Human Subjects Forms and Templates

Forms for Approved Projects

Note: All human subjects related documents are to be submitted through our online protocol management system IRBNet. All forms may be found within IRBNet. A description of the different forms available may be found below.

Research Determination Form – this form can be used to assess the need for IRB review. If you would like an official determination from the ORIA, you must submit this form through IRBNet.
Reportable New Information (Adverse Event Report Form)—Promptly fill out this form and submit it to ORIA if an unexpected problem has occurred that directly relates to your research activity. If the problem that has occurred was described in your consent form and the IRB protocol, unless the problem represents a magnitude or severity that was unanticipated and not described in these documents, you do not need to fill out this form.
Amendment Form and Guidelines—If you make any changes to your project or find that there has been a change in the risk/benefit analysis, please fill out this form and submit it to ORIA for further review.
Continuing Review Form—Please use this form to provide updates on your project to ORIA. Projects reviewed by the IRB (either expedited review or full board review) require annual review.

Templates

Informed Consent Template—Use this form as a base for your own informed consent form.
Assent Template —If you are doing research with minors, you may use this template as the base for your own assent form. Remember that an assent form should be written in an age appropriate way and give the minor-participant all relevant information about the study.

As you review the forms and templates, 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.