Compliance
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AAAHC Takes Pragmatic Approach in Latest Edition of Handbook
There are notable updates regarding surgical site marking, high-alert medications, and quality improvement projects.
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Neurotechnology Takes Human Research Ethics to New Frontiers
It is possible that any IRB might someday review a study that involves making healthy people smarter, cognitively faster, and more resilient mentally. Neurotechnology, including research funded by the government, also is designed to help people with Parkinson’s disease, locked-in syndrome, mental illness, and other issues. But it could take things a step further for people with no chronic conditions. This potential raises ethical questions.
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FDA Answers Audit Questions from Researchers, Industry
The Food and Drug Administration issued new guidance on inspections during the COVID-19 pandemic, as the agency began to resume domestic inspections in July.
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COVID-19 Pandemic Changed Informed Consent for Biobanking
Researchers have used the 2018 public health surveillance exception to the Common Rule for the first time during the COVID-19 pandemic. In the early weeks of the pandemic, researchers might have overused this exception. Federal agencies approved some protocols involving lines of genetic materials with explicit research purposes, even if these were secondary to the public health surveillance purpose.
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Tips to Improve IRB-Researcher Productivity and Relationship
Expectations and communication issues are the two biggest challenges between principal investigators and the IRB community. IRBs set expectations through their websites and response letters, but they might not have articulated those expectations to themselves and investigators. From the principal investigator perspective, researchers might not fully appreciate that IRBs can be advocates and not merely a clearing house or impediment to putting research in the field.
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Tips for Reopening or Closing Research Studies
The 2020 landscape for clinical trials looks different than it did five or 10 years ago. Even before the worldwide disruption in research from the COVID-19 pandemic, there were systemic shifts that have squeezed trials in ways that add pressure to investigators and IRBs.
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IRBs Look at How to Get Through Pandemic — and Beyond
As human research protection programs and IRBs enter the next leg of the COVID-19 pandemic, they can draw on experience to find the best balance between safety and efficiency. Each institution and IRB will face its own challenges. But one of the more common challenges as the United States copes with more than eight months of the crisis is pandemic fatigue and burnout.
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Court Rules Defendants Must Face Malpractice Suit After Botched Delivery, Death of Twin
As with many medical malpractice cases, the primary issues in this case revolve around expert witnesses, who are almost always necessary and who can make or break a malpractice defense.
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Appeals Court Affirms $9.2 Million Noneconomic Damages Award in Medical Battery Case
The most important lesson for physicians and care providers from this case is to always receive fully informed consent for the actual procedure performed. Receiving consent beforehand is a prerequisite, but if the circumstances change, or if a modification to the procedure appears appropriate, seek and receive consent again.
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Malpractice Risks of Telehealth Still Being Determined
Risk managers should be wary of the malpractice risks associated with telehealth, according to several experts who say the sudden increase in usage may have introduced insufficiencies that should be assessed now.