The current pandemic, like all public health crises, forces us to confront difficult questions about how best to find cures or treatments for a disease that is rapidly taking many lives. Although some may argue that the extreme nature of our current circumstances requires throwing out our prior ethical assumptions, we could not disagree more. Adhering to long-established and widely accepted principles of human research ethics must remain an essential component of our efforts to combat COVID-19. Read more
Researchers in the Department of Bioethics at the National Institutes of Health invite IRB members to participate in a short study related to pediatric research ethics. The purpose of the study is to explore and compare the views of members of the general public and the views of members of IRBs on various types of medical research with children. The information collected is intended to inform how IRBs evaluate the ethical acceptability of proposed medical research in the future. Read more
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