Guidelines for Human Embryonic Stem Cell Research (2005) / Chapter Skim
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5 Recruiting Donors and Banking hES Cells
5 Recruiting Donors and Banking hES Cells
Pages 81-96
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From page 81... ...
. Once a couple decides to terminate their fertility treatment, for whatever reason, they have a number of options regarding the disposition of these embryos: they can donate them to another couple, they can make them available for quality assurance activities, they can donate them for research purposes, they can dispose of them, or they can store them indefinitely (Hoffman, et al., 2003)
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From page 82... ...
Some of the protections offered through existing federal regulations can be adapted for application to hES cell research, such as adherence to principles of informed consent and a requirement that an Institutional Review Board (IRB) review the consent process.
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From page 83... ...
Thus, a researcher who wishes to obtain human oocytes or blastocysts for hES cell research must either request and obtain IRB review at his or her own institution (if one exists) to ensure that the informed consent provisions of the federal regulations at 45 CFR 46.116-117 and FDA regulations at 21 CFR 50.20-27 are followed or require that the fertility clinic have its own process for obtaining review from some other duly constituted IRB.
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From page 84... ...
The original National Institutes of Health guidelines for hES cell research developed in 2000 stated "To ensure that the donation of human embryos in excess of the clinical need is voluntary, no inducements, monetary or otherwise, should have been offered for the donation of human embryos for re search purposes. Fertility clinics and/or their affiliated laboratories should have implemented specific written policies and practices to ensure that no such induce ments are made available." Likewise, the Canadian guidelines state "Neither the oocyte nor the sperm from which the embryos were created, nor the embryos themselves, were obtained through commercial transactions, including exchange for service." The European Commission and the U.K.
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From page 85... ...
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.
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From page 86... ...
Many argue that research subjects, or in this case gamete donors, should be paid for their time and inconvenience, as well as their direct expenses, but are concerned about providing payment for incurring risk, a practice that some ethicists would rule out altogether. However, attitudes may differ considerably when the risk is a minor and transient symptom or discomfort (such as sleepiness or dizziness)
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From page 87... ...
This recommendation is based, in part, on the recognition that payments to oocyte donors raise concerns that might undermine public confidence in the responsible management of hES cell research. Following the recommendation will ensure consistency between procurement practices here and in other countries that have major hES cell research programs, thus facilitating international collaborations and the sharing of hES cell lines across national borders.
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From page 88... ...
. In addition, given growing public awareness about hES cell research, some couples might request at the outset of treatment that they be provided the opportunity to donate unneeded embryos to research.
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From page 89... ...
, either upon completion of a study or at some later date in time. This issue is relevant to all research, not just research involving hES cell lines.
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From page 90... ...
Recommendation 18: In the context of donation of gametes or blastocysts for hES cell research, the informed consent process, should, at a minimum, provide the following infor mation: a. A statement that the blastocysts or gametes will be used to derive hES cells for research that may include research on human transplantation.
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From page 91... ...
h. 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; i.
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From page 92... ...
Recommendation 21: 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 collect ing 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)
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From page 93... ...
For example, a common requirement is that any identifiable tissue (including coded tissue) that is collected requires IRB review at the site of collection and informed consent of the subject.
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From page 94... ...
As hES cell research advances, it will be increas ingly important for institutions that are obtaining, storing, and using cell lines to have confidence in the value of stored cells -- that is, that they were obtained ethi cally and with the informed consent of donors, that they are well characterized and screened for safety, and that the conditions under which they are maintained and stored meet the highest scientific standards. Recommendation 22: Institutions that are banking or plan to bank hES cell lines should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by an Institutional Review Board, and that meticu lous records are maintained about all aspects of cell culture.
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From page 95... ...
(e) Clear criteria for distribution of cell lines, including but not limited to evidence of approval of the research by an Embryonic Stem Cell Research Oversight committee or equivalent body at the recipient institution.
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From page 96... ...
Once hES cells are derived, the proper banking and distri bution of hES cell lines will maintain the covenant between donor and scientific community.
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