Compliance
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Potential Adverse Outcomes of Gene Therapy
Gene therapy may warrant long-term follow-up of research subjects due to the risk of delayed adverse events.
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FDA Gene Therapy Draft Calls for Long-term Follow of Subjects
The FDA recently issued multiple draft guideline documents on the fast-emerging field of gene therapy, including guidance on specific diseases like hemophilia and the need to follow some research subjects long-term to assess delayed adverse events.
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Consistency Is a Challenge, but Necessary With Multiple Institutional IRBs
Research institutions that undergo accreditation preparation quickly learn that having separate policies and procedures for each IRB is a problem.
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Newly Accredited Program Has Made Policies and Procedures Easier to Follow
When the human research protection program at the University of Florida decided to undergo accreditation with the Association for the Accreditation of Human Research Protection Programs, officials revised policies and procedures, making them consistent across IRBs and easy to follow.
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Tackling AAHRPP Accreditation Requires Time, Focus, Documentation
Research institutions seeking first-time accreditation or reaccreditation can always expect challenges. These hurdles are a little higher now as rules and regulations will change in 2019 under the new Common Rule.
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Social Media and Young Nurses Could Be Bad Combination
Nurses new to the field should be reminded about the risk to their own careers from careless or unwise posts on social media, which also will help protect the hospital or health system from associated liability.
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Injuries From Fall at Hospital Lead to Patient’s Death, $3 Million Verdict
A subdural hematoma caused brain swelling and left-side paralysis.
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Physician Defeats Liability for Prescribing Without In-person Consultation
The physician warned the patient not to drink alcohol while taking the painkiller.
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CAPTURE Focuses on Coordination, Gait Support
CAPTURE Falls includes the idea that there are eight “rights” of fall risk reduction.
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Staff Workarounds Pose Medication Error Risk
Patient safety is compromised when healthcare workers use workarounds to speed things up when they are busy, or to overcome roadblocks that make it difficult or impossible for them to follow proper procedures in the medication process.