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Westcliff IRB

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Addendums and Renewals

Adverse Events

Westcliff University policy requires principal investigators to promptly report any unanticipated deviation or adverse event related to the conduct of research regardless of the severity.

An unanticipated deviation or adverse event is defined as any potential for harm or risks to participants or others.

The Adverse Event must be reported within 10 days of the incident and all research activities must be suspended until the IRB has completed a review. Failure to adhere to these guidelines will be considered an act of noncompliance and the principal investigator could have their research suspended.

Adverse Event Form

Amendments to the Research Project

On occasion, the principal investigator may find it necessary to make a change in the initial research plan(s) proposed at the time of IRB certification. This includes changes or modifications to the consent form, recruitment procedures, or any other document/research activity related to an IRB certified research project.

The principal investigator must request the changes prior to implementation by submitting the Amendment to Original IRB Certification form to the IRB.

Amendment to Original IRB Certification Form

IRB Close-Out

The last step in the IRB process is submission of the IRB Close-Out Form by the principal investigator at the conclusion of the research project in accordance with federal regulations.

The form is completed after the final defense and is submitted as part of the final dissertation paperwork required before degree conferral.

For other research activities, it is submitted at the conclusion of the research project.

Submission is the responsibility of the principal investigator and faculty research supervisor.

IRB Close Out Form
Submit the IRB Close Out Form

Request for Extension of IRB Certification

IRB certification is valid for one year. It is the responsibility of the principal investigator to request an extension of certification at least 30 days before expiration.

No human participant research may take place after the initial certification expiration date until certification for continuation (i.e., recertification) is granted.

Failure to adhere to these guidelines will be considered an act of noncompliance and the principal investigator may have their research suspended.

Request an Extension