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IRB protocols are approved for one year with the expiration date indicated on the investigator's app

IRB protocols are approved for one year with the expiration date indicated on the investigator's app 2025

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The document outlines the process for submitting an extension request for an Institutional Review Board (IRB) protocol at San Jose State University. It specifies that IRB approvals last for one year and must be renewed if data collection is to continue beyond the expiration date. The form requires details such as investigator information, protocol title, funding source, reasons for the extension, and any changes to the protocol. Additionally, it mandates a faculty member's signature if the investigator is a student.

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What happens if an IRB approval expires?

4) If an IRB approval expires, all research activities involving human subjects must stop, except those that meet very specific and limited criteria. All includes, but is not limited to, subject contact, data collection, and data analysis.

What to do after IRB approval?

After IRB approval, any subsequent changes to the study must be reviewed and approved by the IRB prior to implementation. This includes changes to the research team, recruitment process or material, consent procedures or materials, participant payment, data collection procedures, and target population.

How long is an IRB protocol valid?

If you are conducting your research in a medical setting or prison you will likely be required to submit your protocol to their IRB as well. You will need to leave additional time (up to a month) for each external IRB you are seeking approval from. IRB approvals are valid for one year.

When may an investigator implement a change in research without first obtaining IRB approval?

All changes in research must be reviewed and approved by the IRB before implementing the proposed modification, unless the change is designed to eliminate an apparent immediate hazard to subjects (45 CFR 46.103(b)(4)).

What must a PI do if approval for their IRB protocol expires?

If the protocols approval expires, the PI must submit a new application for IRB review. The research cannot continue until the IRB approves the new application (including subject enrollment, collecting data, etc.). If research continues beyond the expiration date, it is considered to be unapproved research.

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What are the consequences for not meeting IRB Institutional Review Board protocol requirements?

If IRB regulations are not followed, consequences could include: suspension of the research project or of all of a primary investigators research projects; inability to use or publish research results; notification of noncompliance to sponsors, regulatory agencies, and funding agencies; inability to receive federal

What is IRB approval date?

If the project is conditionally approved at a convened meeting, the date of IRB approval is the. date that the Chair or designee confirms that the conditions are satisfied. The date of expiration is one year (minus one day) from the date the Chair or designee confirms. that the conditions are satisfied.

IRB protocols are approved for one year with the expiration date indicated on the investigator's app 2025

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What happens if an IRB approval expires?

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