TAG ARCHIVES FOR informed consent

13
Aug2018

You are the chief human research protections officer at a prestigious academic medical center (AMC). You have just discovered that two doctors on your staff have been secretly conducting a clinical study on their patients. The doctors have broken every rule in the human subjects protection book. They did not even tell their patients they were in a clinical study, and some of them died. The president of the AMC has called a meeting this afternoon where you will have to explain the situation and make your recommendations. What a nightmare! To complicate things, it turns out that the study treatment is an astonishing medical breakthrough that can save thousands of lives. The doctors want to submit a paper to a major medical journal by the end of the week. A Nobel Prize could be in order. Read more

20
Jun2018

On May 10, PRIM&R hosted a webinar, Forward-Looking Strategies for IRBs in the Genomic Age: Preparing for Shifting Concepts of Identifiability, to provide expert input on the impact of breakthroughs in genomics research on traditional notions of identifiability.The panel consisted of Jiayan Chen, JD, a partner at McDermott Will & Emery, LLP, and Suzanne Rivera, PhD, MSW, vice president for research and technology management at Case Western Reserve University. After the webinar, Ms. Chen and Dr. Rivera responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more

18
Jun2018

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials," which was published in the Federal Register on April 9, 2018. PRIM&R suggests a few areas for further clarification, but generally applauds the agency for taking this important step to fill current regulatory gaps around the inclusion of pregnant women in FDA-regulated clinical trials and ultimately believes that the draft guidance will be of great benefit to relevant stakeholders, including industry, IRBs, and research subjects. Read more

15
May2018

On April 19, HHS and 16 other federal agencies released a new Notice of Proposed Rulemaking (NPRM) that would delay the general compliance date for the revised Common Rule an addition six months, to January 21, 2019. The NPRM also proposes to allow institutions to implement three “burden-reducing provisions” during the delay period. Comments on the NPRM are due May 21, and as you consider developing and submitting your comments, I wanted to share the letter PRIM&R has submitted. Read more

17
Apr2018

This post draws on information I learned from two presentations. The first, “SBER in the Era of the Revised Common Rule: An Overview of the Most Relevant Regulatory Changes” by Yvonne Lau, MBBS, MBHL, PhD (Director, Division of Education and Development, Office for Human Research Protections), was given at PRIM&R’s 2017 AER conference. The second, “Clinical Trials in the SBER Context” by Melissa W. Riddle, PhD (Chief, Behavioral and Social Sciences Research Branch, National Institute of Dental and Craniofacial Research) and Cindy S. Shindledecker, CIP (Director, Health Sciences and Behavioral Sciences Institutional Review Board, University of Michigan), was given at PRIM&R’s 2017 SBER conference. (Dr. Riddle was absent, but her colleague Wendy Webber, ND, PhD, MPH (Acting Deputy Director, National Center for Complementary and Integrative Health) was able to do an impromptu presentation on behalf of NIH.) Read more