PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s proposed rule "Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations," which was published in the Federal Register on November 15, 2018. Comments are due February 13. Read more
TAG ARCHIVES FOR minimal risk
At the 2017 AER conference, I caught the plenary session, “New Frontiers: The Changing Landscape of Research Regulations.” One of the presenters, John R. Baumann, PhD, the Associate Vice President for Research Compliance at Indiana University, shared with us how his institution was approaching the upcoming changes to the Common Rule, including the elimination of continuing review. 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. This is Part I of a two-part series. Read more
by David R. Van Houten, MS, research integrity advocate
During PRIM&R’s Best Practices for Assessing Risk in Social and Behavioral Research webinar, Jeffrey M. Cohen, PhD, CIP, CEO of HRP Consulting Group, Inc., discussed challenges for institutional review boards (IRBs) charged with reviewing social and behavioral research.
While human research protections is complicated across all areas of research, the presentation served to illuminate the complexities associated with protecting human subjects in social and behavioral studies. In his presentation, Dr. Cohen pointed out that IRB [...] Read more
On October 24, 2013, PRIM&R hosted a webinar titled Protecting Human Subjects in Qualitative Research: Ethical Considerations for IRBs and Researchers. Julie Simpson, PhD, director of research integrity services at the University of New Hampshire led the webinar while Elisa A. Hurley, PhD, education director at PRIM&R, served as the moderator.
Following the webinar, we connected with Dr. Simpson, and she kindly answered a few more questions that came in from webinar participants, exclusively for Ampersand.
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