Internal Review Boards
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Into the Void: A Staggering Sum of Unreported Research Data
In what amounts to a stunning compromise of research principles, a recent review of clinical trials over a five-year period found that results were never published for almost 90,000 participants.
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How Can IRBs Best Handle Ethical Conflicts in Social Media Research?
IRBs often review protocols in which investigators are using social media as a recruitment tool or a way to inform study participants about a particular disease. They might also use social media to keep tabs on potential or current research subjects. All of these intersections in the use of social media and human research protection can raise ethical red flags.
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How IRBs Can Fill in the RAC Gap
With changes to how gene therapy research is reviewed and regulated, IRBs will need to do more on their own to ensure study participant safety.
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The RAC Is Disappearing — What Will IRBs Be Missing?
The NIH has published new guidelines to streamline gene transfer research by eliminating RAC’s pre-review role and closing a national database of gene transfer studies.
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Unique Informed Consent Challenges of Sequentially Randomized Trials
Some people initially appear to be good candidates for transplant. But complications of treatment may develop — changing the risk-benefit analysis. A repeat consent conference is necessary before each sequential randomization.
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New Tool Helps With Study Recruitment
Department of Energy researchers developed a new tool to connect cancer patients with clinical trials. The tool uses a Netflix-style of analytics to recommend studies that would be a good fit for particular patients.
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Next Challenge for IRBs: Nanomedicine Research Risks
IRB members soon will see — if they haven’t already — protocols involving medical therapies with materials that are so tiny that a human hair is 80,000 times their width.
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Diverse Populations Joining NIH All of Us
Nearly a quarter of a million people have joined the National Institutes of Health’s ambitious All of Us precision medicine initiative — with a large response from racial and ethnic minorities who have been historically victimized or ignored by human research.
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Should IRBs Set an Incentive Pay Limit?
Not all IRBs and research institutions specifically address limits to how much researchers can compensate study participants. But allowing these limits to default to what is reportable to the IRS as income could be a mistake, one IRB chair says.
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Electronic Informed Consent Platform Enhances Education and Engagement
Since Memorial Sloan Kettering Cancer Center implemented the electronic informed consent process, thousands of research participants have consented electronically, increasing at a rate of about 500 per month.