PHS Human Subjects and Clinical Trials Information Form: What It Requires and When It’s Triggered

The PHS Human Subjects and Clinical Trials Information form (often called “HSCTI” or, in older guidance, the “human subjects and clinical trial information form”) is a required attachment in NIH grant application packages whenever a proposed project involves human subjects research. It consolidates information that NIH previously collected across several separate forms — human subjects, inclusion enrollment, and clinical-trial-specific data — into a single, dynamically-branching form built around one or more “Study Records.” It is distinct from the general question of whether a project meets NIH’s definition of a clinical trial: every applicant proposing human subjects research must complete part of this form, but only applications that also meet NIH’s clinical-trial definition must complete its additional clinical-trial-specific sections.

What the form is for

NIH’s Human Subjects and Clinical Trials Information form exists to capture, at the level of an individual study rather than the application as a whole, the information a reviewer or program officer needs to evaluate the ethical, scientific, and administrative aspects of proposed human subjects research: who the study population is, how participants will be protected and monitored, what the statistical design is (for studies that require one), and — for studies that meet NIH’s clinical-trial definition — the clinical-trial-specific elements that align with what NIH ultimately registers on ClinicalTrials.gov. NIH guidance is explicit that applicants should not duplicate this information in the Research Strategy attachment; the form is the authoritative location for study-level human subjects and clinical trial detail, and the Research Strategy should refer back to it rather than restate it.

When it’s required

Every applicant answers a “Are human subjects involved?” question, and everyone completes the form’s baseline “Use of Human Specimens and/or Data” section regardless of the answer. From there the form branches:

• If no human subjects are involved, the applicant completes a short set of sections confirming that (and, where relevant, whether the project involves only non-identifiable specimens or data).
• If human subjects are involved, the applicant must create one or more Study Records — NIH’s form supports up to 150 per application — each covering that study’s population, recruitment and retention plans, protections for vulnerable populations where applicable, and data and safety monitoring arrangements.
• If, in addition, a given study meets NIH’s clinical-trial definition (assessed against NIH’s four-question test: human participants, prospective assignment to an intervention, a design intended to evaluate that intervention’s effect, and a health-related biomedical or behavioral outcome as the effect being evaluated — see What Is a Clinical Trial? The NIH Definition Explained for the full test), that Study Record must additionally include the clinical-trial-specific sections: study design, a protocol synopsis, the study timeline, and a data and safety monitoring plan sized to the trial’s risk level.

A single application can contain a mix of Study Records — some meeting the clinical-trial definition and requiring the fuller sections, others human-subjects research that does not. The form is dynamic and hides sections that don’t apply to a given Study Record’s answers, rather than presenting every applicant with the same fixed set of fields.

Human-subjects sections vs. clinical-trial-specific sections

It helps to keep two layers separate when completing the form:

• Human-subjects-research layer (applies to any study involving human participants, trial or not): study population characteristics, inclusion of women/minorities and children (the Inclusion Enrollment Report), recruitment and retention plan, protection of human subjects from research risks, and data and safety monitoring appropriate to the study’s risk.
• Clinical-trial layer (applies only to Study Records that meet NIH’s clinical-trial definition, stacked on top of the human-subjects layer): study design (arms, intervention, comparator, outcome measures), a protocol synopsis, a study timeline, and a dissemination plan tied to NIH’s results-reporting expectations.

This two-layer structure is why the same underlying question — “does this project need the fuller clinical-trial sections?” — also governs several other administrative requirements that key off NIH’s clinical-trial definition: which funding opportunity announcement type an applicant can apply under, whether NIH’s Good Clinical Practice training policy applies to the study team, whether NIH’s single-IRB (sIRB) policy applies for qualifying multi-site studies, and whether the trial must be registered on ClinicalTrials.gov. The HSCTI form’s clinical-trial sections and these other requirements are all downstream of the same four-question determination, not independent tests.

A note on Basic Experimental Studies with Humans (BESH)

One category has recently changed. NIH previously treated a “Basic Experimental Study Involving Humans” (BESH) — a study meeting both NIH’s basic-research definition and all four clinical-trial questions — as a clinical-trial subtype, subject to the same clinical-trial-specific form sections and downstream requirements. Per NIH notices NOT-OD-26-032 (issued 29 January 2026) and the implementation detail in NOT-OD-26-067 (6 April 2026), BESH will no longer be classified as an NIH-defined clinical trial, effective for applications with due dates on or after 25 May 2026. Human subjects protections and other generally-applicable NIH policies still apply to BESH studies — this change removes clinical-trial-specific administrative requirements (including the HSCTI form’s clinical-trial-specific sections) for that category, not human-subjects oversight itself. Applicants preparing a BESH-type study should confirm which side of the 25 May 2026 cutover their application’s due date falls on before deciding which HSCTI sections to complete.

