Initial Application

Note that all forms must be completed on a computer. No handwritten forms will be accepted for review.

Single-sided hardcopies of all original documents (with signatures) are required, in addition to a single combined scanned pdf of your initial application documents.

Completed original single-sided hardcopies may be submitted to the Human Research Protection Program, Bernstein-Marcus, Room 121 (MS 116). Electronic pdfs may be sent to irb@brandeis.edu.

Before you take the time to prepare your application, you want to make sure the project you are proposing requires IRB approval. The IRB Review Determination Tree can help you make that determination, as well as which application 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) application compile the following and submit to the HRPP office. Use the Application Checklist to ensure you have all the necessary elements. 

Finally, see the 10 Most Common IRB Application Mistakes to help ensure your application travels through the review process as smoothly as possible.
  1. The Application Form

Complete the Exempt Research Protocol, the Secondary Data Research Protocol, or the Initial Research Protocol, as appropriate.

Note that if your research is both exempt and using only existing data, you may use the shorter Exempt Research Protocol. For more information regarding categories of review, see the HRPP’s Review Categories webpage.

  1. The Assurance

Sign and include the Statement of Assurance

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.

  1. Informed Consent

All applications must include a final version of the informed consent form, as it will appear to the subjects (e.g., on letterhead).

If a waiver of documented informed consent or an alteration to documented informed consent is being requested, its justification must be outlined in the application. 

Informed consent is one of the most important requirements of human subject research. For more detailed information about the process, see the HRPP's Informed Consent page. For guidelines on the preparation of an informed consent form, see Elements of Informed Consent and Informed Consent Form Template

  1. Recruitment Materials

Recruitment materials include such things as the fliers 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.

  1. Study Instruments

Study instruments include such things as surveys, questionnaires, interview guides, tests, photographs, etc. If you are using equipment, include diagrams or photographs.

  1. Translated Research Materials

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.

  1. Translation Certifications

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

  1. Permission Letters

Permission letters include such things as Memorandums of Understanding (MOU) and Data Use Agreements (DUA).

  1. International Research Addendum

If your research will be conducted in a foreign country, complete and include an International Research Addendum.

  1. Use or Disclosure of Protected Health Information Use

If you are requesting a waiver/alteration of authorization for use of PHI you must include the Application for Waiver or Modification of Authorization for Use or Disclosure of PHI