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This document is used to submit amendments to a research study for approval by the Institutional Review Board (IRB) at Indiana University East. It includes sections for investigator information, amendment

How to fill out irb study amendment

How to fill out IRB Study Amendment

1. Start by reviewing the original IRB approval documents.
2. Identify the specific changes that need to be made to the study.
3. Complete the amendment form provided by the IRB.
4. Clearly describe each change in detail, including the rationale for each modification.
5. Update any necessary study materials, such as consent forms or questionnaires.
6. Gather any supporting documents that may be needed for the amendment.
7. Submit the completed amendment form and supporting materials to the IRB for review.
8. Respond to any additional questions or requests for clarification from the IRB.

Who needs IRB Study Amendment?

1. Researchers who are conducting studies that require any modifications to previously approved protocols.
2. Institutions that mandate compliance with IRB regulations for research involving human subjects.
3. Any study team member involved in the management of the research project.

People Also Ask about

Which of the following would require an amendment to be submitted to the IRB?

Changes to the following study documents, study information or policies require IRB review: Study protocol (by amendment, administrative letter, or any other format) Informed consent document or process. Participant recruitment plans including payments related to recruitment efforts.

How to write an IRB amendment?

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 is an IRB amendment?

An IRB Amendment is an online form completed in U-M's eResearch Regulatory Management (eRRM) system that provides a description of changes to an approved human subjects study. The amendment has two parts: Coversheet – used to identify the reason for the amendment and the IRB application sections to be changed.

What is an IRB modification?

The terminology used to describe a change to a protocol may vary, including terms such as modification, amendment or revision. All modifications to currently approved research studies are required to have IRB review and approval prior to implementation.

Do amendments involving changes to IRB approved protocol do not need prior IRB approval if?

Amendments involving changes to IRB-approved protocols do NOT need prior IRB approval if: The changes must be immediately implemented for the health and well-being of the subject.

What is an amendment involving changes to the IRB?

The IRB requires an amendment to note any changes related to an approved study. The Amendment application must describe the modification(s) requested including reasons for the change, whether the modification will increase or decrease the risk of harm to the subject, and whether the consent form requires modification.

When should you submit an amendment modification to your protocol?

If the protocol is intended as a longitudinal study or is operating within the planned study timeline and if changes are otherwise closely related to the previously approved study, then submitting an amendment is likely appropriate.

Which of the following would require an amendment to be submitted to the IRB?

Changes to the following study documents, study information or policies require IRB review: Study protocol (by amendment, administrative letter, or any other format) Informed consent document or process. Participant recruitment plans including payments related to recruitment efforts.

For pdfFiller’s FAQs

What is IRB Study Amendment?

An IRB Study Amendment is a formal request submitted to an Institutional Review Board (IRB) to make changes to an approved research study protocol, which may include modifications to the study design, procedures, participant recruitment methods, or any other aspect of the study that affects its conduct.

Who is required to file IRB Study Amendment?

The principal investigator (PI) or any member of the research team involved in the study is required to file an IRB Study Amendment whenever there are changes to the research study that might affect participant safety, the integrity of the study, or regulatory compliance.

How to fill out IRB Study Amendment?

To fill out an IRB Study Amendment, the investigator should provide detailed information about the proposed changes, including a description of the modifications, rationale for the changes, and any relevant supporting documents. The form should be submitted according to the IRB's specific guidelines and requirements.

What is the purpose of IRB Study Amendment?

The purpose of an IRB Study Amendment is to ensure that any changes to an approved study do not negatively impact the rights and welfare of participants, maintain compliance with ethical standards and regulations, and keep the IRB informed about ongoing research activities.

What information must be reported on IRB Study Amendment?

Information that must be reported on an IRB Study Amendment includes the specific changes being proposed, justifications for those changes, any impact on participant risk or benefits, and updates to recruitment methods or participant materials.