Human Subjects Project Triage

Human Subjects Project Triage

Note: As of June 6, 2013, all human subjects related documents are to be submitted through our online protocol management system IRBNet.  More information about IRBNet may be found on the announcement page.  All forms may be found within IRBNet.

When ORIA reviews a project, there are 4 categories in which it will be triaged:

  • Not human subjects research—The project is not research on human subjects (per the federal definitions) and thus does not need to be reviews by ORIA/the IRB.
  • Exempt human subjects research—The project involves research on human subjects per the federal definition, but falls into one of the exemption categories listed in the regulations.
  • Human subjects research subject to expedited review—The project involves research on human subjects and requires review.  However, the project does not require review by the full IRB (likely because it poses no more than minimal risk to research participants).
  • Human subjects research subject to full IRB review—The project involves research on human subjects and must be reviewed by the full IRB.

If you have any questions about any of these categories or about your specific project, please email irb@gmu.edu.

A few additional notes about project triage

  • If you are an experienced ORIA/IRB submitter and are sure that the project in which you plan to conduct is not human subjects research, you may fill out a human subjects determination form (available through IRBNet) and submit to ORIA for record keeping purposes.  We only recommend that experienced protocol drafters/submitters use this form.
  • There are 6 categories of research that are typically considered exempt.  Please review the exemption guidance available on this website to see if you fit in.  Please note that in most circumstances, research on de-identified data (where the researcher has no access to the identified data or code linking identified and de-identified data) is exempt or expiditeable.  Only in extenuating circumstances with extremely sensitive identified pre-existing data will the project require review by the full board.
  • If you are using identified or de-identified pre-existing data for research, you may use the existing data form (available through IRBNet) instead of the longer Human Subjects Application.  Remember, if you are doing research on identified pre-existing data, the research will be reviewed using the expedited procedure.
  • Remember to review the Application Checklist and the list of applicable addenda prior to submitting a human subjects application to make sure that you have included all relevant information (and thereby ensuring that your project can be reviewed as quickly as possible).

As you review the information on this page, you may encounter terms with which you are unfamiliar.  Please check the glossary of terms for definitions.  If you still have a question about a term used that is not answered on the glossary page, please e-mail irb@gmu.edu.