1. 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.

  2. 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;

  3. A statement that the research is not intended to provide direct medical benefit to the donor(s) except in the case of autologous donation.

  4. A statement that embryos will be destroyed in the process of deriving hES cells.

  5. A statement that neither consenting nor refusing to donate embryos for research will affect the quality of any future care provided to potential donors.

  6. 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.

ADHERENCE TO STANDARDS OF CLINICAL CARE

Clinical facilities providing ART services have an obligation to protect the rights and safety of their patients and to behave in an ethical manner. Researchers must not pressure members of the fertility treatment team to generate more embryos than necessary for the optimum chance of reproductive success. An IVF clinic, or other third party responsible for obtaining consent and/or collecting materials should not be able to pay for or be paid for the material it obtains (apart from specifically defined, cost-based reimbursements). Placing such restrictions on paying those who obtain the embryos discourages the creation during routine infertility procedures of excess embryos that would later be used for research purposes.

Finally, no member of the medical or nursing staff should be under any duty to participate in providing donor information or securing donor consent for research use of gametes or blastocysts if he or she has a conscientious objection. However, this privilege does not extend to the appropriate clinical care of a donor or recipient.

Recommendation 19:

Consenting or refusing to donate gametes or embryos for research should not affect or alter in any way the quality of care provided to prospective donors. That is, clinical staff must provide appropriate care to patients without prejudice regarding their decisions about disposition of their embryos.



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