1. Michelle Groy Johnson Quality Improvement Officer Research Integrity Office Houston, We have a Problem: When and How to Report Problems to the IRB

2. What do I report? Deviations from the approved protocol Unexpected problems Complaints from participants Serious adverse medical events

3. Protocol Deviations Examples: Unstamped version of the consent form used. Participant not consented prior to participation in study. Survey questions revised and administered without prior IRB approval. Participant given the wrong dose of study drug. Research team members added or removed without prior IRB approval. Additional recruitment emails sent without prior IRB approval.

4. Unexpected Problems Examples: Laptop with study data on it is stolen. Sponsor ships the wrong drug requiring alterations to the dosing schedule. A participant in a study not approved to use prisoners is incarcerated. Participants’ discomfort with study procedures are significantly greater than anticipated (that is, the risks are greater). A research team member inadvertently destroys the master code list linking participants to their data before data collection is complete.

5. Complaints Examples: Participant emails the PI after participating stating that a research team member wouldn’t let them have a bathroom break until s/he finished the questionnaire. Participant contacts the researchers after reading their article and states that, despite the use of a pseudonym, the descriptions are detailed enough that s/he feels identifiable. Participant in an MRI study contacts the PIs department chair accusing the PI of implanting a chip in his/her skull that transmits his/her thoughts to a computer. This procedure is not described in the protocol application or consent document.

6. Serious Adverse Events (SAEs) SAEs are medical events that are: Unanticipated Related or possibly related to the study Indicates increased risks

7. Serious Adverse Events (SAEs) Examples: Participant is given a dose of experimental anti-biotic then experiences anaphylactic shock. Participant in an experimental psychological intervention attempts suicide. Participant in a study of the effect of physical exercise on the morbidly obese experiences chest pains and is admitted to the hospital.

8. Corrective Actions The investigator must include a description of any corrective actions that have been initiated in the conduct of the research to prevent a reoccurrence of the problem or to protect research participants from potential or further harm.

9. How do I report? For researchers: Reporting Form for Internal or Local Medical Event, Incident or Occurrence (for SEAs) Reporting Form for Unexpected Problems or Events For participants: Complaint Form

10. When do I report? Report SAEs and unanticipated problems to the IRB within five (5) business days. Report SAEs that are fatal or life-threatening within forty-eight (48) hours.

11. What will happen after I report? Review of Report or Complaint by QIO Preliminary assessment Investigation? File review? Full IRB committee? Corrective actions Federal reporting? Implementation of corrective actions

12. Contact The Research Integrity Office 218 Ross Hall ~ Mail Stop 0331 Reno, NV 89557-0331 (775) 327-2368