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Embryos are human subjects too. (at the center).

Late this summer, the Secretary of Health and Human Services dissolved the National Human Research Protections Advisory Committee, a body charged with advising the department on ethical and policy questions in the conduct of research with human subjects. In October, the Bush administration revised the charge to a soon-to-be-reconstituted committee explicitly to include embryos within the category of "human subjects." What this means for regulation remains to be seen. Only last December, the Department promulgated final revisions to "Subpart B" of the federal regulations to give pregnant women greater authority in consenting to participate in clinical trials.

Meanwhile, the Fred G. Hutchison Cancer Center in Seattle has been embroiled in a serious conflict of interest scandal, the Office for Human Research Protections temporarily suspended all human subjects research at Johns Hopkins University following the death of a healthy volunteer, and two independent bodies have begun developing accreditation programs for institutional review boards. This on top of long-standing concerns that young researchers, clinical or other, are not getting enough training in the responsible conduct of research ("RCR"). Tell me this isn't an environment made for IRB: Ethics & Human Research.

Some of you may have known IRB in its former incarnation, IRB: A Review of Human Subjects Research, edited by Bob Levine of Yale University Medical School. Some of you may know the "new" IRB, now edited in house at the Center by--oh, but you are clever readers all!--the present writer, also known as "the former editor of the Hastings Center Report" (among other things; but we won't go into that now).

Like most significant changes in publications, the redesign and relaunching of IRB flow from many motivations. But the most important, for us, is to make IRB an even more valuable resource in addressing the resurgence of public and professional concern about ethical issues in research involving human participants. IRB's revitalized mission is threefold: to promote protection of human subjects in biomedical and behavioral research; to facilitate conduct of ethically well-informed research; and to enhance understanding of the collaborative nature of the research enterprise for all participants--subjects, investigators, sponsors, IRBs, administrators, and regulators.

To live up to its new subtitle, Ethics & Human Research, and wider intended audience, IRB has enhanced its content as well as its look. Regular columns featuring the "voices" of different participants--notably investigators and "subjects"--have joined scholarly articles of philosophical reflection, discussions of law and policy, and practical conversations about the common concerns IRB members grapple with as they review research protocols.

Does IRB aspire to be the Report of human research? It's already well on the way to matching its sibling publication; a bit shorter in length just now, but taking on the same challenge of bringing critical reflection to bear on a broad range of pressing ethical questions, in a way that's as accessible and useful as we can devise.
Bette-Jane Crigger
Associate for Cultural Studies
Editor, IRB: Ethics & Human Research
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Author:Crigger, Bette-Jane
Publication:The Hastings Center Report
Geographic Code:1USA
Date:Nov 1, 2002
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