Guam § 24107 - Criteria for Board Approval of Research.

§ 24107. Criteria for Board Approval of Research.

In order to approve research subject to regulation, the Board shall

determine that all the following requirements are satisfied:

(a) Risks to subject are minimized: (i) by using procedures which are

consistent with sound research design and which do not unnecessarily

expose subject's to risk; and (ii) whenever appropriate by using procedures

already being performed on the subjects for diagnostic or treatment

purposes.

(b) Risks to subject are reasonable in relation to anticipated benefits, if

any, to subjects and the importance of the knowledge that may reasonably

be expected to result. In evaluating risks and benefits, the Board should

consider only those risks and benefits that may result from the research, as

distinguished from risks and benefits of therapies subject would receive

even if not participating in the research. The Board should not consider

possible long range effects of applying knowledge gained in the research

(for example, the possible effects of the research on public policy) as among

those research risks that fall within the purview of its responsibility.

(c) Selection of the subjects is equitable. In making this assessment the

Board should take into account the purposes of the research and the setting

in which the research would be conducted and should be particularly

cognizant of the special problems that research involving vulnerable

populations, such as children, prisoners, pregnant woman, persons with

disabilities, the elderly, or economically or educationally disadvantaged

persons.

(d) Informed consent will be sought from each prospective subject or

the subject's legally authorized representative, in accordance with, and to

the extent required by Board regulation.

(e) Informed consent will be appropriately documented, in accordance

with, and to the extent required by Board regulation.

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(f) When appropriate, the research plan makes adequate provision for

monitoring the data collected to ensure the safety of subjects.

(g) When appropriate, there are adequate provisions to protect the

privacy of subjects and to maintain the confidentiality of data.

When some or all of the subjects are likely to be vulnerable to coercion

or undue influence, such as children, the elderly, prisoners, pregnant

women, mentally disabled persons or economically or educationally

disadvantaged persons, additional safeguards have been included in the

research plans, procedures or protocols to protect the rights and welfare of

these subjects.

(h) Progress reports or thesis shall be made available to subjects

participating in the research as appropriate.