Recommendation 14:

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.

Recommendation 15:

No cash or in kind payments may be provided for donating blastocysts in excess of clinical need for research purposes.

Recruiting and Paying Donors of Gametes for Research Purposes

Although there is widespread consensus that donors should not be paid for blastocysts they donate for research, there is less consensus about inducements for women to donate oocytes or men to donate sperm for research purposes. It is probably least problematic when women opt to donate oocytes for research in conjunction with a clinical procedure already scheduled (such as IVF or oophorectomy). It is most problematic in the case of oocyte donation solely for research purposes, because the invasiveness and risks of the procedure suggest that financial remuneration is most deserved, but at the same time there is a greater likelihood of enticing potential donors to do something that poses some risk to themselves. Of course, some women might wish to donate oocytes solely for research for nonfinancial motives; such a desire might exist among women who have family or friends affected by a particular disease that might be better understood or treated in the future if hES cells were used.

If the need for oocytes in hES cell research increases, it is possible that donations from clinical procedures or for nonfinancial motives may prove insufficient to meet the demand. In such cases—for example, for research involving NT or for research requiring blastocysts that have not been frozen—investigators might want to recruit oocyte donors. In the context of human subjects research, use of advertising to recruit subjects is not considered objectionable, but it is deemed worthy of review. In the context of clinical research, FDA considers direct advertising for study subjects to be the start of the informed consent process and subject selection; therefore, advertisements should be reviewed and approved by an IRB.

No matter how donors are recruited, the issue of whether they should be paid remains. Paying research subjects is “a common and long-standing practice in the United States” (Dickert et al., 2002; Anderson and Weijer, 2002), perhaps because of the need to provide incentives as part of recruitment and because moral principles of fairness and gratitude support providing payment to those who bear the burdens of research on behalf of society. But how much money gamete donors should receive and what they should receive payment for (for example, time, inconvenience, dis-

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