In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied:
a. Risks to subjects are minimized: (1) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (2) whenever appropriate by using procedures already being performed on the subjects for diagnostic or treatment purposes.
b. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and in relation to the importance of the knowledge that may reasonably be expected to result.
c. Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
d. Informed consent will be sought from each prospective subject or the subjectís legally authorized representative. The requirement for a signed consent may be waived by the IRB. When waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
e. Informed consent will be appropriately documented.
f. When appropriate, the research plan makes adequate provision for monitoring 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.
h. When some or all of the subjects are likely to be vulnerable for coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.