In collaboration with First Clinical Research, each month we share a new question and accompanying anonymous survey, designed to encourage critical thinking about questions in clinical research and highlight discussion generated by the prior month’s question.
This month's question:
Researchers have identified a previously unknown but fairly common viral disease in certain developing countries: infant maternalitis, in which an infant is born with a serious allergy to the mere presence of his or her mother. For reasons that are not understood, [...] 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
PRIM&R invites members of our conference Blog Squads to reflect on the conference they attended in an additional post six months after the event. In this post, AER16 Blog Squad member Seth Hall reflects on how he's applied what he learned at AER16 to his day-to-day work. 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
Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”? My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops. Read more