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This document is a request form for the Children & Youth Institutional Review Board (CYIRB) to review modifications or changes made to an approved research protocol. It includes sections for principal

How to fill out cyirb amendment form

How to fill out CYIRB Amendment Form

1. Obtain the CYIRB Amendment Form from the appropriate source.
2. Fill in the project title and the principal investigator's name at the top of the form.
3. Provide the current version of the research protocol and highlight any proposed changes.
4. Include a detailed explanation for each amendment, specifying the reasons for the changes.
5. Attach any relevant documents that support the amendments, such as new consent forms or questionnaires.
6. Ensure all team members involved in the research review and sign the form, if necessary.
7. Submit the completed form to the appropriate Institutional Review Board (IRB) for review.

Who needs CYIRB Amendment Form?

1. Researchers who are conducting studies that require changes to previously approved protocols.
2. Institutions or organizations that are required to follow ethical guidelines when modifying research studies.

People Also Ask about

Can an IRB approved protocol be changed?

Changes in Research Requiring IRB Review Prior to implementation, the IRB must review and approve any modification to research activities or amendments involving changes to an IRB-approved protocol or document.

Can an IRB approved protocol be changed CPP?

Amend (modification): After IRB approval, when the PI(s) would like to change things to the approved protocol, they must submit an Amendment Submission. Renew: When the protocol is close to the expiration date, the PIs will receive notifications.

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 should you do if you deviate from the IRB approved protocol?

For non-exempt research, protocol deviations must be reported to the IRB within five business days of their occurrence or identification. If a protocol deviation meets the criteria of unexpectedness, relatedness to research, and increased risk, it should be reported to the IRB as an Unanticipated Problem.

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

For projects that were approved via expedited or full board reivew, you are required to submit an amendment for IRB approval for any proposed change to the: Study team members. Study protocol or procedures. Study documentation (e.g., informed consent, recruitment materials, survey instruments)

Is a change in the protocol that does not have prior approval of the IRB is considered to be a protocol?

A protocol deviation is defined as a variation from the IRB approved research plan that happens without prior review and approval of the IRB (e.g., study visit outside protocol window, blood work drawn outside protocol window, etc.). Protocol deviations can be major or minor.

How to amend an IRB?

How do I make a change to my 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.).

How long do IRB amendments take?

Amendment Request Instructions Your amendment will take 3-to 5 days for administrative preparation and 10-working days for IRB review. An amendment approval letter will be emailed as a PDF document to the researcher(s).

For pdfFiller’s FAQs

What is CYIRB Amendment Form?

The CYIRB Amendment Form is a document used to request modifications or updates to an existing research project that has been approved by the Colorado Multiple Institutional Review Board (CMIRB). It allows researchers to inform the review board of any changes that may affect the study's compliance with ethical standards.

Who is required to file CYIRB Amendment Form?

Researchers or principal investigators who have an ongoing study that has received prior approval from the CYIRB are required to file the CYIRB Amendment Form when they make changes to the study protocol, recruitment materials, informed consent documents, or any other relevant aspect of the research.

How to fill out CYIRB Amendment Form?

To fill out the CYIRB Amendment Form, researchers should provide detailed information about the proposed changes, including a description of the amendment, the rationale for the changes, and any impact on participant risk, consent processes, or study procedures. Specific sections of the form must be completed based on the type of amendment being requested.

What is the purpose of CYIRB Amendment Form?

The purpose of the CYIRB Amendment Form is to ensure that any modifications to an approved research study are reviewed for ethical compliance and regulatory standards. It helps maintain the integrity of the research and protects participant rights and welfare.

What information must be reported on CYIRB Amendment Form?

The CYIRB Amendment Form must report information such as the study title, principal investigator's name and contact information, the nature of the proposed changes, reasons for the amendments, any potential risks involved, and modifications to informed consent documents if applicable.