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ICMJE Underlines Ethics on Importance of Data Sharing
The International Committee of Medical Journal Editors published an editorial in June 2017, saying there is an ethical obligation to share interventional clinical trial data. Beginning July 1, 2018, manuscripts with clinical trial results that are submitted to the committee's journals must contain a data-sharing statement.
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Paper Calls for More Transparency of Industry-sponsored Clinical Trials
A recent paper offers consensus recommendations and examples of best practices from the published clinical trial literature to help authors and trial sponsors communicate drug adverse events in a more informative and clinically meaningful manner.
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New Report on Research Integrity: Institutions Also Play a Role
It’s not just individual researchers who need to support scientific integrity. Institutions and environments also play important roles, says a new report from the National Academies of Sciences, Engineering, and Medicine.
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Researchers Develop Three Strategies to Shorten Informed Consent Forms
One new study has an answer to overly long consent forms that might appeal to most people who work in human research protection: eliminate repetition.
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Watch Out for ‘Toxic’ Studies When Adding New Hospital to HRPP
When WellSpan Health merged with a community hospital, an unexpected problem came to the attention of the human research protection program -- having to do with 17 open studies at the hospital joining the WellSpan Health system.
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The Central IRB Rule Is Still On — For Now
Soon, all IRBs will need to be ready to contract with central IRBs on cooperative research studies. While many IRBs already participate in reliance agreements, they say it’s becoming more complex and will take time and practice to prepare organizations for the big change.
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The Big Chill: IRB Critic Says Changes Fall Short
IRB Advisor asked Zachary M. Schrag, PhD, to weigh in on his past concerns in light of the revised changes to the Common Rule.
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Social Research Exemptions and Common Rule: It’s Complicated
Social scientists, behavioral researchers, and their respective IRBs find themselves in the midst of a somewhat complicated debate about how and to what extent the Common Rule changes affect or exempt oversight of their endeavors by the Office of Human Research Protections.
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Impossible-to-comprehend Forms ‘Make a Sham of Informed Consent’
Long sentences, large paragraphs, technical language, and multisyllabic words all contribute to reading and comprehension difficulties for informed consent forms, found a recent study.
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New Report on Research Integrity: Institutions Also Play a Role
Institutions and environments — not only individual researchers — play an important role in supporting scientific integrity, stresses a new report from the National Academies of Sciences, Engineering, and Medicine.