The NIH definition of clinical trials: An update for the holiday season

As many of you know, the NIH has broadened its definition of “clinical trials” in a manner that looks like it will include a lot of basic human behavioral and brain sciences that would not normally be included in the conventional definition of a clinical trial. I have outlined this issue in two previous posts here and here.

Folks who are interested in the on-going controversy over the NIH Clinical Trial definition and related policies may want to look at the new piece that Nancy Kanwisher and I have just published in Nature Human Behavior. Bill Riley, Melissa Riddle, and Mike Lauer from NIH have a companion piece giving the NIH perspective.

As you will see, our piece includes a list of issues that that have been raised by the human behavioral and brain science community. The good news is that this list of problems is not the end of the story. Nancy and I shared our piece with NIH and they shared theirs with us. Our hope is that a jointly-authored document will appear in the not-to-distant future that will resolve most if not all of our concerns. This is where you come in. If you have specific concerns that are not on our ‘punchlist’ or comments about items that are on the list, please send them to me and we will do what we can (jwolfe@bwh.harvard.edu).

Meantime, some version of this policy is going into place for the next round of applications and that will require some change in your grant writing behavior. Grant proposals are written in response to specific “funding opportunity announcements” (FOAs). As a result of the new policies, FOAs have been multiplying, with the most recent examples available here.

The standard NIH grant proposals (e.g., R01, R21, R03) used to have one omnibus FOA that you could use. That is no longer true. You have to look to see if the FOA matches the grant you are writing. Some are “Clinical Trial Required”, some are “Clinical Trial Not Allowed”, and some are “Clinical Trial Optional”. Other variations seem to be possible and you have to get this right or there is a real danger that your proposal will get bounced back to you.

This means that, even if you have never read the FOA before, you are going to need to read one (or more) this time and decide which FOA fits your needs. That will depend on whether your experiments are now considered to be clinical trials. You can try to figure that out from the case studies offered up by NIH.

When you look at those, if you have ideas, questions, suggestions for alternate cases, and so on,  send those to me (jwolfe@bwh.harvard.edu). We are trying to help NIH refine these cases as a way of clarifying the clinical trial definition.

As you try to find the right FOA for your grant, if things are just not clear, talk to the relevant NIH Program Officer (often that will be the person listed in the FOA). That will increase your chances of getting this right and getting this right will be important. Going forward, we hope to be able to bring you news that simplifies your life, so watch this space for further developments.

You may also like

Leave a Reply

Your email address will not be published. Required fields are marked *