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How to Submit to the IRB

Institutional Review Board ∙ irb@umd.edu ∙ 301-405-4212 ∙ 1204 Marie Mount Hall ∙ Hours: 8:30 AM - 4:30 PM

Step 0: Confirm if your project is considered Human Subject Research

A project that meets the definition of Human Subject Research is subject to IRB review. If you are not sure if your project meets the definition, we recommend that you submit a Human Subject Research Determination Form. 

The Human Subject Research Determination (HSRD) Form may be used by faculty, staff and students who are not sure if their activity requires IRB review. The HSRD Form will isolate elements of your project so the IRB Office can make a quick and accurate determination.

If you are confident that your project meets the definition of Human Subjects Research, skip this step and proceed to Step 1.

Submit the HSRD Form
  1. Go to irbnet.org and log in. If you do not already have an account, see Step 2. 
  2. Go to Create a New Project on the left hand side and fill in the requested information. 
  3. Go to the Designer and Click Attach a New Document. Upload the completed HSRD Form. 
  4. Click SIGN THIS PACKAGE under the Project Administration menu and follow the instructions. 
  5. Next, if you are the PI listed in IRBNet, click SUBMIT THIS PACKAGE.  If you are not the PI, share the project and direct them to sign.
  6. Select “University of Maryland College Park IRB” in the “Search for Organization” dropdown menu and click Continue. Be careful not to select the IACUC, which reviews animal research.
  7. Be sure all documents are attached and in final form.  Once you “SUBMIT,” the package cannot be edited unless you contact the IRB Office. 
  8. Finally, select New Project as the Submission Type and click “SUBMIT.”
  9. To confirm you have submitted, click PROJECT OVERVIEW to review what has been sent.  
  10. Project Status will reflect “Pending Review” status until the review has been completed.  If status reads “Work in Progress” you have not submitted the project. 

The IRB Office staff will review and make a determination as to whether an IRB Application is required due to the protocol meeting the definition of human subject research or if the protocol does not meet the definition of human subject research. 

If the IRB Office determines that your protocol meets the definition of human subject research and requires IRB review, you will be notified via email to submit an Initial Application. If your project is determined to not require further IRB review, a determination letter will be published in IRBNet.

Step 1: Complete CITI training

The IRB requires all individuals engaged in human subject research at University of Maryland, College Park, to complete CITI Training every three (3) years. Prior to expiration you will receive reminders from the CITI Program to complete the Refresher Course.

Create an account in CITI
  1. Go to www.citiprogram.org.
  2. At the top, right corner of the screen, hit the “Log In” button. This will give you three options: Log In, Log In Through My Institution, OR Register. 
  3. If you are affiliated with the University of Maryland you should choose the Log In Through My Institution option. This will allow you to register for CITI by using your University ID and password. To assist with having external investigators complete the CITI Training, please email the IRB Office at irb@umd.edu. 
  4. Choose the “University of Maryland, College Park” as your institution. 
  5. On the following screen, select “I don’t have a CITI Program account and I need to create one.” 
  6. Follow the prompts to set up your CITI account.
  7. If you are not affiliated with the University, please log in through your institution or choose Register.
Add a course
  1. At the bottom of the page after logging in, under Learner Tools for the University of Maryland College Park, click Add a Course.
  2. For Question 1, select one of the following Basic Courses depending on the scope of your research:
    1. Biomedical Research - Basic/Refresher – 15 Required Modules, 2 Supplemental Modules 
    2. Social and Behavioral Research  - Basic/Refresher  – 11 Required Modules 
  3. If you are only looking to take the course that is REQUIRED by the IRB, only make a selection for Questions 1 and 9 ONLY.
  4. Complete the training. If you cannot complete the training in one sitting, you can save and finish at a later time. You can stop and start as many times as you need.

PLEASE NOTE: The Responsible Conduct of Research Training is NOT the required training. It is recommended, but not required. If investigators complete this training instead of the required training, the IRB will unlock the project and request that you complete the correct training.

Find and view certificate
  1. Your CITI certificate is available on the CITI website through your account. Go to citiprogram.org. 
  2. On the Main Menu, click University of Maryland, College Park Courses. This should give you a list of your completed CITI courses. Under the heading titled “Completion Record,” there is an option to View/Print your certificate. Please be sure to save a copy of your certificate to your computer. You should be able to save this certificate as a PDF. 
  3. You can also access your completed CITI Courses by clicking on My Records. This tab lists all of your completed courses. The View/Print option under Completion Record allows you to print and/or save your CITI certificate as a PDF. 

