Information for Faculty
and Research Administrators

Frequently Asked Questions
on Separating costs and materials
for hESC research using unapproved cell lines

Are there special administrative procedures for my lab if I am conducting hESC research on federally ineligible lines?
According to The UCSD Guidelines for Human Embryonic Stem Cell Research, research involving Human Embryonic Stem Cells that are not listed on the NIH Human Embryonic Stem Cell Registry may not be conducted using personnel, equipment, facilities, supplies or other resources funded by federal monies.

You must be able to show that you have a method to keep costs and funding separate, to demonstrate that you have not used federal resources to support research on non-registry stem cell lines.

What methods can I use to separate federal funding and other funding when I have both sources of funding for my lab?
Different methods can meet the federal and UCSD guidelines. Since the methods have to be able to pass an audit, researchers and business officers should contact the Vice Chancellor for Research if they would like to develop a method to suit their research lab.

Whenever possible, expenditures should be direct-charged to the award that receives the benefit of the item. Direct costs are 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. Materials can then be ordered, labeled, and stored separately based on the source of funds and the award for which the materials will be used.

Researchers may find it useful to use a color-coded system to maintain separation of these materials. For example, red supply order forms could be used for items that will be paid for with federal funding sources and for use only with approved cell lines. When the items are received, a red sticker can be placed on the item to note its funding source and intended use, and the item can be stored in a red color-coded labeled storage space. All storage containers should be labeled including incubators, freezers, refrigerators, shelves, and cabinets. Storage devices purchase with federal money may not be used for supplies that will be use with non-registry cells.

Different colors can be used to denote supplies ordered with non-federal funding that can be used with any hESC lines. Remember, supplies and expenses will include consumables, services, and items with a use-life greater than 1 year which cost less than $5,000.

If it is not possible at the time of order to determine the award that will receive the benefit of the item, the researcher can charge the order to a separate clearing account, and charge back the items to the appropriate award account as they are used.

General Use Items
For general lab supplies, such as salts, buffers and other bulk items that may come into contact with hESCs, supplies costs must be allocated or transferred to benefited projects on reasonable basis. One methods for accomplishing this is to allocate costs to multiple projects based on the proportional benefit. The proportional benefit can be determined based on any reasonable method, such as a proportion of the total expenditures or payroll expenditures during a given time period. Each researcher should consult with the department MSO to determine an appropriate method for determining the proportional benefit. The methodology implemented should be documented and maintained by the Principal Investigator, and updated periodically when the researcher's funding changes.

I have a trainee on the NIH Research on Aging Training Grant, can he work on unapproved lines?
Only after he has completed his 40 hours a week of training. The trainee should maintain logs for time devoted to training (40 hours per week) and time devoted to stem cell research (which should be limited to 10 hours per week).In addition, logs for supplies and use of equipment should also be maintained to ensure that supplies and equipment charged to the federal training grants are not used on the stem cell research.

Can I pay him on my start up funds to work
on unapproved lines?
Yes, but only for hours in addition to his 40 hr training grant week. Logs for time, supplies, and expense should be maintained, as indicated above.

Can you describe a lab in which the standards for separation of federal resources have been met?
Hypothetical laboratory X where research on federally non-approved lines can be conducted is located in a building that was not constructed using federal funds. The floor of the building housing Hypothetical Laboratory X, and almost all of the laboratory equipment (hoods, incubators, freezers, fridges, microscopes, and other) were bought with private funds. The only exceptions were identified by consulting UCSD purchasing and grant records, and these equipment items are labeled with large, easily visible red tags to ensure that no non-approved cells are used with these items of equipment. Other equipment items in a lab on the same floor were purchase with another faculty member's State start up funds, and those equipment items are used according to an agreement made with that colleague. The laboratory personnel, an SRA and a postdoc in Hypothetical Lab X are funded by a CIRM SEED grant. A graduate student mentored by the PI for Hypothetical Lab X is the NIH training grant for another project. He does not conduct research on non-approved cell lines, but may use the H9 cell line, which appears on the federal registry.

I do not want to work in my own lab with federally ineligible hESC. Where else can I conduct human ESC work with unapproved lines?
There are facilities available to conduct research with federally non-approved cell lines.

The Human Embryonic Stem Cell Core Facility (HESCCF) in CMM East meets the standards for Separating costs and materials for hESC research using unapproved cell lines. The HESCCF has cell culture equipment and advanced capabilities purchased solely with non-federal funds, so no direct federal money benefits research on non-approved hESCs conducted there. For more information on using the HESCCF, please contact Karl Willert, Director, at kwillert@ucsd.edu or by telephone at (858)822-3235.

I have federal funding and CIRM funding for ineligible hESC research. Would it be okay for me to buy a microscope split between federally funded research and non-federally funded research and use it for both approved and non-approved stem cell research?
Split-funding one microscope between federally funded research funding and funding for research on non-approved stem cell lines would be the least desirable and most likely problematic approach. This method would not clarify whether the federally funded portion was benefiting non-approved stem cell research.

Some more desirable options include:
1. Use only your non-federal funding to pay for your microscope. There is no prohibition on using non-federal resources/equipment on federal research.

2. Locate a campus microscope facility operated on a recharge basis, charge the federal research use to federal funding and the non-approved research to non-federal funding.

3. Locate an existing non-federally funded microscope (using the campus inventory or having your dept. property administrator do so), which is most convenient or closest to your research, and borrow or use it for your non-approved research. You could also locate an existing federally funded microscope which is most convenient or closest to your research, and borrow or use it only for your federally approved research.

4. You and another researcher buy two microscopes. You each provide 50% of the cost of the first one from federal funding, and you each provide 50% of the cost of the second one from CIRM or other non-federal research funding. You share the microscopes, using the federal funded one for federal research only, and the other one for whatever you want.

5. Fund the microscope with federal funds, establish a recharge operation for access to/use of the microscope, whose charge rate is based on at least the depreciation of the microscope and reimbursement of any other federal costs. Charge all users not on federal funds (including non-approved stem cell research). This is a little more complicated - approval is needed by the federal agency who funds it, and the requirements and criteria for program income must be followed.

I am a recent CIRM SEED grant awardee and I would like to find out more about UCSD policy on non-federally approved lines. Specifically, I would like to find out if I can set up culture for non-federally approved human embryonic stem cell lines in my dept-assigned lab space.
Unless your building appears on the list of buildings with substantial federal funding, you may use your lab space for non-federally approved stem cell research. The list is posted here, and you may direct specific questions to Bill Brophy, Director of Financial Analysis. One caution - since 45% of UCSD's equipment inventory is federally funded (purchased using federal grant/contract funds), you should confirm that the equipment you are using for this research is not federally funded. The department property administrator can look up the items on the campus equipment inventory, or contact Bessie Douglas, Equipment Management, at x4-2847.