This procedure applies to human fetal tissue transplantation research conducted at the University where the intended recipient of the transplant is a relative of the donor or other individual designated by the donor ("donor-designated"). Fetal tissue for donor-designated transplantation may be obtained only from a spontaneous abortion or stillbirth.
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 human fetal tissue transplantation research ineligible for federal/state funding.
|Budget Item||Best Practice||Other Option (if applicable)|
|Personnel: student fellows, trainees, work-study students||Personnel with Pell grant or student loan: allowable; Personnel on training grant: not allowable
Work-study personnel: 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||Use of pre-existing equipment allowable if (1) fully depreciated; and (2) contractual arrangement completed and equipment no longer retains federal obligations|
|Subcontract||Follow the standard University procedures. SPA will add a clause to the subcontract that no federal funds can be used to conduct the work|
|Supplies||Use an outside supplier through the standard University procedures||Contact Internal/External Sales before using an ISO|
|Travel||Follow the standard University policies and procedures|
|Patient Care||Use the applicable rate of the hospital to be used|
|Facilities/Space 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 Internal/External Sales before using an ISO|
|Cost Sharing, Matching, In-Kind||Provide from non-federal funds|
Obtaining Necessary Approvals
Researchers must obtain approval from the Fetal Tissue Research committee (FTR) for the use of human fetal tissue and obtain approval for the research from the Institutional Review Board (IRB).
Disclosing Proposed Research
Principal investigators must disclose intended use of human fetal tissue transplantation research by checking 'yes' to the appropriate question on the Human Subjects Health and Biological/Medical Application (IRB application). If the IRB approves the proposed research, these forms then will be routed to the Facilities and Administration (F&A) Cost in Sponsored Projects Administration. Staff will contact the principal investigator to obtain information regarding:
- The location of the laboratory
- Number of square feet in the laboratory allocable to human fetal tissue transplantation research ineligible for federal/state funding
- An inventory of laboratory equipment to be used on human fetal tissue transplantation 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 human fetal tissue transplantation research ineligible for federal/state funding, the F&A cost unit staff will register the project with Research Compliance Office in the Office of the Vice President for Research.
Before a study involving human fetal tissue transplantation research ineligible for federal/state funding may proceed, the principal investigator, other project staff, and departmental financial staff must obtain the appropriate training regarding financial management of costs related to research ineligible for federal funding. Sponsored Projects Administration will conduct an education session tailored to the particular needs of the project. This training will be based on the curriculum developed for personnel working on embryonic research ineligible for federal/state funding, but the training will be tailored more specifically to the requirements of human fetal tissue transplantation research. See Administrative Procedure: Preparing to Conduct Research Involving Human Embryos or Embryonic Stem Cell Lines Ineligible for Federal/State Funding and Appendix A: Workshop on Using Human Embryos/Embryonic Stem Cells.
The University will administer projects involving human fetal tissue transplantation research ineligible for federal/state funding in the same manner and through the same oversight mechanisms that are used for human embryonic research ineligible for federal/state funding. See Administrative Procedure: Project Administration for Human Embryonic Research Ineligible for Federal/State Funding. However, no material transfer agreement is required where human fetal tissue obtained from single spontaneous abortion or stillbirth is transferred to the University for possible transplantation into a designated recipient.