Decision Trees for Human Subjects Requirements

For more information, see Human Subjects.

Determine if NIH will consider proposed research to be human subjects:

• Research Involving Private Information or Biological Specimens
• HHS Human Subjects Regulations Decision Trees

View how reviewers determine if proposed research has complied with human subjects requirements and the outcomes of their decisions: 

• Research Involving Private Information or Biological Specimens
• Protection of Human Subjects from Research Risk (Text only version)
• Inclusion of Women Plan (Text only version)
• Inclusion of Minorities Plan (Text only version)
• Children Inclusion Plan (Text only version)
• Data and Safety Monitoring Plan (Text only version)

For additional information on applying, see How to Write a Human Subjects Application.

For information about terms and topics that are unfamiliar, check out the Glossary of Funding and Policy Terms and Acronyms.

Numerical coding, identified in the decision trees, is assigned at peer review.

If you wish to print the decision trees, set your printer for landscape printing.