Submit a Human Subjects Application

Submit a Human Subjects Application

How to Submit to the IRB

All human subjects related documents are to be submitted through our online protocol management system RAMP.  The full IRB Toolkit (including templates, checklists, worksheets, and SOPs) may be found in RAMP through the Library tab.

Below you will find a selection of our most commonly used templates and documents. You can find training videos and guidance documents on the George Mason RAMP website.

For new George Mason researchers, click here to view a tutorial video on the basics of what the different protocol templates mean, how to list your PI, and how to submit a project for IRB review via RAMP.

To watch a tutorial video on how to submit a new study via RAMP, click here.

Investigator Manual

This Investigator Manual is designed to guide investigators and study staff through polices and procedures related to the conduct of Human Research that are specific to GMU. General information regarding Human Research protections, as well as relevant federal regulations and guidance, has been incorporated throughout this manual where applicable.

• HRP-103 – INVESTIGATOR MANUAL
• HRP-103p – INVESTIGATOR MANUAL – pSite

Templates & Forms

Note: The IRBNet application forms and addenda are no longer in use. All new IRB applications in RAMP are required to include a study protocol using one of the templates below:

• Protocol Templates
  • HRP-503a – TEMPLATE Social-Behavioral Protocol Template
  • HRP-503 – TEMPLATE Biomedical Protocol Template
  • HRP-503b_Exempt Protocol Template
  • HRP-503c Secondary Use Template– If you are conducting research on pre-existing data, please submit this form.
  • HRP-503e – Human Subjects Research Determination – If you are an experienced applicant, you may use this form for a self-evaluation or to obtain a letter from ORIA indicating that a project that is not research based on the federal definition or does not involve human subjects based on the federal definition.
  • HRP-503d – .118 Determination Letter Request- If you need a .118 determination letter for your funded research, you may submit this form to obtain a letter.

• Consent Templates
  • HRP-502 – TEMPLATE CONSENT DOCUMENT – Biomedical
  • HRP-502a – TEMPLATE CONSENT DOCUMENT_- Social Behavioral
  • HRP-502b – TEMPLATE – Assent 
  • HRP-502c – TEMPLATE MRI CONSENT 

• SONA Recruitment: HRP-502e – TEMPLATE SONA Posting Form

To submit a modification to an existing study that was approved in IRBNet, please use the following instructions:

• Converted Protocols Information and Steps
• PI Guidance to Populate the Study Record
  • To watch a tutorial on how to transfer IRBNet documents into RAMP shell studies, click here.
• Navigating Converted Submissions in the Dashboard
• Submitting a Modification for Exempt Studies 

As you review the application material 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.