U.S. flag

An official website of the United States government

NIH: Fogarty International Center NIH: Fogarty International Center
Advancing Science for Global Health
Advancing Science for Global Health
Home > Grants > Human Subjects Research Print

COVID-19: COVID-19 public health information from the US CDC | COVID-19 research information from the US NIH | Español | COVID-19 resources for global health researchers

Human Subjects Research

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

Clinical Trials

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

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.

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:

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

Updated January 22, 2020