Human Subjects Research

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

Research Involving Human Subjects
NIH Office of Extramural Research (OER)
Annotated NIH grant application forms, including the "PHS Human Subjects and Clinical Trials Information" form
NIH Office of Extramural Research (OER)
Inclusion across the lifespan in NIH applications and proposals involving human subjects research
NIH Office of Extramural Research (OER)
Human Research Protection Training
U.S. Department of Health and Human Services (HHS) Office for Human Research Protections (ORHP)

Clinical Trials

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

Clinical Trial Requirements for NIH Grants and Contracts
NIH Office of Extramural Research (OER)
Training Resources for NIH Clinical Trial Policies
NIH Office of Extramural Research (OER)
Clinical Trials information, including information on the Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials
NIH Office of Science Policy (OSP)
For Researchers from ClinicalTrials.gov

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) from the NIH Office of Extramural Research (OER) electronic Research Administration (eRA)

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.

Updated January 22, 2020