-CITE-

    45 CFR Sec. 46.115

-EXPCITE-

    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.115 IRB records.

-TEXT-

      (a) An institution, or where 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 as required by Sec. 46.103(b)(3).
      (6) Written procedures for the IRB as required by Sec.
    46.103(b)(4).
      (7) Statements of significant new findings provided to subjects,
    as required by Sec. 46.116(b)(5).
      (b) The records required by this regulation shall be retained for
    at least 3 years after completion of the research, and the records
    shall be accessible for inspection and copying by authorized
    representatives of the Department at reasonable times and in a
    reasonable manner.
    (46 FR 8386, Jan. 26, 1981; 46 FR 19195, Mar. 27, 1981)