IRB Forms & Instructions

***IMPORTANT NOTICE***

WE HAVE NEW FORMS!

We have developed a new set of application forms for all human subjects research. These new forms were developed to simplify the application process – a formal protocol will no longer be necessary; instead, the forms are fillable and combine the old cover sheets with the elements of the protocol.

These forms have been mandatory as of March 15, 2018

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Use the instructions below 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.

Single-sided hardcopies of all original documents (with signatures) are required, in addition to a 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.

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Instructions for filling out forms

The Initial IRB Application

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. 

To submit a human subjects research (IRB) application compile the following and submit to the IRB office.

1. The Application Form

Complete the Exempt Research Protocol, the Existing 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 IRB’s Review Categories webpage.

2. 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.

3. 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

4. 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.

5. Study Instruments

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

6. 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.

7. 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

8. Permission Letters

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

9. Grant Proposal

If your research is not exempt and is funded or you have applied for funding, include a copy of the grant proposal.

10. International Research Addendum

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

11. 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

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 research protocol with your modification. The modification request and initial research 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.


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