IRB Advisor – October 1, 2020
October 1, 2020
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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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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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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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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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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.