IRB Forms & Instructions

Please Note:

We have a new -- shorter -- Exempt Research Application
For more information,
see The Exempt Research Application below

Use the following forms and instructions to submit new applications, continuation and modification requests, and termination reports to the Brandeis University IRB.

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

The IRB office requires hardcopy original documents (with signatures) in addition to a scanned pdf of all applications, requests, and reports. 

Completed original hardcopies may be submitted to the IRB office in 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 IRB office. 

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The Exempt Research Application

Federal regulations identify six categories of research activities that are exempt from the federal regulations on the protection of human subjects in research. If your research falls under one of these categories, you may complete the Exempt Research Application in lieu of compiling a formal protocol.

Review the Exempt Categories of Review to determine whether your research qualifies. If you are unsure whether to submit an Exempt Research Application or an Initial Application, feel free to contact the IRB office for help.

To submit an exempt research application, compile the following and submit to the IRB office. 

1. The Application Form

Complete the Exempt Research Application.

2. The Assurance

Sign and include the Principal Investigator Assurance if the research is being initiated by a faculty or staff member.*

                             -- or --

Sign and include the Faculty-Student Assurance if the research is being initiated by a student or postdoctoral fellow**

*Staff members who are conducting human subjects research in fulfillment of a degree program must also have a faculty sponsor serve as Principle Investigator.

**It is Brandeis University policy that only faculty and staff members may serve as Principle Investigators on IRB applications. Therefore, all students and postdoctoral fellows initiating research are designated Student Researchers and must have a Brandeis University faculty or staff member act as Principle Investigator.

3. Statement of Protected Health Information Use

If, and only if, you are working with health or mental health information you are required to sign and include the Statement on HIPAA 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

4. Informed Consent

All applications must include an informed consent form, a waiver of documented informed consent request, or an alteration to documented informed consent request. 

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

5. 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.

6. Study Instruments

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

7. 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.

8. 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

9. Permission Letters

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

10. International Research Addendum

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

The Initial Application

1. The Cover Sheet

Choose and complete the correct cover sheet:

  • The standard Initial Application for research involving data collection or a combination of data collection and existing data analysis

  • The Existing Data Application for research involving no data collection, only existing data analysis

2. The Assurance

Sign and include the Principal Investigator Assurance if the research is being initiated by a faculty or staff member.*

                                         -- or --

Sign and include the Faculty-Student Assurance if the research is being initiated by a student or postdoctoral fellow**

*Staff members who are conducting human subjects research in fulfillment of a degree program must also have a faculty sponsor serve as Principle Investigator.

**It is Brandeis University policy that only faculty and staff members may serve as Principle Investigators on IRB applications. Therefore, all students and postdoctoral fellows initiating research are designated Student Researchers and must have a Brandeis University faculty or staff member act as Principle Investigator.

3. Statement of Protected Health Information Use

If, and only if, you are working with health or mental health information you are required to sign and include the Statement on HIPAA 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

4. The Protocol

The protocol is the bulk of your application and includes detailed information about your research.

The protocol should demonstrate to the IRB that the proposed research is respectful to the needs of the participants; that the investigator thoroughly understands the potential risks to the participants; that those risks are being reduced to a minimum; and that the benefits of the research more than justify any risk, inconvenience, or other cost to the participant as a result of his/her participation.

For step-by-step instructions on how to complete a protocol, see the IRB Application Guide and Checklist.

5. Informed Consent

All applications must include an informed consent form, a waiver of documented informed consent request, or an alteration to documented informed consent request. 

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

6. 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.

7. Study Instruments

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

8. 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.

9. 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

10. Permission Letters

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

11. Grant Proposal

If your research is funded or you have applied for funding, include a copy of the grant proposal.

12. International Research Addendum

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

The Continuation Request

Federal regulations require that all approved IRB protocols be re-reviewed at intervals not greater than one year from the date of the original review. The date of expiration of your approval is listed on the approval letter you received from the IRB office. A continuation of approval is required if you are continuing to recruit subjects and/or plan to continue data collection, or are analyzing data collected for your research.

Note that if your IRB approval lapses -- if your continuation request has not been approved prior to the expiration of your current approval -- you must suspend work on your research until your request has been approved. If you continue to recruit subjects, collect data, or analyze data before your request has been approved you will be out of compliance.

To request a continuation of your current approval, complete and submit a Continuation Request to the IRB office. This form must be submitted at least 30 days in advance of your current approval's expiration to ensure your approval does not lapse.

Note that exempt research does not require the submission of continuation requests. 

The Modification Request

A Modification request is required if you plan to make any changes to your research or deviate from the protocol after approval or exemption has been granted. Such changes include (but are not limited to) the following:

  • Change in PI
  • Addition or removal of personnel
  • Change in planned number of enrolled participants
  • Changes to the procedures or study design
  • Changes to the study instruments (surveys, questionnaires, etc)
  • Changes to the informed consent documents or procedures
  • Changes to recruitment materials
  • Changes in location of research or agency
  • Changes in funding sources

Note that changes may not be implemented before your modification request has been approved by the IRB. If you implement changes before IRB approval, you will be out of compliance.

To request a modification of your current approval, complete and submit a Modification Request to the IRB office. Remember to submit your request with ample time for the IRB to approve it before you plan to make the changes.

Note that if your research has been approved as exempt and your modification disqualifies it from its exemption you must file an initial application protocol with your modification (see The Initial Application: 4. The Protocol above for instructions). The modification request and initial application protocol will be reviewed as expedited or by the full committee as appropriate. 

The Termination and Final Report

When an approved or exempt protocol is nearing an end or has ended, investigators are required to submit a notice of termination to the IRB Office.

Remember, your protocol must remain open if you are continuing to recruit subjects, collect data, or analyze data.

A student protocol for a thesis project should not be formally terminated until a successful defense has been made.

To officially terminate your research, complete and submit a Termination & Final Report to the IRB office.