All studies involving human subjects must be submitted to the IRB.
General Information: Non-Exempt
Human subjects research is research involving a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.
Non-exempt human subject research is research that meets the definition of research involving human subjects and must remain compliant with federal regulations.
- Check "yes" for human subjects
- Check "no" for exempt from federal regulations
- Include the three narrative placeholders
- Protection of Human Subjects
- Inclusion of Women and Minorities
- Inclusion of Children
- If the application involves a clinical trial, include a Data Safety Monitoring Plan (DSMP)
Human subjects should be marked as "pending" unless the application has been added to an existing protocol or a new protocol has been approved for the application.
Back-up documentation is required if an existing or new protocol is being used.
Human Subject Research Exemptions
Research that is considered exempt from federal regulations surrounding the protection of human subjects does not need an FWA or annual IRB approval. Investigators involved in exempt research must still meet the human subjects education requirement. Exempt human subjects research meets the definition of human subjects research but satisifies the criteria of one of the six (6) exempt study designs:
- Exemption 1* - research conducted in an educational setting involving normal educational practice
- Exemption 2* - research using educational tests, survey proecedures, interviews, or observations of public behavior, unless subjects are identifiable and disclosure could place them at risk. This exemption for parts involving educational tests is applicable to children; however, it does not apply to surveys, interview procedures, or observations of public behavior in research involving children, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed
- Exemption 3 - research using educational tests, survey procedures, interviews, or observations of public behavior if the subjects are public officials or candidates for public office or if federal law requires that confidentiality be maintained. This exemption is not typically used in NIH projects
- Exemption 4* - research involving the collection or study of existing data, documents, records, pathological, or diagnostic specimens
- Exemption 5 - research and demonstration projects for the purpose of evaluation
- Exemption 6 - research that evaluates taste and food quality or consumer acceptance of food. This exemption is not typically used in NIH projects
*Exemptions that typically are used for NIH research
- Check "yes" for human subjects
- Check "yes" for exempt from federal regulations
- Check the appropriate exemption number(s)
- Provide a detailed justification in the Protection of Human Subjects section that explains why the study is considered to be exempt from federal regulations
Research that uses non-identifiable data (publicly available, unidentifiable, non-linked cell lines, cadavers/STIFFS)
- Check "no" for human subjects
- Upload the Protection of Human Subjects narrative. Verify that it discusses the source of all human specimens and data and state whether or not anyone on the research team has the ability to link the specimens or data to subjects' identifiable information
Federal guidance regarding the protection of human subjects can be found on the HHS website.