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 […]

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 First there was the draft guidance about children in research; today (Sept. 28, 2022) the FDA has released a proposed rule about single institutional review board review of multisite research.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 […]

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 […]

The Food and Drug Administration has released a draft guidance about children in FDA-regulated research. This draft guidance is intended to describe the FDA’s current thinking about including children in research that involves medical drugs, devices, or biologics. Note that this is a draft guidance only; it may change when (and if) it is finalized. […]

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 […]

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: […]

The Food and Drug Administration has published a draft guidance on charging for investigational drugs under an investigational new drug application (IND). The draft guidance is being made available for comment purposes only; comments on it are due Oct. 24, 2022. If/when finalized (the FDA works in mysterious ways, remember), this draft guidance would replace […]

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 update, most of the changes are pretty minor, and some are limited to formatting/typo correction. However, a few are more substantive. This table […]

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. […]