Defining Noncompliance

Guidelines for Defining Noncompliance:

• Misuse or nonuse of approved informed consent procedures
• Failure to submit protocols in a timely manner
• Breaking confidentiality, unless required by law (e.g., child abuse)
• Unapproved subject recruitment activities
• Failure to secure confidential records in the required manner
• Failure to report problems involving physical or psychological injury to participants or others
• Failure to report risks to participants or others that exceed the protocol as approved
• Report from a subject of abuse by the PI or research staff
• Conducting research involving human participants that has never been approved by the IRB
• Initiating changes to research protocols involving human participants without prior IRB approval
• Continuing research activities beyond the IRB approved end date

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.