Reportable Events Help


Regulatory NonCompliance


Choose the “Regulatory Noncompliance to report noncompliance with IRB paperwork submission errors/oversights involving the protocol, informed consent, and other regulatory paperwork associated with the study. 

 Examples of regulatory compliance include, but are not limited to, the following:

  • Inadvertent oversight or delinquent timing in submitting a revision or SAE received from the study sponsor to the IRB within a specified timeframe
  • Failure to report SAEs, unanticipated problems or deviations to the IRB/sponsor
  • Use of the incorrect version of the ICF to enroll subjects
  • Use of the incorrect protocol version/forms for research related activities
  • Failure to obtain and/or document a subject’s Informed Consent (provided the IRB has not granted a waiver i.e. Informed Consent is required, but study procedures are initiated prior the consent form being signed, or an informed consent form is never signed).
  • Failure to retain copies of signed Informed Consent forms (e.g. the PI lost one or more consent forms while moving offices, or cannot produce a signed consent form for all subjects enrolled in the study, etc.).
  • Conducting research (including data collection) without active IRB approval (including after expiration of the protocol).
  • Enrolling subjects without active IRB approval for the protocol (either prior to initial approval or during a period of expired approval).  Includes research approved with a waiver of consent, such as survey or medical record research.
  • Implementing a project revision without prior IRB approval (unless to protect the subjects against harm). 
  • Implementing planned protocol variations/exceptions without obtaining prior IRB approval – e.g. enrolling a subject who does not fit the inclusion/exclusion criteria specified in the protocol without prior IRB approval, continuing treatment on a subject who has met the definition of withdrawal per protocol.
  • Recruiting/enrolling subjects at a location or in a manner that has not been previously approved.
  • Conducting your research at a site or involving outside investigators without prior IRB approval.

Regulatory Non-Compliance can lead to protocol deviations and/or adverse events, so it would not be uncommon to have (3) reportable events submitted at the same time.  In myIRB you can select all applicable categories as needed.


Protocol Deviation: risk to subjects or research integrity (Major Deviation)


 A deviation is any alteration/modification to study conduct within the IRB approved study without IRB approval on behalf of the PI or study staff.  The term “study” encompasses all IRB-approved materials associated with the research including the protocol, protocol procedures, consent form, recruitment materials, questionnaires, and any other information relating to the research study.

 Deviations are broken in to two types: major and minor

 Major Protocol Deviations have the potential to negatively impact:

  • the rights and welfare of the research subject,
  • subject safety (increase risks and/or decrease benefits to study subjects)
  • the subject’s willingness to continue to participate in the study, or
  • integrity of research data

 Submit these deviations to the IRB within 5 days of the occurrence or learning of the occurrence via Reportable Event in myIRB.

Minor Protocol Deviations do not have the potential to negatively impact:

  • the rights and welfare of the research subject,
  • subject safety (increase risks and/or decrease benefits to study subjects)
  • the subject’s willingness to continue to participate in the study, or
  • integrity of research data

 Submit these deviations to the IRB annually via the Minor Deviation Tracking Log that is uploaded with each Continuing Review.

Examples of Major Deviations include but are not limited to the following:

  • Administering the incorrect dose of study medication.
  • Failure to implement all protocol procedures resulting in increased risk or decreased benefit to the subject.
  • Enrolling a vulnerable subject population without receiving prior IRB approval.
  • Enrolling ineligible subjects who have then gone on to receive study procedures
  • Implementing extra protocol procedures without IRB approval
  • Non-IRB approved research staff engaged in the research
  • Over enrollment of subjects

Examples of Minor Deviations include but are not limited to the following:

  • Study procedure conducted out of timeframe, and did not pose risk to subject
  • Study visit out of timeframe, and did not pose risk to subject
  • Participant failure to initial every page of the consent form
  • Not all lab work ordered on a given visit, and did not pose risk to subject
  • Copy of consent form not given to participant during informed consent process
  • Participant failure to return diary
  • Missing original signed consent, but have a copy of the participant signed consent


Adverse Event that is Serious and Unexpected


A serious and unexpected adverse event is any untoward or undesirable event experienced by a human subject, regardless of whether the event is related to the subject’s involvement in the research and is not known to previously occur (i.e. not listed in the protocol or informed consent or; if listed, is more serious than expected).

 This type of unexpected SAE will be reported to the IRB within 5 days of the event or learning of the event via myIRB Reportable Event submission form.

 Adverse events which are not serious or SAEs that are expected can be reported to the IRB annually via the Cumulative Adverse Event Table which is uploaded with each Continuing Review.


Unanticipated Problem the presents risk to subjects or others


OHRP considers unanticipated problems to include those events that:

 (1) are not expected given the nature of the research procedures that are described in the protocol-related documents and informed consent or consistent with the subject population being studied; and

(2) suggest that the research places subjects or others at greater risk of harm or discomfort related to the research than was previously known or recognized.

In order to determine if the unanticipated problem places subjects at greater risk of harm than was previously known or recognized is dependent on whether the event was related or possibly related to study participation in the research.  The harm can be physical, psychological, economic, or social in nature.

 Examples of Unanticipated Problems that present risk to subjects or others include but are not limited to the following:

  • An adverse event to a local subject that was unexpected and related to the protocol, regardless of the severity of the event.
  • More frequent or severe side effects than were anticipated as described in the protocol and consent form 
  • Experiences or side effects of one or more subjects that were not described in the protocol or consent form;
  • Any unapproved change or modification to an IRB approved protocol (deviation), intentional or unintentional, that places one or more subjects at risk or affects the integrity of study data;
  • Changes to the protocol taken without prior IRB review to eliminate apparent immediate hazard to a subject;
  • Complaints that indicates unexpected risks, or complaint that cannot be resolved by the principal investigator;
  • Malfunctioning of research equipment that results or could result in risk to subjects or others;
  • Suspension of enrollment (by the investigator, sponsor) due to issues identified with the study that may involve risk to subjects;
  • Events that requires prompt reporting to the sponsor (i.e. pregnancy)

Unanticipated Problems that present risk to subjects or others must be reported to the IRB within 5 working days of the event occurring or learning of the event via myIRB Reportable Event submission form.