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- The deviation has harmed or posed a significant or substantive risk of harm to a research participant (this is also an unanticipated problem). Examples: A research participant received the wrong treatment or incorrect dose, A research
participant met withdrawal criteria during the research project but was not withdrawn, A research participant received an excluded concomitant medication.
- The deviation compromises the scientific integrity of the data collected for the research project. Examples: A research participant was enrolled but does not meet the protocol’s eligibility criteria.
- Failure to treat research participants per protocol procedures that specifically relate to primary efficacy outcomes (if it involves patient safety, it meets the first category above).
- Changing the protocol without prior IRB approval (except where necessary to eliminate an apparent immediate hazard to the participant).
- Inadvertent loss of samples or data.
- The deviation is a willful or knowing breach of human subjects’ research protection regulations, policies, or procedures on the part of the investigator(s). Examples: Failure to obtain informed consent prior to initiation of research
project-related procedures, Falsifying research or medical records.
- Performing tests or procedures beyond the individual’s professional scope or privilege status (credentialing).
- The deviation involves a serious or continuing noncompliance with federal, state, local, or University human subjects research protection regulations, policies, or procedures. Examples: Working under an expired professional license
or certification,Failure to follow federal and/or local regulations and intramural research or University policies, Repeated minor deviations, The deviation is inconsistent with the IREC’s research, medical, or ethical principles.
- A breach of confidentiality.
- Inadequate or improper informed consent procedure.