What constitutes as non-compliance for Human Subject Research?
Non-compliance includes, but is not limited to: • 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
