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Learn start-up differences of SCRO committees and IRB
Expert offers this advice
As stem cell research increases in California and elsewhere, IRBs and institutions are investing time and resources in establishing new oversight committees and writing new policies and procedures.
"Setting up a stem cell research oversight (SCRO) committee is very important for making sure research is carried out under strict oversight," says Bernard Lo, MD, professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco (UCSF). Lo co-authored a paper on establishing procedures for oversight of stem cell research, which was published in the January 2007 issue of Academic Medicine.
A special SCRO committee will come up with questions that might not occur to the average IRB, Lo suggests.
For instance, at UCSF there was a protocol before the SCRO that didn't involve human beings directly, but it raised major ethical concerns.
A scientist wanted to use an existing stem cell line that couldn't be linked to its original donors for the purpose of coaxing the cells into human bone cells, Lo explains.
"He proposed to inject these cells into chicken embryos to see if human cells appeared with all of the characteristics of human bone cells," Lo says.
"One of the basic scientists on the committee had concerns about how long human cells would be allowed to grow," Lo says. "He thought they should not be allowed to grow to the point where they would have any structures resembling human characteristics."
The scientist who raised the question pointed out that as early as 12 days, one could see basic limbs of chicken embryos, so he didn't want to see human structures like a human hand rather than a wing, Lo adds.
"This issue wouldn't normally come before an IRB because it doesn't involve potential harms to humans," Lo says. "But it was about creating animals that have characteristics that are uniquely human, so we struggled with this concern."
It's also a concern that wouldn't have been raised except when a committee has scientists who have the knowledge necessary to know what to ask, he adds.
This is one example of why institutions that anticipate even a handful of stem cell research protocols in the near future should consider establishing a separate board to review the studies, Lo says.
"All IRBs need to look to the future because it might be one protocol this month, but it could be a much larger number next year," Lo says.
Lo offers these suggestions for how institutions can establish an effective SCRO that would meet the 2005 National Academy of Sciences (NAS) guidelines, as well as California's state requirements:
1. Find the right people to form the committee.
"Membership is very important," Lo says. "It became clear to us that there were three very different members needed."
The first type of member is the scientist who understands the science of stem cell research because before a committee can understand the ethics, it needs to understand the science, Lo explains.
"We have a lot of scientists from different fields, including developmental endocrinology," Lo says.
Other scientific members include experts in cell biology, stem cell biology, developmental biology, human genetics, and assisted reproduction.1
The second group includes people who have experience in research ethics and the regulations for research, and these might include law professors, ethics faculty members, and IRB members, Lo says.
"Finally, we think it's very important to have public members because this is the type of research the public has been very interested in," Lo says. "We think having people who are not affiliated with UCSF could help us not lose sight of what the public thinks."
Other qualities to seek in SCRO members are the desire to work hard, as well as having an open mind about new scientific and ethical issues, Lo notes.
"We don't want people coming to the committee with preconceived ideas of what research is," he says.
2. Establish policies regarding when informed consent would be needed.
Even if states don't establish guidelines or regulations regarding the source of stem cells for research, institutions need to consider having guidelines in place.
Many people would find it acceptable to allow embryos created through in vitro fertilization processes to be donated to research once they are no longer of use to the infertility couple and are set to be destroyed, Lo says.
"But we need a careful consent process to make sure the woman and couple in IVF understand the implications of what they're doing," Lo says.
"We have argued in other papers that if there is an egg donor or sperm donor in the original creation of the embryo, then those donors also need to have consented to allow the embryo to be used for stem cell research," Lo adds. "So it's not as straightforward as it might appear."
Institutions need to be very careful with their policies regarding informed consent because of the sensitivity of the issue, he says.
An institution's policy might require that the informed consent process take place at the IVF clinic, but will also require the researchers who will be using the embryos to make certain the policies and procedures have been followed, Lo says.
"You have to make sure contractors follow their own policies," he adds.
Studies have shown that of the women who donate oocytes for IVF, about one-fourth of them would not want their embryos to be used for stem cell research, Lo says.
"This is different from other types of research because the donor's DNA is in the laboratory for a long time, and there's a possibility that the cells might be used for transplantation," Lo says. "For example, it's different from a cancer operation in which there is tissue obtained that could be used for research or thrown away, so the general consent is not suitable."
Embryos have special symbolic and emotional significance to people, and so these can't be treated like discarded tissue," Lo explains.
3. Thoroughly analyze potential solutions to ethical dilemmas in research.
"The researchers at UCSF are extremely interested in deriving new stem cell lines, so they've presented several proposals," Lo says. "One is to allow frozen embryos that are not needed now for infertility treatment, but they've also proposed to use two other sources of materials from IVF clinics."
One other potential source would be oocytes, which don't fertilize and can't be used for reproductive purposes, Lo says.
The second category is embryos that were created in the IVF setting but didn't develop sufficiently and, therefore, would not be used for implantation for IVF treatment, Lo says.
"Those embryos also would be discarded, and the proposal was to ask for permission to use those failed-to-develop embryos for research," Lo says. "We approved those ideas, and there was a lot of discussion and concern about the consent process and also about how the determination process would work for deciding whether the oocytes had fertilized or developed."
The SCRO committee asked that the different types of scenarios be mentioned separately in the consent document. Consent for donating oocytes that don't fertilize and embryos that don't develop would have to be obtained at the time the woman is undergoing treatment, whereas the consent for frozen embryos would be obtained after she's completed treatment, Lo explains.
"When it's consent for embryos that haven't fertilized, it should be brought up beforehand," Lo says. "Most women will agree that these can be used for research if there is no way they'll turn into little children, and it's less problematic than frozen embryos."
But the timing of obtaining informed consent is important, and women shouldn't be asked for this informed consent at a time when it's very stressful for them, Lo says.
Also, the SCRO committee wanted to make sure the decisions were entirely impartial and scientifically-sound, he says.
"We put in some additional safeguards in terms of the laboratory embryologist who makes the decisions about whether the oocytes had been fertilized," Lo explains. "He would not know whether those failed-to-develop embryos or oocytes would be discarded because we wanted those decisions to be absolutely unbiased."
Also, SCRO members wanted to make certain that no one involved in collecting embryos or studying them would have conflicts of interest, or even the appearance of a conflict of interest, Lo says.
"The embryologist could not derive any financial interest in stem cell research," Lo adds. "We arrived quickly at the decision to make the process beyond reproach and bias."
For example, if there was a researcher who had financial interest in a company that makes growth media that is used by stem cell investigators, then that would be very damaging to the stem cell research work, Lo says.
"This area is both new and controversial and complicated, and unless you spend a lot of time thinking about it, you won't get all the nuances," Lo says.