NOT-OD-26-067
NIH has released implementation guidance confirming that Basic Experimental Studies with Humans (BESH) will no longer be classified as clinical trials, effective for applications with due dates on or after May 25, 2026.
Key Changes:
- BESH studies are no longer subject to clinical trial requirements, including ClinicalTrials.gov registration and results reporting.
- Applications proposing only BESH should now be submitted to “Clinical Trial Not Allowed” or “Clinical Trial Optional” NOFOs.
- “BESH Required” NOFOs will be phased out for due dates on or after May 25, 2026.
- For application forms, BESH studies will typically follow a Yes/Yes/Yes/No response pattern in the clinical trial questionnaire (indicating no health-related outcome).
- Applicants should not complete clinical trial-specific fields (e.g., protocol synopsis) unless explicitly required.
Important Notes:
- Applications submitted before May 25, 2026, will continue to follow current clinical trial requirements.
- Human subject protections and other NIH policies (e.g., DMS Plan) still apply to all BESH studies.
- Ongoing awards should continue under their existing terms and conditions.
These changes are intended to better align application requirements with the nature of basic research involving human participants.
Notable changes between applications and proposals proposing BESH submitted on or before May 24, 2026, and on or after May 25, 2026:
| Due Dates on or Before May 24, 2026 | Due Dates on or After May 25, 2026 | |
| Appropriate NOFO Types for BESH-Only Applications | Submit to NOFO designated as BESH, Clinical Trial Required, or Clinical Trial Optional | Submit to NOFO designated as Clinical Trial Not Allowed or Clinical Trial Optional |
| Typical Responses to PHS Human Subjects and Clinical Trials Information Form Clinical Trial Questionnaire (1.4) | Yes/Yes/Yes/Yes | Yes/Yes/Yes/No |
| Other PHS Human Subjects and Clinical Trials Information Form Responses | Complete clinical trial-specific fields/attachments as instructed in the NOFO (e.g., protocol synopsis, dissemination plan) or contract solicitation. | Do not complete clinical trial-specific fields/attachments for BESH study records, unless otherwise required by the NOFO or contract solicitation. |
| Clinicaltrials.gov Registration and Reporting | Flexibilities apply as specified in NOT-OD-25-134 | Not required |
| Other Clinical-Trial Specific Requirements (e.g. GCP training, Data and Safety Monitoring) | Required as specified in the terms and conditions of the grant or contract award. | Not required unless otherwise specified in the NOFO or contract solicitation and/or terms and conditions of the grant or contract award. Consult the ICO Data and Safety Monitoring webpage to verify Data and Safety Monitoring requirements. BESH must continue to follow all other applicable laws, regulations, and policies (e.g., Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), 45 CFR 46, and the NIH Data Management and Sharing Policy) |
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