When you next input research data for progress reports into the Human Subjects System (HSS), don’t forget to include the ages of participants during the enrollment phase. Consistent with NIH’s Inclusion Across the Lifespan policy, recipients must upload participant-level data on sex and gender, race, ethnicity, and age at enrollment in HSS using the template provided. Recently, we’ve noticed more recipients overlooking this crucial step.
Policy Background
Participants at NIH’s June 2017 Inclusion Across the Lifespan Workshop identified a lack of easily accessible, detailed information on the number of children (i.e., individuals under the age of 18) and older adults as a barrier to understanding study outcomes across age groups. Participants also identified a lack of flexibility in age groupings, as meaningful units of measurements may vary depending on the population under study.
As a result, the NIH inclusion policy ensures that children must be included in all NIH-conducted human subjects research unless there are scientific or ethical reasons for exclusion. This Inclusion of Individuals Across the Lifespan Policy expands the Inclusion of Children in Clinical Research Policy to include individuals of all ages, including children and older adults. The policy also requires collection of the age of enrollment of each participant for inclusion in progress reports.
Applications & Proposals Procedures
If your applications and proposals involve human subjects research, you must address plans for including individuals across the lifespan in the PHS Human Subjects and Clinical Trial Information Form. Note that age-based exclusions must include a scientific or ethically based justification.
With the data on the age of participants, NIH can provide detailed information on the age of participants in NIH-supported clinical research studies, which helps to identify opportunities across the research portfolio related to age-based inclusion.
For more guidance on what to address in your application, refer to PHS Human Subjects and Clinical Trial Information.
Progress Report Procedures
In progress reports, NIH recipients must submit individual-level data on participant age at enrollment. Units for reporting age at enrollment range from minutes to years. In addition to the age at enrollment, you must also provide information on sex or gender, race, and ethnicity in the Inclusion Enrollment Report.
Should you need to make updates to an already submitted Inclusion Enrollment Report, HSS allows you to switch a report to Work in Progress status, then edit and resubmit. You will create a new report only if you are adding a new study population separate from the currently enrolled population.
Resources
For more information that can help you navigate the inclusion policy while you input data, read the November 13, 2018 NIH Extramural Nexus blog article “Understanding Age in the NIH Portfolio: Implementation of the NIH Inclusion Across the Lifespan Policy” by Dr. Michael Lauer, NIH’s Deputy Director for Extramural Research, and Dawn Corbett, NIH’s Inclusion Policy Officer.
Additionally, NIH’s Inclusion Across the Lifespan provides one pagers on related resources; a 2-part interview with Dawn Corbett on NIH’s All About Grants podcast miniseries: Inclusion Plans (Part 1): The Application and Inclusion Plans (Part 2): Peer Review and Post-Award; and eRA Common’s video tutorials for the Human Subjects System, which cover topics like accessing HHS, entering data, and exporting reports.
If you run into any dilemmas, check NIH’s Inclusion Across the Lifespan FAQs for a solution. For example, the FAQs explain how to navigate a study that will include both an existing dataset and recruitment of new participants.
Contact Information
If you have further questions regarding the NIH inclusion policy, reach out to the HHS Office for Human Research Protections. For practical help navigating HSS, rely instead upon eRA Online Help and the eRA Service Desk. NIAID’s local expert on inclusion policy is Diane Adger-Johnson in our Office of Research Training and Special Programs; you can reach her at dadger@niaid.nih.gov or 240-669-2924.
For questions specific to a particular grant award, contact the grants management specialist assigned to the award (as displayed in the eRA Commons).