Glossary of Terms

An action to temporarily stop data collection and analysis on a project. This is a voluntary action by the Principal Investigator.

Any untoward occurrence in a research participant. The occurrence need not have a clear causal relationship with the individual’s participation in the research; an AE can be any unfavorable and unintended sign, symptom, event, or occurrence affecting a participant’s physical, mental, social, financial, legal, or psychological well-being. An unanticipated AE should be reported to the committee as soon as possible after it is identified.

An unproved assertion of Non-Compliance.

An individual who acts on behalf of a regular voting IRB member in a

Information that was previously recorded without any HIPAA identifiers and no code and key that would allow identification of individual subjects.

agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. An assent is typically paired with permission from a parent/guardian or Legally Authorized Representative, and together they comprise the informed consent to participate.