review is the central collection point for identifying any human stem cell research, including non-registry research. California law requires that all human stem cell research have Institutional Review Board approval, and University policy conforms to this requirement. In addition at UCSF we are asking investigators applying to the Committee on Human Research, Committee on Animal Research, Biological Safety Committee, Contract and Grants or Material Transfer Agreements to answer the questions on the Human Stem Cell Research Supplement about the use of stem cells.

Based on the answers to the questions on this supplement, the UCSF Office of Sponsored Research and the Campus Budget Office will determine whether the study will require any additional information and/or if there are specific restrictions that apply to the research. Once the more detailed information is used to identify non-Registry HESC research, this activity is assigned to an account and fund and a code is provided that marks it as a non-Registry HESC. When an F&A Rate Proposal is prepared, account and fund combinations with a non-Registry HESC code are used to segregate direct and F&A costs associated with this activity and exclude them from the F&A rate calculations.

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Should the Principal Investigator (PI) treat non-Registry HESC research differently for accounting or record-keeping purposes from other privately funded research?

Yes, non-Registry HESC research expenses should be in a separate account and fund combination at UCSF, otherwise the treatment is the same as other research.

Does UCSF have a specific approval process or use special identifiers for non-Registry HESC accounts?

Yes, non-Registry HESC account and fund combinations should be clearly identified to the UCSF Accounting Office and the Budget Office for tracking purposes.

Should you set up special accounts for federally funded HESC research as well?

Federally funded activities each require unique funding. Registry HESC requires no separate segregation beyond what is normally required for a research project. When non-Registry HESC is included, a separate DPA-Fund must be assigned so all related costs can be identified and separated from other activities. Registry HESC can be combined with other allowable activity.

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EFFORT REPORTING

What factors determine how much time researchers can devote to ineligible hESC research?

The total allowable amount of an individual’s committed effort generally cannot exceed 100%. To determine how much work effort you can commit to ineligible hESC research, simply calculate how much of your total work effort have been committed to federally funded projects, other projects and commitments the balance of the time is what you may dedicate to hESC.

Can students or post-docs supported by federal funding work on ineligible hESC research projects?

Yes, subject to the general protocols governing personnel work effort. The extent to which students will be able to engage in hESC research will thus depend on what work terms, if any, are contained in their funding agreements. If a student or post-doc is supported by federal funding s/he must receive written permission from the appropriate NRSA Grants Management Specialist prior to beginning work on non-registry hESC lines. In order to receive approval, the trainee must provide clarification on the following 3 points:

A minimum of 40 hours a week is devoted to the NRSA training program by the fellow. Any work above the minimum 40 hours would be considered "compensation" and would be paid by a salary payment from the other funding source (i.e. not by a stipend which is the payment method for the NRSA training activities).

The work on the CIRM research grant must be for a different research project than that studied under the NRSA training grant.

The Fellowship sponsor must verify that the work on the research grant will not in any way prolong or detract from the training of the NRSA fellow or graduate student.

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Should all individuals in the laboratory who are involved in non-Registry HESC research report and certify their effort regardless of the funding source?

Yes.

What kind of effort reporting system for non-Registry HESC research should be used?

Use UCSF’s standard Effort Reporting system (PARs).

Should UCSF use a different reporting method (e.g., time sheets) or require reporting with greater frequency than the standard federally approved effort reporting system?

No.

REVIEWS AND MONITORING

Should UCSF perform special reviews of grants, etc. involved in non-Registry HESC research? What would be the focus and scope of such review?

Yes, the main focus should be on how will costs be allocated and kept separate. There should also be a review to ensure that no federal funds are being used for non-Registry HESC research.

Does UCSF monitor expenditure of funds for non-Registry HESC research? E.g., place a person in charge of ordering or approving purchases?

No. The primary focus at UCSF is on identifying non-Registry HESC activity at the account and fund level. Once this is done, no monitoring beyond normal should be needed. For direct costs, it is the responsibility of the Principal Investigator, the Department and the School to ensure compliance with University Policy and to make expenditures under the account and fund for which they are used.

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PROCUREMENT

What training should the purchasing agents be provided?

To ensure that orders for materials to be used in non-Registry HESC research are properly identified and segregated from materials to be used on federally funded research, they should receive a briefing on the differences between the two and the importance of separation of the costs.

Is it acceptable to procure materials for non-Registry HESC research using institutional pricing structures that may be based on the assumption of government funding and/or institutional purchasing volume?

The majority of institutional contracts are based on the total volume of institutional purchasing regardless of the sources of funding and the distinction is not necessary. The exception to this might be when the institution is utilizing a federally negotiated purchasing agreement (e.g. a VA type agreement). You should consult Materiel Management for specific contracting restrictions.

Should requisitions for non-Registry HESC related materials be separate or can they be combined with non-government funded requisitions?

As long as the costs are clearly identified and allocated to the appropriate account it is not necessary to separate purchases. However, if the volumes are high enough to make it cost effective such a separation may be warranted.

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TECHNOLOGY TRANSFER

How should the origins and derivation of new materials be documented (e.g., with records of consents, approvals, funding, and other obligations) to insure their future value to researchers and commercial entities?

Complete and accurate records should always be kept for research and patent purposes but while keeping detailed information about donors, including their identities, may increase the value of new materials, ethical considerations and individual donors’ preferences may limit the information that can be kept or disseminated.

What effect does the interest of Wi-Cell, as a patent holder, and other licensees have on non-Registry HESC research? How does the language of Wi-Cell’s Memorandum of Understanding affect an investigator’s opportunity to use non-Registry HESC?

Wi-Cell has broad patent rights covering human embryonic stem cells and thus most if not all research in this area, academic or commercial, whether with Registry or non-Registry stem cells will most likely be subject to those patent rights and require a license from Wi-Cell.

Can researchers use and/or analyze data and information generated from ineligible hESC research in federally funded projects?

Yes, but subject to any applicable restrictions on data usage imposed by other universities or research institutions, funding agencies, or other third parties. The federal government may not be charged for generating or significant manipulation of data from ineligible hESC research.

Can researchers share materials derived from Registry materials within UCSF? Can researchers share such materials outside UCSF?

Transferring materials, whether within or outside an institution, is best accomplished with a Material Transfer Agreement that respects the developer’s property rights and stipulates the terms and conditions under which the recipient may use the materials.

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When, if ever, does research on material derived from HESC stop being considered HESC research? Can these materials be shared with other researchers for use in connection with federally funded projects?

Current guidance from NIH is that research using materials derived from non-Registry stem cell lines faces the same restrictions on funding as use of the stem cell lines.

How does a PI appropriately and sensitively dispose of research materials and/or commercialize materials and research results derived from HESC?

As long as the materials and results cannot be traced to an individual donor, they can be handled in the same manner as other research materials and data.

Page updated: March 2, 2007