When couples undergo in-vitro fertilization (IVF), they must decide what to do with the embryos left over from the treatment: store them, throw them out or — an increasingly popular option — donate them to research. A new procedure developed by the School of Medicine enables couples to make the decision to donate without interacting with the researchers themselves.
“There is concern that conflicts of interest and influence by researchers and clinicians may play a role in donor choice,” said Christopher Scott, director of Stanford’s Program on Stem Cells and Society. “The Stanford biobank process allows people time to make the primary decision to donate on their own, when it’s right for them. It also allowed us to ask whether donors have preferences as to the type of research they will allow on their embryos.”
A description and analysis of the new protocol was unveiled in last Friday’s publication of Cell Stem Cell.
By adopting this new donation process, the Stanford RENEW Biobank functions as a “middle person” between the patient and the researcher, said Austin Freeman, research manager at the biobank.
Researchers no longer have to solicit embryo donations using their own, disparate consent procedures. Instead, the Stanford biobank — armed with a carefully planned, informed consent protocol — collects embryos from patients nationwide and then distributes these embryos among stem cell researchers at Stanford. This way, the patients’ personal information is protected from the researcher.
The donation process was deployed in January 2008 at Stanford and at 39 associated fertility clinics and three storage facilities in 20 states. Donated embryos were then deposited at Stanford’s RENEW Biobank.
The donation protocol described in Cell Stem Cell is a two-part procedure.
Each year, when couples receive a storage bill from their IVF clinic, they must decide whether to dispose of their embryos or to continue storing them.
Clinics participating in this study offered couples a third option: to donate their embryos to research through the Stanford biobank. As a result, patients can make their decisions in the privacy of their own homes, making a knowledgeable and deliberate choice on their own time.
“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,” said Tasha Kalista, Stanford’s previous biobank research manager and the study’s first author.
If couples chose to go ahead with their donation, the biobank sent them an informed consent packet that included detailed donation instructions, a health questionnaire and a consent document.
In the second step of the process, couples were told to call biobank coordinators like Freeman or Kalista, who were unconnected with the original IVF clinic or the researchers who might use their embryos. Couples were encouraged to ask questions and express concerns.
Couples could also choose whether to donate to either human development or stem cell research. Human development research focuses on improving IVF clinical outcomes and maintains the culture of embryos for no longer than 12 days. Stem cell research, on the other hand, produces stem cell lines in order to develop therapies to treat disease, disorders and injured tissues.
Couples did not discriminate between the two different kinds of research. While 32 percent chose to donate only to human development research, 30 percent preferred stem cell research. In addition, 38 percent decided to donate to both types.
Biobank staff also asked both partners whether they wanted to be contacted again if research revealed clinically relevant health or genetic information. Around 67 percent of patients asked to be contacted again.
Under this protocol, 403 couples donated 1,356 embryos to research. With an average age of 39 years, people who decided to donate were predominantly white and of high socio-economic status, Kalista said. She added that these demographics might be explained by the fact that IVF treatment must be paid out-of-pocket.
According to published findings in Cell Stem Cell, a 2003 survey of 340 U.S. clinics estimated that, of the 400,000 embryos stored, only 11,000 have been designated for research.
“Part of the reason why is that a lot of states don’t allow people to donate their embryos for research,” Freeman said. “Another issue is that some clinics don’t offer donation as an option.”
Stanford has one of a small number of biobanks in the United States. The main goal in publishing the consent procedure is to encourage other institutions to establish their own biobanks and thus make it easier for IVF clinics to make donation a viable option for couples.