REVIEW OF EVENTS AND PROBLEMS

This procedure describes the process followed by the IRB to ensure prompt reporting of unanticipated problems, adverse events, or protocol deviations involving risks to participants or others to the IRB, institutional officials and regulatory agencies.

Definitions

            The following definitions are used in this policy:

Protocol deviation is an incident involving non-compliance with the approved protocol, but typically does not have a significant effect on subjects’ rights, safety or welfare, or the integrity of the study.

Related event is an event that in the opinion of the investigator is more likely than not to be caused by or affects the research procedures.

Unanticipated problem involving risks to subjects or others is an event that includes any incident, experience, or outcome that meets all of the following criteria:

Adverse event is any untoward or unfavorable medical occurence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the research.

Unexpected adverse event is an adverse event occurring in one or more subjects participating in a research protocol, the nature, severity, or frequency of which is not consistent with either:

1. the known or foreseeable risk of adverse events associated with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved research protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts; or

2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event.

Serious adverse event is any event that results in death; is life-threatening and places the subject at immediate risk of death from the event as it occurred; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or based upon appropriate medical judgment, may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.

Expected adverse event is an adverse event that does not meet the criteria for an “unexpected event.”

Investigator Reporting Requirements

Investigators are required to report to the Institutional Review Board (IRB) the following using the Full Unanticipated Problem and Adverse Event Problem Report Form when discovered during the course of research and no later than 5 working days after their occurrence:

1. Unexpected AND related adverse events (on-site or off-site)

2. The death of a research subject on site

3. Unanticipated problem that is a serious adverse event (on-site or off-site)

4. Any complaint of a participant that indicates an unanticipated risk or which cannot be resolved by the research staff

5. Any other event or other problems which in the opinion of the principal investigator was (1) previously unforeseen and (2) presents risks to research subjects or others

6. Any event that requires prompt reporting according to the protocol or the sponsor

Investigators are required to report to the Institutional Review Board (IRB) the following using the Protocol Deviation Report Form  when discovered during the course of research and no later than 5 working days after their occurrence:

1. Protocol deviations that may affect the safety of research participants

2. Protocol deviations that have the potential to recur

3. Any change to the protocol taken without prior IRB review to eliminate apparent immediate hazard to a research participant

4. 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

Events that do not meet the above reporting requirements, but which sponsors request Investigators to report to the IRB, should be logged on a Tracking Form of Unanticipated Problems and Adverse Event Report Form and submitted to the IRB as soon as possible.  Multiple events can be reported on a single form, with the IND or manufacturer’s safety report attached.  If the investigator answers “yes” to the following three questions on the form, a Full Unanticipated Problem and Adverse Event Problem Report Form must be filled out and submitted for that event: 1.  Did the event place subjects at greater risk of harm than was previously known or recognized?  2.  Was the event unexpected?  3.  Was the event related to study drug/device or procedure?

IRB Review of Reported Events

The Chair of the IRB or a designated member reviews all reports.  If the IRB Chair determines that the event did not represent an unanticipated problem involving risks to participants or others, the chair signs and dates the report and the report is filed.

If the IRB Chair or designated member determines that an event might represent an unanticipated problem involving risks to participants or others, and related to the investigation, the chair signs and dates the report. The IRB Administrator places the item on the agenda for discussion and provides all IRB members with a copy of the report, all supporting documentation to review, and a copy of the current consent document.  The IRB Chair will review the information, or a primary reviewer is assigned who is given a copy of the currently approved protocol and investigator’s brochure.  The IRB Chair determines whether to ask the Principal Investigator to present the report.

The IRB votes to determine whether the event is an unanticipated and related problem involving risks to participants or others and the determination of the IRB is recorded in the minutes.  If IRB determines that an event is an unanticipated problem involving risks to participants or others, the IRB administrator will follow the procedures outlined in “Reporting of IRB Findings to Federal Agencies.”

If IRB determines that an event is an unanticipated and related problem involving risks to participants or others, it will consider 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.    Referral to other organizational entities (e.g., legal counsel, risk management, or institutional official)

If no action is required, a copy of the fully executed reporting form is sent to the Principal Investigator, and the original document is filed in the protocol file labeled “Safety Reports and Unanticipated Adverse Events”.  If the IRB takes any actions or imposes any requirements, the IRB Administrator documents those actions and requirements in the minutes and in a letter to the Investigator.

Reporting Adverse Events to Federal Agencies

The Chairman or the Administrator of the IRB will report to the OHRP, and if applicable, to the FDA, and inform the signatory of the FWA, within 48 hours of any unanticipated problems involving risk to human subjects or others that occur at this site. 

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