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 […]
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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 First there was the draft guidance about children in research; today (Sept. 28, 2022) the FDA has released a proposed rule about single institutional review board review of multisite research.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FDA Issues Draft Guidance About Children in Research
The Food and Drug Administration has released a draft guidance about children in FDA-regulated research. This draft guidance is intended to describe the FDA’s current thinking about including children in research that involves medical drugs, devices, or biologics. Note that this is a draft guidance only; it may change when (and if) it is finalized.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 […]
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 […]
FDA Releases Good Clinical Practice Q&A
Have a few minutes/hours/days to fill? The Food and Drug Administration has released a compilation of all of its Good Clinical Practice questions and answers from 2017 through 2021. The good news: The Q&A is in a searchable Excel spreadsheet. The bad news: The spreadsheet contains close to 1,400 individual questions. Anyway, the resource might […]