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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.
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Single IRB NIH guidance may leave more questions than answers
In December 2014, the National Institutes of Health (NIH) released draft guidance detailing its support and expectations for the use of a single IRB for multisite NIH-funded studies. But for many in the IRB community, the guidance raised more questions than answers.
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Compliance Corner: IRB has CR sites correct errors with action plans
IRBs and research offices need a variety of procedures and tools to ensure compliance. One tool that sometimes is overlooked is requiring research sites to develop corrective action plans (CAPs) when they have problems. -
Groups finding common ground on Common Rule
In the waning days of the comment period for the advance notice of proposed rule-making (ANPRM) for human subjects protection regulation, some of the IRB community's heavy hitters have weighed in. -
Dispatching CARs to inform the public
When investigators seek an exception from informed consent (EFIC) for emergency research, they must show that they have engaged in community consultation and public disclosure, informing the public that they may encounter an experimental intervention while being treated in an emergency setting. -
IC experts advocate improvements to process
In the proposed revision of the Common Rule, the Department of Health and Human Services (HHS) responds to years of complaints about informed consent documents that they're too long, too complicated, too full of boilerplate and risk management language.