Reportable Events听
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SUBJECT:
Reportable Events |
Policy Number:
10.3.5 |
Effective Date:
May 26, 2026 |
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Supersedes:
10.3.15 鈥淣on-Compliance/ Allegations of Non-Compliance鈥 and March 24, 2022 October 20, 2014 |
Page 1 of 7 |
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Responsible Authorities:
Vice President, Research Associate Vice President, Research Integrity Institutional Review Board |
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Background
Federal regulations [45 CFR 46.108 (3)(iii); 21 CFR 56.108 (a)(4)] require that changes to previously approved research be reviewed and approved by the IRB before being implemented, except where necessary to eliminate apparent immediate hazards to human subjects. Federal regulations [45 CFR 46.108 (a)(4); 21 CFR 56.108 (b)(1)] also require researchers to promptly report to the IRB all serious adverse events (SAEs) and unanticipated problems (UAPs) involving risk to human subjects or others that occur during an IRB-approved research protocol. Any change to a research protocol that is carried out without IRB approval is considered a protocol deviation. In addition, researchers may need to report these events to the study sponsor, institutional officials, and the appropriate regulatory agencies, when applicable.
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Purpose
This policy provides researchers with guidance on responsibilities for reporting serious adverse events, unanticipated problems, and non-compliance/ alleged non-compliance involving risk to human subjects or others during an IRB-approved research protocol.
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General Statement
糖心Vlog investigators are responsible for ensuring their human subjects research protocol is carried out as approved by the IRB and in accordance with applicable University and regulatory requirements. When research does not follow this plan, such occurrences can have a negative impact on research participants. Protocol deviations can alter the risk-benefit ratio for participants or may jeopardize the safety, rights, and welfare of research participants, or the integrity and validity of the study design.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although they can and do occur in social- behavioral research. Many adverse events are expected based on previous studies in the literature and are outlined in the informed consent document. These do not need to be reported to the IRB. However, if an adverse event is a) serious; b) unexpected in nature, severity, and frequency; c) a potential risk to human subjects or others; and d) a result of the research, it meets the definition of a 鈥渟erious adverse event.鈥 Serious adverse events require closer examination and must be reported to the IRB.
Similarly, 鈥渦nanticipated problems鈥 that are not physical or medical in nature can also arise in the context of a research study. For example, a breach of confidentiality or an error in how human subjects data has been analyzed, are both unanticipated problems that do not show up as a physical or psychological symptom in the subject. However, if they are unexpected, and can potentially pose a risk to the human subjects involved, or others, they must be reported to the IRB.
Both serious adverse events and unanticipated problems, whether they occur in a clinical trial, social/behavioral research study, or other human subjects study, may signal that risks to subjects are greater than expected. They may also trigger modifications to the research protocol, informed consent, or other information presented to the research subjects. In some cases, they may require that a study be suspended or terminated. To make appropriate decisions concerning the protection of human subjects in research, the IRB requires these events to be reported appropriately. The principal investigator (PI) of any research study is responsible for reporting these events.
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Definitions
Adverse Event: any untoward or unfavorable medical occurrence (physical or psychological), cognitive, or affective response in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory findings), symptom, or disease, temporally associated with the subject鈥檚 participation in the research, whether or not considered related to the subjects鈥 participation in research.
Adverse events may be caused by one or more of the following:
- the procedures involved in the research;
- an underlying disease, disorder, or condition of the subject; or
- other circumstances unrelated to either the research or any underlying disease, disorder, or condition of the subject.
In general, adverse events that are determined to be at least partially caused by research procedures are considered related to participation in the research. Adverse events determined to be solely caused by an underlying cause or non-research related circumstances would be considered unrelated to participation in the research.
Allegation of Non-compliance: An unconfirmed report of non-compliance with applicable laws, regulations, organizational policies and procedures, or the requirements or determinations of the IRB.
Continuing Non-compliance: An event is determined to be continuing if it involves repeated incidents which suggest that non-compliance will continue unless the IRB intervenes. For example, the IRB may determine that repeated minor deviations (continuing non-compliance) are equivalent in severity to a major deviation.
Non-compliance: Failure to comply with the laws, regulations pertaining to the protection of human subjects in research, organizational policies and procedures, or the requirements or determinations of the IRB.
Protocol Deviation: An incidence of non-compliance caused by change to a research protocol without approval by the IRB prior to its initiation or implementation. A protocol deviation may be categorized as major or minor.
