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This document is an annual review request for research projects approved by the UTB/TSC Biological Chemical Radiation Safety Committee, requiring the Principal Investigator or Project Manager to report

How to fill out request to continue approved

How to fill out Request to Continue Approved Research Protocol (Annual Review)

1. Begin by gathering all necessary documents related to the research protocol.
2. Open the Request to Continue Approved Research Protocol form.
3. Fill in the title of your research project at the top of the form.
4. Include your name and contact information in the designated fields.
5. Indicate the approval date of the original research protocol.
6. Provide a summary of the research outcomes achieved to date.
7. Detail any changes or updates to the research protocol since the last review.
8. Explain the rationale for continuing the research project.
9. Include any new risks or ethical considerations that have arisen.
10. Sign and date the form before submission.

Who needs Request to Continue Approved Research Protocol (Annual Review)?

1. Researchers who have an approved research protocol and wish to continue their study.
2. Institutional Review Board (IRB) members overseeing ongoing research projects.
3. Administrative staff managing research compliance and approvals.

People Also Ask about

What is the continuing IRB review required for?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

Is it not mandatory for IRB to review and approve the protocol?

IRB approval is typically required before research can begin. A study protocol must meet specific criteria to be approved by the IRB. First, the protocol must have a clear scientific purpose. Second, the protocol must be designed to minimize the risks to participants.

How long is IRB approval good for?

Most IRB approvals expire one year from the date of approval (exceptions may occur). However, some research may be considered EXEMPT from continuing IRB review and will not be required to submit a scheduled continuation review (renewal) application on an annual basis.

What is the continuing IRB review required for?

Continuing review provides the IRB with an opportunity to determine whether there is any new information that should be considered to represent such a significant new finding and therefore be communicated to subjects who have already enrolled in the research (e.g., important new toxicity information or new adverse

How long does IRB last?

For projects that required full-board review, it is the responsibility of the researcher to submit an annual update to the IRB. The first annual update is due twelve months following the date the protocol received IRB approval. Researchers will receive one notification regarding the due date of the annual update.

When should all ongoing research protocols be reviewed?

Most protocols will be reviewed every 12 months. However, the timeframe may be shortened by the IRB if the IRB determines that more frequent review is required. Possible reasons the IRB may require more frequent CR is if the protocol is high risk, or the protocol requires prompt modifications.

Does IRB expire?

The IRB sets the date for expiration of IRB approval, usually based on the risk level of a study. Current regulations specify that the period of time until expiration of IRB approval may be no more than one year.

How often does IRB-approved research have to be reviewed?

When an IRB approves a study, continuing review should be performed at least annually. All of the records listed in 21 CFR 56.115(a)(1) - (4) are required to be maintained. The clock starts on the date of approval, whether or not subjects have been enrolled.

For pdfFiller’s FAQs

What is Request to Continue Approved Research Protocol (Annual Review)?

Request to Continue Approved Research Protocol (Annual Review) is a formal process that researchers must follow to provide updates on their ongoing research studies, ensuring that they continue to meet ethical and regulatory standards for the duration of the study.

Who is required to file Request to Continue Approved Research Protocol (Annual Review)?

Researchers who have an approved research protocol and wish to continue their study beyond its initial approval period are required to file the Request to Continue Approved Research Protocol (Annual Review).

How to fill out Request to Continue Approved Research Protocol (Annual Review)?

To fill out the Request to Continue Approved Research Protocol (Annual Review), researchers should complete the designated form with updated information about the research study, addressing any changes in methodology, participant recruitment, and any issues encountered during the study.

What is the purpose of Request to Continue Approved Research Protocol (Annual Review)?

The purpose of the Request to Continue Approved Research Protocol (Annual Review) is to provide oversight and ensure that ongoing research complies with ethical guidelines and regulatory requirements, thereby safeguarding participant welfare and research integrity.

What information must be reported on Request to Continue Approved Research Protocol (Annual Review)?

The information that must be reported includes updates on research progress, data collection status, any adverse events or changes in the study protocol, and assurances of continued compliance with ethical guidelines.