Preparing to Conduct Research Involving Human Embryos or Embryonic Stem Cell Lines Ineligible for Federal/State Funding
Obtaining Necessary Approvals
All researchers proposing to use human embryos or embryonic stem cell lines in their research, regardless of eligibility for federal funding, must obtain approval from the Stem Cell Research Oversight (SCRO) panel before the research can proceed. When required by other University policies and federal regulations, researchers also must obtain approval from the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), and/or the Institutional Biosafety Committee (IBC).
Approved Human Embryonic Stem Cells (hESC)
Researchers using federally approved hESC lines are subject to the same project administration requirements that apply to other federally-sponsored projects. The National Institutes of Health provides specific information on writing a grant application for projects with federally approved hESC lines at the NIH Human Pluripotent Stem Cell Registry.
Federally Unapproved Human Embryonic Stem Cells (hESC) and Research Involving more than Minimal Risk to Human Embryos
The remaining sections of this procedure apply to research using human embryos or embryonic stem cell lines that is ineligible for federal or state funding. These sections address how to set up a project that will involve federally unapproved hESC lines and/or research that involves more than minimal risk to human embryos.
Preparing the Proposal Budget
The principal investigator is responsible for preparing the proposal budget. The chart below outlines the best practices for handling common budgetary items. If these practices are followed, it will be much easier to correctly administer embryonic research ineligible for federal/state funding.
|Budget Item||Best Practice||Other Option (if applicable)|
|Personnel: student fellows, trainees, work-study students||Work-study personnel: not allowable
Personnel with Pell grant or student loan: allowable
Personnel on Federal/State training grant: not allowable
|Personnel: all others, including principal investigator||These personnel must certify their correct and exact effort on the project|
|Consultant||Follow the standard University policies and procedures|
|Equipment||Purchase new with an allowable source of funds||Obtain authorization to use equipment acquired in whole or in part with federal/state dollars via "UM 1671: Equipment Screening Form for hESC Lines Ineligible for Federal/State Funding." This form is necessary because use of pre-existing equipment is only allowable if (1) fully depreciated or if the equipment is verified to be excluded from University F&A pools and that any applicable ISO rate does not include depreciation costs for the federal or state-funded portion of the acquisition cost and (2) pre-existing sponsor obligations are appropriately addressed.|
|Subcontract||Follow the standard University procedures. SPA will add a clause to the subcontract that no federal/state funds can be used to conduct the work.|
|Supplies||Use an outside supplier through the standard University procedures||Contact Accounting Services before using an ISO|
|Travel||Follow the standard University policies and procedures|
|Patient Care||Use the applicable rate of the hospital to be used|
|Alterations and Renovations||Follow the capital budgeting policy and procedures|
|F&A Costs||Use the applicable F&A rate|
|Other: Animal Care Costs||Purchase through Research Animal Resources|
|Other: Services||Use outside suppliers whenever possible||Contact Accounting Services before using an ISO|
|Cost Sharing, Matching, In-Kind||Provide from non-federal funds|
Principal investigators must disclose intended use of embryos or embryonic stem cells ineligible for federal funding by checking 'yes' to the appropriate question on the SCRO panel application form, and, if applicable, the Proposal Routing Form (PRF), and the Material Transfer Application Routing Form (MTARF). If the SCRO panel approves the proposed research, these forms will then be routed to the Assistant Director of Facilities and Administration (F&A) Cost in Sponsored Projects Administration. The assistant director will contact the principal investigator to obtain information regarding:
- The location of the laboratory
- Number of square feet in the laboratory allocable to embryonic research ineligible for federal/state funding
- An inventory of laboratory equipment to be used on embryonic research ineligible for federal/state funding, including core facilities/resources
- The account string assigned to the project
- Any internal service organization (ISOs) from which research services might be purchased
- Whether Fairview or any other affiliated organization (UMF) will be involved
- Other information as needed
Staff members in Sponsored Projects Administration will also schedule training for the principal investigator and other individuals working on the project.
Registering the Project
Once details have been determined regarding the embryonic research ineligible for federal/state funding, the Assistant Director of F&A cost will register the project with the Research Compliance Office (RCO) in the Office of the Vice President for Research.
Before a study involving embryonic research ineligible for federal/state funding may proceed, the principal investigator, other project staff, and departmental financial staff must obtain the appropriate training. Sponsored Projects Administration will conduct an education session tailored to the particular needs of the project. See Appendix A for a sample curriculum.