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Handling mental illness during pregnancy can be a double-edged sword. Because of the scarcity of clinical research with pregnant women, there are no FDA-approved medications for treating such illnesses. On the other hand, untreated mental illness in pregnancy carries its own risks.
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It's a constant refrain: IRBs are overburdened by adverse event reports (AERs) â many of which are unnecessarily reported to them and which they often lack the information to properly analyze.
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Device sponsors and others often seek answers and input from Marti Benedict, RN, BSN, chief compliance officer for research at SUNY Upstate Medical University in Syracuse, NY.
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The U.S. Food and Drug Administration (FDA) published two final rules on Aug. 13, 2009, detailing how seriously ill patients might gain access to investigational new drugs.
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A new online decision tree for reporting unanticipated problems (UPs) and serious adverse events (SAEs) has helped a research ethics office reduce unnecessary paperwork and reports and improved compliance with the institution's policies and federal regulations, an IRB compliance coordinator says.
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Research enterprises rarely offer staff ethics consultation services, although a clinical ethics consultation service commonly is offered in hospitals to physicians.
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When a human subjects protection program wants to ensure that participants have a confidential means of reporting concerns about studies, one alternative is a commercial "whistleblower" hotline service, which provides anonymity to callers.
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The use of proxy consent for adults who lack the capacity to consent on their own is a complicated issue, thanks to vague and often inadequate state laws describing who can make such decisions.
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It could be months before IRBs in New York state may see any protocols calling for compensation of women who donate eggs for stem cell research.
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The board that oversees New York state's $600 million stem cell research program will allow researchers to pay compensation to women who donate eggs for research a decision believed to be the first in the U.S. to allow state research money for this purpose.