Stem cell research needs separate oversight
Stem cell research needs separate oversight
National Academies release guidelines
The National Academies have released a set of recommended guidelines for research using human embryonic stem cells, advising research institutions to establish separate oversight committees for such research. Those involved in the report say that the extra layer of oversight is essential to enhance public confidence in stem cell research.
"While we were hesitant to recommend another bureaucratic oversight entity, the burden in this case is justified, given the novel and controversial nature of embryonic stem cell research," committee co-chair Jonathan D. Moreno, PhD, said in a statement. Moreno is a professor of biomedical ethics and director of the Center for Biomedical Ethics at the University of Virginia in Charlottesville.
While an institution could choose to involve IRB members on a so-called Embryonic Stem Cell Research Oversight (ESCRO) committee, it should be a separate entity, the report recommends.
"The ESCRO committee should not be a subcommittee of the IRB, as its responsibilities extend beyond human subject protections," the guidelines state. "Furthermore, much [human embryonic stem cell] research does not require IRB review."
The guidelines, which were a joint project of the National Academies’ National Research Council and the Institute of Medicine, were released in late April.
The guidelines apply to stem cell lines derived from blastocysts made for reproductive purposes and later donated for research as well as those created specifically for research.
They spell out the responsibilities of IRBs in the course of human embryonic stem cell research, including:
— Reviewing procurement of all gametes, blastocysts or somatic cells for the purpose of generating new stem cell lines.
"Requests to the ESCRO committee for permission to attempt derivation of new [stem cell] lines from donated embryos or blastocysts must include evidence of IRB approval of the procurement process."
— Ensuring proper informed consent to donors regarding the potential uses of the stem cells, the potential for the release of any traceable information about the donors and possible risks to the donor.
— Reviewing any reimbursements to women who undergo hormonal induction to produce eggs for research purposes. The guidelines state that only the cost of the procedure should be reimbursed; similarly, no payments should be provided to couples who donate stored blastocysts for research.
Once stem cell lines have been derived, the ESCRO committee and other relevant committees, such as an institutional animal care and use committee or an institutional biosafety committee, would monitor the use of the lines in research.
The National Academies have released a set of recommended guidelines for research using human embryonic stem cells, advising research institutions to establish separate oversight committees for such research.Subscribe Now for Access
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