In December 2014, the National Institutes of Health (NIH) released draft guidance detailing its support and expectations for the use of a single IRB for multisite NIH-funded studies.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.
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.
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.
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.