IRB Advisor
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Assent Is Not Consent: Children in Clinical Trials Are Not Little Adults
The classic admonition in pediatric medicine is “children are not little adults,” implying in part that you cannot just scale down adult care and treatment. Does this phrase resonate as well in human research trials involving children, particularly around issues of consent for the former and assent for the latter?
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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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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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Study: Research Misconduct Rarely Reported by Authors of Systematic Reviews
Research misconduct — not publishing completed research, duplicate publications, or selective reporting of outcomes — sometimes is identified by authors of systematic reviews, but is rarely reported, found a recent study.
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Questions From UW Madison’s QI Program Evaluation Tool
The University of Wisconsin-Madison IRB developed an online quality improvement/program evaluation self-certification tool that helps project leaders determine whether their projects qualify as research.