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 opportunity announcements, bioethics information, links to OHRP, and more.
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.
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.
An Overview of NIH Policies on Human Subjects
- Transcript (PDF - 305 KB)
- Slides (Powerpoint - 3.6 MB)
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
- Transcript (PDF- 266 KB)
- Slides (Powerpoint - 3.6 MB)
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)
- Human Subjects Research Infographic: defining human subjects research and what is required when receiving NIH funding.
- Exempt Human Subjects Research Infographic: summary of exempt human subjects research and examples for each exemption
Other Human Subjects Research Resources
Grants applications and funding
- NIH Grant Application or Proposal Considerations
- NIH Guide for Grants and Contracts Funding Opportunities and Notices
NIH Inclusion Policy Information
HHS Office of Human Research Protections (OHRP) resources
- Visit the Office for Human Research Protections (OHRP ) for additional online education information and resources related to the protection of human subjects.
- OHRP Biospecimen Resource