UW-Madison Guidance for Investigators Requesting to Add hESC Lines to the UW-Madison hESC Registry

The UW-Madison SCRO SCRO Committee provides oversight for all research on campus involving campus faculty or staff that involves either: 1) the use of human embryonic stem cells or their derivatives; or 2) the introduction of human pluripotent stem cells, or their derivatives, obtained from a non-embryonic source, into non-human animals at any embryonic, fetal, or postnatal stage, if an expected effect is that human cells will be integrated into the central nervous system, testes, or ovaries of the animal; or 3) all research that (a) involves pre-implantation stages of human development, human embryos, or embryo-derived cells or (b) entails the production of human gametes in vitro when such gametes are tested by fertilization or used for the creation of embryos; or 4) the storage or disposition of human embryos or gametes obtained for the purposes of stem cell research. This oversight applies regardless of funding source.

If you are planning on using non-approved hESC lines, you must submit additional documentation with your protocol. SCRO must review the consent form (please see # 5), the IRB approval notice, and information on the procurement process. In addition you must address each of the following:

1. Was the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hESCs the same person? If it was the same person, please provide justification.
   
   
2.  Were cash or in kind payments may be provided for donating pre-implantation embryos in excess of clinical need for research purposes? If yes, please provide justification.
   
   
3. Please provide information as to whether or not women were compensated for oocyte generation and men who donated sperm were compensated. If compensated, please provide justification.
1. Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for nuclear transfer) may be reimbursed for direct expenses incurred as a result of the procedure, as determined by an appropriate Institutional Review Board. Oocytes and sperm donors may be compensated at a level consistent with compensation provided for in vitro fertilization donors at the locale where the donation occurs. In locales where reimbursement for research participation is allowed, there must be a detailed and rigorous review to ensure that reimbursement of direct expenses or financial considerations of any kind do not constitute an undue inducement. Due to the unknown long-term effects of ovulation induction, women should not undergo an excessive number of hormonally induced ovarian stimulation cycles in a lifetime. ^[1]
   
   
4. Were potential donors of pre-implantation embryos be informed of all available options for the disposition of their embryos, including donation to others for reproductive purposes as well as destruction? If no, please provide rationale.
   
   
5. Donors who may have specified their intent to donate embryos to research prior to completion of their clinical care must provide specific informed consent for donation to stem cell research after their clinical care has been completed. Donors must also be informed that they retain the right to withdraw consent until the embryos are actually used to derive embryonic stem cells or until information which could link the identity of the embryo donor(s) with the embryo is no longer retained, if applicable. Embryo donors should be told, however, that once the embryos have been transferred to a researcher, they will no longer be usable for clinical purposes.
   
   
6. In the context of donation of gametes or pre-implantation embryos for hESC research, the informed consent process will, at a minimum, provide the following information:
   
   
1. A statement that the pre-implantation embryo or gametes will be used to derive hESCs for research that may include research on human transplantation.
2. A statement that the donation is made without any restriction or direction regarding who may be the recipient of transplants of the cells derived, except in the case of autologous donation.
3. A statement as to whether the identities of the donors will be readily ascertainable to those who derive or work with the resulting hESC lines.
4. If the identities of the donors are retained (even if coded), a statement as to whether donors wish to be contacted in the future to receive information obtained through studies of the cell lines.
5. An assurance that participants in research projects will follow applicable and appropriate best practices for donation, procurement, culture, and storage of cells and tissues to ensure, in particular, the traceability of stem cells. (Traceable information, however, must be secured to ensure confidentiality.)
6.  A statement that derived hESCs and/or cell lines might be kept for many years.
7. A statement that the hESCs and/or cell lines might be used in research involving genetic manipulation of the cells or the mixing of human and nonhuman cells in animal models subject to approval of the appropriate institutional committee. ^[2]
8. Disclosure of the possibility that the results of study of the hESCs may have commercial potential and a statement that the donor will not receive financial or any other benefits from any future commercial development.
9. A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation.
10. A statement that embryos may be destroyed in the process of deriving hESCs.
11. A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors.
12. A statement of the risks involved to the donor.
    
    
7. Researchers may not ask members of the infertility treatment team to generate more oocytes than necessary for the optimal chance of reproductive success. An infertility clinic or other third party responsible for obtaining consent or collecting materials will not pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services).