DETERMINE IF YOUR PROJECT IS HUMAN SUBJECT RESEARCH
Review this OHRS guidance document for help determining whether your proposed project will likely meet the regulatory definition for human subject research.
WHAT Needs review?
An activity requires IRB review if it is research with human subjects. The OHRP and FDA definitions of research and clinical research with human subjects are available on our website in the guidance for Determining Whether a Project is Human Subjects Research.
Not Human Subjects Research
At OHRS, there is a process for review of research even when the project does not meet the definitions of research, clinical investigations, or human subjects.
Watch our e-learning module on Secondary Use and Non-Human Subject Research Determinations. If you have additional questions, please email OHRS@dfci.harvard.edu for assistance.
Human Subjects Research
When a project meets the definition on human subjects research, it is reviewed according to the following categories:
Exempt and Expedited Review
Minimal Risk Research may be reviewed as exempt or expedited, depending on the nature of the research and the Exempt and Expedited Categories in which the research fits. Exempt reviews are conducted by a member of IRB staff, whereas expedited reviews are conducted by a member of the IRB committee.
Research that does not qualify for expedited or exempt review (presents more than minimal risks to subjects) will receive review at a fully convened IRB committee meeting.
Does your research involve existing specimens or data?
Before submitting your research project, familiarize yourself with the regulatory requirements for studies that plan to use data or samples previously collected for research or clinical purposes. Visit the OHRS page on Research with Biological Materials & Data and watch our e-learning on Secondary Use and Non-Human Subject Research Determinations
Verify Training is Up to Date
Please ensure that the Principal Investigator has completed all required education and has up to date training documentation prior to submission. New investigators should refer to the New Research Staff section of this page for more information.