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Should Research Subjects Be Guaranteed Care if Injured?
At a time when social justice movements are coming to the fore, what if research subjects boycotted trials until they were guaranteed medical care if injured?
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SACHRP Approves Guidance on Exemptions From Single IRB
A committee recently approved a “points to consider” document that outlines three general areas where exceptions to single IRB oversight can be an option.
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Rule Delay, Confusion Cloud SACHRP Meeting
Most of the requirements of the final rule were to become effective Jan. 19, 2018. However, HHS and a host of other federal agencies issued an 11th-hour “interim final rule” that moved the effective date to July 19, 2018.
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Committee Helps IRB Prepare for Accreditation and New Common Rule
Accreditation experts say IRBs should not make too many changes when they first seek accreditation from the Association for the Accreditation of Human Research Protection Programs. It’s better to focus on what has to be done and to not do everything.
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Change Management Process Can Bring All Sides Together for Quality Improvement
One IRB receives process improvement help from a well-designed change management process that provides information, implements new procedures, and addresses the revised Common Rule and its effects.
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Preparing for Revised Common Rule? Aim for Efficient, Faster, Better IRB
With just a couple of months remaining to prepare for the revised Common Rule, the question for human research protection programs is: What needs to be done to make programs more efficient, faster, better quality, and compliant?
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State Supreme Court Reverses $22 Million Malpractice Case
Untreated hypoxia led to a patient's brain damage and quadriplegia for the rest of her life.
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Inability to Break Up Blood Clot Results in $6.6 Million Jury Verdict
A patient sued a hospital and several physicians, arguing that they were negligent in failing to timely diagnose her blood clot.
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Postoperative Atrial Fibrillation After Coronary Artery Bypass Graft
The data from this study do not indicate that new-onset postoperative atrial fibrillation should be regarded as having the same risks as primary nonvalvular atrial fibrillation in terms of long-term thromboembolic risk, and that anticoagulation in this group may not be necessary unless the atrial fibrillation is persistent.
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Opioids Not Better for Chronic Back Pain
Chronic use of opioids for management of back pain is controversial and hotly debated. This randomized trial showed no benefit of opioids over multimodality non-opioid treatments, consistent with many other observational studies.