Internal Review Boards
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Ethical Oversight of Chimeric Research
A key concern is whether evidence will emerge indicating significant functional changes in the cognition and behavior of nonhuman animals that contain human cells. If so, it may be difficult to resolve ethical issues regarding the moral status of those chimeric animals.
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IRBs Likely Need Outside Expertise When Reviewing Xenotransplantation Study Protocols
An enthusiastic surgeon who wants to initiate a clinical trial for xenotransplantation may, in their enthusiasm, minimize the potential problems to the IRB. The surgeon might win approval, but the IRB might lack the expertise to know if they are receiving all the facts.
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For Researchers Using Social Media Data, Consent Is Ethical Worry
Researchers struggle with the ethical implications of sharing information that enables Twitter users to be identified. More guidance is needed from IRBs, as there does not seem to be a consensus on best practice in terms of research ethics.
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Alzheimer’s Research Funding Receives Boost
The fiscal year 2023 federal budget also includes provisions to strengthen accelerated drug approval and Alzheimer’s public health infrastructure.
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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.