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COVID-19 Increases Need for Case Managers
COVID-19 has spurred myriad changes in hospitals as providers scrambled to adapt to the new normal. That includes new and creative ways to connect and support patients.
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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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Recurrent Stroke After Embolic Stroke of Undetermined Source
Twenty percent to 40% of ischemic strokes are classified as cryptogenic, meaning a specific cause cannot be identified. A subset of those have been classified by some investigators as embolic stroke of undetermined source. However, this remains a controversial category and classification.
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Can Anticoagulant Strategies Reduce Covert Brain Infarcts in Patients with Cardiovascular Disease?
Covert brain infarcts are detected on magnetic resonance imaging studies in the aging brain in about 10% of people at age 65 years, increasing to 25% at age 80 years. Most patients who develop dementia have a combination of multiple small infarcts, plus amyloid deposition. Prevention of covert infarcts is a strategy to mitigate the frequency and severity of late-life dementia.
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Carotid Endarterectomy vs. Medical Therapy in Patients with Asymptomatic Carotid Stenosis
Multiple randomized clinical trials have demonstrated that carotid endarterectomy is beneficial in patients who have symptomatic carotid stenosis, and currently, that is the recommendation for such patients. However, in the intervening years, advances in medical therapy, as well as significant improvement in the management of blood pressure, diabetes, diet, and exercise, have been shown to reduce stroke rate. Therefore, it is currently controversial whether carotid endarterectomy is still beneficial in asymptomatic patients with carotid artery stenosis compared to current medical management.