Human Subjects Research Policies

These NIH policies, regulations, training and resources can help when proposing or conducting NIH extramural research involving human subjects.

Research involving human subjects: Useful information about proposing and conducting NIH extramural research involving human subjects, including policies, regulations, training, and resources.
Decision Tool: Am I Doing Human Subjects Research?: A quick decision tool to assist you with determining if your research involves human subjects.
Annotated NIH grant application forms, including the "PHS Human Subjects and Clinical Trials Information" form.
Inclusion across the lifespan in NIH applications and proposals involving human subjects research: Overview of the NIH Inclusion Across the Lifespan Policy.

Clinical Trials

Studies involving human subjects may meet the NIH definition of a clinical trial.

Clinical trial requirements for NIH grants and contracts: Includes the NIH definition of a clinical trial, clinical trial-specific review criteria, and other resources.
Clinical trial case studies designed to help you identify whether your study would be considered by NIH to be a clinical trial.
Comparison chart of funding opportunity announcement types [PDF]: Use this table to help determine which funding opportunity announcement (FOA) to use if you are including a clinical trial.
Information about ClinicalTrials.gov for researchers provides an overview of how and why you should register your trial.

Training

Training in human research protections from the U.S. Department of Health and Human Services (HHS)
Training opportunities and resources for NIH clinical trial policies
Good Clinical Practice training policy

NIH Human Subjects System (HSS)

NIH grantees are required to submit information on research and trainee research projects that include human subjects to the NIH Human Subjects System.

Overview of Human Subjects System (HSS)

The following supplemental guidance on submitting information to the NIH Human Subjects System is specific to Fogarty grantees:

Supplemental guidance: R25 - Education Projects

For Fogarty-supported R25 "Education Projects" that support trainees conducting mentored human subject studies:

Enter each trainee human subjects research project study record separately.
Enter whether the study is exempt. Determine if the study is exempt using the Exempt Human Subjects Research Infographic.
Respond to the clinical trial questions.
Respond “No” to the Phase III clinical trial question.
Respond “No” to the Food and Drug Administration Amendments Act FDAAA question.
Add or upload an inclusion enrollment report for each study record.

Supplemental guidance: D43 - International Research Training Grants and U2R - International Research Training Cooperative Agreements

For Fogarty-supported D43 "International Research Training Grants" and U2R “International Research Training Cooperative Agreements" that support trainees conducting human subject (HS) studies:

Enter at least one study record for the non-clinical trial studies for the training program:

Inclusion Enrollment Records (IERs) are not required for non-clinical trial trainee studies.
Phase III questions must be marked “No.”
Food and Drug Administration Amendments Act (FDAAA) question must be marked “No.”

If a trainee is conducting an independent clinical trial, a separate individual record must be created for this study:

All the required information must be completed.
An Inclusion Enrollment Record (IER) must be uploaded into HSS.
Phase III question must be answered.
Food and Drug Administration Amendments Act (FDAAA) question must be answered.

Phase III Studies

NIH-Defined Phase 3 updates:
Recipients can navigate to the study record and edit the item in Section 4 as they would edit any other items on their study record.

Instructions for editing study records are available in the HSS Online Help for External Users.

Updated February 21, 2023