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.

  1. A statement that the blastocysts or gametes will be used to derive hES cells 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 hES cell 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

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement