Steps to Submitting a New IRB Application

Not all projects require IRB review and approval. Before getting started, determine if IRB approval is required.

Step 1: Complete the Required Human Subject Protection Training

Principal Investigators and their co-investigators/study staff are required to take a human subjects protection training.

To begin your training, review the Required Human Subject Training information page that is located on the Office of Research Compliance website.

Step 2: Determine Which Application to Submit

Projects that involve human subjects research may undergo one of three types of review:

  • Exempt Review
  • Expedited Review
  • Full Board Review

The type of review depends on the risk level of the research and if the research falls into one of the expedited or exempt categories as defined by the federal regulations.

For assistance in determining which application should be completed for your study, please refer to the IRB’s guidance: The Difference Between Exempt, Expedited and Full Board Studies.

Once the application is received by the IRB, the IRB will make the final determination on the type of review.

What happens if you send in the wrong application?

The IRB may be able to obtain the necessary information from the application that was initially submitted. If additional information is needed, the IRB will let you know. In some cases, the IRB will ask that you complete the correct application for your study type.

Step 3: Obtain Appropriate Signatures & Approvals

There are several signatures required on the IRB application. The IRB does accept scanned versions of the signature page. If you do not have access to a scanner, you can mail a copy of the signature page to us at 25 Buick Street, Room 157. Be sure to include a cover sheet that indicates the study title and Principal Investigator.

For Student Investigators

  • Your signature is required on the application
  • Your Faculty Advisor must also sign the application and be listed as a co-investigator
  • Some schools/departments have an IRB pre-reviewer and IRB applications must first be reviewed by the pre-reviewer. If your school does not have a designated pre-reviewer, you may submit the application without this signature.

For Faculty Investigators

  • Your signature is required on the application
  • Your Department Chair must also sign the application. If you are the Department Chair, your Dean must sign the application.

Step 4: Assemble Study-Related Documents for IRB Review

The IRB reviews most study-related documents. The following documents should be included with your submission, as applicable:

  • Consent/Assent forms or information sheet (submit as a Word document)
  • Recruitment materials
  • Questionnaires
  • Participant diaries
  • A text version of any website or audio/video advertisements
  • Grant application
  • A device description/manual
  • FDA letters
  • Drug label information/package insert, Investigator Brochure etc.
  • Data and Safety Monitoring Board (DSMB) Charter

Student investigators: Student investigators should submit a copy of the thesis/dissertation prospectus. If the prospectus is extremely lengthy, students may submit the introduction/summary and the design/methods section including:

  • Research Plan
  • Specific Aims
  • Background and Significance
  • Preliminary Studies
  • Research Design and Methods
  • Human Subjects
  • Appendices that relate to the conduct of the research (survey instruments, data collection forms, etc.)

If the project is federally funded and BU is the prime awardee, submit a full copy of the grant application. If BU receives a subcontract, submit relevant sections of the grant application and/or the scope of work.

Step 5: Email Application to the IRB Inbox

Prior to sending in your application, make sure that:

  1. You and your study staff/co-investigators have taken the required human subjects protection training
  2. You have completed the appropriate IRB application
  3. You have obtained all of the proper signatures
  4. You have assembled all study-related documents

After you complete the above steps, you may email your completed application and relevant documents to the IRB inbox at irb@bu.edu.

Expedited and exempt submissions are reviewed on a rolling basis. If the study qualifies for Full Board review, it will be reviewed at the next Full Board meeting in accordance with the submission deadline dates.

Review the most recent IRB submission metrics for a sense of how long it will take for your submission to be reviewed.