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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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Does Use of Biospecimens From Children Require Reconsent When They Are Adults?
There is considerable ethical debate about the issue of reconsent at age 18 from research subjects who provided biospecimens as infants, children, or adolescents. Practices currently vary widely among institutions.
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Instantaneous Wave-free Ratio vs. Fractional Flow Reserve: Defining Low-risk Population for Deferral of PCI
Researchers recently found that deferral of percutaneous coronary intervention based on fractional flow reserve and instantaneous wave-free ratio is equally safe, with a low one-year major adverse cardiac event rate of approximately 4%.
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Substance Abuse and Myocardial Infarction
Among patients ≤ 50 years of age with first myocardial infarctions, use of cocaine or marijuana increased the likelihood of an ST-segment elevation myocardial infarction and the subsequent risk of all-cause and cardiovascular mortality.
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Risk of Infective Endocarditis Revisited
In a comparison of patients with infective endocarditis (IE) and either bicuspid aortic valve (BAV) or mitral valve prolapse (MVP) vs. other IE patients at high or low to moderate risk of IE, BAV and MVP patients were more likely to exhibit viridans streptococci group infections of suspected odontogenic origin and cardiac complications at similar rates to high-risk patients.
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Home-based Detection of Undiagnosed Atrial Fibrillation
In patients with risk factors for atrial fibrillation, screening with a self-applied wearable ECG patch resulted in significantly increased rates of new atrial fibrillation diagnoses within four months, along with greater use of anticoagulants and healthcare resources.