Another Human Subjects Proposal Change: Inclusion across the Lifespan
On the heels of the recent sea change in how PIs describe clinical trials in their grant applications, NIH is making another change to the grant proposal format for research involving human subjects. For applications going in on or after January 25, 2019, NIH’s Deputy Director for Extramural Research Dr. Mike Lauer writes:
“[I]f you propose a study involving human subjects, you must have a plan describing how participants across the lifespan will be included and justify the proposed age range of participants. Reviewers will consider whether the proposed age range is appropriate in the context of the specific scientific aims. Should the study be funded, keep in mind that your progress reports will include de-identified individual-level participant data on sex/gender, race, ethnicity, and age at enrollment (in units ranging from hours to years).”
NIH has added this requirement to remediate underrepresentation of older adults in clinical trials, and to head off poorly justified age-based exclusions. (See his blog entry on the subject for citations for these concerns.) Valid age-based exclusions are, of course, still allowed. As the notice itself states, no one’s going to be studying Alzheimer’s disease in children. Other potential reasons for age-based exclusions include studying a drug already approved in one age population in a different age group, analyzing data from participants in studies that enrolled them prior to this requirement, and research that poses an unacceptable risk to members of the excluded group (e.g., Phase I trials for treatments including risk of death cannot include children).
Even if you just received funding or are submitting in 2018, remember that competing renewals will be required to adhere to this guidance in the future, so consider how your study might need to change based on this new policy.Home Page Image