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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.
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In the absence of changes to HIPAA that would clarify the use of the privacy rule in historical medical archives, institutions, archivists and IRBs are left to sort through the complicated issues themselves.
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The archives of medical colleges and hospitals can be a rich source of information for historians interested in how health care has been delivered throughout our nation's history. Old case files, collections of physicians' personal papers, even old photographs were donated to archives so that others could learn from them decades later.
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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.
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The IRB at East Carolina University of Greenville, NC, was able to satisfy investigators' complaints and improve response times, partly through an overhaul of its policies and procedures.
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When faculty and researchers' anger and complaints rose heavily against a university's IRB, a new vice chancellor of health sciences took charge, hiring someone to answer the criticism through policy and personnel changes.
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When the University of California, San Francisco's IRB denied a plan to have volunteers attempt to buy single cigarettes illegally at neighborhood stores, they cited the following concerns:
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A California IRB that had turned down a proposed study of cigarette sales in two San Francisco neighborhoods, instead found itself to be the object of scrutiny in the form of a journal article about its decision.
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Many of the same ethical issues need to be considered for on-line research as with any other type of research, but there are a few differences, an expert says.
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The debate about the appropriateness of placebos in clinical trials recently spilled over into the pages of the journal Obstetrics and Gynecology, where two obstetricians and a representative of the national public-interest watchdog group Public Citizen wrote to complain about a published study of an antiviral drug used to prevent herpes outbreaks in pregnant women.