University researchers (“researchers”) may conduct research on the transplantation of human fetal tissue or cell lines derived from human fetal tissue (“human fetal tissue”) for therapeutic purposes only in accordance with applicable federal and state laws and regulations and University policies and procedures. These researchers must do all the following:
- 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);
- submit a fetal tissue acquisition form to the Anatomy Bequest Program (ABP) or obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor;
- register the research with the Research Compliance Office (RCO) in the Office of the Vice President for Research;
- follow Food and Drug Administration (FDA) requirements under an approved Investigational New Drug (IND) application;
- follow the necessary accounting standards if the research is not eligible for federal funding; and
- use the appropriate source of funds;
- retain the tissue only for the amount of time necessary to complete the research; and
- notify ABP when the research is complete to arrange for disposition of any remaining human fetal tissue.
Research ineligible for federal or state funding must use only private funding.
Researchers may accept and/or use human fetal tissue for transplantation into a relative of the donor or other individual designated by the donor (i.e., donor-designated recipient) only if the tissue is obtained from a spontaneous abortion or stillbirth.
University personnel (“personnel”) may not perform research on a human fetus which meets the definition of a living human conceptus under Minnesota law (shows the presence of evidence of life, such as movement, heart or respiratory activity, or the presence of electroencephalographic or electrocardiographic activity), except to protect the life or health of the fetus.
Personnel, regardless of source of funding, cannot:
- receive or use human fetal tissue which is obtained through an induced abortion for the purpose of transplantation into a relative of the donor or other recipient designated by the donor;
- (when leaving the University) transfer human fetal tissue that was not used for transplantation to other institutions;
- distribute acquired human fetal tissue to an internal or external researcher without the advance approval of the FTR and notification to the ABP;
- offer or provide payment for any costs associated with the donor's induced abortion; nor
- buy or sell human fetal tissue, except reasonable payments are permitted associated with the transportation, implantation, processing, preservation, quality control or storage of human fetal tissue.
Approval of Research Prior to Acquiring Human Fetal Tissue
Researchers must apply for approval from the FTR for the use of human fetal tissue and apply for approval from the IRB to conduct human fetal tissue transplantation research. The application to FTR will include a written explanation of the need for human fetal tissue from induced abortions. FTR will assess whether alternatives, including non-aborted human fetal tissue can be used for the research, and share that assessment with the IRB before the IRB makes its decision.
Acquiring Human Fetal Tissue
Researchers must contact the Anatomy Bequest Program (ABP) prior to obtaining human fetal tissue from any source. Researchers must either: 1) obtain the human fetal tissue through ABP or 2) obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor or collaborator. ABP will procure fetal tissue from tissue procurement organization or clinics outside Minnesota that operate in compliance with federal law and applicable state laws and certify they do not obtain tissue from abortions performed in Minnesota. ABP also may accept donations of tissue obtained from a stillborn infant, or an embryo or fetus that died of natural causes in utero as authorized under applicable state laws.
Disposing of Human Fetal Tissue
Researchers must notify ABP when the research is complete. ABP will dispose of the human fetal tissue in a culturally-sensitive, dignified manner through cremation and/or burial.
Researchers must contact the ABP if the intended use of the fetal tissue changes or if the study will take longer than anticipated.
The Principal Investigator, other project staff, and departmental financial staff must obtain training from Sponsored Projects Administration relative to the financial management of costs related to research ineligible for federal funding (“ineligible study”) prior to beginning an ineligible study involving human fetal tissue transplantation research.
All personnel, including students, using human fetal issue in research must complete the training provided by ABP. The training will cover applicable federal and state laws, University policies and procedures, and other professional standards related to the respectful, humane, and ethical treatment of human fetal tissue used in research.
Separation of Roles
Personnel who performs human fetal tissue transplantation research must be separate from the attending physician treating the person undergoing an induced abortion. Personnel may have no part in any decisions on the timing, method or procedures used to end the pregnancy and may have no part in determining fetal viability.
The University must submit an annual report to the Minnesota Legislature, no later than January 15th of each year, providing information about human fetal tissue research (including transplantation research) at the University as mandated by Legislature in a 2017 law.
Researchers who wish to use federal funds for human fetal tissue transplantation research must meet the requirements imposed under federal law to obtain and use federal funds for this purpose. Federal funds are allowable only when:
- the recipient of the transplant is unknown to the donor;
- the recipient of the transplant is not a relative of the donor;
- the recipient of the transplant has not been designated by the donor;
- all other federal requirements are satisfied.
In situations where use of federal and/or state funds is not allowable units must charge direct costs associated with a registered study to a private source of funding. A registered study must have in place a method of separating the costs of supporting the research so that any of the facilities and administrative (F&A) costs allocable to the ineligible research are excluded from the rates established and used to charge F&A costs to federal/state funded research. In addition, the principal investigator and the responsible laboratory administrator must carefully and consistently allocate all costs of the ineligible research to a private funding source.
Administrative Procedures: Preparing to Conduct Human Fetal Transplantation Research Ineligible for Federal/State Funding and Conducting Research Using Human Fetal Tissue for Transplantation into Designated Recipients do not apply to human fetal tissue transplantation research where the recipient of the transplant is unknown to the donor and all other federal requirements are satisfied.
This policy does not address the acquisition or use of excess in vitro fertilization human embryos or embryonic stem cells or stem cell lines derived from such embryos, (see Administrative Policy: Conducting Research with Human Embryos or Embryonic Stem Cells.)
Research for non-transplantation purposes using human fetal tissue is covered in Administrative Policy: Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Research (Non-Transplantation) or Teaching
Reason for Policy
Research on the transplantation of human fetal tissue for therapeutic purposes shows much promise in treating serious diseases and disorders such as those amenable to blood and bone marrow transplantation (leukemia, congenital and acquired bone marrow failure syndrome, selected inborn errors of metabolic and immuno-deficiencies) and spinal cord injuries. This policy is intended to inform and assist University researchers who wish to conduct human fetal tissue transplantation research, while at the same time assuring that all such research conducted at the University meets legal, policy and funding requirements. This policy also specifies the official unit responsible for the acquisition and disposition of fetal tissue used in research, thereby reducing legal, reputational, financial and other risks to the University and researchers.