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.
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.
A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation.
A statement that embryos will be destroyed in the process of deriving hES cells.
A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors.
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).
4.1. Requests to the ESCRO committee for permission to attempt derivation of new hES cell lines from donated embryos or blastocysts must include evidence of IRB approval of the procurement process (see Section 3.0 above).