Protocol amendments often entail changes to consent forms. However, sometimes a revised protocol is ready for submission before the revised consent form is. When is it acceptable to submit a protocol change before the new consent form is ready? This practice should be avoided when possible, according to a recent blog post by WCG IRB. […]
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.
Updated HIPAA Research Authorization Template
The HIPAA Research Authorization template has been updated with one big and a couple of little changes. The revised form is now posted on the IRB’s website’s “Templates, Training, and Tools” page. The little changes include some minor wording changes to clarify what we’re trying to convey in the form. Specifically, we now state that […]
Willowbrook Study to be discussed March 10th
The Willowbrook study, in which institutionalized, mentally disabled children were deliberately infected with hepatitis, will be the topic of the next Research Ethics Book and Journal Club meeting, scheduled for March 10 at 10 am. Location and the in-person v. Zoom decisions are still being finalized, but it’s not too early to save the date […]
Completing modification forms
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 […]
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 First there was the draft guidance about children in research; today (Sept. 28, 2022) the FDA has released a proposed rule about single institutional review board review of multisite research.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: […]