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1. Introduction

Projects need to be submitted to the IRB for review when research involving human interaction is about a person or group, and includes a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102.d). 

For a detailed breakdown of whether your research may require IRB review or at what review category it should be submitted, please see the OHRP Human Subjects Regulations Decision Charts.  Please note that all Exempt studies MUST be submitted to the RU IRB for review.  For further information, please contact the IRB Office at 540-831-5290 or irb-iacuc@radford.edu.

If you are new to submitting projects to the IRB, the below steps will help guide you through the process of developing and submitting your human subjects research activity.

These steps are a recommended sequence of events to plan, prepare, and submit your protocol in an efficient manner to the IRB:

- Plan Ahead and Complete Your Training
- Prepare Your Protocol
- The Submission and Review Process
- Things to Know for After IRB Approval (Amendments, Continuations, Stamped Material and Other Important Information)

2. New User OVERVIEW

Radford University's IRB uses IRBNet, a web-based electronic protocol submission and management system, for all new submissions, amendments, and continuations.

New users will need to:

  1. Register as a user with IRBNet to access IRB application forms and to submit their project.

  2. Complete their appropriate CITI Program training.

  3. Locate additional materials as needed, including forms and templates, as well as other training information, instructions, and tutorials, on this website and on IRBNet.

View the IRB Submission Process tutorial below or on the RU Tutorials webpage for an added overview to help learn the steps to submission, review and approval of your protocol!

Tutorial - IRB Submission Process for New Applicants PPT | PDF

For a complete listing of our tutorials, please view our Tutorials webpage.
 

3. Plan Ahead and complete your Training

The IRB process takes time.  This website provides all of the necessary tutorials, templates, and checklists to help guide you towards IRB Approval for your project as quickly as possible.

As you know, before any research can be conducted, a researcher must complete the appropriate IRB training and receive approval from the Radford University IRB for a submitted and reviewed protocol.

Here are some tutorials and resources to help you quickly find the right IRB training modules and to help you learn how to use IRBNet effectively:

    Getting Started With CITI Course Modules

  1. View the Student or Faculty CITI Training Tutorial
  2. Complete the Human Subjects Training on CITIProgram.org

    Getting Started With IRBNet

  1. View our IRBNet Registration Tutorial
  2. Access and view IRBNet's Training Tutorials to Effectively Utilize IRBNet
  3. Go to IRBNet to Create Your Account

4. Prepare your Protocol

Once you have completed your CITI Program training modules and are familiar with navigating around IRBNet, it's time to create your protocol.

All required documentation for submission can be found on our Forms and Templates webpage or on IRBNet. Be sure to check out our IRB Checklist - Word | PDF - for assistance in selecting the correct documents for your study.

Here is a recommended sequence of events for developing your submission:

  1. Create your Project in IRBNet so that you will have a space to upload your documents as you develop them. 

    1. Think of your Project as a "shell", "workspace", or "empty room" that you will fill up with your documents as you develop them before submitting them to the IRB.  You can also share your workspace with collaborators during and after the development phase.

    2. Please note that students can't be the PI of their own project so please make the faculty mentor the PI of the project and the student a co-researcher or similar title available from the drop-down menu in IRBNet.
  2. Download and complete the Application Form along with any other required or relevant documents from IRBNet and the Radford University IRB website, as needed.

  3. Please see these webpages for added information in guiding you while you develop your project if you have questions on submission categories (Exempt, Expedited and Full Board) or on meeting dates and deadlines:

    1. Review Categories for Submission

    2. IRB Meeting Dates for Full Review Submissions
  4. Download and complete any additional supplemental templates and materials specific to your study from the Forms and Templates webpage.

  5. Upload any instruments or recruitment material that will be associated with the Project.

5. the submission and Review process

Once your IRBNet Project has been created and all of the necessary documents for your study have been uploaded to IRBNet, the Project is ready to be signed and submitted for review.

The review process will provide you with feedback about any changes required on your protocol.

Students - To Sign and Submit Your Project*

  1. Students must share their research projects with their Principal Investigator (PI) or faculty advisor by selecting "Share This Project" in IRBNet. 

    1. Unfortunately, students cannot be the PI of their own research projects because they may not be here when the protocol needs maintenance such as the submission of a Continuation or Closure document. 

    2. As such, they should complete all necessary documents in conjunction with the PI/ faculty advisor.

    3. See the Tutorial for more information.

  2. Faculty mentor/advisor must "sign" and "submit" the Project in IRBNet, as described below for Faculty submissions.

Faculty - To Sign and Submit Your Project*

  1. Click on "Sign This Package" and respond to the prompts to digitally sign your submission. 

    This tells us that you have deemed the submission ready to be reviewed.

