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Office of Research and Sponsored Programs Administration

IRB Actions

IRB actions are taken when the required determinations are made that allows research involving human subjects to proceed consistent with federal regulations, state, and local laws, and university policy.

 Applying for Review

Review and approval by ÃÛÌÒÊÓƵ University IRB is required before starting research involving human subjects. The IRB is to ensure safe and ethical treatment of research participants.

Students: If your account says it is disabled, you MUST contact your faculty advisor.

 

  

 Modifying or Renewing an IRB

Are there changes in your approved IRB? If the answer is YES, then an IRB modification needs to be completed.

 

To modify your approved IRB, login in to Cayuse. On the IRB dashboard in the approved studies section click on your IRB. From the Study Details page click the blue box that says New Study and then in the drop down, click modification.

ÌýAll modifications and renewals must be approved by the IRB before any changes can be initiated.

ÌýClosure

When should an IRB study be closed?

An IRB study should be closed when all protocol indicated research activities including interaction with participants and collection of data or specimens are complete. To close an IRB study, simply login to Cayuse and complete an IRB study closure.

ÌýIncident Report

Unanticipated problems involving potential risk to participants or others must be reported to the IRB. A complete review of all violations will be conducted. Additional information may be requested and subsequent action may follow.

Major protocol violations include but are not limited to:

  • Harm, significant or substantive risk to the research participant.
  • Change to the participant's clinical or emotional condition or status.
  • Damage to the scientific completeness or soundness of the data collected.
  • Serious or continuing noncompliance with federal, state, or local regulations.
  • Breach of privacy or confidentiality
  • Changes to eliminate or reduce an apparent immediate hazard to the safety of participants.

Minor protocol violations include but are not limited to:

  • No harm or significant risk of substantive harm to the research participant.
  • No change in the participants clinical or emotional condition or status.
  • No damage to the completeness, accuracy and reliability of the data collection for the study.
  • No willful or knowing misconduct on the part of the investigator(s).
  • Non problematic or no significant potential harm to the research participants.
  • ÌýParticipant failure to initial every page of the consent form.
  • Study procedures conducted out of timeframe.