IRB Incident Report

for Unanticipated Problems

** All research activities must be suspended until the issues are resolved with IRB approval **


Student researchers: Your SEU faculty advisor is the responsible party who must complete and submit this form.


An unanticipated problem is any unexpected occurrence during IRB-approved research that increases risk to subjects. Federal regulations and the SEU IRB require the prompt reporting of research problems, incidents, or new risks to participants in an approved study. Reporting must occur via this form within five (5) business days of an event. Contact IRB@stedwards.edu with any questions.


Use this form when all of the following conditions are met:

  • the issue was not anticipated or foreseen (e.g. not described in the Consent form).
  • the issue involves risk or harm to research participant(s) or others.
  • the issue is probably or definitely related to or caused by the research.
 

Enter your protocol number below including zeros. Or type "Exempt" if applicable.

 

Enter the date this research protocol was approved by the SEU IRB.

 

If a student, your faculty advisor should be filling out this form for you.


Faculty advisors: provide your name/email under SEU Status when "Student" is selected, and indicate Acknowledgement at the bottom of this form by typing your full name.

 
 
 
 

If the research is being conducted for a specific class.

 
 
 
 

Does this unanticipated problem warrant immediate attention by the IRB and possibly others?

 

Select all that apply.

 

What occurred? What is your assessment of the increased risk or harm caused by this event?

 
 

Include the current status of the situation. If applicable, provide descriptions of the protocol violation or deviation.

 
 

Modifications request to an existing IRB protocol must be submitted separately via the IRB Application for Modifications or Continuing Review.

 
 

Follow up reports or any subsequent relevant information can be emailed separately to IRB@stedwards.edu.

 

 

Acceptable formats: all Microsoft Office files, .pdf, .jpg, and .zip.

Drop your files here
 

The SEU IRB will evaluate this report as soon as possible and, if necessary, refer to a Full Board review.

 

Acknowledgement

  • I have suspended all research activities under this protocol and will not resume until the IRB reviews and approves a resolution to the reported unanticipated problem(s).


  • I have personally reviewed each of the reported items and ensured accurate classification and description.


  • I understand my responsibility to provide follow-up information to the SEU IRB as it becomes available.
 
 

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.