IRB Forms & Instructions
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 are fillable pdfs, and as such 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 application, 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 email@example.com.
The Initial Application
1. The Cover Sheet
There are two initial application cover sheets:
If you are unsure which cover sheet to use, feel free to contact the IRB office for help in making that determination.
2. The Assurance
Sign and include the Principle 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.
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. Permission Letters
Permission letters include such things as Memorandums of Understanding (MOU) and Data Use Agreements (DUA).
9. Grant Proposal
If your research is funded or you have applied for funding, include a copy of the grant proposal.
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.
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.
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.