Internal Review Boards
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When Researchers Discover Incidental Findings During Clinical Trial
If a study includes genomic testing, it is possible incidental findings will be discovered. As it stands, there is no clear guidance for whether researchers should tell participants about those findings.
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What Happens if Your Study Fails to Meet Recruitment Targets?
Failure to find enough clinical trial participants is more than just a logistical problem. There also are important ethical concerns. If the study remains incomplete, investigators risk violating the principle of beneficence.
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Staffing Shortages Are Hindering Clinical Trial Completion
Some sites are curtailing new enrollment across all studies, or at least for studies that are not as economically sustainable as others. Sites estimate the average added cost to recruit and train a new patient-facing staff member is approximately six months pay. Due to the limited availability of qualified research staff, sites are replacing research coordinators with individuals without clinical research experience.
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Can Interactive Tools Make Informed Consent Patient Friendly?
For someone weighing whether to participate in a clinical trial, receiving a 20-page consent form can act as a deterrent. IRBs should be thinking about the consequences of information overload.
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Decision-Making Capacity Is Concern for Older Study Participants
It likely is an accident if investigators enroll participants lacking decision-making capacity in trials. Since capacity to consent is not a mandated area to report for most journals publishing research, it may be left out for space or other reasons. Nevertheless, some researchers are seeking to start a conversation about this.
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Researchers Are Revamping Processes to Gather Community Input
Input from community members can help researchers make the study more effective by providing participants with regular updates on the results and proactively translating research consent forms into preferred languages. Investigators also could hire a staff representative of the community who can navigate cultural nuances and speak the preferred languages.
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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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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.