All animals used in Public Health Service (PHS)-funded research are protected by laws, regulations and policies to ensure the smallest possible number of subjects are used in the research and the greatest commitment to their welfare is implemented. Fulfilling these protections is a collaborative effort between NIH and you — scientific investigators and research institutions.
PHS-supported scientists are accountable for the protection of research animals’ welfare from the earliest stages of planning until the project’s completion. Before beginning the research, scientists must provide a thorough, written justification for animal use in their application. The NIH peer review system evaluates these descriptions very rigorously. Their evaluations ensure that NIH considers only the highest quality research projects for funding.
To clarify the specific responsibilities of applicants, scientific review groups (SRG) and NIH staff in the review of the Vertebrate Animal Section and the role of the institution in the oversight of animal care and use, OER’s Office of Laboratory Animal Welfare (OLAW) recently released Guide Notice NOT-OD-10-027. The Notice reviews the information that must be included in the Vertebrate Animal Section of an application when live vertebrate animals are used in PHS-funded animal activities. This information is required as described in PHS Policy on Humane Care and Use of Laboratory Animals IV.D.1., the NIH Grants Policy Statement, and instructions for the PHS398 and SF424 grant applications.
To assist investigators in the preparation of the Vertebrate Animal Section, and aid SRG members in the evaluation of this section, we also developed a new Vertebrate Animal Section worksheet. This optional worksheet includes detailed instructions for completion of the section, an overview of applicant and reviewer responsibilities, and an example of an acceptable Vertebrate Animal Section.
It is important to note that there are no changes to the required elements of the Vertebrate Animal Section. A survey of historical files in the Office of Policy for Extramural Research Administration (OPERA) found that completion of a Vertebrate Animal Section was required as early as the 1979 version of the PHS398 application and that the required elements have remained unchanged since 1986.