Source: https://www.law.cornell.edu/cfr/text/38/16.103
Timestamp: 2018-05-25 21:00:49
Document Index: 612128866

Matched Legal Cases: ['art 16', '§ 16', '§ 16', '§ 16', '§ 16', '§ 16']

38 CFR 16.103 - Assuring compliance with this policy - research conducted or supported by any Federal Department or Agency. | US Law | LII / Legal Information Institute
CFR › Title 38 › Chapter I › Part 16 › Section 16.103
38 CFR 16.103 - 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 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 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.
(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 § 16.101 (b) or (i).
(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 § 16.103(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.
(f) Certification is required when the research is supported by a federal department or agency and not otherwise exempted or waived under § 16.101 (b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by § 16.103 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 § 16.103 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.
[ 56 FR 28012, 28021, June 18, 1991; 56 FR 29756, June 28, 1991, as amended at 70 FR 36328, June 23, 2005]
38 CFR 16.103 — Assuring Compliance With This Policy - Research Conducted or Supported by Any Federal Department or Agency.
38 CFR 16.108 — IRB Functions and Operations.