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Collaboration Between IRBs Can Result in Better SOPs, Tools
IRBs can ensure smoother, more effective collaboration between institutions and pave the way for reliance agreements through the use of an IRB working group.
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IRB Develops Method for Creating Informed Consent Summary
The informed consent template that now is required through the revised Common Rule can be developed thoughtfully and effectively through the use of an expert panel or working group, experts say.
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Implementing the New Common Rule Is No Easy Task
The new rule also forces institutions to decide whether older studies should move forward under the new Common Rule or be grandfathered under the old rule.
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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.
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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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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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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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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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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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OHRP Issues Guidance on Public Health Surveillance vs. Research
The Office for Human Research Protections recently published new draft guidance to clarify the difference between human research that might require IRB review and public health surveillance that is not defined as research.