Regardless of the source of funding and the applicability of federal regulations, an Institutional Review Board or its equivalent should review the procurement of 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 in vitro fertilization specifically for research purposes, and oocytes, sperm, and somatic cells donated for development of hES cell lines through nuclear transfer.
The donors of sperm, oocytes, or somatic cells used to make blastocysts for research are themselves rarely the subject of the research. Nevertheless, the physical interaction needed to obtain the materials brings them under the purview of the human subjects protections system, and IRB review is required. Thus, their fully informed and voluntary consent is required before such research use.
Institutional Review Boards may not waive the requirement for obtaining informed consent from any person whose somatic cells, gametes, or blastocysts are used in hES cell research.
When donor gametes have been used in the in vitro fertilization process, resulting blastocysts may not be used for research without consent of all gamete donors.
In addition to ensuring voluntary informed consent of all donors, there should be no financial incentives in the solicitation or donation of blastocysts, gametes, or somatic cells for research purposes. Nonfinancial incentives also should be avoided. For example, a donor’s decision should not be influenced by anticipated personal medical benefits or by concerns about the quality of later care. Thus, a potential donor should be informed that there is no obligation to make such a donation, that no personal benefit will accrue as a result of the decision to donate (except in cases of autologous transplantation), and that no penalty will result from a decision to refuse to donate.
To facilitate autonomous choice, decisions related to the production 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.
No cash or in kind payments may be provided for donating blastocysts in excess of clinical need for research purposes.