The proposed Supplement subverts the aims of scientific transparency in a manner that potentially harms public health, increases time and resource burdens on scientists, and threatens to reduce the ability of researchers to recruit study subjects. PRIM&R joins stakeholders in urging the EPA to reconsider the rule, so that vital, potentially life-saving research may continue. Read more
Is your IRB reviewing research or expanded access requests related to COVID-19? If so, our team of NIH-funded researchers at Washington University in St. Louis wants to learn about your IRB experiences reviewing and overseeing COVID-19 research and expanded access requests. Read more
This week’s Research Ethics Roundup covers ClinicalTrials.gov reporting, animal researchers scrambling to deal with paused research, funders’ responses to COVID-19, and a novel form of being that challenges the computer-animal barrier. Read more
On October 23, 2019, PRIM&R hosted a webinar, Real-World Approaches to Informed Consent under the Revised Common Rule. This webinar served as a check-in on how the human subjects research oversight community is adapting to the new requirements, particularly the revised Common Rule's implications for informed consent. Presenters Karen Blackwell, MS, CIP; Patrick Herbison, MEd, CIP, and Ann Johnson, PhD, MPH, covered challenges and successes pertaining to informed consent requirements in the revised Common Rule and helped attendees identify strategies to benefit their organizations in adapting to the regulatory changes. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
Studies that deliberately infect people with diseases are on the rise. They promise speedier vaccine development, but there’s a need to shore up informed consent. Read more
The COVID-19 pandemic is impacting human subjects research in unprecedented ways. On March 23, PRIM&R hosted a forum to provide an opportunity to hear from HRPP leaders representing universities, academic health care systems, and an independent IRB on the key issues and strategies HRPPs should be considering and implementing in the face of the COVID-19 pandemic. After the webinar, the speakers responded to attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more
