Patients who use in-vitro fertilization (IVF) services to help them conceive sometimes need eggs and sperm – called gametes – from third-party donors.
According to a new policy report by members of the UCSF faculty and staff and members of UCSF’s stem cell research advisory panel, the National Institutes of Health (NIH) should require that these gamete donors be told about the possible use of embryos in stem cell research.
Gamete donors should be informed before they grant the IVF patient unrestricted authority to determine the fate of embryos that remain after IVF treatment is completed, the authors recommend. The recommended policy changes are published in the February 19 issue of the prominent journal, Science.
New federal guidelines established in July 2009 expand the number of human embryonic stem cell lines that may be used in research funded by the NIH. This is regarded as a watershed change from earlier, more restrictive regulations, and the announcement of the new guidelines generally pleased stem cell scientists and advocates of regenerative medicine research.
But the new guidelines do not address what sort of permission ought to be required of donors of sperm and eggs, notes Bernard Lo, MD, a UCSF bioethicist and the lead author of the policy report. Each donated egg or sperm contains genes that will be incorporated into embryos.
State, national and international recommendations vary in their approach to consenting egg donors in the research context.
“The NIH guidelines are weaker than other recommendations and regulations, which do require some kind of consent from third-party gamete donors for research,” Lo says.
The disposition of extra embryos that remain after a woman becomes pregnant through an IVF procedure is up to her. Along with parental rights, gamete donors routinely sign over disposition rights to the IVF patient. The donors then have no say as to whether embryos are donated to another infertility patient, discarded, or used for research.
In what is called a dispositional authorization, Lo says, “The gamete donor signs over a lot of authority without necessarily being given much detail and specificity. This sweeping power really only makes sense if, before you sign it, you are told the options might be -- what sorts of decisions the IVF patient might make about the embryos.”
The authorizations often make no reference to stem cell research, Lo says. “What we’re saying is that the decision about use of donated gametes in research should be on the same footing as these other major decisions.” IVF clinics should provide standard information about the possible fate of donated gametes, Lo says. This could be done through a brochure or through discussions.
The UCSF authors did not recommend the use of long, detailed informed-consent forms instead of dispositional authorizations. As it stands, the gamete donor is required to sign an informed-consent form for medical procedures such as ovary stimulation and egg removal, but is not normally required to sign such a form to give up parental or dispositional rights.
“It would be unfair to require gamete donors to follow stricter standards to authorize the donation of embryos to human embryonic stem cell research than to authorize these other major decisions,” the authors state.
In addition, informed consent for egg donors is not practical, Lo says. The use of embryos in stem cell research typically is not being considered at the time of donation. If IVF clinicians were to ask for consent at the time of donation it might raise the issue of conflict of interest. Furthermore, it often would be difficult for researchers to track down donors to obtain informed consent much later.
“We understand the reason for obtaining unlimited dispositional authority,” Lo says. “We don’t think it’s appropriate to turn it into a detailed consent form. We should treat it the way we treat these other big decisions -- by providing information and using a blanket authorization.”
As a practical matter, a uniform federal guideline and its consistent application would incline institutional review boards and oversight committees to allow the use of NIH-approved embryonic stem cell lines, the authors say. Without overarching standards, inconsistent institutional policy or state law might lead to institutional pressure to use the least restrictive standards, Lo says.
How might publishing the recommendations in such a high-profile journal impact NIH decision makers? “I expect they are going to discuss it,” Lo says. “What they are going to do, of course, I can’t control.”
Other authors of the policy report are Lindsay Parham, a UCSF research analyst; Arnold Kriegstein, MD, PhD, director of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF ; stem cell researcher Susan Fisher, PhD; Linda Giudice, MD, PhD, Marcelle Cedars, MD, and Elena Gates, MD, from the UCSF Department of Obstetrics, Gynecology and Reproductive Sciences; UCSF research administrators Dina Gould Halme, PhD, Clifford Roberts, DVM, and Richard Wagner; and two community members of UCSF’s stem cell research oversight committee: William Hershon and Radhika Rao.