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. COL120106 CH. 24 GUAM R ESEARCH REVIEW BOARD

(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.