  2. Click on "Submit This Package" in IRBNet.

    1. An automatic email will be sent to the IRB Office, notifying us that a submission is ready for review.

The Review Process

  1. Pre-Review - Your protocol will first be pre-reviewed by the IRB Office for completeness and other basic issues. 

    1. You will be contacted if we find anything missing from your submission at this stage of review.
  2. Review - Once the protocol passes the pre-review stage, your submission will then be sent on to an appropriate reviewer or to the full Board for the review.

  3. Be available to correspond with the Research Compliance Office through Pre-Review and Review processes to address any comments that may be sent to you during the review process.
     
    1. Remember: All revisions to documents in IRBNet are completed by uploading the revised documents via the Designer Page. (IRBNet is not a web-based program and does not have smart forms, thus you must complete the revisions to documents on your desktop and then upload to IRBNet from the Designer Page, just as when you first uploaded your project.)

    2. Please note that most of Radford University's IRB reviewers are faculty volunteering their time to support the Radford University IRB and the protocol review process.

    3. For more information, please see who conducts reviews of my protocols?

*Please note that "Package" and "Project" are used somewhat interchangeably in IRBNet but, in general, a Package is a subset of a Project.  Packages are used to create amendment requests, continuations and other subsequent additions to the main Project.

6. after IRB approval - Amendments, Continuations, Stamped Materials and Other Important Information

Even after obtaining approval, there are important considerations to be aware of for your submissions.

Printed Materials to be Stamped At the Time of Approval

  1. Consent forms and any printed recruitment materials (posters, letters, etc) will be stamped, dated and initialed by the IRB Office upon approval.

    1. You MUST ONLY provide, distribute, or display a copy of the stamped version of such materials to participants.

    2. If you have posters or other promotional material that can't be readily printed by the IRB Office and/or reproduced from the stamped copy for use/distribution for the project, please provide the necessary amount of materials for stamping.

    3. Stamped materials expire at the end of the ONE YEAR approval period of the protocol.

Amendments/Modifications

  1. Any changes made in the protocol must be approved.

    1. All changes are to be submitted in the form of an amendment, including a Request for Modification form and any supporting documentation (e.g., revised Consent Forms, surveys, etc.), in an IRBNet package within your overall Project.

  2. Go to IRBNet and select the protocol that you wish to modify/amend.

    1. Select "Project History" from the left hand menu to find the "Create New Package" button and to view any other packages (other continuations or amendments, usually) within a Project (IRBNet's name for your original submission). 

    2. Select "Create New Package".

    3. Download and complete the "Request for Modification" form from either "Step 1" on the Designer Page or from the Forms and Templates Library in IRBNet.

    4. Upload the completed "Request for Modification" form and any additional supporting documentation as needed.

    5. Sign and Submit the Package as usual.

    6. The new package or "sub-package" will now have a "-2" (or higher) at the end of the IRBNet ID to denote that this is a new submission package within your overall project.

 

Expirations, Continuations, and Closures of Submissions

  1. All Expedited and Full Review Protocols are approved for 1 year (Exempt protocols do not expire).

  2. NO WORK may be conducted on a project, INCLUDING most data analysis, after the expiration date of a submission.

  3. On or before the expiration date, either a Closure Report or a Continuation Form must be submitted for a protocol.

  4. Continuations:

    1. Continuations are to be submitted using the Continuation form and uploaded as a separate IRBNet package within your original submission (or "Project", as it is called in IRBNet). 

      1. Go to IRBNet and select your specified protocol.

      2. Select Project History from the left hand menu to find and select the "Create New Package" button. 

      3. The new package or "sub-package" will now have a "-2" (or higher if there have been other packages created before this) at the end of the IRBNet ID to denote this new submission package within your overall project. 

      4. Upload your documents, then sign, and submit the new package as usual.

    2. Continuations for Full Board submissions typically require review at another convened meeting of the IRB, so please plan accordingly.

    3. Full Board protocols that are no longer recruiting participants may usually be reviewed by the Expedited review process, however.

    4. New consent and recruiting materials must be restamped upon approval, and must be submitted along with the previously approved copies for direct comparison for any changes.

    5. A Continuation Approval Form and any new stamped documents will be generated by the IRB Office when the Contintuation is approved.
  5. Closures:

    1. Continations are to be submitted using the Study Closure form and uploaded as a separate IRBNet package.

    2. An Acknowledgement Letter will be sent to the PI when the study is closed in IRBNet.