Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Research (Non-Transplantation) or Teaching

University personnel (“personnel”) may use human fetal tissue or cell lines derived from human fetal tissue ("human fetal tissue") for purposes of non-transplantation research and teaching only in accordance with applicable federal and state laws and regulations, and University policies and procedures. This policy does not apply to the use of cell lines derived from human fetal tissue that historically have been available and are widely used and distributed on a national basis.

Requirements that Apply to Research

Researchers who wish to conduct research studies involving human fetal tissue must:

• obtain approval from the Fetal Tissue Research (FTR) committee; and
• obtain approval for the research from the IRB if the researcher obtains identifying information about the person donating the human fetal tissue or meets other criteria for IRB review.

If the research requires IRB approval, the FTR will share its assessment with the IRB.  

Requirements that Apply to Research and Teaching

All personnel who use human fetal tissue in research or teaching must:

• submit a request for human fetal tissue to the Anatomy Bequest Program (ABP) or obtain approval from ABP for the source of human fetal tissue supplied by a research sponsor;
• participate in mandatory training provided by ABP;
• retain the human fetal tissue only for the amount of time necessary to complete the research or teaching use; and
• notify ABP when the research or teaching use is complete to arrange for disposition of any remaining human fetal tissue.

Prohibited Activities

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:

• (when leaving the University) transfer human fetal tissue to other institutions;
• distribute acquired human fetal tissue to an internal or external researcher without the advance approval of the FTR and notification to ABP;
• offer or provide payment for any costs associated with a 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

Except for research that meets the criteria for review by the Institutional Review Board (IRB), the FTR must review and approve all research with human fetal tissue or cell lines derived from human fetal tissue, before the research begins.

The FTR has authority to approve, require modifications to or disapprove proposed research, and to suspend or terminate approved research for serious non-compliance or unanticipated problems.

The FTR will consider whether alternatives to human fetal tissue would be sufficient for the research. If the proposed research involves aborted fetal tissue, the FTR will require researchers to provide a written explanation of the need for human fetal tissue from induced abortions and whether alternatives, including non-aborted human fetal tissue, can be used for the research. The FTR will submit its decisions to the University’s Institutional Review Board (IRB) for review by the IRB to ensure all alternatives have been considered.

Acquiring Human Fetal Tissue

Personnel must contact the Anatomy Bequest Program (ABP) prior to obtaining human fetal tissue from any source, and 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, collaborator or other source. ABP will acquire human fetal tissue from tissue procurement organizations or clinics outside Minnesota that operate in compliance with federal law and applicable state laws and certify they do not obtain human fetal tissue from abortions performed in Minnesota. ABP also may accept donations of human fetal 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

Personnel must notify ABP when the research or teaching use is complete. ABP will dispose of the human fetal tissue in a culturally-sensitive, dignified manner through cremation, burial or other lawful disposition method.

Personnel must contact the ABP if the intended use of the human fetal tissue changes or if the study or teaching use will take longer than anticipated.

Training

All personnel, including students, using human fetal issue in research or teaching 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 or teaching.

Separation of Roles

Personnel who perform human fetal tissue research must be separate from the attending physician treating the person undergoing an induced abortion. The 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.

Required Reporting

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 at the University as mandated by the Legislature in a 2017 law.

Exclusions

This policy excludes the use of cell lines derived from human fetal tissue that historically have been available and are widely used and distributed on a national basis. In addition, 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 Pluripotent Stem Cells).

Personnel conducting research with human fetal tissue for the purpose of transplantation must follow Administrative Policy: Acquisition, Use, and Disposition of Donated Human Fetal Tissue for Transplantation Research.