-
News: A 66-year-old man presented to the hospital with symptoms of alcohol withdrawal. The man was placed on an IV and put in bed. The patient later attempted to get out of bed, but he fell down and struck his head on the floor. The hospital settled with the man for $500,000.
-
The emergency department (ED) is perhaps the worst hospital unit in which to have strangers working together, says Dan Sullivan, MD, FACEP, JD, president and CEO of The Sullivan Group, a risk and safety consulting group in Oakbrook Terrace, IL, and an associate professor of emergency medicine at Cook County Hospital/Rush Medical College in Chicago.
-
IRBs and research offices need a variety of procedures and tools to ensure compliance. One tool that sometimes is overlooked is requiring research sites to develop corrective action plans (CAPs) when they have problems.
-
Most major corporations and business sectors have adopted business quality improvement (QI) measures like Six Sigma, Lean Process, and others. But in human subjects research, this type of QI approach is fairly new, an expert says.
-
In assessing the recent revisions to the Common Rule proposed by the Department of Health and Human Services (HHS), the accrediting agency for human subjects protection programs suggests that HHS may lack the necessary information to move forward with a final rule.
-
Research ethicists and others have long described the value of recruiting more minorities in clinical research (CR) trials, but the question is whether or not IRBs have a role to play in advancing this goal.
-
In the proposed revision of the Common Rule, the Department of Health and Human Services (HHS) responds to years of complaints about informed consent documents that they're too long, too complicated, too full of boilerplate and risk management language.
-
When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting.
-
In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the IRB community's heavy hitters have weighed in.
-
In August 2011, emergency department (ED) registrars at University of Mississippi Health Care in Jackson were trained on patient estimator software, which increased collections by 124% compared to the previous year, while admissions areas saw a 319% increase.
