UCSD Guidelines For Separating Costs and Materials for Research on Non-Registry hESC Lines from Those for Federally Funded Research

I.

Background
On August 9, 2001, President Bush announced that federal funds may not be used for research using human embryonic stem cell (hESC) lines unless (1) the stem cells were derived from an embryo that was created for reproductive purposes and was no longer needed; (2) informed consent was obtained for the donation of the embryo, and the donation did not involve financial inducements; and (3) the process of derivation was begun prior to 9 pm EDT on August 9, 2001. The National Institutes of Health (NIH) has established a registry of the stem cell lines that satisfy these criteria (“registry lines”); research on these lines is therefore eligible for federal funding. Research on hESC lines not listed on the NIH registry (“non-registry lines”) is ineligible for federal funding.

The Registry of federally approved stem cell lines is a definitive list of those cell lines that can be used in research supported by federal funds.  The list is found at: http://stemcells.nih.gov/research/registry/.

Non-registry lines are also known as unapproved, ineligible, non-federal, or non-approved human embryonic stem cell lines.

II.

Statement of Guidelines
UCSD Researchers may conduct research on human embryonic stem cells and their derivatives which are not on the Federal Registry in UCSD research space provided that researchers adhere to the guidelines which follow.  Researchers should also adhere to the UCSD Guidelines for Human Embryonic Stem Cell Research http://escro.ucsd.edu/UCSD_guidelines.html; the Policy and Guidelines found on the NIH web site http://stemcells.nih.gov/policy/guidelines.asp, the FAQ from the NIH Stem Cell web site http://stemcells.nih.gov/info/faqs.asp and NIH standards for separation of costs outlined in OMB Circular A-21.

Non-registry cell lines, such as the HUES cell lines from Harvard, do not qualify for Federal support. Accordingly, researchers must implement practices that adhere to the NIH standards for separation found at http://stemcells.nih.gov/info/faqs.asp#both and further outlined in OMB Circular A-21.  Principal Investigators who receive federal funds and study both federal Registry and non-federal registry human embryonic stem cells are responsible for insuring that research costs involving non-federal-registry lines are only charged to non-federal sources of funding.

Costs and materials for non-registry human embryonic stem cell research projects must be separate from costs and materials for federally funded research.  To summarize, federal resources may not be used to support projects on non-registry hESC lines.

III.

How to Ensure Separation of Costs and Materials
The following measures can ensure that a researcher strictly separates costs and resources for all research conducted with non-registry lines from costs for federal research projects.

A.

PERSONNEL

 

1.

Concept
Employees and key individuals may work on hESC research projects or activities only with prior ESCRO approval of a research protocol. Approval is required whether or not the hESC research is eligible for federal funding, and whether or not the individual receives federal funding for any purpose.  UCSD’s existing policies and procedures for tracking work effort on federally funded research will apply so that appropriate effort is devoted to commitments under federal grants, and so that other activities, including work on ineligible stem cell lines, are not supported with federal funds.

All personnel working with hESC lines may only use the hESC lines appropriate to his or her funding source.  Any person fully funded through federal sources will work solely with federally eligible hESC lines. Individuals funded through private or state sources may work with both federally eligible and federally ineligible hESC lines. Those individuals supported by both federal funding and other funding who want to work with non-registry cell lines must be paid by the federal funding source only for the time they spend on federal registry cells.  They must be paid by a non-federal source for the time they spend on non-registry lines.  If their effort is not captured by the effort reporting system, individuals must track their time through daily logs.

2.

Academic Salaries

a)

Federally funded UCSD salary and effort cannot be used to conduct research using non-registry lines.

b)

VA academic appointments and salaries are recorded and counted separately from UCSD academic appointments, and researchers cannot conduct research using non-registry lines while on VA time, since it is federally funded.

c)

Salary for VMRF academic appointments are in most cases transferred to UCSD via a personnel agreement. If the salary funding is federal, the effort for that salary, along with any UCSD salary that is federally funded, is included in the UCSD effort certification. Federally funded VMRF salary/effort cannot be used to conduct research using non-registry lines.

d)

If a UCSD faculty member has a university source for salary above the NIH cap, the effort funded by the federal salary source and by the University source for the portion above the cap must be devoted to and certified to the federal project. Non-registry hESC lines may not be used for these efforts, despite the University salary above the cap.

e)

For UCSD researchers located in VA or VA leased space, research using non-registry lines may not be conducted there. Non-registry hESC research must be located in campus space that is not supported by federal resources. Please see 4. SPACE, below.

3.

