Articles Tagged With: irbs
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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.
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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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Participant Distress Is Concern for IRBs Reviewing Child Maltreatment Studies
Surveys measuring prevalence of child maltreatment are important knowledge, but IRBs might overestimate the risk to participants.
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Unique Challenges for IRBs Evaluating Radiation Oncology Study Protocols
There may be few if any radiation oncology investigators at some institutions, and radiation therapy involves rapidly advancing technology. In light of this, IRBs might lack the necessary expertise to review these studies.
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Critical Care Nurse Researchers Must Know IRB Process
Many critical care nurses are involved in study recruitment. Lack of basic knowledge on how IRBs work can hinder this process.
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IRBs Strive to Improve Consistency of Study Protocol Decisions
Is a study protocol OK to go forward? Or are many changes needed for recruitment, consent, or other processes? IRB decisions often are inconsistent on these points — even at the same institution, and sometimes at the same IRB.
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Much Remains for IRBs to Learn About Performance Measurement
One researcher argues a more appropriate definition of IRB quality is how well the board implements the Common Rule — not just mere compliance, but how well boards put the Common Rule into effect.
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New Data on IRB Members’ Perceptions of Violations
Failure to properly store data and neglecting to maintain project records are the two most common IRB violations, according to a recent survey of 242 faculty members at research-intensive universities in the United States.
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Needlessly Delayed IRB Approval Raises Ethical Concerns
Delayed study startup times obstruct the enrollment process for prospective participants in clinical trials with a therapeutic intent. That is an ethical concern. Delays in IRB approval hinder enrollment, data collection and analysis, and submissions to regulatory oversight agencies. It takes longer to learn if new therapies are effective and safe. Updated product labeling and product approvals are held up. This delays the opportunity for individuals and society at large to benefit from research.