One of primary tasks of the IRB is the evaluation of the informed consent process to make sure it facilitates participant understanding of the research project. The revised Common Rule emphasizes this responsibility and includes several new provisions focused on highlighting key information meant to improve participant understanding. It is clear that there are areas for improvement in conveying information about research involvement and explaining the choice participants need to make. But, how do we know whether these efforts are truly improving understanding and how do we assess participants’ views on their experiences in research? Read more
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Just before I left for San Antonio, I held an educational session with my IRB members, focusing on the revisions to the Common Rule that were likely to have the greatest impact on our processes. As an institution focused primarily on social, behavioral, and educational research (SBER), it seems likely that a large number of our currently expedited review projects will become exempt projects, especially under .104(d)(2) and .104(d)(3). Read more
The National Institutes of Health (NIH) has sponsored the RAND Corporation, in cooperation with the Scripps Translational Sciences Institute, to conduct a survey of IRBs. Read more
In this post, I continue my closer look at a few select areas of the revised Common Rule, which was published January 18, 2017 of this year, and is scheduled to go into effect January 19, 2018. One set of changes that has not gotten very much attention is that around the definition and categorization of “vulnerable” research subjects. In this post, I explain what those changes are and reflect a bit on their significance. Read more
In June 2017, PRIM&R hosted the webinar series Focus on the Revised Common Rule. Comprising four sessions on the topics of informed consent, exemptions and types of review, biospecimens and identifiable private information, and implications for social, behavioral, and educational research (SBER), these webinars provided a close look at the most significant areas of change described in the revised Common Rule.
The effective and compliance date for the revised rule is January 19, 2018, and with this date on the horizon, webinar attendees had many questions for the presenters about the new rule and what implementation might look like in their own human [...] Read more