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Research institutions and IRBs can keep trial sites in compliance through proactive measures that address regulatory issues before an IRB or federal audit reveal problems.
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A new online course for IRB members will use animation, audio and interactive features in order to teach members not just the principles of human subjects protection but also what would be expected of them in real board meetings.
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In analyzing the potential obstacles to conducting schizophrenia research, it's tempting for some to see IRBs as the sticking point. But a recent study of mental health researchers suggests that the situation is more complex than that.
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Many universities are rewriting their student subject pool policies in the wake of a decision by the Office of Human Research Protections (OHRP) regarding penalizing students who fail to show up for research appointments.
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There are a variety of models for research ethics consultation services (RECS), but a common factor that has made these new ethics boards appealing to top U.S. health officials and foundations is the idea that they can work collaboratively with IRBs to improve human subjects protection, an expert says.
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The Office of Protocol Research of the University of Texas M.D. Anderson Cancer Center in Houston developed its administrative research-monitoring plan (ARMP) as a simple, user-friendly systematic tool.
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While federal regulations require that subjects be informed of the possible alternatives to their participation in a clinical trial, often subjects don't learn enough about those alternatives to make an informed decision, says a bioethicist who has studied the issue.
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Tufts University researchers studying immigrant workers in a nearby community engaged local leaders and teens to help them create a survey and recruit and translate for the immigrant population. It was an example of community-based participatory research (CBPR), involving the community from start to finish.
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Three institutions recently were honored by the Health Improvement Institute for their contributions to enhancing the protection of research subjects.
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The current system of regulating community-based participatory research (CBPR) doesn't truly engage or protect communities as it should and fails to follow up on promises made by researchers to IRBs and to those whom they study, says one community researcher.