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ID Groups Demand Border Patrol Give Detainees Flu Shots
The U.S. Customs and Border Protection’s (CBP) decision to not vaccinate migrants in detention facilities against flu and other infections is being slammed by leading clinicians and public health officials. -
Sepsis Can Begin With a Single Infection
The goal of antibiotic stewardship is to stop unnecessary use, but for those with sepsis, a critical step is to assess antibiotic therapy 48 to 72 hours after initiation.
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IPs Playing Critical Role in Antibiotic Stewardship
Infection preventionists (IPs) are playing key roles in antibiotic stewardship programs, which are now in place in most U.S. hospitals and making some hard-earned progress against a horde of multidrug-resistant bacteria. -
Tips for Including Plain Language in Informed Consent Form
Many informed consent forms fail to communicate simply and clearly. They might use language prospective research participants may not process easily. While the new Common Rule provides some suggestions for making informed consent documents more readable, there are additional steps IRBs and researchers could take to improve the forms, including incorporating plain language.
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Sample Models of Post-Approval Monitoring Programs
There are many ways IRBs could conduct post-approval monitoring programs. These can range from simple email questions and answers to full reviews at the research site. These programs often are designed to be educational, as well as adding a layer of accountability in the human research protection process.
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In New Common Rule Era, There Is Role for Post-Approval Monitoring
Post-approval monitoring (PAM) is one method that IRBs could employ when keeping tabs on minimal-risk studies or studies that no longer have to go through the continuing review process. It also can be a way for a small IRB to improve office efficiency and enhance relationships with investigators. IRBs that would like additional information from studies, after continuing review ends, could use PAM to obtain that information.
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‘Re-Consent’ a Gray Area for IRBs
Wading into a thicket of ethical and legal issues, SACHRP is trying to clarify the concept of “re-consent” and when is it necessary.
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SACHRP Approves Participant Payment Guidelines
The Secretary’s Advisory Committee on Human Research Protections (SACHRP) recently approved guidelines on paying research participants, addressing a range of issues from “token” payments to frank coercion. After considerable discussion into the ethical implications of paying subjects too much or too little, SACHRP approved the guidelines, entitled “Addressing Ethical Concerns Regarding Offers of Payment to Research Participants.”
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Physician Not Liable for Alleged Complications After Gallbladder Removal
This successful defense case reveals potent methods for defeating medical malpractice claims. On the substance, the defendant physician successfully challenged one of the necessary elements that an injured patient must prove when alleging medical malpractice: causation. Causation includes factual and legal aspects, where the physician’s actions must have been a “substantial factor” in contributing to the patient’s harm, but there may be an intervening action or event that cuts off the physician’s liability. If the risk of injury exists, even when a procedure is performed correctly, then simply because an injury occurred does not mean that the physician was negligent.
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Negligent Thyroid Surgery Results in $2.2 Million Verdict
One of the primary lessons from the case for physicians and care providers is that assistant physicians, including residents, may be subject to liability for failing to provide services within the standard of care as well, and that standard does not change for a resident still in training.