IRB

Research Assistance

Department Specific Information

Adverse Events Policy

Reporting

To report an adverse event, complete the Adverse Event Form and submit it to the IRB.


Purpose of Policy

Review of unanticipated problems or adverse events provides an important safeguard to identify concerns about:

  • Risk to subjects or others
  • The risk/benefit ratio of the research project
  • The appropriateness of the currently approved informed consent document
  • The need for re-consent

More information is provided in the Adverse Events Policy.


Reporting System

In response to regulatory obligations, the Liberty University IRB utilizes a three category reporting system. This system facilitates review of reports and permits determination of whether the problem/event raises new concerns. The reporting categories are as follows:

Prompt (within 48 hours)

Reporting of an unanticipated problem involving risk to subjects or others (including unanticipated serious or life-threatening adverse events) and anticipated or unanticipated related deaths to the IRB.

Non-Prompt (after 48 hours)

Reporting to the IRB of anticipated problems/anticipated serious adverse events or unrelated deaths.

Continuation Review Reporting

If any problems/adverse events occurred within 12 months prior to the continuation review (CR) request for a written summary of all problems/adverse events involving participants since the study was initiated, whether anticipated or unanticipated, serious or non-serious, life-threatening or not life threatening, or related or not related.


Definitions

Unanticipated Problems

Any unforeseen or unexpected incident or experience (including an unanticipated adverse event) which is not described in the general investigational plan or elsewhere in the current IRB application or with the current investigator brochure, or in the consent document.

Adverse Events

An undesirable effect detected in participants in a study. The effect may be the result of:

  • Interventions and interactions used in the research
  • An underlying disease, disorder, or condition of the subject
  • Other circumstances unrelated to the research or any underlying disease, disorder, or condition of the subject

Unanticipated Problem involving Risk to Participants or Others

Any unforeseen or unexpected event or experience that adversely affects the rights, safety, or welfare of subjects or others (which is not described in the general investigational plan or elsewhere in the current application or with the current investigator brochure, or in the consent document). The event or experience could involve:

  • Psychological harm or risk
  • Physical harm or risk
  • Social harm or risk (such as an inappropriate breach in confidentiality)
  • Harm to a subject’s reputation
  • Invasion of privacy
  • Legal harm or risk

Anticipated Problem/Adverse Event

Any foreseen or expected incident/experience which was described in the general investigational plan or elsewhere in the current application or with the current investigator brochure, or in the consent document.

Serious Problem/Adverse Event

Any incident that results in significant harm to or increased risk for the subject or others. Examples of events which are serious would include but are not limited to:

  • Inpatient psychiatric or medical hospitalization or prolongation of existing hospitalization
  • A persistent or significant disability/incapacity
  • A congenital anomaly/birth defect

Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the subject’s health or welfare and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include:

  • Allergic bronchospasm requiring intensive treatment in an emergency room or at home
  • Blood dyscrasias or convulsions that do not result in inpatient hospitalization
  • Development of drug dependency or drug abuse.
  • A disability or a substantial disruption of a person’s ability to conduct normal life functions

Life Threatening Event

Any experience that places the subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred (i.e., it does not include a reaction that, had it occurred in a more severe form, might have caused death).

Related

There is a reasonable possibility, in the opinion of the Principal Investigator, that the experience was likely to have been caused by the research procedures.

Internal Event/Problem

Occurrence involves research subjects enrolled in a project approved by the Liberty University IRB and directed by a principal investigator employed by Liberty University or one whose project is under the purview of the Liberty University IRB (e.g., student dissertations and theses).

External Event/Problem

Occurrence involves research subjects enrolled in multi-center research projects that do not fall under the purview of the Liberty University IRB.