Articles Tagged With:
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Pregnant Pause: Time to Push ‘Play’ on Trials With Expectant Mothers
There are many obstacles to including pregnant women in research, and IRBs may understandably err on the side of caution when it comes to expectant mothers in clinical trials.
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Gene Expert: IRBs Should Prepare for Somatic Cell Trials
With somatic gene cell editing already underway in some trials, IRBs should prepare to deal with protocols involving noninheritable genetic changes.
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The Single IRB: One Board to Rule Them All
The National Institutes of Health recently delayed the effective date of its requirement to designate a single IRB in research involving multiple boards, but NIH officials have lost none of their enthusiasm for the idea.
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Community Research Training Helps Subjects Become Investigators
A new social-behavioral research model IRBs might encounter is one in which researchers include people who also could be participants, or their guardians, for the same studies.
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Finding the Best Role for Community Members: A Look at Two Strategies
IRB questions sometimes arise about the role and responsibility of community members/nonscientists on review boards. Should their — and other nonaffiliated members’ — contributions be limited? Do they have enough training to be primary or secondary reviewers?
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Newest Oncology Studies Raise Ethical, Other Questions for IRBs
Clinical research — especially involving oncology trials — is evolving with the introduction of new therapies and therapeutic mechanisms. These raise new and sometimes challenging questions for IRBs reviewing the study protocols.
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Failure to Wean From the Ventilator: Is Pleural Effusion the Culprit?
The authors of a multicenter, prospective cohort study did not find an association between the presence of moderate or large pleural effusion and ventilator weaning failure.
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Functional Outcomes After Receiving Life-sustaining Therapy in the ICU
Among patients who have spent at least three days in an ICU and required even brief mechanical ventilation and/or vasopressor support, almost half are dead and only one-third return to their baseline at six months. Several factors present on the first day of admission are associated with not returning to baseline status.
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Thrombocytopenia in the Critically Ill
Thrombocytopenia is not only a pathologic entity, but the severity of thrombocytopenia and the recovery time of the platelets often predicts outcome, including overall mortality of ICU patients. Critically ill patients with moderate and severe thrombocytopenia demonstrate higher ICU and hospital mortality. If the recovery is delayed beyond day four, several studies have demonstrated higher morbidity and mortality.
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Reproductive Rights in 2017: Follow-up and Call for Advocacy
The Trump administration has made good on a number of promises to roll back reproductive rights. As clinicians, we need to fight back to ensure access for our patients to essential services. This article seeks to document where we stand as of summer 2017, and present opportunities for engagement.