Appendix C to Part 1122 - Terms and Conditions for NP Article III, “National Policy Requirements Concerning Live Organisms”
2:1.2.8.5.9.2.64.6.26 : Appendix C
Appendix C to Part 1122 - Terms and Conditions for NP Article III,
“National Policy Requirements Concerning Live Organisms”
A DoD Component must use the following wording for NP Article
III of its general terms and conditions in accordance with the
provisions of Subpart B of this part.
NP Article III. National policy requirements concerning live
organisms. (December 2014)
Section A. Cross-cutting requirements concerning live
organisms.
1. Human subjects.
a. You must protect the rights and welfare of individuals who
participate as human subjects in research under this award and
comply with the requirements at 32 CFR part 219, DoD Instruction
(DoDI) 3216.02, 10 U.S.C. 980, and when applicable, Food and Drug
Administration (FDA) regulations.
b. You must not begin performance of research involving human
subjects, also known as human subjects research (HSR), that is
covered under 32 CFR part 219, or that meets exemption criteria
under 32 CFR 219.101(b), until you receive a formal notification of
approval from a DoD Human Research Protection Official (HRPO).
Approval to perform HSR under this award is received after the HRPO
has performed a review of your documentation of planned HSR
activities and has officially furnished a concurrence with your
determination as presented in the documentation.
c. In order for the HRPO to accomplish this concurrence review,
you must provide sufficient documentation to enable his or her
assessment as follows:
i. If the HSR meets an exemption criterion under 32 CFR
219.101(b), the documentation must include a citation of the
exemption category under 32 CFR 219.101(b) and a rationale
statement.
ii. If your activity is determined as “non-exempt research
involving human subjects”, the documentation must include:
(A) Assurance of Compliance (i.e., Department of Health
and Human Services Office for Human Research Protections (OHRP)
Federalwide Assurance (FWA)) appropriate for the scope of work or
program plan; and
(B) Institutional Review Board (IRB) approval, as well as all
documentation reviewed by the IRB to make their determination.
d. The HRPO retains final judgment on what activities constitute
HSR, whether an exempt category applies, whether the risk
determination is appropriate, and whether the planned HSR
activities comply with the requirements in paragraph 1.a of this
section.
e. You must notify the HRPO immediately of any suspensions or
terminations of the Assurance of Compliance.
f. DoD staff, consultants, and advisory groups may independently
review and inspect your research and research procedures involving
human subjects and, based on such findings, DoD may prohibit
research that presents unacceptable hazards or otherwise fails to
comply with DoD requirements.
g. Definitions for terms used in paragraph 1 of this article are
found in DoDI 3216.02.
2. Animals.
a. Prior to initiating any animal work under the award, you
must:
i. Register your research, development, test, and evaluation or
training facility with the Secretary of Agriculture in accordance
with 7 U.S.C. 2136 and 9 CFR 2.30, unless otherwise exempt from
this requirement by meeting the conditions in 7 U.S.C. 2136 and 9
CFR parts 1-4 for the duration of the activity.
ii. Have your proposed animal use approved in accordance with
Department of Defense Instruction (DoDI) 3216.01, Use of Animals in
DoD Programs by a DoD Component Headquarters Oversight Office.
iii. Furnish evidence of such registration and approval to the
grants officer.
b. You must make the animals on which the research is being
conducted, and all premises, facilities, vehicles, equipment, and
records that support animal care and use available during business
hours and at other times mutually agreeable to you, the United
States Department of Agriculture Office of Animal and Plant Health
Inspection Service (USDA/APHIS) representative, personnel
representing the DoD component oversight offices, as well as the
grants officer, to ascertain that you are compliant with 7 U.S.C.
2131 et seq., 9 CFR parts 1-4, and DoDI 3216.01.
c. Your care and use of animals must conform with the pertinent
laws of the United States, regulations of the Department of
Agriculture, and regulations, policies, and procedures of the
Department of Defense (see 7 U.S.C. 2131 et seq., 9 CFR
parts 1-4, and DoDI 3216.01).
d. You must acquire animals in accordance with DoDI 3216.01.
3. Use of Remedies.
Failure to comply with the applicable requirements in paragraphs
1-2 of this section may result in the DoD Component's use of
remedies, e.g., wholly or partially terminating or
suspending the award, temporarily withholding payment under the
award pending correction of the deficiency, or disallowing all or
part of the cost of the activity or action (including the federal
share and any required cost sharing or matching) that is not in
compliance. See OAR Article III.
Section B. [Reserved]