December 2020

PURPOSE of POLICY:

Federal regulations require that institutions engaging in human subjects research have written procedures to ensure investigators properly report certain events to the Institutional Review Board (“IRB”).  This policy defines those events that require prompt reporting the Johns Hopkins Medicine (JHM) IRB.  The policy applies to all research studies that are overseen by the JHM IRB. For studies involving JHM investigators where JHU has designated another IRB as the IRB of record, investigators must still report to the JHM IRB in accordance with this policy.

Please note that not all events require prompt reporting.  (See the organizational policy on continuing review for a description of the types of events that do not require prompt reporting, but that must be instead reported at the time of continuing review).

I. REPORTING TIMEFRAME

For the purposes of this policy, “prompt” means as soon as possible after the event is discovered, but in all cases within 10 working days after discovery of the event.

Reportable deaths must be reported within 72 hours after discovery.

II. WHAT EVENTS MUST BE PROMPTLY REPORTED TO THE IRB?

The following types of events must be promptly reported to the IRB:

A. UPIRSO: 

All potential “unanticipated problems involving risks to subjects or others”(“UPIRSO”).An event is considered an UPIRSO when it meets all of the following criteria:

(1) It is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the population being studied;

Unexpected events could be either medical or non-medical events.

(2)  It is related or possibly related to participation in the research ( i.e. there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research);

and,

(3) It places subjects or others [e.g. study team members or relatives of a subject] at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized

B. POTENTIAL SERIOUS OR CONTINUING NON-COMPLIANCE:    

Non-Compliance is defined by the Organization as the failure to follow the research protocol, federal, state, or local laws or regulations governing human subjects research, institutional policies, or the requirements or determinations of the IRB.  Only incidents that may qualify as serious or continuing non-compliance must be promptly reported:

(1) Serious Non-compliance is defined by the Organization as non-compliance that either (a) significantly harms or poses an increased risk of significant harm to subjects or others, or (b) significantly compromises the rights and welfare of the subjects or the integrity of the Organization’s human research protection program.

(2) Continuing Non-compliance is defined by the Organization as a pattern of non-compliance that significantly compromises the scientific integrity of the study or the rights and welfare of the subjects or the integrity of the Organization’s human research protection program.  When applying this definition, particular consideration may be given by the IRB to activity that recurs after a previous report has been evaluated by the IRB and corrective action has been instituted.

C. OTHER EVENTS THAT REQUIRE PROMPT REPORTING:

In addition the above, investigators must also promptly report the following:.

1) Unexpected adverse device effects (UADEs):

UADEs are defined as: “any serious adverse effect on health or safety or any life-threatening problem or death cause by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.”[1]

2) Potential Breaches of Confidentiality:  Any unauthorized disclosure of subject’s personally identifiable information.

Please Note: Potential breaches of confidentiality that involve protected health information (PHI) must also be reported promptly to the HIPAA Privacy Officer. Please see guidance for further detail.

3) Incarceration of a participant in a study not approved by the IRB to involve prisoners and the study team plans to continue study activities with prisoners while incarcerated.

4) Unresolved Subject Complaints:  Complaints of subjects when the complaint indicates unexpected risks or cannot be resolved by the research team.

5) Other events: There may be other events that should be promptly reportable to the IRB. If you have questions about whether an event is immediately reportable, please contact a Human Research Compliance Associate in the Office of Human Subjects Research.

Events that do not meet the above criteria should be summarized and reported to the IRB at the time of continuing review. Please see the companion reportable event guidance for additional information about the types of events that are reportable under this policy.

III. PROCEDURE FOR REPORTING TO IRB

The PI has the ultimate responsibility to review each event and determine if it meets any of the above reporting criteria. 

If the JHM IRB has ceded IRB review to an external IRB, it is the responsibility of the JHM PI to be familiar and comply with the external IRB’s policies and procedures for reporting, including its timelines for submissions.  In such cases, the JHM PI must also submit any events requiring prompt reporting to the JHM IRB in accordance with this policy.

Events that require prompt reporting shall be reported to the IRB via a Protocol Event Report (PER) in eIRB per the JHM timelines defined above and/or as defined by the external IRB if applicable.

IV. REVIEW OF EVENT AND INSTITUTIONAL REPORTING

Each PER will be reviewed by the IRB.   PERs may be referred to the Board that originally reviewed and approved the protocol. For events not specific to a single protocol or for which a protocol has not yet received IRB approval, they may be referred to the Executive IRB for review. Upon receipt, the event will be assessed to determine the level of review required. The IRB is authorized to take any actions necessary to address the event, including but not limited to:

1) Requiring modification of the study protocol, informed consent, or other aspects of the study;

2) Requiring notification of subjects;

3) Requiring monitoring or auditing;

4) Suspending or terminating the research;

5) Referring the event to organizational officials for their consideration;

6) Requiring further reporting of the event to regulatory agencies or sponsors.

As part of its review, the IRB is responsible for determining whether an event qualifies as an UPIRSO, Serious Non-compliance, and/or Continuing Non-compliance.  Only a convened IRB may make a formal finding that an event(s) constituted an UPIRSO, Serious Non-compliance, and/or Continuing Non-compliance.  Such findings require additional reporting by the Institution.  See policy 103.6a Organization Policy on Reporting.