The US National Institutes of Health (NIH) is still at it: If you’ve been following along, you know that NIH has been attempting to classify basic behavioral science research as clinical trials. Just on principle, this reclassification is offensive. But there are practical implications as well. Among other things, psychological scientists funded by NIH will have to satisfy many additional rules and regulations that may make sense for true clinical trials — but not for basic research. And NIH has tried to justify this move by connecting it to efforts to increase registering and reporting of research studies. Simply put, this makes no sense.
APS and many other scientific and academic organizations and thousands of individual scientists were unanimous in telling NIH that they opposed the definition. But NIH was unreceptive to the community’s concerns and continued to move ahead with implementing the objectionable redefinition amid widespread confusion within and outside NIH about its purpose.
At a loss, APS and other groups turned to Congress to express our disappointment with NIH’s policy changes; Congress, recognizing our concerns were valid, instructed NIH to delay its policies and consult with the scientific community.
And that’s where we are now. At the direction of Congress, NIH has issued a Request for Information (RFI) asking the community to weigh in on a number of questions related to basic behavioral science. The title would lead you to believe that that the focus of the RFI is on registration and reporting, but you’ll see that NIH has used the RFI to double down and is treating the redefinition of basic research as clinical trials as a done deal.
NIH needs to hear from individual scientists like you that basic human subjects research should not be classified as clinical trials.
APS has weighed in, and you can read our response to NIH’s RFI below. Feel free to use it as a model for your own RFI response; the bottom line is that it is critically important to let NIH know you do not accept a redefinition of basic research with human subjects as clinical trials.
To respond individually to NIH’s RFI, you should:
- Read APS’s response to NIH’s RFI, shown on the next page
- Access NIH’s RFI — don’t be distracted by the title, which only captures part of the broader issues raised by the RFI
- Enter your comments into whichever individual comment boxes that you feel you are able to address
- Submit the RFI form prior to November 12, 2018, 11:59 PM EDT
- Encourage your colleagues to weigh in as well
- Feel free to share your response with APS by emailing it to firstname.lastname@example.org with the subject line “NIH RFI.”
After submitting your response to NIH’s RFI, treat yourself to “The Basic Research Blues,” a song on this issue written and performed by Sarah Brookhart, APS Executive Director. You may even want to do your own version of the song — be sure to share it with APS if you do!
Below follows APS’s response to the NIH RFI on clinical trails.