No investigator may involve a human being in research subject to regulation unless the investigator has obtained the legally effective informed consent of the subject, or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. Unless otherwise provided by law or regulation, no informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the research sponsor, if different, or their agents from liability for negligence.
(a) Basic Elements of Informed Consent. Except as provided in
Paragraphs (c) or (d) of this Section, in seeking informed consent the

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following information shall be provided to each human subject or the subject’s legally authorized representative:
(1) a statement that the study involves research, an explanation of the purpose of the research and the expected duration of the subject’s participation, description of the procedures to be followed and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risk or discomforts to the subject;
(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;
(4) a disclosure of appropriate alternative procedures or courses or treatment, if any, that might be advantageous to the subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what it consists of or whether further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research-related injury to the subject; and
(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) Additional Elements of Informed Consent. When appropriate, the Board may require that one (1) or more of the following elements of information shall also be provided to each subject:

(1) a statement that the particular treatment or procedure may involve risks to the subject, or to the embryo or fetus, if the subject is or may become pregnant, which are currently unforeseeable;

(2) anticipated circumstances under which the subject’s participation may be terminated by an investigator without regard to the subject’s consent;

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(3) any additional cost to the subject that may result from participation in the research;
(4) the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
(5) a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and
(6) the approximate number of subjects involved in the study. (c) The Board may approve a consent procedure which does not
include, or which alters, some or all of the elements of informed consent set
forth above, or waive the requirements to obtain informed consent;
provided, that the Board finds and documents that:

(1) the research or demonstration project is to be conducted by, or subject to, the approval of Federal, state, territorial or local government officials, and is designed to study, evaluate or otherwise examine: (i) public benefit of service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes and/or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs; and

(2) the research could not practically be carried out without the waiver or alteration.

(d) The Board may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this Section, or waives the requirements to obtain informed consent; provided, that the Board finds and documents that:
(1) the research involves no more than minimal risk to the subject; (2) the waiver or alteration will not adversely affect the rights and
welfare of the subject;

(3) the research could not practically be carried out without the waiver or alteration; and

(4) whenever appropriate, the subjects will be provided with additional and pertinent information after participation.

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(e) The informed consent requirements are not intended to preempt any applicable Federal, state or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

(f) Nothing in this Section is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, state, or territorial law.