Guam § 24101 - Definitions.

§ 24101. Definitions.

As used in this Chapter:

(a) Board means the Guam Research Review Board.

(b) Investigator means any individual, public or private entity, or

agency engaged in or purposing to engage in research subject to regulation.

(c) Legally authorized representative means 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.

(d) Research as defined in the Federal Register, '102 Definitions.

(e) Research subject to regulation means research involving human

subjects.

(f) Human subjects means a living individual about whom an

investigator conducting research obtains:

(1) Data Through Intervention or Interaction with the Individual.

Intervention includes both physical procedures by which data are

gathered and manipulations of the subject or the subject's environment

that are performed for research purposes. Interaction includes

communication or interpersonal contact between investigator and

subject.

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(2) Identifiable Private Information. Private information may

include 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, medical records). Private

information must be individually identifiable in order for obtaining the

information to constitute research involving human subjects.

(g) Minimal risk means that 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 examination or tests.