-CITE-

    45 CFR Sec. 46.103

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    Title 45
    SUBTITLE A
    PART 46
    Subpart A

-HEAD-

    Sec. 46.103 Assurances.

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      (a) Each institution engaged in research covered by these
    regulations shall provide written assurance satisfactory to the
    Secretary that it will comply with the requirements set forth in
    these regulations.
      (b) The Department will conduct or fund research covered by these
    regulations only if the institution has an assurance approved as
    provided in this section, and only if the institution has certified
    to the Secretary that the research has been reviewed and approved
    by an IRB provided for in the assurance, and will be subject to
    continuing review by the IRB. This assurance shall at a minimum
    include:
      (1) A statement of principles governing the institution in the
    discharge of its responsibilities for protecting the rights and
    welfare of human subjects of research conducted at or sponsored by
    the institution, regardless of source of funding.  This may include
    an appropriate existing code, declaration, or statement of ethical
    principles, or a statement formulated by the institution itself.
    This requirement does not preempt provisions of these regulations
    applicable to Department-funded research and is not applicable to
    any research in an exempt category listed in Sec. 46.101.
      (2) Designation of one or more IRBs established in accordance
    with the requirements of this subpart, and for which provisions are
    made for meeting space and sufficient staff to support the IRB's
    review and recordkeeping duties.
      (3) A list of the IRB members identified by name; earned degrees;
    representative capacity; indications of experience such as board
    certifications, licenses, etc., sufficient to describe each
    member's chief anticipated contributions to IRB deliberations; and
    any employment or other relationship between each member and the
    institution; for example: full-time employee, part-time employee,
    member of governing panel or board, stockholder, paid or unpaid
    consultant.  Changes in IRB membership shall be reported to the
    Secretary. (SUPERSCRIPT )
       (SUPERSCRIPT 1)Reports should be filed with the Office for
    Protection from Research Risks, National Institutes of Health,
    Department of Health and Human Services, Bethesda, Maryland 20205.
      (4) Written procedures which the IRB will follow (i) for
    conducting its initial and continuing review of research and for
    reporting its findings and actions to the investigator and the
    institution; (ii) for determining which projects require review
    more often than annually and which projects need verification from
    sources other than the investigators that no material changes have
    occurred since previous IRB review; (iii) for insuring prompt
    reporting to the IRB of proposed changes in a research activity,
    and for insuring that changes in approved research, during the
    period for which IRB approval has already been given, may not be
    initiated without IRB review and approval except where necessary to
    eliminate apparent immediate hazards to the subject; and (iv) for
    insuring prompt reporting to the IRB and to the Secretary
    (SUPERSCRIPT ) of unanticipated problems involving risks to
    subjects or others.
      (c) The assurance shall be executed by an individual authorized
    to act for the institution and to assume on behalf of the
    institution the obligations imposed by these regulations, and shall
    be filed in such form and manner as the Secretary may prescribe.
      (d) The Secretary will evaluate all assurances submitted in
    accordance with these regulations through such officers and
    employees of the Department and such experts or consultants engaged
    for this purpose as the Secretary determines to be appropriate.
    The Secretary's evaluation will take into consideration the
    adequacy of the proposed IRB in light of the anticipated scope of
    the institution's research activities and the types of subject
    populations likely to be involved, the appropriateness of the
    proposed initial and continuing review procedures in light of the
    probable risks, and the size and complexity of the institution.
      (e) On the basis of this evaluation, the Secretary may approve or
    disapprove the assurance, or enter into negotiations to develop an
    approvable one.  The Secretary may limit the period during which
    any particular approved assurance or class of approved assurances
    shall remain effective or otherwise condition or restrict approval.
      (f) Within 60 days after the date of submission to HHS of an
    application or proposal, an institution with an approved assurance
    covering the proposed research shall certify that the application
    or proposal has been reviewed and approved by the IRB. Other
    institutions shall certify that the application or proposal has
    been approved by the IRB within 30 days after receipt of a request
    for such a certification from the Department. If the certification
    is not submitted within these time limits, the application or
    proposal may be returned to the institution.
    Sec.6.104 - 46.106 (Reserved)