In order to approve research covered by this policy the IRB shall determine that all
of the following requirements are satisfied:
Risks to subjects are minimized: (i) By using procedures which are consistent with
sound research design and which do not unnecessarily expose subjects to risk, and
(ii) whenever appropriate, by using procedures already being performed on the subjects
for diagnostic or treatment purposes.
Risks to subjects 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 IRB should consider only those risks and benefits
that may result from the research (as distinguished from risks and benefits or therapies
subjects would receive even if not participating in the research). The IRB 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 purview of its responsibility.
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.
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 §46.116.
Informed consent will be appropriately documented, in accordance with, and to the
extent required by §46.117.
When appropriate, the research plan makes adequate provision for monitoring the data
collected to ensure the safety of subjects.
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, 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.