3.1. An IRB, as described in federal regulations at 45 CFR 46.107, should review the procurement of all gametes, blastocysts, or somatic cells for the purpose of generating new hES cell lines, including the procurement of blastocysts in excess of clinical need from infertility clinics, blastocysts made through IVF specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines derived through NT or by parthenogenesis or androgenesis.
3.2. Consent for donation should be obtained from each donor at the time of donation. Even people who have given prior indication of their intent to donate to research any blastocysts that remain after clinical care should nonetheless give informed consent at the time of donation. Donors should be informed that they retain the right to withdraw consent until the blastocysts are actually used in cell line derivation.
3.3. When donor gametes have been used in the IVF process, resulting blastocysts may not be used for research without consent of all gamete donors.
3.4a. No payments, cash or in kind, may be provided for donating blastocysts in excess of clinical need for research purposes. People who elect to donate stored blastocysts for research should not be reimbursed for the costs of storage prior to the decision to donate.
3.4b. Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for NT) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an IRB. No payments, cash or in kind, should be provided for donating oocytes for research purposes. Similarly, no payments should be made for donations of sperm for research purposes or of somatic cells for use in NT.
3.5. To facilitate autonomous choice, decisions related to the creation of embryos for infertility treatment should be free of the influence of investigators who propose to derive or use hES cells in research. Whenever it is practicable, the attending physician responsible for the infertility treatment and the investigator deriving or proposing to use hES cells should not be the same person.
3.6. In the context of donation of gametes or blastocysts for hES cell research, the informed consent process, should, at a minimum, provide the following information.
(a) A statement that the blastocysts or gametes will be used to derive hES cells for research that may include research on human transplantation.
(b) 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.
(c) A statement as to whether the identities of the donors will be readily ascertainable to those who derive or work with the resulting hES cell lines.
(d) 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.
(e) 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.)
(f) A statement that derived hES cells and/or cell lines might be kept for many years.
(g) A statement that the hES cells 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.
(h) Disclosure of the possibility that the results of study of the hES cells may have commercial potential and a statement that the donor will not receive financial or any other benefits from any future commercial development.
(i) A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation.
(j) A statement that embryos will be destroyed in the process of deriving hES cells.
(k) A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors.
(l) A statement of the risks involved to the donor.
In addition, donors could be offered the option of agreeing to some forms of hES cell research but not others. For example, donors might agree to have their materials used for deriving new hES cell lines but might not want their materials used, for example, for NT. The consent process should fully explore whether donors have objections to any specific forms of research to ensure that their wishes are honored.
3.7. Clinical personnel who have a conscientious objection to hES cell research should not be required to participate in providing donor information or securing donor consent for research use of gametes or blastocysts. That privilege should not extend to the care of a donor or recipient.
3.8. 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 should not be able to pay for or be paid for the material obtained (except for specifically defined cost-based reimbursements and payments for professional services).
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