Internal Review Boards
RSSArticles
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Informed Consent Requirements May Hinder Innovation in Stroke Treatments
IRBs and regulatory bodies should consider the changing scope of acute stroke care, and collaborate with investigators to design studies that can ethically answer important questions and allow innovation and progress in the field.
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IRBs Tend to Err on the Side of Protection, Not Inclusion
Researchers must strike a balance between protecting and including participants in their protocol design. Building in additional safeguards for those deemed vulnerable could help.
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The Trouble with Electronically Tracking Study Medications
Digital pills allow data to be recorded automatically about patients’ medication adherence, but patients and providers have expressed significant ethical concerns.
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New Tools to Facilitate Single IRB Process
The intent of the revised Common Rule requiring institutions to rely on a single IRB for review of multisite research was to make the process simpler and prevent redundancies. Yet several years after the requirement became effective, research teams still struggle with frustrating operational challenges.
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IRBs Must Review Study Protocols Rapidly and Ethically During Public Health Emergency
Conducting clinical research during an infectious disease outbreak takes careful planning and coordination. The entire process hinges on excellent communication among everyone involved.
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Pain Researchers Are Engaging Patients as Partners
Pain researchers would benefit by enacting a comprehensive approach to patient engagement, perhaps engaging people with lived experience of chronic pain in developing study recruitment materials.
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Parents, IRBs Hold Different Views on Phase I Pediatric Oncology Trials
IRB members are more likely than the public to think the risks outweigh the potential medical benefits. Parents think about the possibility of caring for a child with severe cancer and no treatment alternatives. IRBs ensure trials are ethical and that pediatric subjects are not exposed to excessive risk.
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New Guidance on Incorporating Patient-Reported Outcomes in Clinical Research
Patient-reported outcomes can be used to develop healthcare policy and regulatory decisions, and also to monitor symptoms to provide timely care tailored to the patient’s needs.
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Few People with Limited English Proficiency Participate in Stroke Studies
Rather than making the IRB processes more difficult for researchers who wish to include underrepresented populations in their study, IRBs should work with researchers to overcome obstacles.
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Updated Guidance Provides Sense of Urgency to Improve Clinical Trial Diversity
Organizations must invest in research infrastructure to support investigators in enrolling and retaining diverse study populations.