A major deviation is one that:
- Increases the risk and/or decreases the benefit to individual participants, or resulted in detrimental change to a participant鈥檚 clinical or emotional status, or compromised the integrity or validity of the study;
- Has occurred without appropriate IRB review and approval;
- Is egregious or intentional; and/or
- Has been determined by the IRB to be a major deviation.
A minor deviation is an unintentional deviation or omission from a protocol that does not impact research participant safety or does not substantially alter risks to research participants. An example would be slight over enrollment.
Serious Adverse Event (SAE): Any adverse event occurring during the time period of a subject's participation in research that meets any of the following criteria:
- Results in death during the period of protocol defined surveillance.
- Is life threatening (defined as a subject at immediate risk of death at the time of the event).
- Requires inpatient hospitalization or prolonged hospitalization during the period of protocol-defined surveillance.
- Results in a congenital anomaly or birth defect.
- Results in a persistent or significant disability/incapacity.
- Any other important medical event that may not result in death, be life threatening, or require hospitalization, may be considered a Serious Adverse Event based upon appropriate medical / psychological judgment, if the event may jeopardize the subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
This definition includes serious adverse drug or biologic experiences and unanticipated adverse device experiences under FDA regulations.
Serious Non-compliance: Any behavior, action or omission in the conduct of research as determined by the convened IRB to adversely affect the rights and welfare of participants; harm or pose an increased risk of substantial harm to research participants; compromise the integrity or validity of the research.
Unanticipated Problem (UAP) any incident, experience, or outcome that involves risks to subjects or others and meets the following criteria:
- 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 documents; and (b) the characteristics of the subject population being studied; and
- Related or possibly related to participation in the research (possibly related means there is some likelihood in the judgment of the investigator that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Unanticipated problems may be physical, psychological, economic or social. Examples include:
- Adverse emotional reactions to study procedures, such as depression or threat of harm to self or others.
- Major complaints by subjects about the safety or ethics of research procedures.
- Breaches of confidentiality, such as the loss of a computer containing confidential information about human subjects or others.
- A finding that lab reports on blood or other samples were in error.
- A participant in a focus group on employment practices reports he has been demoted or unfavorably treated after the research study.
- Unexpected data collection on a subject for which whom? no informed consent exists.
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Policy
All Studies
Any concerns, complaints or allegations of non-compliance related to human subjects research are to be promptly reported to the Research Integrity Office. Protocol deviations associated with an IRB approved protocol must be reported to the Research Integrity office for an assessment and, if necessary, review by the IRB.
Serious adverse events and unanticipated problems that occur within a study that the 糖心Vlog IRB has approved must be reported to 糖心Vlog鈥檚 IRB within the timeframes noted below.
A serious adverse event or unanticipated problem should only be reported if it meets the definitions in Section IV of this document. A serious adverse event or unanticipated problem is reportable if it occurs between the time that a subject is participating on a protocol and for 30 days following the active intervention phase of the protocol. If the event occurs more than 30 days after the active intervention has stopped, a report may be necessary if there are more stringent reporting requirements outlined in the protocol or mandated by the sponsor. For example: the development of cancer or the identification of a congenital anomaly/birth defect in the offspring of a subject who received a study drug is always reportable, even if the event occurs more than 30 days after the end of the active intervention phase.
The closing of a study does not terminate the PI鈥檚 obligation to report a serious adverse event.
Specific to Clinical Trials
All serious adverse events and unanticipated problems that occur during the performance of an investigator-initiated clinical trial (i.e., a research study designed by a 糖心Vlog investigator) must be reported to the IRB and to the FDA if an IND (Investigational New Drug) or IDE (Investigational Device Exemption) has been obtained.
If a 糖心Vlog PI coordinates a multi-site clinical trial, they must first send any report of a serious adverse event or unanticipated problem to the Data Safety Monitoring Board (DSMB), unless otherwise stated in the IRB-approved protocol. The DSMB (or an equivalent safety monitoring committee) for an IRB-approved research protocol plays a significant part in the reporting of adverse events and unanticipated problems. The DSMB is responsible for reviewing these events, determining their significance, and recommending changes to be made to the approved research protocol and/or consent documents. If the DSMB receives a report(s) of an adverse event or unanticipated problem that represents serious and/or unexpected events, the DSMB should send a report to the PIs and study sponsor in a prompt manner. It is the responsibility of the PI to review the report and submit a Serious Adverse Event/Unanticipated Problem report to the IRB within the appropriate timeframes noted below. If there is no DSMB or equivalent monitoring committee for an IRB-approved research protocol, the PI must review the event and determine whether it represents a serious and/or unexpected event that should be reported to the IRB under this policy.
