Human Subjects Research Review Process

Human Subjects Research Review Process

Note: If any term used on this page is unclear, please check the glossary page.

ORIA’s human subject research review process begins with the submission of the human subjects application. The application should be completed and submitted to ORIA prior to the applicable submission deadline listed on the IRB Meeting Schedule.  Note that handwritten submissions will not be accepted.  Please make sure to review the instructions for submitting an application as ORIA/the IRB will only review complete applications. Incomplete submissions may result in delays in the review process. ORIA staff will let you know upon submission if an application is complete.

Some research involving human subjects is exempt from review by the IRB. ORIA reviews all of the human subjects applications and determines whether the research is exempt or nonexempt. Mason faculty, staff, and students may not conduct research involving human subjects until the researcher receives either written documentation from ORIA that the research is exempt or written documentation that the research has been reviewed and approved by ORIA/the IRB. If ORIA finds that the research is exempt, ORIA will send a formal letter to the Principal Investigator and Co-investigator.

If ORIA staff finds that the research is nonexempt, ORIA will determine if the non-exempt research requires review by the full board or qualifies for expedited review. Under the expedited review process, at least one member of the IRB will review the research after receipt of a completed application. If the nonexempt research does not qualify for expedited review, ORIA staff will schedule the research for review by the full board which meets once a month. See the IRB Meeting Schedule for meeting and submission dates. Once a project has been approved by ORIA staff or the IRB as necessary, ORIA staff will send a formal letter to the Principal Investigator and Co-investigator (if one is designated on the application). No research may begin until written approval has been provided.