Human Subjects Policies, Procedures, & Guidelines
Note: All human subjects related documents are to be submitted through our online protocol management system IRBNet.
- Human Subjects (Definition) – The federal definition of “human subject” and “research.”
- Human Subjects SOPs – Approved Standard Operating Procedures to be followed by ORIA, the IRB, and researchers conducting human subjects research.
- Includes Mason’s Adverse Event Reporting. Any unexpected problem that occurs during the course of a research activity that relates to that research activity must be reported to ORIA using the form available on IRBNet. See Human Subjects SOP 2.6.5
- Includes Classroom Projects SOP. Guidelines for ORIA/IRB review of projects conducted by students taking pedagogy classes. See Human Subjects SOP 1.3.5
- Human Subjects Research Review Process – The process that a project undergoes from the submission to review.
- Forms and Templates – A description of common forms required for research with human subjects.
- Exempt Research – A description of which research activities are considered exempt from IRB review.
- Research in VA Schools – Information on doing research in Virginia public schools.
- 2017-2018 Updates to Human Subjects Regulations – An overview of new changes to federal polices concerning research with human subjects.
- Clinical Trials Registration information – Information about registering a study on the ClinicalTrials.gov website.
- FERPA – Information about FERPA regulations
- Mandatory Reporting of Child Abuse and Neglect – All Mason employees are required by law to report abuse and neglect.
As you review the policies, procedures, and guidelines 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 firstname.lastname@example.org.