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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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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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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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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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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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In the days after a child has been diagnosed with leukemia, parents often must wrestle with decisions about participation in clinical trials. It's a busy and stressful period, as family members are still dealing with the trauma of the diagnosis.
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Using the National Cancer Institute's Central IRB (CIRB) saved affiliated institutions money, staff time and time spent on review, according to a recent study of the costs and benefits associated with the CIRB.
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For more than 30 years, the National Surgical Adjuvant Breast and Bowel Project has collected copies of every consent form signed by the more than 130,000 patients enrolled in its clinical cooperative group trials.
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When an institution conducts IRB reviews of hundreds of protocols, it can be hard to maintain consistency on such details as language used in informed consent to describe potential risks and adverse events.
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Some of the thorniest questions that IRBs face are those for which there are no clear-cut answers opinions may vary, arguments on both sides may be compelling, regulatory guidance may be scanty.
