In an attempt to ensure that all populations that may benefit from research findings are included in clinical research, the NIH will soon require more discussions about including all age groups in NIH proposals. Specifically, says NIH’s Dr. Michael Lauer on his blog, “For application due dates on or after January 25, 2019 (yes, one year from now), if 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.” NIH policy will require participants of all ages to be included, unless there ethical or scientific reasons to exclude certain groups.
Please click on the above link to read Dr. Lauer’s full blog post and to access more links about the new policy, which takes affect in one year. Note that ongoing NIH-funded studies are exempt from the policy, but the new policy will apply for competitive renewal applications on or after Jan. 25, 2019.