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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§ 26.109 IRB review of research.
(a) An IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this policy.
(b) An IRB shall require that information given to subjects as part of
informed consent is in accordance with §26.116. The IRB may require that
information, in addition to that specifically mentioned in §26.116, be
given to the subjects when in the IRB's judgment the information would
meaningfully add to the protection of the rights and welfare of
subjects.
(c) An IRB shall require documentation of informed consent or may waive
documentation in accordance with §26.117.
(d) An IRB shall notify investigators and the institution in writing of
its decision to approve or disapprove the proposed research activity, or
of modifications required to secure IRB approval of the research activity.
If the IRB decides to disapprove a research activity, it shall include in
its written notification a statement of the reasons for its decision and
give the investigator an opportunity to respond in person or in
writing.
(e) An IRB shall conduct continuing review of research covered by this
policy at intervals appropriate to the degree of risk, but not less than
once per year, and shall have authority to observe or have a third party
observe the consent process and the research.
(Approved by the Office
of Management and Budget under Control Number 09900260.)
[56 FR 28012, 28022, June 18, 1991, as amended at 70 FR 36328, June 23,
2005]
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