Definitions

Experienced IRB Member: An IRB member is considered experienced if the IRB Chair and Board consider the IRB member to have sufficient experience in and knowledge of conducting IRB reviews.

Expiration Date:  The first date that the study is no longer approved. The date after the end date of the approval period.

Full Board Review: All review processes that require a convened IRB.

Human Subject (as defined by DHHS): A living individual about whom an investigator (whether professional or student) conducting research (i) Obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

• • Intervention: Physical procedures by which data are gathered (for example, venipuncture or buccal swab); or manipulations of the subject or the subject’s environment that are performed for research purposes.

  • Interaction: Communication or interpersonal contact between investigator and subject.

  • Private Information: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research that are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Noncompliance: Failure to follow the regulations or the requirements, determinations, or policies of the IRB.

Non-Full Board Review: All review processes that do not require a convened IRB including non-human research determinations, non-engagement determinations, exemption determinations, and expedited review.

Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Principal Reviewer: The IRB Chair or an Experienced IRB Member designated by the IRB chair to conduct Non-Full Board Reviews.

Serious Noncompliance: Noncompliance that has or has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program.

Suspension of IRB Approval: Temporary or permanent withdrawal of IRB approval for some or all research procedures, including enrollment, short of Termination of IRB Approval.

Termination of IRB Approval: Withdrawal of IRB approval for all research procedures where the IRB does not anticipate re-opening the study.

Unanticipated Problems Involving Risks to Subjects or Others: Information that is unexpected (inconsistent with information previously reviewed by the IRB); and indicates that subjects or others are at increased risk of harm because of the research study.