Internal Review Boards
RSSArticles
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Q&A Part 1: IRBs Face Their Toughest Challenges with COVID-19
IRB leaders describe the challenges staff faced during the transition to remote working.
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IRB Pandemic Impact Report
In this question and answer special report, a dozen IRB administrators, directors, chairs, and other leaders from across the United States were asked about their facilities’ experiences during the COVID-19 pandemic’s early weeks.
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IRB Experts Offer Advice for Changing Research Landscape
It is clear that clinical trials now exist in a different world from what researchers, IRBs, and sponsors experienced in 2019. The key challenges are how to restart clinical trials, how to return to in-person visits, and how to manage the growing number of studies related to COVID-19.
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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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IRBs Can Prepare for Cannabis Research
The cannabis industry is a booming economic force across the nation as states increasingly legalize the sale of medical and/or recreational marijuana. It remains on the national Schedule I list of drugs that are not acceptable for legal sale. But what do healthcare providers really understand about the drug’s safety, risks, and benefits? Not enough, human research protection professionals say.