Guidelines for Defining Noncompliance:
Even though these types of events must be reported, the PI is encouraged to contact the IRB Chairperson and OSRP if anything occurs that causes concern regarding the protection of human participants.
Reporting of Problems or Noncompliance by the PI:
The PI must contact the IRB Chairperson via phone and/or e-mail immediately following an incident of injury, increase in risk, unanticipated risk, other adverse effects experienced by participants or others involved in research, or incident(s) of noncompliance. Additionally, the PI must submit a written report of the incident to the OSRP, care of the IRB Chairperson, as soon as possible thereafter, but no later than 5 working days after first awareness of the problem. If the incident is severe or increases the risk to participants or others, the PI may be asked to suspend research activities pending further review by the IRB and/or OSRP.