Get the free Request for Continuing IRB Approval Part 1 Administrative - lmunet

Request for Continuing IRB Approval Part 1 Administrative Information 1. Protocol Information LMU IRB #: Title: Protocol approval date: 2. Contact Information 2.1. Principal Investigator (PI) Name:

How to fill out request for continuing irb

How to fill out a request for continuing IRB:

1. Start by obtaining the necessary forms. Visit the website of your institution's Institutional Review Board (IRB) or contact them directly to obtain the specific forms required for requesting continuing IRB approval.
2. Read the instructions carefully. Before filling out the request form, thoroughly review the provided instructions. Pay attention to any specific requirements, guidelines, or deadlines mentioned.
3. Provide your study information. Begin the request form by providing the necessary details about your research study. This may include the study title, investigator(s) involved, study objectives, and a brief summary of the study procedures.
4. Indicate the duration of your request. In the request form, specify the time period for which you are seeking continuing IRB approval. This period should align with the anticipated duration of your study or any changes made since the initial IRB approval.
5. Describe any modifications made. If any changes have been made to the study since the initial IRB approval, clearly explain these modifications in detail. This includes any changes to the study design, recruitment procedures, informed consent process, or data analysis methods. Provide justification for each modification and describe how it aligns with ethical considerations.
6. Address participant safety and confidentiality. In the request form, outline the measures you have taken or will take to ensure participant safety and maintain confidentiality. This may involve explaining the steps taken to minimize risks, protect privacy, and secure any sensitive data collected during the study.
7. Discuss any adverse events. If any adverse events or unanticipated problems have occurred during the study, describe them in the request form. Provide a detailed analysis of each event, including actions taken to address the issue, any changes made to the study protocol, and any additional measures implemented to prevent recurrence.
8. Include supporting documentation. Attach any necessary supporting documents to your request form. This may include updated informed consent forms, recruitment materials, questionnaires, or any other relevant documents.
9. Obtain required signatures. Ensure that all required signatures are obtained before submitting the request form. This may include signatures from principal investigators, co-investigators, and department heads or supervisors, depending on your institution's requirements.

Who needs a request for continuing IRB?

1. Researchers conducting human subjects research. If you are involved in conducting research involving human participants, you likely need to submit a request for continuing IRB approval. This ensures that your study continues to meet ethical standards and participant safety and maintains compliance with the IRB regulations.
2. Institutions with an IRB oversight. Any institution that oversees research involving human subjects is responsible for ensuring compliance with ethical guidelines. Therefore, researchers affiliated with these institutions need to submit a request for continuing IRB to maintain approval for their studies.
3. Studies with a prolonged duration or modifications. Research studies that extend beyond the initial approval period or have undergone significant modifications since the initial approval require a request for continuing IRB. This helps the IRB evaluate whether the ongoing study still meets ethical standards and ensures the protection of participants.

Note: The specific requirements for a request for continuing IRB approval may vary depending on your institution and the nature of your research study. It is always important to refer to your institution's IRB guidelines and seek guidance from your institution's IRB office if you have any specific questions or concerns.

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What is request for continuing irb?

A request for continuing IRB is a formal application submitted to continue a research project that has been approved by an Institutional Review Board (IRB).

Who is required to file request for continuing irb?

The Principal Investigator of the research project is typically responsible for filing the request for continuing IRB.

How to fill out request for continuing irb?

The request for continuing IRB form can usually be filled out online or by submitting a paper application to the IRB office. The form typically requires information about any changes to the research protocol, recruitment methods, or risks to participants.

What is the purpose of request for continuing irb?

The purpose of the request for continuing IRB is to ensure that the research project continues to meet ethical standards and that the rights and welfare of research participants are protected.

What information must be reported on request for continuing irb?

Information that must be reported on the request for continuing IRB includes any changes to the research protocol, recruitment methods, risks to participants, informed consent process, and any adverse events that have occurred.