Hospital Management
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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.
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Quality Improvement Project Reveals Reasons for Long IRB Approval Process
Researchers analyzed minutes of IRB meetings for 33 protocols that were approved in 2019. All 33 protocols required at least two full board reviews before approval. They also evaluated 244 protocols that were reviewed faster. Most delays were attributed to protocols that did not adequately describe the research. Some consent documents are incomprehensible to people without medical backgrounds. Safety risks, duration, and allocation of cost sometimes are unclear. All this requires feedback from the IRB, to which researchers must respond.
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Minority Residents’ Palliative Care Training Quality Trails Other Medical Education
The 91 residents surveyed reported receiving less training on palliative care than they did on sepsis management. Half the residents reported receiving negative messages about palliative care. Two-thirds said they considered care for dying patients to be depressing.
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IRBs Scrutinizing Recruitment of Adolescents via Social Media
When recruiting adolescents online, investigators should think about how they would proceed if recruitment was conducted in person. Researchers would not be able to barge into an in-person group meeting without an invitation, just as they cannot post in a private Facebook group without the moderator’s permission.
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Ethical Concerns on Conscience Clauses in Genetic Counseling
Of 274 genetic counselors surveyed, 90% were not even aware the conscience clauses existed. On the issue of whether genetic counselors had the right to use a conscience clause, responses were mixed: 24% said yes, 31% said no, and 45% were unsure. Ninety percent of respondents agreed counselors were ethically obligated to refer a patient to another provider if using a conscience clause.
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IRBs Use Inconsistent Processes for Informed Consent with Non-English Speakers
Translations, interpretation services, and other necessary accommodations for non-English speakers need to be built into study budgets
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To Eliminate Race-Based Disparities, Start by Asking Questions
"If not the bioethicist, who else in the hospital system is going to be responsible for checking to make sure that systemic racism isn’t occurring within the hospital?"
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IRBs Facing Ethically Controversial Questions on Brain Research
The field of brain research sounds a lot like science fiction, but human neural organoids, human neural transplants, and human-animal chimeras all are imminent realities. IRBs are going to be facing some difficult decisions on whether this research can proceed. The authors of a recent report examined these issues.
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Pediatricians Urge FDA to Approve Shots for Kids
The American Academy of Pediatrics is urging the FDA to work aggressively to authorize a safe and effective COVID-19 vaccine for children younger than age 12 years as soon as possible. -
Before the COVID-19 Vaccine, Most HCWs Infected in Community
Researchers found during the pre-vaccine pandemic in 2020 that 11.5% of healthcare workers who acquired COVID-19 in their hospital were occupationally infected. Thus, as has often been observed by employee health professionals, the lion’s share of exposures and SARS-CoV-2 infections in hospital staff have occurred in the community.