TAG ARCHIVES FOR human subjects protections

30
Oct2018

I am thrilled to attend my second PRIM&R Advancing Ethical Research Conference (AER18) and to share my experiences as a Blog Squad member! With so many recent and forthcoming regulatory changes—the revised Common Rule, NIH single IRB of record mandate, and the EU General Data Protection Regulation (GDPR), just to name a few—this is an exciting time for the human research projections community, and I am delighted to explore these topics with you! Read more

21
Aug2018

On May 30, 2018, the four-year Right to Try (RTT) movement culminated in a new federal law, with the stated goal of providing terminally ill patients with a new route of access to early phase investigational drugs that are currently in clinical development and not approved or generally available to all patients in need. RTT laws seek to remove federal FDA oversight and regulations from the pre-approval process, in which patients seek to access experimental drugs in development outside of the clinical trials in which the drugs are being tested, despite the fact that terminally ill patients already had the right to request such access under FDA regulations for decades through the Expanded Access Program. Read more

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

21
May2018

On April 30, 2018, the EPA published in the Federal Register a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” According to the notice, the proposed rule is “designed to increase transparency in the preparation, identification, and use of science in policymaking.” On its face, this sounds good; however, many in the scientific community are expressing deep concern that this proposed rule is actually a way for EPA to limit the types of science it can and will use in regulatory decision-making, to the detriment of environmental policy and the public’s health. Comments on the proposed rule are due May 30. Read more

10
Apr2018

One of the most illuminating sessions from PRIM&R’s 2017 SBER Conference was “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). 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. She offered guidance on how to interpret the NIH definition of clinical trials by breaking down its various components.   Read more