A new paper by CIRM grantees at Stanford University is reporting on an innovative way of ensuring that people considering donating left over in vitro fertilization embryos to research make the best possible decision for themselves. The paper was published on April 8 in Cell Stem Cell.
People who undergo IVF are often left with excess embryos after they complete their families or abandon the process. Storing these embryos in nitrogen comes with a monthly or yearly cost, which is why many people choose to stop storing, which destroys the embryo, donate to another couple or donate to science. In some cases, donating to science includes donating the embryo for stem cell research.
The Stanford group developed a procedure for ensuring that people considering donating to research do so in privacy and aren’t influenced by the scientists who could benefit from the research. A Stanford press release describes the procedure quoting senior author Christopher Scott:
In the two-part procedure described in the study, which is now used routinely at Stanford, information about potential donation for research is included in the normal embryo-storage bill from the clinic. “At that point,” Scott said, “the recipients are free to throw the information away or put it on the coffee table to consider and talk about.” Only after the couple has made the initial decision to donate do they interact with Stanford biobank staff members, who use a script to confirm donation choices and answer any questions the potential donors may have.
Specifically, people who indicated that they would like to donate were sent an informed-consent packet outlining the types of research that could be done with the embryos, such as creating embryonic stem cell lines or studying human development. (Research into human development typically occurs during the first 12 days of culture, after which the embryos are no longer grown. Embryonic stem cell research entails creating stem cell lines that can be propagated indefinitely in the laboratory and may be used for both research and therapy.)
Once the potential donors had time to review the material, they then participated in a phone interview with staff members at Stanford’s biobank who were unconnected with either the original in vitro fertilization clinic or the researchers who might use the embryos. Staff members followed a script to confirm the donors’ preferences and make sure they understood their options — including whether they wanted to be notified if the research unearthed any genetic information that might affect their health or the health of their relatives.
People were equally likely to donate to the creation of new stem cell lines or to studying human development. Interestingly, the study found that most donors were primarily concerned that their donated embryo not be used to make a baby for another person.
My colleague Geoff Lomax heads CIRM’s Standards Working Group, which sets CIRM regulations for embryo donation for creating embryonic stem cell lines. He told me, “The study results demonstrating differences in research preferences reinforces the need for comprehensive consent for research. I’m glad that development of a safe and supportive stem cell research environment in California can contribute to innovative practice supporting research ethics.”
The Stanford press release quotes Stanford biobank research manager and study first author Tasha Kalista:
“Many couples were very relieved to have the option to donate their embryos for research and to participate in the field of stem cell research.”
In some states, people would not have the option of donating embryos and would instead have to destroy the embryo or donate for adoption if they could not or chose not to pay the storage fees.