Addressing Inclusion in Applications

Applicants should include a rationale for the age range of study participants and justification for age-based exclusion in the Inclusion of Women, Minorities, and Children section of the PHS Human Subjects and Clinical Trials Information Form (Section 2.4). This section will continue to have the heading “Inclusion of Women, Minorities, and Children” until the next forms update. See the instructions under Inclusion of Children in the application guide for additional information.

Have more questions on the Inclusion Across the Lifespan policy? Check out this FAQ page.

Julie Johnson, PharmD, is the Director and Principal Investigator at The Ohio State University Center for Clinical and Translational Science.