- Note that all forms must be completed on a computer. No handwritten forms will be accepted for review.
Before you take the time to prepare your protocol, you want to make sure the project you are proposing requires Institutional Review Board approval.
The IRB Review Determination Tree (pdf) can help you make that determination, as well as which protocol to submit. If you are still unsure whether your project requires IRB approval, please do not hesitate to contact the HRPP office.
To submit a human subjects research (IRB) protocol, compile the information described in the accordions below and submit to the HRPP office. Use the Protocol Checklist (pdf) to ensure you have all the necessary elements.
Finally, see the 10 most common IRB protocol mistakes to help ensure your protocol travels through the review process as smoothly as possible.
Sign and include the Statement of Assurance. Please note that the Statement of Assurance is embedded in the Initial Protocol Protocol and does not need to be submitted separately.
Note that, for research that is being initiated by a student or postdoctoral fellow, both the principal investigator and the student must sign the assurance.
All protocol must include a final version of the informed consent form(s), as they appear to the subjects (e.g., with graphics/letterhead and without extraneous text).
If a waiver of documented informed consent or an alteration to documented informed consent is being requested, its justification must be outlined in the protocol.
Informed consent is one of the most important requirements of human subject research.
Recruitment materials include such things as the flyers you plan to post, emails you plan to send to potential participants, scripts you plan to use for calling potential participants and letters you plan to send enlisting the help of others (institutions, programs, organizations) in your recruitment of participants.
For detailed information about recruitment requirements, see the Recruitment webpage.
Study instruments include such things as surveys, questionnaires, interview guides, tests, photographs, etc. If you are using equipment, include diagrams or photographs.
If your research will be conducted in a language other than English, include a translation of all research materials (informed consent form/script, recruitment materials, study instruments) in every language in which the research will be conducted.
If your research is being conducted in a language other than English, you must submit certified translations of all research materials (recruitment flyers, consent forms, study instruments) as well as a signed Translation Certification.
If research is being conducted at a non-Brandeis private facility or space, a site permission letter is generally required for each such facility or space.
For detailed information about permission letter requirements, see the Off-campus Site Permission webpage.