Get the free IRB Protocol Amendment/Addendum Form - wssu

Winston-Salem State University. Institutional Review Board. IRB Protocol Amendment/Addendum Form. IRB Protocol ...

How to fill out irb protocol amendmentaddendum form

How to fill out an IRB protocol amendment/addendum form:

1. Start by reviewing the instructions provided with the form. This will give you a clear understanding of the requirements and guidelines for completing the document.
2. Begin filling out the form by providing your study's title, protocol number, and your contact information. This ensures that the amendment/addendum is accurately associated with the correct study.
3. Next, you will need to explain the purpose of the amendment/addendum. Clearly describe the changes or additions you wish to make to the original IRB protocol.
4. Provide a detailed justification for the proposed changes. It is important to explain why these modifications are necessary and how they align with the ethical considerations and intended outcomes of your study.
5. If applicable, include any supporting documentation or references to further clarify and support your proposed modifications.
6. Remember to include any additional personnel who will be involved in the amended study. Provide their names, roles, and qualifications.
7. Indicate whether any consent documents or participant materials will require modifications as a result of the proposed changes. If so, explain how these documents will be updated and submit the revised versions.
8. Finally, review the completed form to ensure accuracy and completeness. Make sure all sections are properly filled out, and double-check for any errors or omissions.

Who needs an IRB protocol amendment/addendum form?

1. Researchers who have an ongoing study that requires modifications or additions to the original approved protocol need an IRB protocol amendment/addendum form.
2. Institutions and organizations that have established Institutional Review Boards (IRBs) for the ethical review and oversight of research involving human participants use this form to ensure researchers adhere to the required ethical standards and guidelines.
3. Participants involved in a study may also need to be informed and provide their consent to the proposed changes through the amendment/addendum form.

Note: It is important to consult with your specific institution or IRB for any additional requirements or guidelines regarding the completion and submission of an IRB protocol amendment/addendum form.

For pdfFiller’s FAQs

What is irb protocol amendmentaddendum form?

The irb protocol amendmentaddendum form is a document used to make changes to an existing research protocol approved by an Institutional Review Board (IRB).

Who is required to file irb protocol amendmentaddendum form?

Researchers and institutions conducting human subjects research that have an approved IRB protocol are required to file the irb protocol amendmentaddendum form.

How to fill out irb protocol amendmentaddendum form?

Researchers must provide details about the proposed changes to the existing protocol, rationale for the changes, and any potential impact on human subjects.

What is the purpose of irb protocol amendmentaddendum form?

The purpose of the irb protocol amendmentaddendum form is to ensure that any changes to an approved research protocol involving human subjects are reviewed and approved by the IRB to protect the rights and welfare of research participants.

What information must be reported on irb protocol amendmentaddendum form?

Researchers must report detailed information about the proposed changes, justification for the changes, potential risks and benefits to human subjects, and any new information that may impact the research.

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