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Modification Request Form Sample Questions

The Modification Request Form is similar to the Initial Protocol in that it is an interactive form with built-in logic. That means that the answers to some questions will reveal other questions. Only the questions that need to be answered for your specific research protocol will be visible to you. Please provide complete and detailed answers to every question that you see.

Below is a preview of the questions on the Modification Request Form, organized by section of the form. Many of the conditional questions can be seen here, even if you may not see them when you are working on your submission.

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Project Details

Please choose the following from the drop down menus:

PI Last Name
Protocol Number "Protocol Title"

The combination of these two pieces of information will direct our system to autofill fields with project details, such as the PI's full name and department, the supervised researcher's full name and status (if there is a supervised researcher), and the funding status of the project, that you won't see on the form as you fill it out. These fields will appear on the resulting PDF that will be produced for your records and our review.

Changes in Risk Level

Changes in Personnel

New personnel will be added to this protocol.
- Describe the responsibilities, qualifications, and relevant experience of all new personnel.
Personnel will be leaving this protocol.
- Explain why personnel are leaving and the expected date of departure.
Principal investigator will be changing.
- Attach letter from original PI stating the change in responsibility.

Changes in Agencies

A new facility/agency will be involved in the research activities.
- What is the new facility and how will it be involved?
- Attach a letter of support for the research from the new facility on facility letterhead containing a statement that the agency will "review, abide by, and comply with the procedures approved by the Brandeis University Institutional Review Board."
A new funding agency will be involved in the research activities.
- List the funding source, grant title, agency award number, and Brandeis University/Olin College account number.

Modification to Study Description

Describe and justify proposed modification. Include a discussion of the effects on the risks and benefits to the subjects and the procedures that will be taken to manage the risk(s).
New or revised consent forms are attached, with changes highlighted.
New or revised study instruments are attached, with changes highlighted.
New or revised recruitment materials are attached, with changes highlighted.