Definitions

IRB reviews activities that meet the federal definitions of “research” and “human subject” (45 CFR 46.102):

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject: A living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.

Intervention: includes physical procedures such as blood samples, x-rays; or the manipulation of the environment in order to stimulate certain types of behavior.

Interaction: includes interpersonal communication between the investigator and subject through surveys, interviews, administration of educational tests etc.

Identifiable: the identity of the subject is or may readily be ascertained by the investigator with the information obtained as part of the research.

Private information: a context in which an individual can reasonably expect that no observation or recording is taking place or information that is provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.

Other definitions you may find helpful are listed below:

Legally authorized representative: An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.

IRB approval:  The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

Minimal risk:  The probability and magnitude of harm or discomfort anticipated in the research 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.

Children:  Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

Assent:  A child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Permission:  The agreement of parent(s) or guardian to the participation of their child or ward in research.

Parent:  A child’s biological or adoptive parent.

Guardian:  An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

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