Compliance
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Lack of Metrics, Specificity, and Regulations Concern Some Ethics Services
To some, there is a perception that regulatory agencies still consider ethics a small-volume service handled by a volunteer committee instead of a critical, high-volume service run by paid ethics staff. A few professionals in the trenches believe this critical subject is taken too lightly.
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TJC Offers Guidance on Accreditation and Effects from COVID-19
COVID-19 has affected hospitals and health systems in many ways, extending to the accreditation requirements and processes of The Joint Commission (TJC). Responding to many questions and concerns from accredited facilities, TJC recently offered answers in a webinar. The topics were wide-ranging, from the waiver of certain requirements to telehealth and documentation.
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CMS Extends Hospital Survey Limitations
Agency restricts hospital complaint surveys to immediate jeopardy allegations.
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Prominent Pastor, Scientists, Researchers Seek to Ease Vaccine Fears in Minority Populations
Minority populations are more likely to participate in clinical research activities when they are encouraged by trusted authority figures, such as family physicians or pastors. One such pastor and author, Bishop T.D. Jakes of The Potter’s House in Dallas, decided to use his popular YouTube channel to broadcast information about the COVID-19 vaccine to dispel myths and to encourage his followers to take the shots.
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IRB Improves and Simplifies Board Meeting Minutes Process
An IRB revised its board meeting minutes process from a clunky system of writing everything into an electronic document to one in which the minutes are automatically populated through the IRB’s electronic system, saving staff time and work. The old way of creating board meeting minutes sometimes took as long as a month for IRB staff to generate. Since the IRB revised its process, the staff can generate board meeting minutes within a week.
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IRB Reduces Student Study Review Time from 65 Days to 8 Days
It is possible to shorten IRB review time dramatically, but it requires some resources and time. The IRB of Northcentral University serves a nontraditional population of students, some of whom want to complete a research study as part of their academic plan. The IRB’s streamlining process reduced the submission-to-approval time to eight days, down from an average of 65 days before the new process, according to new, unpublished data.
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Researchers and IRBs Reconsider Minimal Risk After Trial Results
A clinical trial that involved studying electronic health record alerts for acute kidney injury seemed to be minimal risk to both the researchers and the IRBs that approved it. However, when two hospitals involved in the study reported an increased mortality rate, the researchers and the IRBs reconsidered what is truly minimal risk in these types of studies.
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Study Shows Research Programs and IRBs Responded Quickly to the Pandemic
Human research protection programs and IRBs nationwide responded quickly and efficiently to changing processes and policies during the early months of the COVID-19 pandemic, according to the results of a recent study.
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OCR Audit Findings Show Where to Focus HIPAA Compliance
Covered entities should take note of some key findings from audits conducted by the OCR in 2016 and 2017. OCR assessed covered entities’ and business associates’ compliance with selected provisions of HIPAA rules.
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Lessons Learned from Overturned $4.3 Million HIPAA Penalty
A covered entity’s victory over proposed penalties from the Department of Health and Human Services was good news for those responsible for HIPAA compliance, showing that good faith efforts and a willingness to fight the allegations can pay off.