Post Approval Forms

Ethics Study Protocol Non-Compliance (Deviation or Violations) Report 

Use this form to document, explain, and report to the UIC REC any compliance from the approved protocol, whether minor or major deviations. The investigator may implement a deviation from the protocol to eliminate an immediate hazard (s) to study subjects without prior UIC REC approval but must submit as soon as possible a report of deviation or change, the reasons for it, and, if appropriate, an appropriate study protocol amendment (s).

Final Report Form 

Use this form to indicate that the study has been completed. This will serve as a summary of the outcome of the study, especially of the human participants who were involved, in the form of an end-of-study report. The Final report form should be submitted to UIC-REC before the final defense.

Reportable Negative Event Report 

Use this form to report negative events experienced by the researchers that involve personal safety issues (related to both research and research participants) in the conduct of research, such as sexual harassment, physical threats, stalking, and other hostile reactions. This report must be submitted without delay, ideally within one week. The UIC Research Ethics Committee (REC) will evaluate the situation and determine the appropriate course of action, which may include recommending the suspension of the study until the identified risks are adequately addressed, withdrawing ethical clearance, requiring a risk mitigation plan, mandating an amendment to the research protocol, or maintaining the original ethical clearance.

Progress Report 

Use this form to report progress in the protocols submitted to know the frequency based on the level of risk of the study. This form only applies to the study submitted that is ongoing or has ended.

Protocol Amendment

Use this form if you have changes or formal clarification regarding protocol and/or informed consent documents. 

Ethics Continuing Review Application Form

Use this form to renew or extend your ethical clearance if you have not yet collected your data beyond the specified period of Ethics Approval.  The researcher is required to submit this form three months prior to the expiry date. 

Ethics Early Study Termination Application Form 

Use this form to apply for early study termination when a study approved by the UIC REC is being recommended for termination before its scheduled completion. This is done when the safety of the study participant is doubtful or at risk and also upon the request of the PI or the sponsor owing to the existence of unresolvable valid complaints.