IRB Application

The IRB review of human subjects research is the process through which Berklee ensures the safe and responsible conduct of any such research carried out on behalf of the institution. Researchers, whether faculty, students, or staff, are expected to submit an application for any project that constitutes human subjects research (see the IRB page for more information). Researchers from other institutions who wish to include Berklee students, faculty, staff, or alumni as human subjects must also submit an application to the IRB. The steps for the application process and the necessary documentation are outlined below.

Before you submit your application, please review the Office for Human Research Protections decision charts on what is considered research and what needs IRB approval. After reviewing the information, if you have questions about whether your project needs IRB review, please contact the Berklee IRB at BerkleeIRB@berklee.edu.

1. Complete and submit a Berklee IRB application. The application and other helpful tools can be found below.
   • Berklee IRB Application Form
   • Researchers must have Human Subjects Research Certification through PHRP or the CITI program. Please contact the Berklee IRB if you need this training.
   • Overview of questions asked on the IRB application
   • Frequently Asked Questions
   • Informed Consent Form guidelines and templates
   • If you have any questions about how to complete the forms, please contact BerkleeIRB@berklee.edu.
   • If you have already submitted your application and wish to update it, you may do so with the application update form. 
2. Your application will be reviewed once the IRB receives your completed application. One of three actions will be taken, all based on the relevant federal regulations (45 CFR 46). The level of review is determined by the nature of your interaction with human subjects and the use of the data obtained, and only the IRB can make this determination.
   • The IRB may determine that your research is exempt from the requirements and can proceed without further review.
   • The IRB may determine that your research can receive an expedited review without going before the full board. 
   • The IRB may determine that your research must receive board review. If your project requires board approval, you will be informed of the date and time of the board meeting at which your project will be reviewed. You will be informed and may be asked, with co-researchers, to attend the meeting where your proposal will be reviewed. 
3. Following the review of your submission, the IRB response may include one of the following:
   • Your proposal will be approved without any required changes.
   • The IRB will provide you with a list of changes that must be made. When those changes are resubmitted, your proposal will be reviewed again and may require an additional board review. 
   • If your application does not meet the requirements for IRB approval after a second review by the IRB, your proposal may be rejected.

Changes to the scope of your research after approval has been granted must be approved by the IRB. 

If you have any questions about this, feel free to contact the IRB at BerkleeIRB@berklee.edu.