Step 2: Create an IRBNet account

If you do not already have an account, follow the instructions below:

  1. Go to irbnet.org 
  2. Complete the User Profile using your @umd.edu email address.  
  3. Accept terms of IRBNet.org. 
  4. Select "University of Maryland-College Park” for location.  
  5. Create your password.  
  6. Go to your email. 
  7. You will have received an email from IRBNet. Please note that this may take up to an hour to be delivered.
  8. Click the link in the email to activate your account in IRBNet. 

Please note that your IRBNet account is not linked to your UMD ID.

Step 3: Add your completed CITI Training to your IRBNet User Profile

  1. Log into IRBNet. 
  2. Click User Profile in the upper, right corner of the screen. 
  3. Scroll to the bottom of the page and click Add New Training & Credentials Record under the Training and Credentials section. 
  4. Follow the prompts to attach the PDF version of your completed CITI Training.

NOTE: You do not need to “submit” your training to a Board in order to upload your Completion Report to your profile or to link your report to an IRBNet submission. Additionally, the training will continue to appear as “Not Submitted,” even after the training has been added to the User Profile and linked to a project. 

Step 4: Create your project in IRBNet and prepare and attach the materials

  1. Click CREATE NEW PROJECT on the left hand side and fill in the information about your study (title, names, etc.).
  2. Next, click START A WIZARD and select UMCP – IRB Initial Application - Part 1 from the second drop down box.  Follow the prompts to complete the form. Once complete, this will automatically create a PDF that is attached to your project.
  3. Complete the Initial Application Part 2 using the Initial Application Part 2 Instructions document. 
  4. Prepare the Consent Forms as needed. 
  5. Please also prepare any participant-facing materials such as recruitment materials and survey/interview questions and response options.
  6. Upload these materials to the project in IRBNet. Go to DESIGNER to attach these documents. For each document you wish to submit, click ATTACH NEW DOCUMENT and follow the instructions. 

Please view this video for a step-by-step tutorial on completing the Part 1 Application and uploading other materials to IRBNet. 

Step 5: Share the project with the project team

Sharing a project in IRBNet gives others (Co-Investigators, Advisors) access to your research. There are three levels of access when sharing:

Signature Only (Read): Users whose ONLY role is to sign off on project documentation should be granted "Read" access. Users with Read access can view project documentation, communicate with the project team and add their signature. NOTE: Read access should be provided to IRB Liaisons.

Write: Users that are granted "Write" access can view and edit project documents, collaborate with other users and add their signature, but MAY NOT grant access to other users, submit packages for review or perform any other administrative functions.

Full: Users that are granted "Full" access can perform all functions without restriction. This includes editing project documents, sharing the project with other users, submitting document packages for review and deleting document packages. NOTE: ONLY Project Owners with day-to-day responsibility for the project should be granted Full access. Users with Full access will receive automatic email copies of all project notifications and alerts that are sent to the Project Owners.

To share a project:
  1. The PI will need to Share the Project with Co-Investigators and the Faculty Advisor by navigating to “Share My Project” under the Project Administration menu.
  2. Then, click the first blue link titled “share.” 
  3. Select the University of Maryland – College Park (UMCP) as the organization.
  4. Then, at the bottom of the page you will see a search box to search for users by last name.
  5. To “share” your research project with someone, they must have an IRBNet account. If you are unable to find them, you may be searching in the “Search for an Organization” text box or they may not have an IRBNet account. 
  6. In order for someone to be able to link their certificate to a project, they need at least “Write” access (see Step 6 below for how to link CITI training to a project).

Step 6: Link CITI training records for all investigators

The Principal Investigator, any UMD Co-Investigators, and the Faculty Advisor (if the PI is a student) are required to link their CITI training record to the project. 

If the project will have Co-Investigators (anyone who will interact with human subjects and/or their identifiable information for the purposes of research), they will also need to link their completed CITI training to the project. External Co-Investigators (e.g. people who are not faculty, student, or staff at UMD) do not need to create an IRBNet account to link their training. The PI may upload a copy of their CITI training (or equivalent) as a Supporting Document. 

If the PI is a student, the Faculty Advisor must link their completed CITI training certificate to the project. 

UMD-affiliated Co-Investigators and Faculty Advisors will need to follow the same steps for completing the training (Step 1) and adding the training to their IRBNet User profile (Step 3). 

