IRB Advisor – May 1, 2020
May 1, 2020
View Issues
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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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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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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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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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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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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.