“One person’s flexibility is another person’s ambiguity.”
I kept going back to this comment, articulated by Carrie Wolinetz (NIH), as I helped my HRPP prepare for the revised Common Rule implementation in January. Although Dr. Wolinetz was referring to the NIH’s Genomic Data Sharing Policy, the phrase is a perfect expression of my thoughts on the “concise and focused presentation of the key information” that now must appear at the beginning of consent forms.
This topic was addressed at the AER18 plenary session “To Participate or Not to Participate, that Is the Question.” Moderated by Ivor Pritchard (OHRP), panelists Celia Fisher (Fordham University), Jonathan [...] Read more
by Rebecca S. Ohnemus, MAA, CRA, Research Officer at University of the Incarnate Word
As IRB administrators, we find ourselves on the frontlines. Whether you’re a director, administrative support person, or anywhere in between, an incredible amount of time is consumed facilitating the transfer of information between the IRB and your institution’s research community.
If all a [...] Read more
by Avery Avrakotos, Education and Policy Manager
PRIM&R has long been committed to the protection of the rights and welfare of human subjects, and strongly believes that informed consent is an essential mechanism for providing potential subjects with the information they need to make considered, autonomous decisions about research participation.
In July, the US Food and Drug Administration (FDA) announced it [...] Read more
by Veena Joshi, PhD, Independent Consultant, India
During my previous job at a tertiary hospital in India, a pediatrician from the institution approached the IRB office with a grant proposal. He wished to conduct a study with children under 12 years of age. While he had reviewed information online about the necessary documentation and regulatory requirements, he still sought the help of the IRB office since it was his first time serving as a principal investigator (PI).
Upon reviewing his documents, the IRB administrative staff found that the assent form was missing. The PI was not aware that an assent form [...] Read more