IRB Advisor
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IRBs Look at How to Get Through Pandemic — and Beyond
As human research protection programs and IRBs enter the next leg of the COVID-19 pandemic, they can draw on experience to find the best balance between safety and efficiency. Each institution and IRB will face its own challenges. But one of the more common challenges as the United States copes with more than eight months of the crisis is pandemic fatigue and burnout.
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Lessons Learned — or Not — from Hydroxychloroquine Mishap
The research community’s decades of work to build public trust in IRB oversight and the clinical trial process has reached one of its greatest challenges during the COVID-19 pandemic. Misinformation spread through social media and some media outlets, as well as contradictory instructions and information from political and public health officials, have helped create distrust. Through the spring of 2020, misinformation about hydroxychloroquine as a COVID-19 therapeutic proliferated after President Trump spoke about it as a cure.
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Minority Recruitment for COVID-19 Trials Is Low While Disease Burden Is High
More than 350,000 people said they were interested in volunteering for a COVID-19 vaccine trial in the United States, and only 10% of those who signed up are Black and Hispanic. Actual trial enrollment among two companies with large COVID-19 vaccine trials in the U.S. includes only one in five volunteers who are Black and Hispanic.
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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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A COVID-19 Vaccine at ‘Warp Speed’ Raises Myriad Ethical Questions
The United States is at a challenging and possibly dangerous crossroad as the desire for speedy development of a COVID-19 vaccine might be pushing political concerns ahead of safety, efficacy, and the regulatory process, bioethicists and researchers say.
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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.