We’ve found some more reports about the new NIH rules pertaining to clinical trials that we thought we’d share with the UAMS research community. One of the biggest changes is the expansion of NIH’s definition of “clinical trial,” which will apply to some UAMS and ACH researchers who are now conducting NIH-funded “clinical trials,” which they weren’t before this revised rule took effect. Our totally unscientific review of the literature out there shows that this is particularly true of investigators doing basic research into how the brain works, as that’s an example that keeps popping up in these articles.
Please see the following sources for more information, including discussion of some the concerns researchers have raised to date. Note that some of these articles contain links to other resources, including some that illustrate the new definition of “clinical trial.” Tracy Gatlin in the UAMS Office of Research Regulatory Affairs can assist researchers with how to apply these new NIH requirements. She can be reaced at tlgatlin@uams.edu or 501-686-6803.
The American Society of Human Genetics had a blog item about the changes. This item includes links to other helpful resources.
Science Magazine, not surprisingly, has published several items about the change. A July 19, 2017, article highlights the concerns basic behavioral and brain researchers have about the new definition. By the time a Jan. 23, 2018, article was published, some of those fears had been allayed somewhat, Science reported.
The Wall Street Journal also weighed in Feb. 4, 2018, including some discussion about new reporting requirements for study findings, and also how institutions are adapting to the new requirements. (This article may be behind a paywall; please contact the IRB Blog Sharing of Primary Sources Office at paalediths@uams.edu to get a PDF copy if you can’t use the link.)