This policy outlines additional state and federal regulations and institutional requirements for the use of fetal materials in research by University of Wisconsin-Madison faculty, staff and students.
For purposes of this policy:
“Fetus” means the product of conception from implantation until delivery.
"Fetal material" includes the dead fetus; or cells, material, or organs excised from a dead fetus.
This policy does not apply to cell lines derived from fetal materials, placental or umbilical materials and their cell lines, or human embryonic stem cells and their cell lines.
Research involving human fetal material shall be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.
If information associated with the fetal material described above is recorded for research purposes in a manner that living individuals (e.g. living donor(s) of the material) can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects.
All research using human fetal materials derived from an induced abortion or which otherwise meets the criteria for IRB review must be submitted for review and ongoing approval to a UW-Madison Health Sciences Institutional Review Board (IRB).
UW-Madison retains oversight of research in which UW-Madison employees or agents are engaged in research collaborations, including when the research with fetal materials is conducted at other sites.
Research involving fetal material will undergo ongoing review by the IRB in parallel with the policies covering non-exempt human subjects research.
UW-Madison does not permit this research to qualify for exemption.
No UW-Madison employee or agent may knowingly acquire, receive or otherwise transfer any fetal material in exchange for valuable consideration.
“Valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal material.
Transplantation Using Fetal Tissue Research
For purposes of this section fetal tissue means tissue or cells obtained from a dead human embryo or fetus after a spontaneous or induced abortion, or after a stillbirth.
Federal funds may only be used to support research involving the transplantation of fetal tissue for therapeutic purposes if all of the below outlined provisions are met.
The woman donating the fetal tissue for transplantation must sign a written informed consent document declaring that:
She is donating the tissue for research involving transplantation for therapeutic purposes;
The donation is made without any restriction regarding the individuals who may be the recipients of the transplanted tissue;
She has not been informed of the identity of the individuals who may be the recipients of the transplanted tissue.
The attending physician who obtains the fetal tissue from the woman donating such material for transplantation must sign a written statement declaring that:
The tissue was donated with the informed consent of the donor, as described above in IV. B. 1.
Full disclosure was made to the donor with regard to,
Such physician’s interest, if any, in the research to be conducted with the tissue; and
Any known medical risks to the donor or risks to her privacy that might be associated with the donation of the tissue and that are in addition to risks of such type that are associated with her medical care.
In the case of tissue obtained pursuant to an induced abortion,
The consent of the woman for the abortion was obtained prior to requesting or obtaining consent for a donation of the tissue for use in the research;
No alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
The abortion was performed in accordance with applicable state law.
The individual with principal responsibility for conducting the research must sign a written statement declaring that he or she:
Is aware that the tissue is human fetal tissue; that it may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and that the tissue was donated for research purposes;
Has informed other individuals with responsibilities in the research that the tissue is human fetal tissue; that it may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and that the tissue was donated for research purposes;
Will require, prior to obtaining the consent of an individual receiving transplantation of the tissue, written acknowledgement of the recipient that he or she has received the information that the tissue is human fetal tissue; that it may have been obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth; and that the tissue was donated for research purposes;
Has had no part in any decisions as to the timing, method, or procedures used to terminate the pregnancy made solely for the purposes of the research.
The University must certify to the Secretary of Health and Human Services that the required statements will be available for audit by the Secretary.
No UW-Madison employee or agent may solicit or knowingly acquire, receive or accept a donation of human fetal tissue for the purpose of transplantation of such tissue into another person if the tissue will be or is obtained pursuant to an induced abortion, and
the donation will be or is made pursuant to a promise to the donating individual;
the donated tissue will be transplanted into a recipient specified by or relative of the donating individual; or
the person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.