How to link training certificates
  1. Once your CITI Training is added to your User Profile, click the My Projects tab. 
  2. Click on the title of the project you would like to link the CITI training record to.
  3. Go to the Designer page. You should see the documents you have already uploaded to the project. Underneath these documents, click the blue Link/Unlink Training Records button. 
  4. On the next page, your CITI Training records should appear.  
    • If your training does not appear, it must first be added to your User Profile in the upper right corner of the IRBNet screen (see Step 3). 
    • If Co-Investigators and Faculty Advisors have at least “Write” access to the project (see Step 5) and have added their CITI training records to their User profiles (see Step 3), their CITI Training records should also appear. 
    • Anyone with access to the project can link CITI training to an individual project for themselves and others on the project. 
  5. You will need to click the box on the left of each training record for each investigator. Then click save. Your training records should appear as linked on your project. 

NOTE: You must link your training with EACH project of which you are a research team member. If the IRB Office receives your application without the CITI Completion Report of each research team member, the project will be unlocked so you may add them before we continue with the review process.

Step 7: Request project signatures in IRBNet

All initial applications require a signature from the Department’s IRB Liaison, a Faculty Advisor (if the PI is a student, graduate or undergraduate), and the Principal Investigator. 

Liaison Signature

To request a signature from the Liaison:

  1. Share the project with your Department’s IRB Liaison. It is recommended that the Department Liaison be granted “Read” access.
  2. To share your project with your liaison, find “Share My Project” under the Project Administration menu. 
  3. Then, click the first blue link titled “share.” 
  4. Select the University of Maryland – College Park (UMCP) as the organization. 
  5. Then, at the bottom of the page you will see a search box to search for users by last name.
  6. To “share” your research project with someone, they must have an IRBNet account.
  7. Add a message in the text box when sharing the package requesting that the Liaison review and sign off. 
  8. You will receive an email notification via IRBNet when the Liaison has signed off. 
Advisor Signature (for students)

Students also must request a signature from their Advisor: 

  1. The Advisor should already have access to the project per Step 5, since their CITI training is required to be linked for the IRB to proceed with review. 
  2. When the project is ready for signature, the IRB Office recommends sending a message either in IRBNet or via email to let the Advisor know to review and sign off. 
  3. To send a message in IRBNet:
    1. Click on “Send Project Mail” under the Project Administration menu.
    2. Select the check box next to their name under “Send Mail.”
    3. Write a message in the Message section requesting that they review and sign off on the package.
  4. You will receive an email notification via IRBNet when the Advisor has signed off. 
Principal Investigator Signature

The person listed as Principal Investigator must also sign off:

  1. If you are the Principal Investigator in IRBNet, Click SIGN THIS PACKAGE under the Project Administration menu and follow the instructions.
  2. If you are not listed as the Principal Investigator in IRBNet, send them a message by clicking “Send Project Mail” requesting that they review and sign off.

Step 8: Submit your application materials

When is my project ready to submit?
  1. CITI training certificates for the Principal Investigator, Faculty Advisor (if PI is a student), and any Co-Investigators are linked to the project in IRBNet using the Link/Unlink function
  2. Initial Application Part 1 and Part 2 are completed 
  3. The Department IRB Liaison has signed off
  4. The Faculty Advisor (if PI is a student) has signed off
  5. The Principal Investigator has signed off

Please DO NOT submit before each of the above items have been satisfied. If you submit an incomplete application, we will unlock your project and the review process will be stalled until you address the modifications and mark your revisions complete. Turning in an incomplete application will slow down the review process.

How to submit your application
  1. Click SUBMIT THIS PACKAGE.  
  2. Select “University of Maryland College Park IRB” in the “Search for Organization” dropdown menu and click Continue.

NOTE: Please be careful when selecting where to submit your project as there are two review boards at the University of Maryland, the IRB (human subjects only) and the IACUC (animal research only). Selecting the incorrect board will require your application to be withdrawn and then will need to be resubmitted to the correct board. This will DELAY your REVIEW and APPROVAL.

  1. Be sure all documents are attached and in final form.  Once you “SUBMIT,” the package cannot be edited unless you contact the IRB Office. 
  2. Finally, select New Project as the Submission Type and click “SUBMIT.”
  3. To confirm you have submitted, click PROJECT OVERVIEW to review what has been sent.  
  4. Project Status will reflect “Pending Review” status until the review has been completed.  If status reads “Work in Progress” you have not submitted the project. 
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