Adverse Event and Protocol Deviation Reporting Policy

1. Definitions
2. Investigator Reporting Requirements
3. IRB Review of Adverse Events

It is the responsibility of the Principal Investigator to assess events that occur during the course of a research protocol, and determine which of the following descriptions apply. The IRB will review reports and make a final determination, indicating agreement or disagreement with the P.I.'s assessment, and why.

1. Definitions

   An Adverse Event is an event that occurs during the course of a research protocol that either causes physical or psychological harm, or increases the risk of physical or psychological harm, or results in a loss of privacy and/or confidentiality to a research participant or others (such as family members).

   An Anticipated Adverse Event is one that is reasonably expected and/or listed in the protocol and consent form as a possible risk of participating in the research.

   An Unanticipated Adverse Event is one that was not reasonably expected and/or is not listed in the protocol and consent form as a possible risk of participating in the research.

   A Serious adverse event is one whose magnitude or frequency is above expectation.

   A Related adverse event is one that, in the opinion of the investigator, is likely caused by or affects the research.

   A Protocol Deviation is an incident involving non-compliance with the approved protocol, but typically does not have a significant effect on the integrity of the research or on the subjects' rights, safety or welfare. Protocol Deviations are to be reported to the Institutional Review Board (IRB) using the Protocol Deviation Report, IRB-6 Form.

2. Investigator Reporting Requirements

   Using the Adverse Event Report, IRB-4 Form, Investigators are required to report to the IRB the serious and related events, when discovered during the course of research and no later than 2 working days after their occurrence. All other events must be reported within 5 working days after their occurrence. This policy applies to events that occur at UConn or off-campus site. Examples of serious and related adverse events are:

   1. The death of a research subject;
   2. Any change to the protocol made without prior IRB review to eliminate apparent immediate hazard to a research participant or others;
   3. Any event that requires prompt reporting according to the protocol or the sponsor;
   4. A serious breach of privacy or confidentiality of research subjects or others (such as family members);
   5. Any publication in the literature, safety monitoring report, interim result, or other finding that indicates an unexpected change to the risks or potential benefits of the research;
   6. Any complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff;
   7. Any other event or other problem which, in the opinion of the Principal Investigator, was (1) previously unforeseen and (2) presents risks to research subjects or others;
   8. This policy applies to events that occur at UConn or at an off-campus site.

3. IRB Review of Adverse Events

   Adverse Event Report Forms are reviewed by the IRB Chair or a designated IRB member. Anticipated Adverse Events will be reviewed by the IRB Chair or a designee of the Chair within 5 working days of receipt of the report. If it is determined that the event did not represent an unanticipated problem involving risks to participants or others, a letter of acknowledgement is sent to the Principal Investigator, and the report is filed.

   If an Adverse Event is serious, related and unanticipated, the IRB Chair or designated IRB member(s) will review the report within 5 working days of receipt of the report, and determine whether the event requires review by the full board. All adverse event reports requiring full board review will be placed on the agenda for the next fully convened meeting of the IRB. IRB members will be provided with a copy of the report and all supporting documentation to review. Pending review by the full board, the IRB Chair and reviewing member(s) will determine whether immediate action, such as suspension of new enrollment or termination, is warranted.

   The IRB votes on whether the event is an Unanticipated, Serious or Related Adverse Event involving risks to participants or others, and the determination of the IRB is recorded in the minutes. If the IRB determines that an event is an Unanticipated Adverse Event involving risks to participants or others, the procedures outlined in the section of the University's IRB Policies and Procedures entitled "Reporting of IRB Findings to Federal Agencies" will be followed, and the IRB will consider taking the following actions:

   1. No action;
   2. Modification of the research protocol;
   3. Modification of the information disclosed during the consent process;
   4. Additional information provided to past participants;
   5. Notification of current participants (required when such information may relate to participants' willingness to continue to take part in the research);
   6. Requirement that current participants re-consent to participation;
   7. Modification of the continuing review schedule;
   8. Monitoring of the research;
   9. Monitoring of the consent;
   10. Suspension or termination of the research;
   11. Confiscation of data;
   12. Referral to other organizational entities (e.g., Assistant Attorney General, Dean, Department Head, Institutional Official, or the Office of Sponsored Programs).

   If no action is required, a letter of acknowledgement will be sent to the Principal Investigator, and a copy of the letter filed in the protocol file. If the IRB takes any actions or imposes any requirements, the actions and requirements are documented in the minutes and in a letter to the Principal Investigator.