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 […]
HIPAA and Identifiable Health Information From Outside the U.S.
The HIPAA privacy regulation is, of course, a U.S. federal law. However, human subject research has porous borders — some UAMS research studies involve identifiable health information originally created/collected outside the U.S. We recently reviewed a study that involved clinically created data collected outside the country and then brought to UAMS. That got us to wondering […]
The FDA Continues to Work on Harmonization With the Revised Common Rule
The Food and Drug Administration continues its efforts to harmonize its human subject protection regulations with those of the Office for Human Research Protections. You’ll recall that OHRP regs apply to all federally funded or supported research, and FDA regs apply to studies looking at FDA-regulated products, including industry sponsored studies. Revisions that are in […]
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 […]