Protocol Deviations/Violations

Protocol Deviation

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that is under the investigator's control and that has not been approved by the IRB. Upon discovery, the Principal Investigator is responsible for reporting protocol deviations to the IRB using the Deviation Report Form.

Examples:

• A research subject is scheduled by study personnel for follow-up visits and/or treatment outside of the protocol defined window only if this does not adversely affect the well-being of the subject or the scientific validity of the study.
• Enrollment of subjects beyond the number approved by the IRB.
• Study schedule of events is not followed, i.e. study questionnaires are administered out of order.
• Unapproved advertisements are utilized for recruitment

Protocol Violation

A protocol violation is a deviation from the IRB approved protocol that may affect the subject's rights, safety, or well being and/or the completeness, accuracy and reliability of the study data. Protocol Violations must be submitted for Full Board IRB review.

If the deviation meets any of the following criteria, it is considered a protocol violation.

The deviation has harmed or posed a significant or substantive risk of harm to the research subject.

Examples

• A research subject received the wrong treatment or incorrect dose.
• A research subject met withdrawal criteria during the study but was not withdrawn.
• A research subject received an excluded concomitant medication.

The deviation compromises the scientific integrity of the data collected for the study.

Examples

• A research subject was enrolled but does not meet the protocol's eligibility criteria.
• Failure to treat research subjects 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.
• Inadvertent loss of samples or data.

The deviation is a willful or knowing breach of human subject protection regulations, policies, or procedures on the part of the investigator(s).

Examples

• Failure to obtain informed consent prior to initiation of study-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 institutional human subject protection regulations, policies, or procedures

Examples

• Working under an expired professional license or certification
• Failure to follow federal and/or local regulations
• Repeated deviations.

The deviation is inconsistent with UMDNJ research, medical, and ethical principles.

Examples

• A breach of confidentiality.
• Improper destruction or removal of research records.
• Inadequate or improper informed consent procedure.

Protocol Deviations receive expedited review and are assigned to reviewers on a rolling basis.

The following must be included in the submission of a Protocol Deviation Report:

1 original and 2 copies of the Deviation Report Form and all supporting materials

If changes are to be made in the approved study protocol or documents in response to the deviation, then the following must also be included with the submission:

1 original and 2 copies of the Modification Request Form outlining what changes have been made and where.

1 original and 2 copies of all revised documents with proposed changes highlighted.

1 original of any revised documents with no highlighting for approval stamping.

Protocol Violations require full board review and are assigned to a full board meeting based upon date and time of submission to the IRB office.

The following must be included in the submission of a Protocol Violation Report.

1 original and 20 copies of the Deviation Report Form and all supporting materials

If changes are to be made in the approved study protocol or documents in response to the Violation, then the following must also be included with the submission:

1 original and 20 copies of the Modification Request Form outlining what changes have been made and where.

1 original and 20 copies of all revised documents with proposed changes highlighted.

1 original of any revised documents with no highlighting for approval stamping.

Following review, your Deviation/Violation will receive one of the following status determinations: Accepted or Non-Accepted. This determination will be provided to the principal investigator, outlining follow-up steps as deemed necessary by the committee.