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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§ 26.115 IRB records.
(a) An institution, or when appropriate an IRB, shall prepare and
maintain adequate documentation of IRB activities, including the
following:
(1) Copies of all research proposals reviewed, scientific evaluations,
if any, that accompany the proposals, approved sample consent documents,
progress reports submitted by investigators, and reports of injuries to
subjects.
(2) Minutes of IRB meetings which shall be in sufficient detail to show
attendance at the meetings; actions taken by the IRB; the vote on these
actions including the number of members voting for, against, and
abstaining; the basis for requiring changes in or disapproving research;
and a written summary of the discussion of controverted issues and their
resolution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between the IRB and the
investigators.
(5) A list of IRB members in the same detail as described is
§26.103(b)(3).
(6) Written procedures for the IRB in the same detail as described in
§26.103(b)(4) and §26.103(b)(5).
(7) Statements of significant new findings provided to subjects, as
required by §26.116(b)(5).
(b) The records required by this policy shall be retained for at least
3 years, and records relating to research which is conducted shall be
retained for at least 3 years after completion of the research. All
records shall be accessible for inspection and copying by authorized
representatives of the department or agency at reasonable times and in a
reasonable manner.
(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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