• Submit a New Project Application
• Submit a Response to a letter from the IRB
• Amend an existing project
• Submit information for Continuing Review
  
• Submit a "Resubmission" of an existing, approved project after 7 IRB reviews completed
• Sumbit a Study Withdrawal or Closure
  

Submit a New Project Application

The New Project Submission (and 7-year resubmission of an existing project) includes the following steps: 

1. Download the Instructions for filling out the Research Plan template.
2. Download a Word template for describing your Research Plan.  This is the document that contains contains headings for each of the areas on which the IRB must base its judgement of safety and ethics.
3. Fill in the template document using the Instructions, the same way you would if producing a paper submission and save it on your computer. The difference between the e-IRB and paper-based review process is that you will upload this Word document to this website rather than printing multiple copies of it.
4. Create your consent document(s) in Word for Windows format. Save the informed consent(s) and adolescent or child assents, if needed, one consent document per file, on your computer. You will have the opportunity to upload each consent or assent separately.
5. Once your Research Plan document and consents are ready and saved on your workstation, fill out the Biomedical Application Facesheets.  These face pages are in Adobe Acrobat format and must be submitted online via your web browser. Please note that Facesheets signed by the Principal Investigator, Department Chair --and for VA projects the VA Service Chief-- is required as a hardcopy document unless they can be provided as an uploaded document. If provided as a hardcopy document, the document should be mailed to the HRPP Office, mailcode, 0052.
6. When you submit the Facesheets online, the system will give you a Temporary Project ID (a "T-number"). Once your information has been imported into the HRPP database, usually within 1-2 working days, the project will receive a HRPP project number, and you will receive an e-mail noting the HRPP project number. You will then need to log into your "My Protocols at a Glance" through eIRB services. Click on the link for your "new" project and you may begin to upload your documents.

1. Download the Instructions for filling out the Research Plan template.
2. Download a Word template for describing your Research Plan.  This is the document that contains contains headings for each of the areas on which the IRB must base its judgement of safety and ethics.
3. Fill in the template document using the Instructions, the same way you would if producing a paper submission and save it on your computer. The difference between the e-IRB and paper-based review process is that you will upload this Word document to this website rather than printing multiple copies of it.
4. Create your consent document(s) in Word for Windows format. Save the informed consent(s) and adolescent or child assents, if needed, one consent document per file, on your computer. You will have the opportunity to upload each consent or assent separately.
5. Once your Research Plan document and consents are ready and saved on your workstation, fill out the SBS Application Facesheets.  These facesheets are in Adobe Acrobat format and must be submitted online via your web browser. Please note that Facesheets signed by the Principal Investigator, Department Chair and Faculty Advisor (if appropriate) is required as a hardcopy submission unless it can be provided as an uploaded document. If provided as a hardcopy document, the document should be mailed to the HRPP Office, mailcode, 0052.
6. When you submit the Facesheets online, the system will give you a Temporary Project ID (a "T-number"). Once your information has been imported into the HRPP database, usually within 1-2 working days, the project will receive a HRPP project number, and you will receive an e-mail noting the HRPP project number. You will then need to log into your "My Protocols at a Glance" through eIRB services. Click on the link for your "new" project and you may begin to upload your documents.

Submit a Response to a Letter from the IRB

Responses should be submitted online as a series of protocol-associated documents via the e-IRB services.

Amend an Existing Project

1. See the Fact Sheet on Making Amendments and Changes to an existing protocol.
2. Amendments are submitted online via our e-IRB services.  (Please do not submit amendments as a New Project submission.)
3. Please note that a seven-year renewal is a New Project Application, not an amendment of an existing project.  See the instructions at the top of this page for a New Project Submission.

