Key Dates

Related Announcements

NOT-OD-18-179 - Transition from Inclusion Management System to New Human Subjects System (HSS) as of June 9, 2018

NOT-OD-18-116 - Revision: NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects

NOT-OD-20-026 - New NIH "FORMS-F" Grant Application Forms and Instructions Coming for Due Dates on or after May 25, 2020

Issued by

Office of The Director, National Institutes of Health (OD)

Purpose

NIH applicants and recipients submitting post-submission updates using the electronic Research Administration (eRA) Human Subjects System (HSS) are reminded of recent updates to the FORMS-F PHS Human Subjects and Clinical Trials Form and requirements for participant-level data on sex/gender, race, ethnicity, and age at enrollment for projects subject to the NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects. Users with records currently in progress as of June 13, 2020 must submit any updates prior to this date or modify the records to meet new FORMS-F requirements after June 13. Note: HSS is used for submission of human subjects-related information after peer review (e.g.Just-in-Time, Research Progress Performance Reports (RPPRs)). HSS is not used for post-submission materials prior to initial peer review as referenced in the NIH Policy on Post-Submission Materials. The PHS Human Subjects and Clinical Trials Information Form is not applicable to NIH training (T) grants.

Key FORMS-F Changes to the PHS Human Subjects and Clinical Trials Information Form

As of June 13, all applicants and recipients submitting post-submission updates in the Human Subjects System (HSS) will use the FORMS-F PHS Human Subjects and Clinical Trials Information Form for the submission. All records with a status of “Work in Progress” or “Ready for Submission” will include the FORMS-F fields and must meet the corresponding requirements as of this date. All records with a status of “Ready for Submission” will be changed to “Work in Progress” on June 13. Significant changes include:

1. A new Inclusion Enrollment Report title field is now available. Users creating a new Inclusion Enrollment Report or with a Work In Progress record as of June 13, 2020 will be prompted to enter an Inclusion Enrollment Report title. The human subjects study title will appear by default for records submitted prior to June 13, 2020 and may be changed by the user.
2. For clinical trials, the “Brief Summary” field will no longer appear in Section 4. Brief Summary information submitted in applications and progress reports prior to June 13, 2020 will continue to be available in the PDF images of those documents.
3. Question 1.4.a. “Does the study involve human subjects/participants” now has a default value of yes and cannot be changed if a user selects "yes" to the human subjects involvement question on the R&R Other Project Information Form. As a study record should be completed only for research involving human participants, the “No,” option is no longer available for this question on the PHS Human Subjects and Clinical Trials Information Form
4. For a full list of significant FORMS-F changes, see https://grants.nih.gov/grants/electronicreceipt/files/high-level-form-change-summary-FORMS-F.pdf.

Key Inclusion Across the Lifespan Changes

The NIH Policy and Guidelines on the Inclusion of Individuals Across the Lifespan as Participants in Research Involving Human Subjects, announced December 19, 2017 in NOT-OD-18-116, requires individual-level participant data on sex/gender, race, ethnicity, and age at enrollment in progress reports for research supported by NIH projects with an awarded competing grant application submitted on or after January 25, 2019, intramural research initiated on/after this date, and research conducted in response to contract solicitations posted on/after this date.

1. Recipients reporting actual enrollment progress for a grant application submitted for due dates January 25, 2019 or later must provide participant-level data on sex/gender, race, ethnicity, and age at enrollment in the Inclusion Enrollment Report of the PHS Human Subjects and Clinical Trials Information Form using HSS.
2. Users must use the spreadsheet template available in HSS to submit participant-level data. The column titles must not be altered, and data should be provided using the values modeled in the template. Changes to the template may result in a submission error.
3. Participant-level data must be uploaded in a comma separated values (.csv) file. Users should be sure to save the template in .csv format.
4. Users do not need to separately enter the individual numerical fields in the Actual (Cumulative) Inclusion Enrollment Report table once the .csv file is successfully uploaded. The data provided will populate the actual (cumulative) enrollment table within the system.

Resources

• Entering Inclusion Data Using the Participant Level Data Template video and transcript
• Participant-level Data Template
• The eRA Human Subjects System (HSS) information page
• Information about the PHS Human Subjects and Clinical Trials Information form

Inquiries

Please direct all inquiries to:

For questions about this notice, contact:

Office of Policy for Extramural Research Administration
Telephone: 301-435-0949
Email:grantspolicy@mail.nih.gov

For requests for technical assistance using HSS, contact the eRAService Desk.