Employee Management
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Part-Time Documentation Eased Among Many Favorable Rule Changes
Proposed rule changes regarding anti-kickback restrictions offer compliance relief to physicians and hospitals. The revisions propose three levels of protected value-based arrangements.
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Stark Anti-Kickback Law Refined for Clarity
The Department of Health and Human Services recently revised federal anti-kickback laws, changes that are seen as primarily good news for risk managers. The revisions clarify issues that were unclear and easing some restrictions that created compliance risks.
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Hospital Creates Harm Collaborative to Improve Communication With Executives
Some patient safety issues are so important that risk managers and other safety leaders need direct access to the C-suite so that concerns can be addressed quickly. Helen DeVos Children’s Hospital in Grand Rapids, MI, devised a harm collaborative that makes that possible. The collaborative meets weekly so that risk managers and other safety or quality professionals can address the executive team about individual patient cases or trends that are concerning.
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Bioengineered Organ Research on the Recently Deceased
The next frontier in transplant medicine includes bioengineered organs, which raise ethical issues but could help alleviate a critical shortage that leaves more than 100,000 people on organ wait lists annually in the United States.
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Bioemergency Research Might Weigh Risk-Benefit Ratio Differently
The risk-benefit ratio can be different when studies are proposed in response to a national bioemergency, such as Ebola outbreaks and epidemics. Researchers may need to tolerate greater risk to subjects, experts say. The bioemergency research tradeoff is that there might be a greater amount of benefit to society.
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Suggestions for Improving Exempt Determinations by IRBs
Federal regulations provide some room for interpretation in how IRBs might handle exempt determinations under the revised Common Rule. Research programs need to revise their own rules about who makes the determination and how these are handled, given the expansion of the exempt status.
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Preparation Needed to Follow Common Rule Exemption Changes
The number of exempt determinations is increasing as IRBs and research organizations adjust to the new Common Rule’s expanded definition of what types of research are exempt from IRB review.
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SACHRP Recommendations on Pay-to-Participate Research
The Secretary’s Advisory Committee on Human Research Protections used a series of questions in crafting recommendations on the complex issue of requiring research subjects to pay to participate. While still subject to some wordsmithing, the unpublished, finalized draft discussed at the SACHRP meeting included five questions and committee answers.
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New SACHRP Guidelines on ‘Pay-to-Participate’ Research
The Secretary’s Advisory Committee on Human Research Protections has finalized recommendations to assist IRBs dealing with “pay-for-participation” studies, which raise numerous ethical issues but may produce meaningful data if properly vetted.
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Nurse Suicides Finally Coming to Light
Overcoming the historic dearth of data on a critical issue, the authors of a new study reported that nurses are at higher risk of suicide than the general population. Researchers reported that female nurse suicide rates in the United States were significantly higher than for women in general, with a rate of 11.9 per 100,000 nurses, compared to 7.5 suicides per 100,000 women in the population. Male nurse suicides are even higher, with a rate of 39.8 per 100,000, compared to 28.2 per 100,000 men in general.