Get the free Institutional Review Board Amendment Request Form - Virginia Tech - scholar lib vt

Institutional Review Board Amendment Request Form INSTRUCTIONS: Email completed form and all revised and/or new study documents to IRB VT.edu (PDFs preferred). Note: The project’s IRB-approved Research

How to fill out institutional review board amendment

How to fill out an institutional review board amendment:

1. Start by reviewing the current institutional review board (IRB) amendment form provided by your institution. This form will outline the specific sections you need to complete and any supporting documents required.
2. Carefully read and understand the instructions provided with the amendment form. It is crucial to follow these instructions to ensure your submission is complete and accurate.
3. Begin by filling out the required general information section of the amendment form. This typically includes details such as the project title, the primary investigator's name, contact information, and the date of submission.
4. Next, provide a brief summary of the proposed amendments. Clearly explain what changes need to be made to the existing research protocol and why they are necessary.
5. If applicable, include any additional documentation required to support your proposed amendments. This could include revised consent forms, updated recruitment materials, or any other relevant documents. Make sure these documents are neat, organized, and clearly labeled.
6. Address any potential risks or ethical concerns associated with the proposed amendments. Explain how you plan to mitigate these risks and ensure the safety and well-being of participants.
7. If there is a need for additional resources or budgetary changes due to the proposed amendments, clearly outline these in the appropriate section of the form.
8. Review the completed amendment form thoroughly to ensure all the necessary information is provided and there are no errors or omissions. It may be helpful to have a colleague or mentor review the form as well.
9. Submit the filled-out amendment form along with any supporting documents to the relevant IRB office or committee as per your institution's guidelines.
10. After submission, regularly check the status of your amendment and promptly address any additional inquiries or requests for information from the IRB.

Who needs an institutional review board amendment?

1. Researchers conducting studies involving human subjects or animals typically need an institutional review board (IRB) amendment if any changes are made to the approved research protocol.
2. Researchers who have received prior approval from an IRB for their study but wish to modify aspects such as study procedures, participant eligibility criteria, data analysis methods, or the research team may need an amendment.
3. Institutions and research organizations often require IRB amendments for any proposed changes that could potentially impact participant safety, consent procedures, ethical considerations, or study outcomes.
4. It is crucial to consult your institution's IRB policies and guidelines to determine when an amendment is necessary. Additionally, researchers should seek guidance from their IRB office or committee if they are unsure about the need for an amendment.

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