In March, PRIM&R hosted the webinar Electronic Informed Consent: Ethical, Regulatory, and Practical Implications. Presented by Cheryl Grandinetti, PharmD, a health science policy analyst at the FDA, and Christian Simon, PhD, a bioethicist at the University of Iowa who conducts research on electronic informed consent (eIC), this webinar helped attendees understand the definition of eIC, grasp its regulatory requirements and context for using it in FDA-regulated clinical trials, better anticipate the challenges and benefits associated with eIC, and recognize how investigators and IRBs can promote its ethical and effective use. The presenters were joined by additional panelists Leonard Sacks, MD from the FDA and [...] Read more
TAG ARCHIVES FOR informed consent
Research partners”—that’s what scientists and doctors call people who serve as study subjects. Government officials and ethicists use the same term, depicting subjects as equal to the professionals who conduct and oversee health research. But there’s a problem with the egalitarian language. It simply isn’t accurate. Read more
This session at the 2015 Advancing Ethical Research (AER) Conference was a follow up to the 2014 AER Conference session "Using Empirical Evidence to Reduce Consent Form Length" presented by Amy Corneli, PhD, MPH, and Jeremy Sugarman, MD, MPH, MA. In last year’s talk, they shared preliminary data about their effective delivery of informed consent (EDICT) study based on interviews questioning what participants thought must be in the informed consent form (ICF) and what could be removed. This year’s follow-up session by Amy Corneli shared the study findings submitted for publication. What was learned can be put to use by [...] Read more
On September 8, the Department of Health and Human Services (DHHS) issued a Notice of Proposed Rulemaking (NPRM) for revisions to the Federal Policy for the Protection of Human Subjects , or "Common Rule." If adopted, the proposals in the NPRM will result in the most substantive revisions to the core regulation governing federally funded human subjects research in the United States since 1981.
The much-anticipated Notice of Proposed Rulemaking—offering the first changes to the Common Rule since its publication in 1991—has now been released. in the interest of providing PRIM&R’s community with as much exposure to the issues raised within it, and the writing and scholarship around the proposed rules changes, PRIM&R and other organizations are cross-posting their thoughts. This post, from Dr. Celia B. Fisher at Fordham University, focuses on the proposed changes to minimal risk. It originally appeared on Ethics & Society, the Fordham University Center for Ethics Education blog.