[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR46.103]



[Page 118-120]

 

                        TITLE 45--PUBLIC WELFARE

 

           SUBTITLE A--DEPARTMENT OF HEALTH AND HUMAN SERVICES

 

PART 46_PROTECTION OF HUMAN SUBJECTS--Table of Contents

 

  Subpart A_Basic HHS Policy for Protection of Human Research Subjects

 

Sec. 46.103  Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.



    (a) Each institution engaged in research which is covered by this 

policy and which is conducted or supported by a federal department or 

agency shall provide written assurance satisfactory to the department or 

agency head that it will comply with the requirements



[[Page 119]]



set forth in this policy. In lieu of requiring submission of an 

assurance, individual department or agency heads shall accept the 

existence of a current assurance, appropriate for the research in 

question, on file with the Office for Human Research Protections, HHS, 

or any successor office, and approved for federalwide use by that 

office. When the existence of an HHS-approved assurance is accepted in 

lieu of requiring submission of an assurance, reports (except 

certification) required by this policy to be made to department and 

agency heads shall also be made to the Office for Human Research 

Protections, HHS, or any successor office.

    (b) Departments and agencies will conduct or support research 

covered by this policy only if the institution has an assurance approved 

as provided in this section, and only if the institution has certified 

to the department or agency head 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. Assurances applicable to federally 

supported or conducted research 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 whether the research is subject to federal 

regulation. 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 this 

policy applicable to department- or agency-supported or regulated 

research and need not be applicable to any research exempted or waived 

under Sec. 46.101 (b) or (i).

    (2) Designation of one or more IRBs established in accordance with 

the requirements of this policy, 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 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 department or agency head, unless in 

accord with Sec. 46.103(a) of this policy, the existence of an HHS-

approved assurance is accepted. In this case, change in IRB membership 

shall be reported to the Office for Human Research Protections, HHS, or 

any successor office.

    (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; and (iii) for ensuring prompt reporting to the IRB of proposed 

changes in a research activity, and for ensuring that such 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 

when necessary to eliminate apparent immediate hazards to the subject.

    (5) Written procedures for ensuring prompt reporting to the IRB, 

appropriate institutional officials, and the department or agency head 

of (i) any unanticipated problems involving risks to subjects or others 

or any serious or continuing noncompliance with this policy or the 

requirements or determinations of the IRB and (ii) any suspension or 

termination of IRB approval.

    (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 this policy and shall be filed in such form and 

manner as the department or agency head prescribes.

    (d) The department or agency head will evaluate all assurances 

submitted in accordance with this policy through



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such officers and employees of the department or agency and such experts 

or consultants engaged for this purpose as the department or agency head 

determines to be appropriate. The department or agency head'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 department or agency head 

may approve or disapprove the assurance, or enter into negotiations to 

develop an approvable one. The department or agency head 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) Certification is required when the research is supported by a 

federal department or agency and not otherwise exempted or waived under 

Sec. 46.101 (b) or (i). An institution with an approved assurance shall 

certify that each application or proposal for research covered by the 

assurance and by Sec. 46.103 of this Policy has been reviewed and 

approved by the IRB. Such certification must be submitted with the 

application or proposal or by such later date as may be prescribed by 

the department or agency to which the application or proposal is 

submitted. Under no condition shall research covered by Sec. 46.103 of 

the Policy be supported prior to receipt of the certification that the 

research has been reviewed and approved by the IRB. Institutions without 

an approved assurance covering the research shall certify within 30 days 

after receipt of a request for such a certification from the department 

or agency, that the application or proposal has been approved by the 

IRB. If the certification is not submitted within these time limits, the 

application or proposal may be returned to the institution.



(Approved by the Office of Management and Budget under Control Number 

0990-0260)



[56 FR 28012, 28022, June 18, 1991; 56 FR 29756, June 28, 1991, as 

amended at 70 FR 36328, June 23, 2005]