Articles Tagged With: irbs
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COVID-19 Misinformation Affects Everyone in Research Community
Clinical trial recruitment for COVID-19 studies faces a new challenge: Rampant misinformation. Since COVID-19 was declared a national emergency and pandemic, fake news, false cures, ill-informed posts, and conspiracy theories have dominated the social media space. One of the challenges from an IRB perspective involves informed consent and public trust in the shadows of the misinformation world.
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Vaccine Trials Should Follow the Four Ethical Principles
All human research, including COVID-19 vaccine trials, should be guided by the four ethical principles of autonomy, beneficence, nonmaleficence, and justice. When researchers, data safety monitoring boards, or the Food and Drug Administration decide to stop a clinical trial or expedite approval or use of an investigational product, these principles still apply.
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IRBs, Research Organizations Adjust to New Norms in COVID-19 Era
The research world’s axis shifted in 2020 with the COVID-19 pandemic. Research organizations and IRBs should expect that shift to be the new normal. There will be no return to the way it was before.
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More Research Needed Into How IRBs Operate and Make Decisions
The revised Common Rule’s provision that a single IRB should review protocols for multisite studies raises questions about how these IRBs handle conflicts of interest, local knowledge, and other issues. When a group of researchers sought to answer these questions, they found a big obstacle: Some IRBs, including the largest ones, were unwilling to participate.
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Steps for IRBs to Better Safeguard Participants
Technology is moving far faster than federal human research protection laws and regulations. But there are a few things IRBs can do that will help protect study participants.
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Combining Large Data Sets Challenges IRBs, Researchers to Ensure Privacy
The problems with HIPAA and current methods of protecting the privacy of individuals in research are being challenged in ways that were not possible in previous decades due to the ease and use of big data. Data scientists and other savvy investigators can combine de-identified data in a way that makes cross-references and re-identification possible.
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Mobile Technology, Wearables Are Changing Research, Challenging IRBs
Mobile technology and wearable sensors are broadening the limits of research and changing how IRBs view privacy. The voluminous data can point to health strategies previously unimaginable.
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Big Data Are Changing How IRBs Think About Research
Researchers and sponsors are adapting quickly to virtual technologies and using big data in studies, forcing IRBs and research protection programs to adapt — particularly when it comes to privacy. When IRBs review studies that use big data, they need to be reviewed through the lens of ethical review.
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SBER Programs Face Challenges with Revised Common Rule
Social-behavioral-educational research programs have always faced challenges fitting their work into the parameters of human research protection rules and regulations devised with biomedical research in mind. But the revised Common Rule has produced new issues with informed consent.
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IRB Members Can Build Good Relationships in Virtual Space
One long-time virtual IRB has learned how to develop camaraderie and rapport among IRB members without ever meeting in person — or seeing each other’s faces.