Transcript Houston, We have a Problem: When and How to Report

Houston, We have a Problem:
When and How to Report Problems to the IRB
Michelle Groy Johnson
Quality Improvement Officer
Research Integrity Office
What do I report?
Deviations from the approved protocol
Unexpected problems
Complaints from participants
Serious adverse medical events
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.
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.
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.
Serious Adverse Events (SAEs)
SAEs are medical events that are:
Unanticipated
Related or possibly related to the study
Indicates increased risks
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.
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.
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
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.
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
Contact
The Research Integrity Office
218 Ross Hall ~ Mail Stop 0331
Reno, NV 89557-0331
(775) 327-2368