Internal Review Boards
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Network of bioethicists gives guidance to investigators faced with complex ethics issues
IRBs typically give guidance to researchers only during the pre-study regulatory review process, but investigators also struggle with ethical questions that arise during research. “For years, this has been done informally,” says Benjamin Wilfond, MD, director of the Treuman Katz Center for Pediatric Bioethics at Seattle Children’s Research Institute.
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Case study: IRB deals with social network analysis issues
The IRB at the University of Illinois at Urbana-Champaign had a number of issues to consider when researchers submitted a study involving a social network analysis on sensitive issues. In this case, the sensitive issue was sexual assault on a college campus.
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IRB’s HRPP training class covers multiple areas
A research institution’s centralized research training program began as a way to help new investigators and research teams learn more about the IRB process and human research protection. But the program, called Navigating Clinical Research, has expanded into a comprehensive training course that uses a variety of adult learning strategies.
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Clinical research training course provides interactive instruction
Human research protection program (HRPP) training at the institutional level often lacks uniformity and evidence-based strategies, some experts say. Some organizations and research programs require new investigators and IRB staff to have extensive online coursework or on-campus classes, and others provide only general guidelines and requirements.
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OHRP and FDA address electronic informed consent
Federal regulatory agencies acknowledged in recent draft guidance that research informed consent is moving in directions not quite imagined several decades ago. The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) published draft guidance for industry, clinical investigators, and IRBs in the “Use of an Electronic Informed Consent in Clinical Investigations” in the March 9, 2015, Federal Register.
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Smartphone apps are a new frontier for minimal risk studies
Now, entire research studies are being run through a handful of apps, released in mid-March, through the iTunes App Store. These apps consent study participants, determine eligibility of participants, and run study tasks — all without the need for participants to travel to study sites.
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IRBs win awards for best practices, innovation
The Health Improvement Institute’s (HII’s) Awards for Excellence in Human Research Protection recently honored two IRBs that streamlined and implemented new systems for efficiency and information-sharing to improve approval turnaround times and quality of human subjects protection in the areas of best practices and innovation.
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IRB considerations for nanotechnology protocols
Once the stuff of sci-fi novels and movies, nanotechnology (NT) — the manipulation of matter on the tiny nanoscale — now has practical applications in everyday areas such as engineering and healthcare. NT is currently being used in clinical trials to develop diagnostic tests and targeted drug delivery devices, especially for cancer treatment, experts say.
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THRIVE model shows how IRBs can collaborate effectively
The theory behind a hospital-university research and IRB collaboration is that both organizations have different strengths, and together they can facilitate studies and research ethics review more efficiently. One such model is THRIVE, a new, inter-organizational partnership model.
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Research data warehousing is a complicated project for IRBs
One of the biggest research changes many health systems and universities are facing involves building an enterprise data warehouse that integrates data from various institutions. Its potential has grown in recent years with the growth of electronic health records.