Title 40:
Protection of Environment
PART 26PROTECTION OF HUMAN SUBJECTS
Subpart ABasic EPA Policy for Protection of Subjects
in Human Research Conducted or Supported by EPA
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§ 26.111 Criteria for IRB approval of
research.
(a) In order to approve research covered by this policy the IRB shall
determine that all of the following requirements are satisfied:
(1) 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.
(2) 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 of 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 the
purview of its responsibility.
(3) 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.
(4) 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 §26.116.
(5) Informed consent will be appropriately documented, in accordance
with, and to the extent required by §26.117.
(6) When appropriate, the research plan makes adequate provision for
monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of data.
(b) 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.
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