Submit information for Continuing Review

1. Federal Regulation required that projects undergo Continuing Review at intervals not greater than 365 days. Courtesy reminders regarding upcoming expiration dates may be sent electronically at intervals set by users of the HRPP system. The default reminders are sent 75, 60 and 45 days before a project expires, but these intervals, and the entire reminder service, can be set to a user's preference using our e-IRB services. However, this courtesy notification should not substitute for the researcher's own internal tracking of expiration dates. Ultimately, it is the PI's responsibility to submit documentation within the due dates provided.
   
2. A Continuing Review submission has three or more components:
• A cover letter for submission of Continuing Review documents
  
• Continuing Review Facepages. There are two different Facepages, one for a Biomedical project and one for a SBS project. The Facepages must be signed by the PI and submitted to HRPP at mailcode 0052, if provided as a  hardcopy document, or uploaded as a pdf file through eIRB services.
  
• A Narrative Summary of Progress made since the most recent IRB review. This is a Word document that can be downloaded and saved on your workstation. There are two different Narrative Summary forms, one for a Biomedical project and one for a SBS project.
  
• A copy of the IRB-stamped, approved blank consent/assent form currently in use by the project. (Note: although HRPP has a copy of this on file, federal regulations require that you send us the current consent/assent so that the IRB can determine that you are using the correct version.) Do not send a consent/assent that has been signed by a study participant.
• A "clean" copy of the consent/assent form, as a Word document, for "restamping."
  
• Associated study documentation, including a copy of any site monitoring reports, progress reports, audits, communication to/from the FDA, and/or publications associated with the project, as applicable, since the most recent IRB review. 
  
3. The items should be uploaded to the HRPP not less than 45 days before expiration of the current IRB approval.
   

Submit a 7 year project "Resubmission" application for an existing approved project

Therefore, DO NOT submit the revised project application as a set of documents associated with an existing application.  Rather, on the Facesheets, please list the number of the protocol being renewed in the appropriate place on the form and submit the application as a New Project submission.  The steps for doing this are listed at the top of this page.

Submit a Study Withdrawal or Closure

1. To withdraw a study before initial approval has been granted by the IRB, a letter signed by the PI must be submitted to the HRPP. The letter must indicate that the PI is asking for the study to be withdrawn and describe the reason(s) for the withdrawal. Upon receipt of the letter, the IRB Director, Associate Director, or HRPP staff designee will review the submission for completeness. A request to the PI may be made to clarify any questions or to provide additional information. Once any answers to questions and/or additional information has been submitted, the study withdrawal submission will be reviewed by the IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the withdrawal and/or acceptance of the withdrawal, as appropriate.
2. To close a study that has received IRB approval, but no study procedures have been done, such as enrolling participants, a letter signed by the PI must submitted to the HRPP. The letter must indicate that the PI is asking for the study to be closed  and describe the reason(s) for the study closure. Upon receipt of the letter, the IRB Director, Associate Director, or HRPP staff designee will review the submission for completeness. A request to the PI may be made to clarify any questions or to provide additional information. Once any answers to questions and/or additional information has been submitted, the study closure submission will be reviewed by the IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the closure and/or acceptance of the closure, as appropriate.
   
3. To close a study that has received IRB approval and has performed study procedures such as enrolling participants, PI completed Study Closure Facepages and Narrative Summary of Progress at Study Closure must be provided to the HRPP. For Biomedical studies, the Biomedical Study Closure Facepages and Narrative must be used. For Social and Behavioral studies, the Social and Behavioral Study Closure Facepages and Narrative must be used. These forms can be found on the HRPP website "Forms" page. In addition, copies of relevant associated information, such a copy of the stamped, approved consent if participants have been enrolled since the last review by the IRB (initial or continuing), formal study closure from the sponsor, site monitoring reports, audits, other reviews, etc. must also be submitted for review. The Study Closure submission must be submitted within 30 days of study closure. For more information, see the HRPP fact sheet, Closure/Withdrawal of Study. The study closure submission will be reviewed by a convened IRB, IRB Chair, or by the IRB Chair's designee, and the PI will be provided with written notice of the review of the closure and/or acceptance of the closure, as appropriate.