Conducting Research Using Donated Human Fetal Tissue for Transplantation into Designated Recipients
This procedure applies to human fetal tissue transplantation research at the University where the intended recipient of the transplant is a relative of the donor or other individual designated by the donor. Human fetal tissue transplantation research is subject to federal laws and regulations and Minnesota law. Combining the restrictions under both federal and state laws, the following rules apply:
Source of Human Fetal Tissue
University personnel (personnel) 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. It is a crime, and a violation of University policy, for personnel to receive and/or use human fetal tissue from an induced abortion for transplantation into a donor-designated recipient.
Separation of Roles
Personnel who perform human fetal tissue transplantation research must be separate from the attending physician treating the woman undergoing a spontaneous abortion or stillbirth. 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.
Human fetal tissue from a spontaneous abortion or stillbirth may be used for human fetal tissue transplantation research only with the informed consent of both parents of the fetus. Informed consent must be obtained after the spontaneous abortion or stillbirth occurs, but prior to the collection, testing and/or transplantation of the fetal tissue. If either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, it is sufficient to obtain the informed consent of one parent to donate the tissue for human fetal transplantation research. A separate informed consent must be obtained for the transplantation procedure from the recipient of the transplant or the recipient's parent/legal guardian.
Status of Fetus
Personnel may not perform research on a human fetus which meets the definition of a living human conceptus under Minnesota law. It is a crime and a violation of University policy for personnel to perform research on a fetus which shows the presence of evidence of life, such as movement, heart or respiratory activity, or the presence of electroencephalographic or electrocardiographic activity.
University researchers must obtain all required regulatory approvals before engaging in human fetal tissue transplantation research. This includes registering the project with the Research Compliance Office, prior approval from the University of Minnesota Institutional Review Board (IRB) to collect and test the fetal tissue and prior IRB approval to transplant the tissue into an individual recipient. The researcher also must obtain prior approval from the Food and Drug Administration (FDA) by filing an Investigational New Drug (IND) application or following other review and approval procedures as determined by the FDA.
Personnel engaging in human fetal tissue transplantation research must not offer or provide payment for any costs associated with the donor's spontaneous abortion or stillbirth. Further, it is a crime, and a violation of University policy, for personnel to buy or sell human fetal tissue. Reasonable payments are permitted associated with the transportation, implantation, processing, preservation, quality control or storage of human fetal tissue.