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Training & Resources - Human Subjects

The Office of Extramural Research (OER) provides training and communication tools such as web-based tutorials, presentations, and other resources to assist you in accessing and understanding information in determining if your research involves human subjects, may be exempt from federal regulations, or is not considered human subjects research. 

On this page:

  • Education Requirement, including information about fulfilling the required education in the protection of human research participants.  
  • Training, including required training, information for completing applications, training for using the Human Subjects System (HSS), and Single IRB training.
  • Resources, including the course content from the retired PHRP course, the Human Subjects Research and Exempt Human Subjects Research infographics, funding opportunities, bioethics information, links to OHRP, and more.

Education Requirement

Protection of Human Subjects Education

Investigators and all key personnel who will be involved in the design or conduct of NIH-funded human subjects research must fulfill the protection of human subjects education requirement. One way to achieve this is by completing the Human Research Protection Training offered by the HHS Office for Human Research Protections (OHRP). For additional information, please see the Human Subjects Research FAQs. ​Additional information about the requirement for education on the protection of human subjects policy can be found here.

Training

Assistance Preparing the PHS Human Subjects and Clinical Trials Information Form

Find useful resources for filling out the PHS Human Subjects and Clinical Trials Information form, study records application submission presentations, and annotated form sets.  

Human Subjects System (HSS) Overview Video Tutorials and Resources

The HSS system is a shared system that enables grant recipients to electronically report and update their data on human subjects research and clinical trials to NIH; and for NIH agency staff to monitor and manage the study progress.

Resources

Division of Human Subjects Research Resources

Human Subjects, Clinical Trials and Inclusion Resources One-Pager

Find useful links to tools, workflows, websites and other important resources for human subjects, clinical trials and inclusion.

An Overview of NIH Policies on Human Subjects

This recorded presentation from the December 2022 NIH Grants Conference PreCon event on Human Subjects Research: Policies, Clinical Trials, & Inclusion helps participants identify NIH policies involving research with human subjects and understand what to consider when applying for NIH funding for human subjects research.

Human Subjects System 

Learn about the Human Subjects System (HSS), an electronic eRA system for grant recipients to electronically report and update their data on human subjects and clinical trials to NIH; and for NIH staff to monitor and manage this data.

Essentials of sIRB Requirements

Presented during the December 2022 NIH Grants Conference PreCon event on Human Subjects Research: Policies, Clinical Trials, & Inclusion, this recorded training describes the single IRB (sIRB) requirements under the revised Common Rule and the NIH sIRB policy, and explains how to apply them to NIH funded research.

Protecting Human Research Participants (PHRP)

NIH no longer offers a course on PHRP. Institutions seeking to fulfill the requirement for education in the protection of human research can complete the Human Research Protection Training offered by the HHS Office for Human Research Protections (OHRP). Archived course content is available below. Note that this content is no longer maintained or updated as of September 26, 2018, but is available as a reference. 

Archived Course Content (English language)
Archived Course Content (Spanish language)
Archived Quiz Questions (English language)
Archived Quiz Questions (Spanish language)

Infographics


Other Human Subjects Research Resources

Grants applications and funding

Bioethics

NIH Inclusion Policy Information

International Research

HHS Office of Human Research Protections (OHRP) resources

This page last updated on: May 10, 2023

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