IRB Advisor – February 1, 2019
February 1, 2019
View Issues
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Low Health Literacy Is Major Barrier to Research Participation
Researchers may design an informed consent form at a fifth-grade reading level, but even that is too high, according to experts.
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Study Sheds Light on Improving Informed Consent Readability
A small study about improving readability of informed consent examines how investigators and IRBs can make research understandable to people with very limited reading skills.
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Right to Try Off to a Cautious Start
While the federal Right to Try law enacted last year essentially bypassed IRB oversight of patients seeking investigational drugs, research ethics panels and their institutions can codify a requirement for local oversight into their policies and procedures.
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FDA Unveils Real-World Data Initiative
The FDA recently opened a promising path to capture real-world data and evidence to complement traditional clinical trials and open new avenues of research.
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Research Program Closely Monitors ClinicalTrials.gov Compliance
Compliance with the 2017 changes to ClinicalTrials.gov registration can be time-consuming, as at least one organization has learned over the past year.
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Earning the Trust of Research Subjects
Achieving trust in human research can be challenging in an age of precision medicine that calls for long-term relationships and potential unintended consequences far beyond a simple informed consent document.