Compliance
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Small IRB Copes with COVID-19 Pandemic Under Limited Budget
Many IRBs have seen clinical trial submissions decline since the COVID-19 pandemic began. Clinical trials also were put on hold. But work at Great Bay Community College — a one-person IRB office — has increased.
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New FDA Guidance Explains COVID-19 Expanded Access Policy
The Food and Drug Administration published an eight-page guidance for IRBs handling expanded access to investigational products during the pandemic. The guidance, issued in June, explains how IRBs might review individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
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Actions for IRBs Reviewing Vaccine Challenge Trials
As the world looks for a safe and effective vaccine against SARS-CoV-2, IRBs should review the bioethical implications of this type of study design, including assessing risks and benefits.
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Vaccine Challenge Trials Present Ethical Issues to IRBs, HRPPs
Bioethicists and researchers say it may be possible to shorten the typical 15-year-plus vaccine timeline through a challenge trial. In this model, participants receive the study vaccine, the are deliberately exposed to SARS-CoV-2. Safety and efficacy are important, but the risk-benefit balance for study participants is weighed more heavily in favor of the greater public good.
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Failure to Diagnose and Treat Infection After Surgery Results in $2.75 Million Award
This case demonstrates the need to carefully monitor patients during the relevant times, particularly during and after surgery, and to investigate abnormal conditions. The primary basis for the medical malpractice liability in this case was the surgeon’s failure to diagnose and timely treat the infection, which escalated and caused severe, irreparable damage and pain to the patient.
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$30 Million Award Upheld for Negligent Treatment of Kidney Disease
Although unsuccessful in this matter, the defendant care provider raised an important defensive tool in medical malpractice actions: comparative negligence. States employ different applications of this legal principle.
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Assessing Malpractice Coverage for Improvements
Medical malpractice insurance is a vital part of any risk management program, but it is easy to assume that whatever coverage you have had for a while is adequate. It may not be, and a regular review of your insurance policies is a good way to avoid nasty surprises.
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OSHA Enforcement Prioritizing Hazards Related to COVID-19 Response
The Occupational Safety and Health Administration has vowed to take a hard look at complaints and referrals related to employee safety during the COVID-19 pandemic. Healthcare employers should prepare to answer concerns about employee safety.
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HHS Distributing $175 Billion in CARES Act Provider Relief Fund
The Department of Health and Human Services is distributing $175 billion to hospitals and healthcare providers to compensate for their coronavirus response. Through the Provider Relief Funds, $50 billion is allocated proportional to providers’ share of 2018 net patient revenue.
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Compliance Oversight Necessary with COVID-19 Relief Funds
Funds provided to hospitals through the Coronavirus Aid, Relief, and Economic Security Act require careful compliance efforts to avoid substantial liability. The money comes with many strings attached.