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Making changes under the Health Insurance Portability and Accountability Act (HIPAA) has not been easy for many research institutions and their IRBs.
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Monitoring student research isnt always a top priority for an IRB, and often the job may be partly handled by the students department and graduate advisor. However, in the cases where the student research involves human subjects who are children, the issue becomes far more complicated.
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For years, inmates of a Philadelphia city jail, known as Holmesburg Prison, participated in medical experiments. From the mid-1950s to 1974, when medical testing was banned, research, ranging from dermatological treatments to the effects of mind-altering drugs, was conducted at the jail.
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The Partnership for Human Research Protection (PHRP) in Oakbrook Terrace, IL, recently announced the approval of final standards for a new accreditation program to safeguard the interests of human subjects participating in research efforts.
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Except on the television drama ER, it rarely occurs, even at medical universities and affiliated hospitals, but occasionally an IRB may encounter a case where an investigator desires to have informed consent waived in order to conduct emergency medical research.
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Inevitably, some investigators will not be compliant with the federal or state statutes and regulations, institutional rules, or IRB policies when conducting clinical research.
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This article completes a four-part series on abdominal pain that began with the January issue of ED Legal Letter. The first two parts outlined risk management strategies for dealing with adult abdominal pain. The third part detailed obstetric emergencies and the difficulty in caring for both mother and unborn child. This concluding segment will review the evaluation and management of pediatric abdominal pain.
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