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Reporting Research-Related Problems

INTRODUCTION/ PI RESPONSIBILITIES:

Federal Regulations [45 CFR 46.103(b)(5) and 21 CFR 56.108(b)(1)] and UAB IRB policy (POL006) requires Principal Investigators of all human subject’s research (FDA-regulated or not), and their designated study teams must report any unanticipated problems involving risks to research subjects or others be promptly reported to the IRB.

Investigators and their research staff are responsible for reporting events that are or may be (1) unexpected, (2) related to study participation, and (3) increase the risk or potential for risks to research subjects or others. Only the IRB can determine whether an event meets the federal definition of an Unanticipated problem involving risks to subjects or others (UPIRSO) which requires further reporting.

Events that meet the IRB’s reporting criteria should be promptly submitted to the IRB using the electronic Problem Report Form.  See the timeline table below.

If the IRB determines that a reported event constitutes an UPIRSO, it promptly reports its determination and actions to the investigator and the Institutional Official. The Institutional Official, in turn, is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies.

Note: Investigators serving as sponsors of FDA-regulated research have additional reporting responsibilities (see FDA-Regulated Research).

 

DEFINITIONS:

This section defines these terms in relation to UAB IRB requirements.

Reportable Event: A reportable event is any unanticipated problem, adverse event or other incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others.

Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO): An unanticipated problem is any incident, experience or outcome that meets all three of the following criteria:

  1. It is unexpected (in terms of nature, severity, or frequency) given (a) the research procedures described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied.
  2. It is related or possibly related to participation in the research (possibly related means there is some likelihood in the judgment of a reasonable investigator that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. The event suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, social, economic, legal, or informational harm) than was previously than was previously known or recognized.

NOTE: Unanticipated problems that meet the three criteria above, will often warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others.

Adverse Event: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory findings), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subjects’ participation in research. Adverse events encompass both physical and psychological harms.

Serious Adverse Event: Any adverse event temporally associated with the subject's participation in research (including serious adverse drug or biological experience and unanticipated adverse device experiences under FDA regulations) that meets any of the following criteria:

  • When the outcome results in death.
  • Is life threatening (places the subject at immediate risk of death from the event as it occurred).
  • Requires admission to the hospital or prolongation of existing hospitalization.
  • Results in a persistent or significant disability/incapacity.
  • Results in congenital anomaly or birth defect.
  • For Medical Devices: requires medical or surgical intervention to prevent permanent impairment or damage.
  • Event that changes the risk/benefit ratio of the study
  • Any other adverse event that, 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 previously listed. Examples include an allergic reaction requiring treatment in an ER, seizures/convulsions, development of drug dependence or drug abuse, suicide attempt, etc.)

For more information visit: https://www.fda.gov/safety/reporting-serious-problems-fda/what-serious-adverse-event

 

REPORTING TIMEFRAME:


Report to the IRB as soon as possible but in all cases no later than:

 

5 Working Days

10 Working Days

At Continuing Review

Any changes to the protocol that were taken to eliminate an apparent hazard to a participant in an emergency

Any adverse event occurring at a performance site under UAB IRB oversight that, in the opinion of the PI, is both unexpected and related (or possibly related) to the research

All adverse events at performance sites under UAB IRB oversight.

Any deviations from the investigational plan for an investigational device taken to protect the life or physical well-being of a participant in an emergency

Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research subject

All problems reported to the UAB IRB, including serious adverse events.

Any emergency use of an FDA-regulated test article or Humanitarian Use Device prior to IRB approval

Information, including adverse events or safety reports, that indicates a change to the risks or potential benefits of the research.

For example:

  • An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different from those initially presented to the IRB.
  • A paper is published from another study that shows the risks or potential benefits of the research might be different from those initially presented to the IRB.

Safety monitoring or DSMB reports received from sponsor and not previously forwarded to the IRB, if any.
 

Change in FDA labeling or withdrawal from marketing of a drug, device, or biologic used in a research protocol

  
 

A breach of confidentiality

  
 

Incarceration of a subject enrolled in a protocol not approved to enroll prisoners.

  
 

Event that requires prompt reporting to the sponsor.

  
 

Sponsor-imposed suspension for risk

  
 

Unresolved participant compliant

  
 

Protocol violation (i.e., an accidental or unintentional change to the IRB-approved protocol) that harmed subjects or others or that indicates subjects or others may be at increased risk of harm

  
 

Safety monitoring reports and DSMB reports from the sponsor. NOTE: These should be submitted via Amendment.

  

 

IRB & Institutional Reporting

If the IRB determines that a reported event constitutes an unanticipated problem that alters the risk of the research, it promptly reports its determination and actions to the investigator and the Institutional Official. The Institutional Official, in turn, is responsible for promptly reporting the IRB findings to the sponsor and applicable federal agencies.