Updates on NIH clinical trial policy


Larry Tabak says that NIH has developed a plan to “address the shared interests of involved stakeholders” and that NIH was “prepared to move forward so that [they] can widely communicate the delayed enforcement and lenient implementation described in the plan.”

NIH’s plan to address the concerns about the reach of the clinical trials policies looks very promising, but of course, the devil is in the details, and many of those details are not yet known. Here’s what we know:

(1)  NIH will delay enforcement of a registration and reporting system for basic science involving humans until July 1, 2019.

(2)  NIH will allow scientists to register and report their basic science research involving humans through other portals such as Open Science. Eventually, NIH will pull data elements from these portals in order to track what they fund and comply with their own reporting requirements to Congress.

(3)  A Request for Information (RFI) will be released soon so that NIH can get feedback on what reporting standards are appropriate for the range of basic science research involving humans. FABBS will respond, and we welcome input from our member societies and affiliates. Once the RFI is released, we will share it with you and seek your input.

(4)  NIH will be “flexible” and “lenient” with regard to enforcement of other clinical trial policies for basic science. Although NIH’s plan is not specific, presumably this applies to the requirements that basic scientists whose research was defined as a clinical trial respond only to clinical trial FOAs and take good clinical practice training. NIH had previously told us that Review would not change for basic scientists responding to a clinical trial FOA. We would welcome feedback from our community about the last two review cycles, although NIH’s new plan may also alleviate the concerns.

(5)  NIH will issue a Basic Science Parent FOA by October 30, 2018. We will interact with NIH over the coming months regarding this since it will be important to our sciences as the policies evolve.

What is still uncertain is how NIH will define basic science vs. a clinical trial. The plan itself references “basic science trials,” “public health trials,” and “prospective interventional human trials.” We will continue to interact with NIH to ensure that the definition of a clinical trial does not continue to capture basic science research involving humans.

For now, we consider NIH’s plan and engagement with us to be a very promising step. In addition, NIH’s plan (to be described in a NIH Guide Notice, which we will circulate to you) to be flexible and lenient in its implementation of the clinical trial policies as they relate to basic science studies should provide some reassurance to the basic science communities that FABBS represents.