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IRBs can learn from the experiences of early SCROs
California ESCRO follows NAS guidelines
As funding barriers are slowly being chipped away in California and some other parts of the country, increasing numbers of institutions are forming stem cell research oversight committees (SCROs), or embryonic stem cell research oversight committees (ESCRO), which often have some overlapping responsibilities with IRBs.
IRBs and institutions could learn from the California pioneers in this area of human subjects research and be prepared for the day when stem cell research, which has public support, is funded federally beyond the approved cell lines.
"Because stem cell research is a new and very promising field, a lot of institutions and universities are going to be looking at protocols to do this kind of research," says Bernard Lo, MD, professor of medicine and director of the Program in Medical Ethics at the University of California, San Francisco. 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.1
"It is clear IRBs are not really set up to address and oversee stem cell research," Lo notes. "So setting up SCRO committees is very important to make sure the research is carried out under strict oversight."
The National Academy of Sciences (NAS) of Washington, DC, defined ESCROs and published guidelines in 2005.
These were the guidelines adopted in California by the California Institute for Regenerative Medicine, which is the agency formed after the passage of proposition 71, which allowed the state to sell bonds to provide funding for research using embryonic stem cells, says Steven Peckman, an associate director for the Institute for Stem Cell Biology & Medicine at the University of California, Los Angeles. Peckman spoke about ESCROs and IRBs at the 2006 annual Human Protection Program Conference of Public Responsibility in Medicine & Research (PRIM&R), held Nov. 15-18, 2006, in Washington, DC.
"The first thing we did was meet with IRB members and staff and talk about how to interface between our [ESCRO] program and theirs, Peckman recalls.
"California has a unique law that requires IRB review of all stem cell research, regardless of whether it has human subjects," Peckman notes. "So when we developed the ESCRO mechanism, we had to develop some kind of interface for the IRB committee and IRB staff, and the members have been helpful in the process."
While previously there were at least two review committees reviewing all embryonic stem cell research, this changed in January, 2007, Peckman says.
This was when a new California law designated that IRBs only will review stem cell research that includes human subjects, while the ESCRO committee will handle reviews of all human embryonic stem cell research, Peckman adds.
Studies that will continue to need both IRB and ESCRO review are those in which cells have direct or indirect identifiers of the donor, and studies in which there is a direct donor interaction, such as collecting embryos from an in vitro fertilization clinic for the purpose of deriving embryonic stem cells, Peckman explains.
"There will always be some overlap of compliance committees," Peckman says. "If you take embryonic stem cells and put them in animals, then you have animal committees involved; if there is radiation, you have a radiation committee involved."
The SCRO oversight is required in California by state law, but other institutions in other states may follow suit because of recommendations by the National Academies panel, Lo says.
Since IRBs have a lot of experience with consent forms, stem cell research oversight committees might defer to the IRB's recommendations when certain issues are considered, such as when embryos are donated for new stem cell lines, Lo notes.
"We have deferred details of consent to the IRB, but they are not set up to think about the science of stem cell research and go into depth [like the SCRO committee]," Lo adds. "So we try not to duplicate reviews but will partition various aspects of the protocol, according to the expertise of the committee."
Several members of the ESCRO and IRB overlap at UCSF, and the institution has a process that facilitates effective communication and convenient timing between the IRB and SCRO committee, Lo explains.
"That's important because researchers already are concerned that the review process adds time to their work," Lo says. "So we try to schedule the committees to meet during the same week."
At UCLA, the IRB and ESCRO committees share the same application form, simplifying the process for investigators.
"That cuts down on the paper and application burden for investigators, and at the same time it ensures information flow between two compliance committees," Peckman says. "It promotes collaboration and a relationship between the two committees."
At UCLA, the ESCRO committee has the responsibility for doing a scientific review, and the ESCRO committee members are available to attend IRB meetings in order to answer IRB members' questions about the science aspects of a proposed study.
The IRB won't review a protocol until the ESCRO committee approves the study's scientific basis, Peckman says.
"We won't waste IRB resources on something that's not scientifically adequate," Peckman says. "So once the ESCRO committee says the science is sound, the IRB will review it immediately."
The IRB committee meets every other week, and the ESCRO committee meets when needed, he adds.
ESCRO committees look at the ethics of human subject participation, and they're responsible for a list of oversight items, according to the NAS guidelines, Peckman says.
Also, the ESCRO committee is charged with making sure a protocol receives oversight review from all other applicable committees, including the IRB, conflict of interest committee, etc.
"So the ESCRO committee makes sure all committees have done their review before the investigator does research," Peckman says. "The ESCRO committee is responsible for maintaining registries for embryonic stem cell research, as well as the cells at the institution."
ESCRO committees also educate the research community about embryonic cell research.
At UCLA, the ESCRO office shares two fulltime employees, including Peckman, with other departments. The office will be expanded once more stem cell research is underway, Peckman says.
Although proposition 71 was passed in November, 2004, by 59% of voters, several opposition groups immediately filed lawsuits to stop its implementation, basing their claim on the state's constitution, he explains.
"The bonds can't be sold until those suits are resolved, and this has created significant delays for the funding agency," Peckman says.
As an interim measure, the agency handling the stem cell research funding created bridge notes to sell to individuals or organizations in support of the agency and its research mandate, he says.
"If the lawsuits are resolved in favor of the state, then the bridge notes will be repaid," Peckman says. "If the plaintiffs are successful, then the donor notes will be considered a gift to the state."
So far, $81 million in bridge notes were sold, and the state government also has agreed to lend the state agency $150 million. UCLA was awarded $3.75 million over three years from this initial round of funding, which is earmarked for training five pre-doctoral fellows, five post-doctoral fellows, and six clinical fellows in stem cell science, Peckman says.
The plaintiffs lost in the first round, and the case is now in the appellate court and may ultimately end up in the California Supreme Court, with a decision expected by the summer of 2007, he adds.
If the state wins the case, then bond sales can take place, and the enterprise may raise up to $3 billion dollars, Peckman says.
The money raised must be distributed within 10 years of the bill's passage, according to the law, and at least two of those years have been used up by the lawsuit, he adds.
Despite the delay, research institutes already are seeing benefits to the state's passage of the proposition.
"One thing that has been a great benefit for academic centers is it has helped to recruit young faculty," Peckman says. "UCLA recruited five young, very creative and motivated stem cell faculty members, and that's been absolutely wonderful."
By California law, the ESCRO committee includes members with scientific, medical, and ethical expertise, as well as non-affiliated/non-scientific members, which makes it a little different from the IRB, which is not required to have an ethics expert, Peckman notes.
"The ESCRO committee is required to have members who are biologists, assisted reproduction specialists — which is a more explicit roster than the IRB membership requirement," he says.
Since there is no federal law governing the process, there is some flexibility in the establishment of an ESCRO committee at institutions in states without applicable local law, Peckman says.
"We focus on two elements: members come with expertise in stem cell science and expertise in ethics and the community perspective," Peckman says. "By California law, the ESCRO committee has to have community members."
UCLA's ESCRO committee's community members include people who have been involved in the HIV/AIDS community, as well as a person who is involved with the Parkinson's disease community, he says.
Unless the lawsuit prevails, the future is bright for the state's embryonic stem cell research.
"People need to see this as a creative opportunity, and it's important to ensure that through the process of stem cell science and oversight, we have the highest quality science and achieve the highest ethical standards," Peckman says.
While California cannot compete with National Institutes of Health funding, the expected $3 billion in bond money will provide a good start in this research, Peckman says.
"We hope in the future the federal government will change its policy and other monies will be available to help scientists conduct stem cell research," Peckman says.