A recent conversation from my IRB work—for several reasons, I must limit the details of the case:
An IRB had received, for review and approval, a research protocol for gene editing of human embryos obtained from an IVF clinic. The embryos would be at about the 150-cell stage—an early stage at which some (incorrectly, as I understand the science) believe a fertilized, dividing-and-differentiating zygote has not yet attained sufficient maturity to be called an embryo. These embryos would have been “donated,” in compliance with current law and regulation, including informed consent from the relevant party or parties. Further, the embryos would have been found to have a “life-threatening” mutation by preimplantation genetic diagnosis (PGD).
The first impression of the IRB’s primary reviewer (a scientific member for you readers familiar with regulations about the makeup of an IRB) was that the study was approvable on an expedited basis—that is, without a discussion at a full IRB meeting. Current regulations identify nine categories of research eligible for expedited review. The study in question arguably fits criterion #3: “Prospective collection of biological specimens for research purposes by noninvasive means.”
Under current law and regulation, this is a reasonable view. The Code of Federal Regulations (45 CFR 46.204) includes requirements for the protection of live human fetuses who are subjects of research. The regulations define “fetus” as “the product of conception from implantation until delivery.” Research involving dead fetuses, in whole or in part, including those obtained as a result of elective abortion, is to “be conducted only in accord with any applicable federal, state, or local laws and regulations regarding such activities.” As the Congressional Research Service points out in a general reader-friendly FAQ document (go to https://www.fas.org/sgp/crs/misc/R44129.pdf), any research involving human subjects must be approved by an IRB in advance, but the dead fetus is not considered to be a human subject.
The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.