Key Dates

Related Announcements

• May 11, 2018 - Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018. See Notice NOT-OD-18-179. 
• December 19, 2017 - Revision: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects. See Notice NOT-OD-18-116.
• November 28, 2017 - Amendment: NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research. See Notice NOT-OD-18-014.

Issued by

NATIONAL INSTITUTES OF HEALTH (NIH)

Purpose

Announce implementation of new eRA system capabilities to allow for NIH R&D contract vendors to submit and update data associated with NIH policies on participant inclusion in clinical research directly into the Human Subjects System (HSS) if requested by NIH staff. 

The new capabilities are available now for all new and existing contracts.

Background

The NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research requires women and members of racial and ethnic minority groups be included in all NIH funded clinical research unless there is a compelling rationale for their exclusion.

The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects requires that individuals of all ages, including children and older adults, must be included in all human subjects research, conducted, or supported by the NIH, unless there are scientific or ethical reasons not to include them.

The policy also requires NIH recipients submit participant-level data on sex or gender, race, ethnicity, and age at enrollment. The existing process for contract vendors to submit participant inclusion data to NIH is email based. NIH sends a request for inclusion data to vendors and the vendors send the data in a PDF form via email, which is then manually entered into HSS by NIH staff.

NIH is now providing the ability for contract vendors to submit inclusion data directly into HSS, accessible via the eRA Commons, if requested by an NIH staff member.

Direct submission of inclusion data will streamline the process; ensure secure data transfer in HSS; and harmonize with the process currently utilized under grants.

Implementation

NIH has provided the ability for R&D contract vendors to submit inclusion data through HSS for all new and existing contracts. Affected contract vendors will be notified of any changes to contract requirements by their NIH Contracting Officer.

In order to access HSS, the vendor organization must be registered in eRA Commons (the vendor’s signing official (SO) creates their account at that time). The SO can create Commons accounts for any principal investigators associated with the vendor organization who will be entering information in HSS.

Note that HSS also interacts with ClinicalTrials.gov. Data entered into HSS can also be exported to ClinicalTrials.gov and HSS allows import of some Clinicaltrials.gov fields directly into HSS.

Resources

• Quick Start Guide for Contract Vendors: Updating Inclusion Data for Awarded R&D Contracts
• Updating Inclusion Data for Awarded R&D Contracts (video tutorial)
• Human Subjects System and Reporting (webpage)
• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects (webpage)
• Registration in eRA Commons (webpage)
• eRA Commons login
   

Inquiries

Please direct all inquiries to:

eRA Service Desk: https://www.era.nih.gov/need-help