June 29, 2018
In response to Congressional report language (see pages 34-35), and in follow up to a recent meeting among NIH and a group of stakeholders, NIH has developed a plan to “address the shared interests of involved stakeholders” and is preparing to “move forward so that [they] can widely communicate the delayed enforcement and lenient implementation described in the plan.” Within the next two weeks, NIH will issue guide notices and a Request for Information (RFI). FABBS will share information as it becomes available and plans to respond to the RFI, working collaboratively with other stakeholders.
NIH’s plan involves five parts that address primary concerns in our basic science communities including: delaying implementation of the clinical trials policies as they relate to basic science; excluding basic science from the clinical trials policies; and development/utilization of a separate registration and reporting framework that is tailored to basic science.
The plan looks promising, but of course, “the devil is in the details” and many of those details are not yet known. NIH welcomed input as they released the plan to stakeholders. Initial questions about the plan that were shared with NIH include:
- Will NIH be using its current definition of “basic research” (Systematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind.) to define basic science?
- Does the NIH definition of basic science explicitly exclude it from being considered a clinical trial? Will NIH return to the 2014 clinical trial case studies for determining which research is a clinical trial?
- Since NIH’s goals (as described in the final minutes of the May 2nd meeting) will be accomplished through registration and reporting frameworks tailored to basic science (e.g., Open Science), will NIH allow investigators to determine whether their research would be more appropriately reported through a basic science portal or clinicaltrials.gov, which FOAs are appropriate for submitting applications, and whether good clinical practice training is appropriate for the research proposed, perhaps in consultation with their program officers?
- As it is important to meet the goal of transparency for the registration and reporting of basic research, will NIH be providing examples of existing portals, such as the Open Science Framework, while expressing that any portal that accomplishes registering and reporting will be acceptable?
- How will the application process be affected? Will basic science applications using a human subject be exempt from related policies for clinical trials including the Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials, New Review Criteria for Research Project Applications Involving Clinical Trials, and the NIH Policy on Funding Opportunity Announcements [FOA] for Clinical Trials? Will basic science no longer be required to respond only to clinical trial specific FOAs, including prior to publication of the basic science FOA? And, how will a “basic science parent FOA” impact the application process?
- In 2nd section of Details, it states that “NIH will delay enforcement through July 1, 2019”. Is the purpose of the delay to give time to develop a new portal for basic research and to develop appropriate reporting standards for basic research? What happens after July 1, 2019? Also what is meant by “lenient implementation”? In the 3rd section of Details, does NIH exclude basic science research from “interventional human trials”? What is the NIH definition of “interventional human trials”?
- After the RFI process, will NIH continue to collaborate with stakeholders and consult with Congress before implementing a final policy, given the interest among Congressional appropriators and the priority this issue has for the basic science community?
At FABBS, we are hopeful that we are on the right path to resolving the issue for our basic science communities. We are appreciative to NIH for taking these steps to address the concerns, and we will continue to work with them until it’s complete. Stay tuned for more details as they become available.