Form version: FORMS-E, FORMS-H, FORMS-I

The consolidated Human Subjects and Clinical Trials Information form was introduced as part of NIH’s FORMS-E application package, published from 25 October 2017 for funding opportunity announcements with due dates on or after 25 January 2018 — the same effective date as NIH’s single-IRB policy, part of the same 2014–2018 wave of NIH clinical-trial reforms. NIH revises its numbered forms packages periodically; the form has since carried forward, with field-level updates, through FORMS-H (used for due dates from 25 January 2022) and the current FORMS-I package (used for due dates on or after 25 January 2025). Applicants should always confirm which forms package a given funding opportunity announcement requires rather than assuming the most recent one applies, since NIH typically allows a transition window during which either the outgoing or incoming package may be valid depending on the specific due date.

Practical tips

• Don’t duplicate the Research Strategy. Study-level human subjects and clinical trial detail belongs in the HSCTI form, not restated at length in the Research Strategy attachment.
• Plan Study Records around actual studies, not aims. A Study Record corresponds to a distinct study within the application, which does not always map one-to-one with a specific aim; complex multi-study applications should think through their Study Record structure early, well before the submission deadline.
• Respect the file-format requirements. Study Record attachments are fillable PDFs generated by the system (ASSIST, or a system-to-system submission tool); NIH guidance instructs applicants not to alter their format.
• Coordinate with your IRB and biostatistics team early, since the protection-of-human-subjects and statistical-design content the form asks for is substantive, not boilerplate, and both typically need lead time to produce for a clinical-trial-classified study.
• Check inclusion of the “Other Requested Information” attachment only if your specific funding opportunity announcement requires it — NIH guidance is explicit that this optional attachment should not be used unless the solicitation calls for it.

Frequently asked questions

Does every NIH grant application need the HSCTI form?

Every applicant completes the form’s baseline section, but the fuller human-subjects sections only apply if the project involves human subjects, and the clinical-trial-specific sections only apply to Study Records that separately meet NIH’s four-question clinical-trial definition. A project with no human subjects involvement completes a much shorter version of the form.

What is a “Study Record” in the HSCTI form?

A Study Record is the form’s unit of data collection for an individual study within an application — NIH’s form accommodates up to 150 per application. Each Study Record captures that study’s human-subjects information and, if applicable, its clinical-trial-specific information; an application proposing several distinct studies (for example, a parent trial plus an ancillary mechanistic sub-study) will typically need more than one Study Record.

How does the HSCTI form relate to ClinicalTrials.gov?

NIH designed the clinical-trial-specific sections of the form to align with the data elements ClinicalTrials.gov collects, and the form supports data exchange with ClinicalTrials.gov where applicable, reducing duplicate data entry for a study that will eventually need to be registered there. See Clinical Trial Registration and Reporting Compliance for the registration and results-reporting obligations that follow once an award is made.

What’s the difference between FORMS-H and FORMS-I?

Both are numbered NIH application forms packages that include the Human Subjects and Clinical Trials Information form; FORMS-I is the current package, required for funding opportunity announcements with due dates on or after 25 January 2025, superseding FORMS-H (used for due dates from 25 January 2022 through 24 January 2025). The underlying HSCTI form structure has carried forward across these packages with field-level revisions rather than a wholesale redesign.

Related CASRAI resources

• What Is a Clinical Trial? The NIH Definition Explained — the four-question test that determines whether a Study Record needs the clinical-trial-specific HSCTI sections.
• Clinical Trial Registration and Reporting Compliance — what happens after award, including ClinicalTrials.gov registration and results reporting.
• Central IRB / Single IRB (sIRB) — the related NIH policy that shares the HSCTI form’s 2018 effective-date wave of clinical-trial reforms.
• Exempt Human Subjects Research — for studies that may not require the fuller human-subjects sections at all.
• Clinical Study — background on how NIH and others distinguish this broader term from “clinical trial.”
• FDA Form 1571: IND Application Cover Sheet — a comparable required-form deep dive for FDA-regulated drug trials, for applications that also require an IND.

Primary source: NIH’s Human Subjects and Clinical Trials Information form guidance and the FORMS-I application guide are published at grants.nih.gov; that guidance page returned an access error on direct automated retrieval during research for this article, so form-structure and effective-date details above were cross-verified against NIH’s Annotated Form Set for FORMS-H/FORMS-I, institutional research-office summaries (Columbia, MUSC, University of Delaware, GWU, Michigan State), and NIH’s own notices (NOT-OD-26-032, NOT-OD-26-067). Readers preparing an actual submission should confirm current field-level requirements directly against the funding opportunity announcement and grants.nih.gov before finalizing a Study Record.