Guidelines For Separating Costs and Materials for Research on Non-Registry hESC Lines
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.
Guidelines
UCSC researchers may conduct research on human embryonic stems cells and their derivatives that are not on the Federal Registry in UCSC research space provided that federal resources are not be used to support projects on non-registry hESC lines. Researchers should also adhere to 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. Costs and materials for non-registry human embryonic stem cell research projects must be separate from costs and materials for federally funded research.
How to Ensure Separation of Costs and Materials
The following measures can help 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. Researchers may work on hESC research projects or activities only with prior approval of a research protocol by the UCSC IRB and ROCSC. 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.
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 should track their time through daily logs.
2. Academic Salaries
- Federally funded UCSC salary and effort cannot be used to conduct research using non-registry lines.
- If a UCSC 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.
3. Stipends
- Graduate Students who receive federal stipends 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, they must account for their time using daily logs that can demonstrate that they have not performed ineligible research while compensated with federal funds.
- 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. 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, departments should track additional effort or maintain 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
- Undergraduate 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.
- Volunteers receive no compensation whatsoever for their contribution of effort to any activity at UCSC. They need not track time spent in support of federally ineligible hESC research.
B. EQUIPMENT
1. 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. With certain exceptions, equipment purchased with federal funds cannot be used to support projects on non-registry hESC lines.
2. Removing Restrictions on Federally-Funded Equipment
Most federal research awards provide that the title to equipment purchased on those awards is vested with UCSC. 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 UCSC, 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.
C. SUPPLIES
Research involving hESC 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.