Stipends

a)

Graduate Students
Graduate student paid a stipend on an NIH fellowship or training grant has a 40 hours-per-week training commitment for receipt of that stipend.  NIH may allow for additional salary on research projects as long as it does not interfere with, detract from or prolong the training program.  Graduate students who receive federal stipends are not tracked in the UCSD system for Certification of Effort on federal projects.  They may be permitted under the terms of their funding to engage in limited or part time work beyond their commitment to a federally funded education or training grant.  Any such additional work, including ineligible hESC work, must be conducted in addition to the duties of their education or training grant, and cannot be simultaneous with it.

If a graduate student is to receive additional salary compensation, the Office of Graduate Studies requires the student sign to an agreement verifying that they are working on a project different than their training grant.  Graduate students must strictly account for their time using daily logs that can demonstrate that they have not performed ineligible research while compensated with federal funds.

b)

Postdoctoral Scholars
A postdoctoral scholar paid a stipend on an NIH fellowship or training grant has a 40 hours-per-week training commitment for receipt of that stipend.  NIH allows for additional compensation (i.e. salary) on research projects as long as it does not interfere with, detract from or prolong the training program.

UCSD limits total additional salary support to ten hours per week.  This additional service may be on a CIRM funded research project or may be for research on non-registry lines, as long as all requirements for the conduct of stem cell research are met.

Postdoctoral participation on a federal fellowship or training grant does not include effort certification.  If a postdoc is funded on a federal training grant and receives additional salary compensation from CIRM or another non-federal funding source, no effort report is generated since federal training grants and fellowships do not require effort reporting. Departments should track additional effort in the same way they do for sick leave and time off, or by maintaining a log of hours spent by the postdoc on the non-federal project.  If a postdoc is funded on a CIRM training grant, however, and receives additional salary compensation from a federal research grant, the effort on the federal grant must be certified and the postdoc may not use non-registry hESC in his or her federally-supported research.

NIH Service Payback requirements for postdoctoral fellows or trainees can be completed in the subsequent year with any research appointment, even if the source of funding for the service payback research appointment allows work on non-registry human embryonic stem cell lines.

4.

Other Personnel

a)

Undergraduate Students
Students may receive compensation as student workers for work performed on federally ineligible hESC, as long as the source of funding is non-federal.  Department funds and work study funds are among the permitted sources of funding. Students supported by federal scholarships for undergraduate study (such as the NIH UGSP) may not engage in federally-ineligible hESC research.

b)

Volunteers
Volunteers receive no compensation whatsoever for their contribution of effort to any activity at UCSD. They need not track time spent in support of federally ineligible hESC research.

B.

EQUIPMENT

 

1.

Concept
Equipment refers to goods with a useful life greater than one year that cost $5,000 or more. Equipment purchased with non federal funds may be used for hESC research with non-registry cell lines. At UCSD, a large percentage of academic equipment is federally funded. With certain exceptions, equipment purchased with federal funds cannot be used to support projects on non-registry hESC lines. Researchers can identify federally purchased equipment by consulting the UCSD Equipment Inventory or purchasing and grant records. Equipment bought with Federal funds is labeled (as of June, 2007) with large, easily visible red dots to warn potential users that no non-registry cells can be used with these items of equipment. Capital Assets Accounting has been provided with red tags to issue along with UCID tags for federally funded equipment as it is subsequently purchased, and will soon issue a campus notice describing the new procedure and its purpose.

2.

Removing Restrictions on Federally-Funded Equipment
The majority of federal research awards provide that the title to equipment purchased on those awards is vested with UCSD. Nevertheless, the federal awarding agency generally reserves the right to request that title to equipment be transferred to the agency within 120 days of the end of the award period. This right is rarely exercised.

In cases where title vests in UCSD, such equipment also may not be used for projects using non-registry lines unless all three of the following requirements are met:

  • The sponsored project for which it was acquired has been completed (including all competitive segments),
  • More than 120 days have passed since completion and termination of the award or receipt by the federal government of a property report, whichever is later, and,
  • The federal government does not issue instructions to transfer the equipment to the Federal government or to an eligible third party.
The Stem Cell Oversight Working Group has created a process to remove restrictions on use of federally funded equipment. The process is as follows:

a)

Once a sponsored project is completed, including all competitive segments, a Property Report is issued, listing all equipment purchased on that award. A Property Report Date is entered in the Equipment Inventory for each item of equipment included on the Property Report.

b)

On a quarterly basis, all equipment items with a Property Report Date older than 120 days will have the EAMS federal funding indicator removed.

c)

The restriction removal will be reported to the department property administrator, to notify them to remove the red tag on the equipment items, so that their researchers are able to use that equipment for all purposes.

d)

The items from which restrictions have been removed will be reported to the Financial Analysis Office.  The FAO will use this data to exclude any remaining depreciation of these items from the campus overhead rate calculation.

