Approved by: Human Research Protection Program Advisory Committee
Approval Date: April 23, 2009
BACKGROUND
Faculty, staff and students of the University of Wisconsin-Madison are reminded that scientific and ethical considerations associated with research utilizing human fetal tissue make it imperative that University researchers be clearly aware of and comply with the federal laws and regulations concerning such research.
DEFINITIONS
“Fetus” means the product of conception from implantation until delivery.
“Human fetal tissue” means tissue obtained pursuant to a spontaneous or induced abortion or pursuant to a stillbirth. Human embryonic stem cells are not human fetal tissue.
“Valuable consideration” does not include reasonable payments associated with the transportation, implantation, processing, preservation, quality control, or storage of human fetal tissue.
POLICY
I. Research Involving the Use of Human Fetal Tissue Generally
A. Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs exercised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities.
B. If information associated with material described in paragraph A of this section is recorded for research purposes in a manner that living individuals (e.g. living donor(s) of the tissue) can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects.
C. All research using human fetal tissue which is carried out in whole or in part by individuals in their capacity as UW-Madison faculty, staff or students must be submitted for review and approval to a UW-Madison Health Sciences Institutional Review Board (IRB).
D. UW-Madison IRBs do not exempt research using human fetal tissue, nor designate such research as research not involving human subjects.
II. Research Involving the Transplantation of Human Fetal Tissue for Therapeutic Purposes
A. Federal funds may be used to support research involving the transplantation of human fetal tissue for therapeutic purposes if all of the provisions outlined Section II of this policy are met.
B. Informed Consent of the Donor. The woman donating the human fetal tissue for transplantation must sign a written informed consent document declaring that:
1. She is donating the tissue for research involving transplantation for therapeutic purposes;
2. The donation is made without any restriction regarding the individuals who may be the recipients of the transplanted tissue;
3. She has not been informed of the identity of the individuals who may be the recipients of the transplanted tissue.
C. Statement of the Attending Physician. The attending physician who obtains the fetal tissue from the woman donating such tissue for transplantation must sign a written statement declaring that:
1. In the case of tissue obtained pursuant to an induced abortion,
a. 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;
b. No alteration of the timing, method, or procedures used to terminate the pregnancy was made solely for the purposes of obtaining the tissue; and
c. The abortion was performed in accordance with applicable State law.
2. The tissue was donated with the informed consent of the donor, as described in Section II.B.
3. Full disclosure was made to the donor with regard to,
a. Such physician’s interest, if any, in the research to be conducted with the tissue; and
b. 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.
D. Statement of the Researcher. The individual with principal responsibility for conducting the research must sign a written statement declaring that he or she:
1. 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;
2. Has provided the information in Section II.D.1. of this policy to other individuals with responsibilities in the research;
3. Will require, prior to obtaining the consent of an individual to be a recipient of a transplantation of the tissue, written acknowledgement of the recipient that he or she has received the information set forth in Section II.D.1.;
4. 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.
E. Availability of Statements for Audit. The University must certify to the Secretary of Health and Human Services that the statements required herein will be available for audit by the Secretary.
III. Other Prohibitions Regarding Human Fetal Tissue
A. UW-Madison faculty, staff and students may not knowingly acquire, receive or otherwise transfer any fetal tissue for valuable consideration.
B. UW-Madison faculty, staff and student may not 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 one of the following is true:
1. The donation will be or is made pursuant to a promise to the donating individual that the donated tissue will be transplanted into a recipient specified by such individual;
2. The donated tissue will be transplanted into a relative of the donating individual; or
3. The person who solicits or knowingly acquires, receives, or accepts the donation has provided valuable consideration for the costs associated with such abortion.