IRB Advisor – July 1, 2019
July 1, 2019
View Issues
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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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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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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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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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IRB Advisor Wants to Hear From You
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NIH Urges Vigilance to Protect Research
The FBI is continuing an investigation into “utterly unacceptable” foreign theft of and influence on research by the National Institutes of Health.
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IRBs and Institutions Could Improve Monitoring Sites for Protocol Fidelity
When IRBs review multisite studies, particularly when the sites are at different research institutions, there is a question about how faithfully each site sticks to the protocol and avoids deviations. With large, multisite, non-biomedical studies, fidelity — or maintaining protocol compliance — requires considerable resources.
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Study Finds That All Financial Conflicts of Interest Influence Findings
All financial conflicts of interest influence whether study authors report findings favorable to industry sponsors, according to a recent investigation.
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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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FDA Streamlines Expanded Access to Oncology Drugs
Project Facilitate calls for a new call center, which will be a single point of contact for physicians seeking expanded access to investigational oncology drugs. FDA oncology staff will help physicians through the process of submitting the request for expanded access and follow-up as needed.