Get the free IRB Amendment / Modification Request Form Principal Investigator ...

Page 1 of 3 IRB Amendment / Modification Request Form Principal Investigator: Address: Contact Number: Study Title: Study Number: Date: NOTE: NO CHANGES IN THE RESEARCH MAY BE IMPLEMENTED WITHOUT

How to fill out irb amendment modification request

How to fill out irb amendment modification request:

1. Obtain the necessary form: The first step is to obtain the IRB amendment modification request form. This form can typically be found on the website of the Institutional Review Board (IRB) or requested from the IRB office directly.
2. Read the instructions: Before filling out the form, carefully read the instructions provided. These instructions will outline the specific information required and any additional documentation that needs to be attached.
3. Provide study information: Begin by providing all the necessary study information, such as the title of the research project, the principal investigator's name, and the study protocol number. It's essential to accurately provide all the requested details to ensure proper identification of the study.
4. Describe the requested amendment: Clearly describe the amendment or modification you are requesting. This may include changes to the study design, enrolled population, recruitment methods, or any other relevant aspects. Be specific and provide sufficient detail to help the IRB understand the purpose and impact of the proposed amendment.
5. Justify the amendment: On the form, provide a clear justification for why the amendment is necessary. Explain how the proposed change will enhance the study or address any ethical concerns raised during the initial review. It's essential to articulate the rationale behind the amendment and demonstrate that it aligns with the principles of human subject research protection.
6. Attach supporting documents: In many cases, supporting documents may be required to accompany the amendment request. This can include revised consent forms, additional data analysis plans, or any other relevant material. Ensure that all attachments are complete, accurate, and labeled appropriately.
7. Submit the request: Once the amendment modification request form is completed, review it thoroughly for any errors or omissions. Make sure all required fields are filled out, all attachments are included, and the form is signed by the principal investigator. Submit the request to the IRB office following the specified submission instructions.

Who needs irb amendment modification request?

1. Researchers conducting studies involving human subjects: Researchers who have received approval from an Institutional Review Board (IRB) to conduct research involving human subjects may need to submit an IRB amendment modification request if they wish to make changes to the approved protocol. This request ensures that any modifications to the study design or procedures undergo appropriate ethical review.
2. Principal investigators and study coordinators: The responsibility for initiating and submitting an IRB amendment modification request typically rests with the principal investigator. However, study coordinators or other research team members may assist in preparing the request and gathering the necessary information.
3. Institutions with an IRB: Institutions that have established an IRB to oversee human subject research within their organization require researchers to submit an IRB amendment modification request when changes to the approved protocol are proposed. The IRB ensures that research is conducted ethically and in compliance with federal regulations and institutional policies.

For pdfFiller’s FAQs

What is irb amendment modification request?

IRB amendment modification request is a formal request made to the Institutional Review Board (IRB) to make changes to an approved research protocol.

Who is required to file irb amendment modification request?

Researchers conducting a study that has been approved by the IRB and wish to make changes to the approved protocol are required to file an IRB amendment modification request.

How to fill out irb amendment modification request?

To fill out an IRB amendment modification request, researchers must provide detailed information about the proposed changes to the protocol, justification for the changes, and any potential risks or benefits associated with the modifications.

What is the purpose of irb amendment modification request?

The purpose of an IRB amendment modification request is to ensure that any modifications to an approved research protocol are reviewed and approved by the IRB to protect the rights and welfare of research participants.

What information must be reported on irb amendment modification request?

The IRB amendment modification request must include details of the proposed changes, rationale for the modifications, potential risks and benefits, and any updated consent forms or study materials.

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