Exception & Deviation Policy

Title: Protocol Exceptions and Deviations
Date: May 20, 2021

Purpose

The purpose of this policy is to outline the procedure for reporting and reviewing protocol exceptions and protocol deviations.

Defined Terms

Deviation: Any change/alteration to the Charles River Campus IRB-approved protocol without prospective IRB approval.

Major Deviation: Any change/alteration that has the potential to: 1) adversely affect the rights, welfare or safety of the subjects, 2) adversely affect the integrity of the research data, or 3) affect the subject’s willingness to participate. Examples of a major deviation include:

1. Failure to obtain informed consent or assent
2. Obtaining informed consent after study procedures are initiated
3. Performing study procedures that have not been approved by the IRB and may adversely affect the rights, welfare and/or safety of subjects
4. Enrolling a prisoner into the study if the study is not approved to enroll prisoners
5. Failure to report serious adverse events and unanticipated problems to the IRB, Sponsor, and other agencies as outlined in the study protocol and IRB policies and procedures
6. Enrollment of a subject who did not meet the inclusion/exclusion criteria if enrollment adversely affects the rights, safety and/or welfare of those subjects

Minor Deviation: Any change/alteration that has not or does not have the potential to: 1) adversely affect the rights, welfare or safety of the subjects, 2) adversely affect the integrity of the research data, or 3) affect the subject’s willingness to participate in the study. Examples of minor deviations include:

1. Over-enrollment
2. Use of an expired consent form that includes all the required information and elements of informed consent
3. Study visits/procedures that are either omitted, conducted outside of the visit window or in a different order than specified in the protocol that do not affect or have the potential to affect subject safety or data integrity
4. Failure to submit continuing review to the IRB before study expiration
5. Inappropriate documentation of informed consent (e.g. missing signatures, missing dates, copy not given to the subject)

Exception: A one time, intentional change/alteration to the IRB-approved protocol that is approved by the IRB prior to implementation.

Policy

Federal regulations require that the IRB review all changes to an approved research study and ensure that these changes are not initiated without prior IRB review and approval except when necessary to eliminate immediate hazards to the subject; any change that falls outside of this description is considered a deviation. Changes made to the research without prior IRB approval in order to eliminate apparent immediate harm should be reported to the IRB within 5 working days.

Major deviations should be reported to the IRB within 5 working days. Minor deviations should be reported to the IRB within 20 working days. The investigator is responsible for making an initial determination of whether the deviation is major or minor.

When a Principal Investigator (PI) anticipates a one-time change/alteration to the IRB-approved protocol, a protocol exception should be submitted to the IRB for review and approval prior to implementation. If it is expected that this exception may occur more than once, an amendment to the protocol should be submitted instead of a request for an exception.

This policy applies to:

• Full Board Studies
• Expedited Studies
• Exempt Studies which required limited IRB review when the exception or deviation affects  the privacy of the subjects and/or the confidentiality of the data

Procedures

Investigator Submission of Deviation or Exception:

The PI is responsible for completing the Event Form and submitting it to the IRB Office via email (irb@bu.edu) within the timeline listed above. The PI must additionally report deviations/exceptions to the Sponsor and other applicable agencies as required by their sponsor agreements.

IRB Office Screening of Submissions:

When received, the IRB Coordinator will screen the Event Form for completeness. If information/material is missing, the IRB Coordinator will request this information/material from the PI. The Event Form will be given to the IRB Analyst responsible for the reviews of the PI’s Department.

IRB Review of Events:

IRB Analysts will review the Event Form and the protocol using the appropriate Reviewer Checklist to make an initial determination of whether the Event is a Deviation or an Exception. Minor Events including, but not limited to, over-enrollment, lapsed approval, etc. may be reviewed by the IRB Analyst using expedited procedures. Other Events will be forwarded to the IRB Director for review.

The IRB Director will provide an assessment of whether to review the Event using expedited procedures or at a convened meeting. The IRB Director will consult with the IRB Chair if there is uncertainty regarding whether an Event may be reviewed by expedited procedures, or if it should be reviewed by the convened IRB. Ordinarily, Major Events will be referred to the convened IRB for review. If reviewed by the convened IRB, the Chair or other IRB members may serve as Primary Reviewer and a Secondary Reviewer may also be assigned. If additional expertise is needed, the IRB Analysts, IRB Director or Chair will contact the appropriate IRB member or an external source for consultation. For all Major deviations, the convened IRB will determine if the Event meets the definition of Serious and/or Continuing Non-compliance, and if so, the Event will be processed as outlined in the “Non-compliance Policy” and “Reporting Policy.”

Events may require corrective action plans. Most corrective action plans are developed by the PI and described in the Event Form. The IRB (whether via expedited procedures or at a convened meeting) will review the corrective action plans to determine if the plan is appropriate. The IRB may approve the corrective action plan and may also determine that additional corrective action is required. The range of corrective actions include, but are not limited to:

1. Education of the PI and/or research team
2. Modifications to the protocol
3. Notification of current and/or past subjects
4. More frequent IRB review
5. Additional monitoring
6. Prohibit use of study data
7. Suspension of the Study
8. Termination of the Study

Events reviewed by Expedited procedures will be reported to the IRB at the next convened meeting.

Regardless of the type of review the Event receives, the IRB Analyst will communicate the determination to the PI via letter within 5 business days.