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Guidelines for Human Embryonic Stem Cell Research
Women who undergo hormonal induction to generate oocytes specifically for research purposes (such as for nuclear transfer) should be reimbursed only for direct expenses incurred as a result of the procedure, as determined by an Institutional Review Board. No cash or in kind payments 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 nuclear transfer.
Consent for blastocyst 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.
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 statement that the blastocysts or gametes will be used to derive hES cells for research that may include research on human transplantation.
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.
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.
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.
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.)
A statement that derived hES cells and/or cell lines might be kept for many years.
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.