How should investigators handle subject complaints?

Frequently Asked Question

Occasionally, while conducting a research study, subjects may log formal complaints with the study team regarding incidents that occur while they are participating in the study. Below is guidance on the 2 ways subject complaints can be reported to the IRB:


Subject complaints that are minor, NOT unexpected and have resolved without incident can be reported at the next Continuing Review under the Question 4.1 in the “Reportable Events: Other” section.


Subject complaints that involve any unanticipated aspects; such as:

  • The study team is having difficulty resolving the issue
  • The study team is unsure of how to resolve the complaint
  • The complaint involves a previously unknown risk/problem with the study
  • The study team has been in contact with patient relations and patient relations is requesting the study team issue a formal apology to the subject

These types of complaints should be reported to the IRB within 14 business days of the PI becoming aware of the complaint via an Unanticipated Problem report.

If you have any questions regarding subject complaints or this FAQ please contact

Keywords:FAQ unanticipated problem   Doc ID:38417
Owner:Monica E.Group:Health Sciences IRBs
Created:2014-03-13 11:43 CSTUpdated:2016-12-22 12:02 CST
Sites:Health Sciences IRBs
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