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Researchers Identify Ethical Concerns with Pragmatic Trials
Pragmatic trials raise some new ethical issues that need greater attention, according to the authors of a recent study.
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Unique Ethical Concerns for Study Participants in Neuroscience Research
Innovative neuroscience research is vital, but individuals with mental illness pose some unique ethical concerns in terms of their participation. The results of a recent study provided some reassurance on the decision-making processes of individuals.
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Shortcuts in Clinical Trials May Cause More Harm Than Good
Dozens of potential treatments for COVID-19 are under investigation: existing antiretrovirals, anti-malaria drugs, monoclonal antibodies, and Chinese traditional medicines among them. Additionally, companies are rapidly developing new drugs. But poorly designed studies subject patients to the risks of adverse events without learning if the intervention works.
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Second Phase of Pandemic Raises More Questions, Concerns for IRBs
Research organizations and IRBs continue to face challenges and make tough decisions based on the best available information about a pandemic that changes daily as it spreads across the world.
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FDA Guidance Offers Foundation for IRB, Researcher Flexibility
The Food and Drug Administration’s guidance on conducting clinical trials during the pandemic provides reassurance that IRBs and research organizations can employ flexibility as they make changes to accommodate a world in which many patient visits are conducted remotely. The guidance does not change or modify existing regulations, but synthesizes existing regulations and emphasizes the built-in flexibility.
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What Happens to Human Research in the New Pandemic Era?
The big question in the clinical research world is how things will look when the COVID-19 pandemic has ended. Will everything go back to the way it was? If not, what changes will remain?
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The Role of Surgeons in the COVID-19 Era
Accrediting body helps surgery leaders find the right path forward during unusual times.
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Hypertensive Pregnancy Disorders May Negatively Affect Children’s Psychological Development
A recently published paper revealed certain health problems during pregnancy can lead to emotional and behavioral disorders in children.
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State Supreme Court Orders New Trial in Childbirth Death Suit
This case reveals the indisputable importance of experts. Important lessons from this case relate to challenging the sufficiency of such experts and whether the experts have offered opinions relevant to the proceedings. Who qualifies as an “expert” may be the proper subject of debate.
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Appellate Court Affirms $5.1 Million Award for Patient’s Death After Hernia Repair Surgery
This case raises important considerations about making appropriate choices in the selection of equipment and methods for treatment, as well as the importance of retaining a qualified and persuasive expert witness in the event of litigation.