Get the free IRB Addendum/Modification Request Form - valenciacollege

This form is used by internal and external investigators to request modifications or addendums to an already approved research protocol by Valencia College's Institutional Review Board (IRB).

How to fill out irb addendummodification request form

How to fill out IRB Addendum/Modification Request Form

1. Obtain the IRB Addendum/Modification Request Form from your institution's IRB website or office.
2. Complete the project title and principal investigator information at the top of the form.
3. Describe the proposed modifications in detail, including any changes to the research procedures, participant information, or recruitment methods.
4. Provide a rationale for the modifications, explaining why they are necessary.
5. If applicable, include new or updated consent forms that reflect the proposed changes.
6. Indicate any changes in risks to participants and how they will be mitigated.
7. Review the entire form for completeness and accuracy.
8. Obtain necessary signatures from the principal investigator and any co-investigators.
9. Submit the completed form to the designated IRB office, following your institution's submission guidelines.

Who needs IRB Addendum/Modification Request Form?

1. Researchers who are conducting studies approved by the IRB and need to make changes to their protocols.
2. Principal investigators seeking to modify any aspect of their IRB-approved research.
3. Any study team member who is responsible for ongoing compliance and wishes to amend study procedures.

People Also Ask about

How to submit an IRB modification?

Consent Document Changes Click “IRB” in the top left navigation area and select the Active tab. Click the name of the approved study. Open a new Modification submission. Click the Documents tab. Click the consent form in the Final column and save it to your computer.

How do I submit an IRB modification?

To submit a change to your approved IRB protocol: Submit an amendment form explaining the changes being made. Submit an updated application with the changes underlined. Submit any other documents that require updating due to the changes being made (informed consent(s), recruitment materials, etc.).

What requires an IRB amendment?

A principal investigator may not implement any changes to an approved study (including to the protocol or informed consent document) without prior IRB review and approval, unless the change is necessary to eliminate apparent immediate hazards to the subjects.

Can an IRB approved protocol be changed?

An amendment to an existing approved Institutional Review Board (IRB) protocol is viewed as any change to what was previously approved during the period for which approval was given. Amendments are categorized as either major or minor and are distinguished based on the type of changes proposed.

How do I submit something to the IRB?

To prepare for a submission to the IRB, the investigator must generally develop a protocol (not required for studies that meet the criteria for exemption), any relevant consent form(s), recruitment materials (written or printed in alternative media, as applicable), and complete the IRB's electronic application in eIRB.

For pdfFiller’s FAQs

What is IRB Addendum/Modification Request Form?

The IRB Addendum/Modification Request Form is a document used to request changes or additions to an existing Institutional Review Board (IRB) approved research protocol.

Who is required to file IRB Addendum/Modification Request Form?

Any researcher or principal investigator who wishes to modify an approved research protocol must file an IRB Addendum/Modification Request Form.

How to fill out IRB Addendum/Modification Request Form?

To fill out the IRB Addendum/Modification Request Form, provide relevant information about the proposed changes, including the specific modifications being made, their justification, and any potential impact on the study.

What is the purpose of IRB Addendum/Modification Request Form?

The purpose of the IRB Addendum/Modification Request Form is to ensure that any changes to the research protocol are reviewed and approved to maintain compliance with ethical standards and regulations.

What information must be reported on IRB Addendum/Modification Request Form?

The information that must be reported includes details of the proposed modifications, rationale for the changes, any new risks to participants, and how the modifications affect the original study design.