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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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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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Small IRB offices often do not have cross-trained or back-up staff in the event the IRB administrator is unexpectedly absent. So what happens when the people filling in cannot find the right forms or records or schedules?
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When researchers are attempting to persuade subjects to answer questions about themselves, whether on the phone or by filling out a form, sometimes the altruism of participating in research isn't enough.
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A web site designed by Boston's Children's Hospital to better educate parents about pediatric research has won the top award for best practice in human subjects protection by the Health Improvement Institute.
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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.
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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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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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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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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.
