When Complete

Completed original hardcopy applications may be submitted to the IRB Office in Bernstein-Marcus, Room 121 (MS 116).

Electronic pdfs may be sent to irb@brandeis.edu.

IRB Form and Application Instructions

Use the following forms and instructions to submit a review request to the Brandeis Committee for Protection of Human Subjects (BCPHS). All forms are fillable pdfs, and as such must be completed on a computer.

No handwritten forms will be accepted for review.

Keep in mind that the IRB Office requires hardcopy ORIGINAL documents (with signature) in addition to a scanned pdf of the application. Therefore, applicants must print out completed forms and sign them when submitting an application for review.

Completed original hardcopy applications may be submitted to the IRB Office in Bernstein-Marcus, Room 121 (MS 116). Electronic pdfs may be sent to irb@brandeis.edu.

Select an Application Type:

Expand All / Collapse All


Initial

Preparing an Initial Application

To prepare an Initial Application for review by the IRB, follow these guidelines:

IRB Application Guide and Checklist

Informed Consent Guidelines
Please note: The standard Brandeis IRB contact information must be included on the Informed Consent Form:

"If you have questions about your rights as a research subject please contact the Brandeis Institutional Review Board at irb@brandeis.edu or 781-736-8133."

Forms: Cover Sheet (select one):

For projects involving subject recruitment and data collection:
Iinitial Application Form

-- OR --

For projects involving only analysis of existing data:
Existing Data Application Form

To select a Category of Review when completing the Cover Sheet, see Categories of Review

For projects involving health or mental health data, complete the Protected Health Information Use Form

Assurance (select one):

For projects initiated by a faculty or staff member:
Principal Investigator Assurance*

--OR--

For projects initiated by a student or postdoc:
Faculty-Student Assurance*

* It is the policy of Brandeis University that only faculty and staff members may serve as Principal Investigators on IRB Applications. All students and trainees (undergraduates, graduates, and postdoctoral fellows) will serve as the "Student Researcher". Student-initiated research projects require a member of the faculty or staff to serve as Principal Investigator. Staff members who are conducting human subject research in fulfillment of a degree program must also have a faculty sponsor serve as Principal Investigator.

Submission

When all parts of the application are complete, combine the signed forms with the other application documents into one pdf, and make a photocopy for your records. Scanners and a photocopy machine are available on the first floor of the Library, if needed. (See also How do I turn my IRB application into one pdf file?)

Submit the .pdf of your application to irb@brandeis.edu. Drop off the ORIGINAL signed, hard copy of your application to the IRB Office in the Office of Research Administration in Bernstein-Marcus Room 121 or send it to MS 116.

Remember, your application will not be sent for review until both the electronic version and hard-copy original protocol have been received by the IRB Administrator.

Once both the original and electronic versions of your application have been received, the IRB Administrator will send you an e-mail within one week. The e-mail will contain the IRB Application number and any revisions your application requires before it is sent to the Committee for review.


Continuation

Preparing a Continuation Application

Continuing review of approved IRB protocols is required by the Federal Regulations at intervals not greater than one year from the date of the original review. To help our investigators remain in compliance, the IRB office sends investigators an e-mail a few weeks before a protocol is set to expire with instructions for completing the Continuation Forms.

To submit a request for Continuing Review of an approved IRB Protocol, complete the Continuation Form.

To select a Category of Review when completing the Cover Sheet, see Categories of Review.

If you would like to make a modification to your protocol at the time of your Continuation Request, please follow the directions below for preparing a Modification Application.

Submit the .pdf of your application to irb@brandeis.edu. Drop off the ORIGINAL signed, hard copy of your application to the IRB Office in the Office of Research Administration in Bernstein-Marcus Room 121 or send it to MS 116.

Remember, your application will not be sent for review until both the electronic version and hard-copy original protocol have been received by the IRB Administrator.


Modification

Preparing a Modification Application

A Modification Application must be completed if any change is required in the project after approval has been granted. Such changes include (but are not limited to) the following:

  • Change in PI
  • Addition or removal of personnel
  • Changes to the procedures or study design
  • Changes to the study instruments (surveys, questionnaires, etc)
  • Changes to the Informed Consent Document or procedures
  • Changes to recruitment materials
  • Changes in location of research or agency
  • Changes in funding sources

To submit a request for a modification to an approved IRB Protocol, complete the Modification Form.

To select a Category of Review when completing the Cover Sheet, see Categories of Review.

Submit the .pdf of your application to irb@brandeis.edu. Drop off the ORIGINAL signed, hard copy of your application to the IRB Office in the Office of Research Administration in Bernstein-Marcus Room 121 or send it to MS 116.

Remember, your application will not be sent for review until both the electronic version and hard-copy original protocol have been received by the IRB Administrator.


Termination

Preparing a Termination/Final Report

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

To submit a termination notice for a protocol to the IRB Office, complete the Termination Form.

This form should be submitted in a timely fashion with regard to the end of a project. Remember, a protocol must remain open if data are continuing to be analyzed. A student protocol for a thesis project should not be formally terminated until a successful defense has been made.

Submit the .pdf of your Termination to irb@brandeis.edu. Drop off the ORIGINAL signed, hard copy of your application to the IRB Office in the Office of Research Administration in Bernstein-Marcus Room 121 or send it to MS 116.

The IRB Administrator will send you a formal Termination Notice within three business days of receipt of the completed Termination Form.