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Agency designates funding for existing program that promotes behavioral health integration into pediatric primary care using telehealth.
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Juggling the work of an IRB of record and becoming a relying IRB can be challenging. But one underlying goal can keep an IRB on track with both roles: consistency.
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Whether institutions are the IRB of record or the relying IRB, setting up a seamless process involves many time-consuming processes — and it can take years. One of the obstacles to an efficient IRB reliance effort is handling the technological details.
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It is unlikely IRBs will see many studies with one enrolled participant (the N=1 study design), but they should be prepared for this type of protocol. The single-subject study design can be applied to chronic conditions like cystic fibrosis or to ultra-rare diseases.
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One hot topic during a recent webinar on diversity in clinical trials centered around whether researchers should use race in a clinical trial. Using race as a variable is never neutral and never scientific, one expert noted.
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Structural racism is a powerful construct that may influence participation in clinical research studies, panelists of a recent webinar noted.
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Diversity in clinical trials involves more than just including more minority participants, panelists said at a recent webinar. It is a commitment from leadership that addresses the diversity topic within every aspect of the clinical trial process.
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Healthcare professionals can find themselves in a quandary when they want to report fraud or other concerns within their organizations because doing so could require disclosure of protected health information. That could seem like a HIPAA violation; fortunately, there is a whistleblower exception that covers this scenario.
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The Office for Civil Rights announced its 18th settlement of an enforcement action in its HIPAA Right of Access Initiative on March 26.
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With nearly 20 settlements so far, the Office for Civil Rights (OCR) is showing its determination to protect patients’ rights to obtain their medical records from healthcare entities. OCR announced its Right of Access Initiative in 2019 and vowed to “vigorously enforce” patients’ right to access their medical records. OCR continues investigating allegations of improper delays that potentially violated the HIPAA Privacy Rule’s right of access requirements (45 C.F.R. § 164.524).