The National Institute of Health (NIH) Dec. 19 issued a Revision to its NIH Policy and Guidelines on the Inclusion of Children. While the NIH has had a long standing policy that children must be included in all research involving human subjects, there has been concern that they have been omitted from clinical trials too often, leading to a lack of data on treatment for children.
As stated in the announcement, this revision includes three changes:
- The applicability of the policy to individuals of all ages, including children and older adults
- Clarification of potentially acceptable reasons for excluding participants based on age
- A requirement to provide data on participant age at enrollment in progress reports.
In response to a mandate from Section 2038 of the 21st Century Cures Act, passed Dec. 2016, requiring that age must be an inclusion variable in clinical trials, exceptions must be properly justified, and age data must be provided, the NIH proceeded to clarify and implement its lifespan inclusion policies. As required by the Act, a workshop on Inclusion Across the Lifespan was held June 1-2, 2017, during which the opportunities and obstacles to include children and older adults in clinical research was discussed. NIH also issued a Request for Information to solicit comments on their upcoming revision on age inclusion. The NIH’s Notice of Intent to Revise was first announced on Dec. 1.
This policy will be in effect for all competing grants due on or after Jan. 25, 2019.