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Accountability
The Principal Investigator (PI) will be responsible for:
- Ensuring their research protocol is carried out as approved by the IRB and in accordance with applicable regulatory requirements and 糖心Vlog policy and procedure.
- Reporting problems with research, including protocol deviations, SAEs, and UAPs by completing and submitting Form 108, 鈥淧romptly Reportable Information鈥 to the IRB.
- Taking any necessary steps, as appropriate, to ensure subjects receive care or follow-up due to a SAE or UAP.
- Making immediate changes, when appropriate, at the time of testing, sampling, evaluating, etc. to eliminate apparent or immediate hazards to other subjects as a result of a SAE or UAP, even if the IRB has not yet approved the procedure.
- Analyzing the risk profile of the protocol as a result of a SAE or UAP to assess whether it should be reported to the IRB.
- Reporting the event to the IRB if it increases the risk of harm to subjects or others.
- Reporting to the IRB other unexpected adverse events, regardless of severity, that may alter the risk versus potential benefits of the research and, as a result, warrant consideration of substantive changes in the research protocol or informed consent process/documents [NOTE: Serious adverse events that are expected in some subjects but are determined to be occurring at a significantly higher frequency or severity than expected should be reported under this policy].
- Reporting SAEs and UAPs to the IRB as soon as they become aware of them so that the Research Integrity Office can apprise supporting/funding agencies, OHRP, and FDA as applicable, within the timelines outlined in the Code of Federal Regulations.
The IRB will be responsible for:
- Reviewing all reports in a timely manner and determining whether the event constitutes an UAP involving risks to subjects or others.
- Implementing immediate action, where warranted, including suspension of IRB approval to ensure the ongoing safety of research participants.
- Reviewing reports that do not require immediate action via an expedited review mechanism, where warranted, and deferring review to the convened IRB when deemed appropriate. Expedited review shall be limited to problems or events where no or minimal risk changes in the study protocol or informed consent documents are required.
- Asking investigators, Data Safety Monitoring Boards or others for additional clarifying information regarding an SAE/UAP, as warranted.
- Requiring the PI to implement remedial actions, as deemed appropriate, in response to a report including, but not limited to:
- Modifying the inclusion or exclusion criteria to mitigate the newly identified risks;
- Implementing additional monitoring procedures of subjects;
- Modifying informed consent documents to include a description of newly recognized risks;
- Revising the protocol;
- Providing additional information about newly recognized risks to previously enrolled subjects;
- Requiring a corrective action/ preventive action plan;
- Suspending enrollment of new subjects;
- Suspending approval of the research; or
- Terminating approval of the study (via a convened IRB meeting)
- Communicating in writing, the IRB鈥檚 actions/decisions regarding the outcome of the report review.
- Promptly communicating in writing within 30 days of the decision to appropriate institutional officials, funding agencies, and regulatory agencies, the details of any SAEs, UAPs, or serious and/or continuing non-compliance involving risks to subjects or others; the requirements or determinations of the IRB; and any suspension or termination of IRB approval.
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Procedures
Follow all reporting requirements for the IRB providing oversight for the project. If 糖心Vlog is IRB of Record, the PI must adhere to the following for all sites. If another IRB is serving as IRB of Record, follow reporting requirements for the lead institution and 糖心Vlog. Unless specifically noted, use Form 108, 鈥淧romptly Reportable Information Form鈥. If a report is submitted by the PI beyond the timelines outlined by this policy, a written explanation of the delay must be included in the submission to the IRB.
See Appendix A for reporting timelines and process.
- Policy Renewal: As needed
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References
OHRP Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
45 CFR 46.103 (b)(5)(i)
45 CFR 46.108 (3)(iii) and (4)
21 CFR 312.32, 312.66
21 CFR 56.108 (a)(4) and (b)
21 CFR 812.150
POLICY APPROVAL
Initiating Authority
Gregg Fields, Ph.D., Vice President for Research
5/26/2026
Executed signature pages are available in the Initiating Authority Office(s)
Appendix A: Serious Adverse Event and Unanticipated Problems Reporting Timelines
| Event | Reporting Timeline | Additional Information |
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Within 3 Calendar Days of awareness | Event must be related or possibly related to the protocol intervention; if the PI is uncertain, report it within the IRB requested timeframe until further conclusive evidence becomes available. |
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Within 1 week of awareness | If external site, only if the event changes the risk profile of the study and the resulting protocol or consent form. |
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Within 1 week of notification from an External Sponsor | Submit an amendment as needed. |
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No action required | 听 |