The Modification form is what to use when trying to make a change to your study. Filling the questions out completely is crucial for the reviewer looking at it to fully understand WHAT you are changing and WHY. Here are some tips on two of those questions that are often neglected: “Please describe the requested […]
Institutional Review Board Members
Reminders for our Institutional Review Board reviewers about policies, using Clinical Research Administration (CLARA), and other news. Feel free to click on this blog even if you aren’t on the Institutional Review Board. You may get some pointers about what the Institutional Review Board is looking for when it reviews your studies.
Language Understandable to the Subject
We talk about the concepts of health literacy and “language understandable to the subject” a lot in human subject research. What do subjects, and potential subjects, hear when we use certain terms? This vignette found on Twitter, although it doesn’t relate to research, illustrates the divide between what medical and research staff say, and what […]
FDA Proposed Rule Regarding Single Institutional Review Board
The Food and Drug Administration seems to be on a regulatory roll. First there was the draft guidance about children in research; today (Sept. 28, 2022) the FDA has released a proposed rule about single institutional review board review of multisite research. Per the federal register announcement of the proposed rule, the change would harmonize […]
Video About Social Media Use for Research Participants
Social media is everywhere — and that includes in the research space. A recent blog entry on Ampersand, the blog of Public Responsibility in Medicine and Research talks about the pros and cons of research subjects using social media to talk about their research participation. While social media can be a great tool to connect with […]
FDA Issues Draft Guidance About Children in Research
The Food and Drug Administration has released a draft guidance about children in FDA-regulated research. This draft guidance is intended to describe the FDA’s current thinking about including children in research that involves medical drugs, devices, or biologics. Note that this is a draft guidance only; it may change when (and if) it is finalized. […]
New Federal Guidance About Sharing Results Results and Data
The White House Office of Science and Technology Policy has released a new guidance promoting the faster sharing of results and data from federally funded research. Under this guidance, publications and their supporting data are to be made publicly accessible immediately, without an embargo. Federal agencies are to revise their policies to ensure that “all […]
Nice Recap of “Noncompliance” Considerations
What’s involved in making a determination of “noncompliance,” both at the time of initial review of the event and after the determination is made? This blog entry on the Ampersand blog — an online publication of Public Responsibility in Medicine & Research — gives an overview of the considerations related to noncompliance. One important addition to note: […]
FDA Issues Draft Guidance Regarding Charging for Investigational Drugs
The Food and Drug Administration has published a draft guidance on charging for investigational drugs under an investigational new drug application (IND). The draft guidance is being made available for comment purposes only; comments on it are due Oct. 24, 2022. If/when finalized (the FDA works in mysterious ways, remember), this draft guidance would replace […]
Updated Institutional Review Board Policies
The UAMS Institutional Review Board has posted several updated policies on its website. We try to review policies at least annually and make changes as indicated. In this most recent round of updates, most of the changes are pretty minor, and some are limited to formatting/typo correction. However, a few are more substantive. One other […]
Hospital and Drugmaker to Create DNA Database
Mount Sinai Health System in New York and pharmaceutical company Regeneron are collaborating to create a DNA and related health data database focusing on New Yorkers, according to a recent New York Times article. Regeneron will do the sequencing work, and will gain access to the genetic data and partial medical records of each participant. […]