Westcliff IRB

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Addendums and Renewals

Amendments to the Research Project

On occasion, the principal investigator may find it necessary or prudent to make a change in the research plans proposed at the time of IRB certification. This includes changes or modifications to the consent form, or any other document related to an IRB certified research project.

The principal investigator must request the changes prior to any implementation by submitting the Amendment to Original IRB Certification (Appendix J) form to the IRB.

Adverse Events

Westcliff University policy requires principal investigators to promptly report any significant deviation (accidental or otherwise) or adverse event (regardless of severity) related to the conduct of research, regardless of the severity.

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

The Adverse Event Report must be filed within 10 days of the incident and all research activities must be suspended until the IRB has completed a review. Failure to report an adverse event is considered an act of noncompliance, subject to the actions and consequences.

To access the adverse event report, please click below.

Request for Extension of IRB Certification

IRB certification is typically valid for one year. No human participant research may take place after the initial certification expiration date unless or until certification for continuation (i.e., recertification) is granted. It is the responsibility of the principal investigator to request an extension of certification at least 30 days before expiration.

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

Please complete the extension form below.