IRB Advisor
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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.
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University IRBs need clear policies regarding student enrollment, experts say
One of the simpler ways to prevent regulatory problems with student or employee research recruitment is to have clear, well-outlined policies and procedures (P&Ps) or guidance available for all to see.
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OHRP letter highlights importance of having student subject P&Ps
Problems involving student research participants are rare, but even the occasional issue can be a major headache for IRBs and research institutions. That’s what one organization discovered when a confidential complaint resulted in an investigation by the Office for Human Research Protections (OHRP) last year.
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Comic assent/informed consent for biobanking is accessible
As IRBs continue to evaluate informed consent (IC) and youth assent forms according to regulatory guidelines and readability, researchers have come up with a format that engages, informs, and even entertains people being asked to participate in biobanking: comic assent.
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How do IRBs or PIs Rate the Risk of Ordinary Life Experiences?
What might bring emotional distress to one person could be a shoulder-shrug to another.
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Study: Clinical trial site violations not reported in peer-reviewed literature
A study published in JAMA Internal Medicine in February found that serious violations of good clinical practice discovered by the Food and Drug Administration (FDA) at clinical trial sites are not mentioned in peer-reviewed publications in which the trial results are published.
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Here’s what a certification study group program looks like
The only thing better than forming an in-house IRB certification study group is forming a multi-institutional IRB certification group, according to a pair of IRB managers who found good results with their three-institution CIP study group.
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Certification testing can be more successful, less stressful with study group method
As IRB professionals increasingly invest in their careers and seek certification, they sometimes find that taking the certification test can be stressful and all-consuming.