3.

Allowable Options for Purchasing Equipment to be used for both Research on Non-Registry lines and Federal Research
The Stem Cell Oversight Working Group offers these options for purchasing equipment needed for research on non-registry hESC lines, as well as federal research:
  • Use only California Institute for Regenerative Medicine (CIRM) funding or other non-federal funding to pay for equipment. (Note that resources and equipment purchased with other than federal funds may be used for federal research, unless otherwise restricted by the fund source.)
  • Use needed equipment available from a UCSD formal recharge operation such as a microscopy core facility. Charge the use for federal research to federal funding and the research using non-registry lines to non-federal funding.
  • Locate existing non-federally funded equipment (ask the department administrator for assistance) that is most convenient to your research, and borrow it for your non-registry-lines research. Principal Investigators could also locate an existing federally funded item that is convenient to their research, and borrow it only for their federal research.
  • Two or more PI and/or departments can buy two identical items. Each provides their share of the cost of the first one from federal funding, and each provides their share of the cost of the second item using CIRM or other non-federal funding. Principal Investigators share the items, using the federal funded item for federal research. The other item can be used for all research.

C.

SUPPLIES

 

1.

Concept
Research involving Human Embryonic Stem Cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted using supplies or other resources purchased with federal funds. Researchers working with non-federally approved cell lines are responsible for assuring that expenses for such projects are appropriately segregated and charged to a non-federal funding source.

Expenditures should be direct-charged to the award that receives the benefit of the item.  This coincides with the definition of direct costs in the federal costing principles, as those costs that can be identified with the particular award, or that can be directly assigned to the award relatively easily with a high degree of accuracy.

All supplies used for hESC research, such as reagents, plastics, media, pipettes and tissue culture supplies, used with federally approved cell lines and non-approved cell lines must be financially separated using an accounting hierarchy structure that separates the activities by using index and fund numbers distinct to each project.  Supplies must also be identifiable to their funding source and physically separated when possible. An ordering system and a financial tracking system must be in place to ensure clear separation of federal and non-federal materials.

In some cases, an item may benefit two or more projects, such as with bulk laboratory supplies.  If the proportional benefit can be determined without undue effort or cost, the cost should be allocated to the projects based on the proportional benefit. If a cost benefits two or more projects or activities in proportions that cannot be determined because of the interrelationship of the work involved, then the costs may be allocated or transferred to benefited projects on a reasonable basis. The proportion of supplies paid by federal funds should never exceed the proportion of federal research funding to all funding in that research lab.

D.

SPACE (FACILITIES)
UCSD Buildings are listed in three categories to enable researchers and academic departments to determine acceptable research locations for usage of non-registry lines. The listing below will be augmented as more detailed information on funding of building construction and renovation is obtained.

 

1.

Research using non-registry lines is not permitted in these buildings:

 

303 University Center

Mt. Soledad Laboratory 1

Nimitz Marine Facility Pier

Nimitz Marine Facility Laboratory Building

University Extension Complex (buildings A-O and X-Z)

Hydraulics Laboratory

Mt. Soledad Laboratory 2

Theodore Gildred Facility

VA Medical Center

2.

Please check before using these buildings:

 

Applied Physics and Mathematics (APM)

Biomedical Sciences Building (BSB)

Clinical Teaching Facility (CTF)

Medical Teaching Facility (MTF)

Seaweed Canyon Warehouse

Stein Clinical Research Building

Surgery Research Laboratory

Center for Magnetic Recording and Research (CMRR)

Institute of Geophysics and Planetary Physics (IGPP)

San Diego Supercomputer Center (SDSC)

Biology Building

Bonner Hall

Scholander Hall

York Hall

Shiley Eye Center

Sverdrup Hall

Urey Hall

3.

Research using non-registry lines is permitted in these buildings:

 

Cellular and Molecular Medicine (CMM) East

Leichtag Biomedical Research Bldg

Science and Engineering Research Facility (SERF)

Pacific Hall

Moores Cancer Center

There are a number of other campus academic buildings that have no federal funding, and these will be added to listing c) (above) as soon as a final review of capitalization costs is completed. If a building not on this listing is being considered for the conduct of research using non-registry lines, please contact Christine Stevens at 858-822-0704.

IV.

Reference Materials

NIH FAQ
http://stemcells.nih.gov/info/faqs.asp

UCSD Guidelines for hESC research
http://research.ucsd.edu/ESCRO/guidelines.html

UCSD How to Start hESC research – FAQ
http://stemcells.ucsd.edu/research-howtostart.asp