In the past months the NIH has issued several reminders to grantees about actions both required of and prohibited to Universities and investigators using NIH funds. The following paragraphs summarize those most important to the Yale community.
Vertebrate Animal Research
Costs for activities with live vertebrate animals may not be charged to an NIH award unless there is a valid Animal Welfare Assurance in place at the institution and an Institutional Animal Care and Use Committee (IACUC) approval of the project. Terms and conditions applicable to all grant awards that involve live, vertebrate animals - including research, research training, experimentation, biological testing, custom antibody preparation, or related purposes - require a valid Animal Welfare Assurance approved by the NIH Office of Laboratory Animal Welfare (OLAW), and valid IACUC approval. The IACUC approval must be dated within the last three years in order to be valid. Yale University’s Animal Care and Use Committee is registered and holds an approved assurance by the OLAW.(add link to IACUC website) In compliance with this rule Yale Offices of Grant and Contract Administration will not approve a new account until all IACUC requirements are satisfied.
The NIH also reminded grantees that the animal welfare requirements that apply to grantees also apply to consortium participants and subprojects. Yale as the direct and primary recipient of NIH grant funds, is accountable for the performance of the project, the appropriate expenditure of grants funds by all parties, and all other obligations of the grantee as specified in the NIH Grants Policy Statement.
While most Yale subagreements are with other domestic academic institutions registered with the NIH, the increase in international research brings with it an additional responsibility. The University must include these requirements in its agreements with collaborating organizations, and must ensure that all sites engaged in research involving the use of live vertebrate animals have an appropriate Animal Welfare Assurance and that the activity has a valid IACUC approval. When a foreign collaborating institution or performance site is using animals, Yale must ensure that the performance site has an appropriate Foreign Assurance and must provide verification of Yale IACUC approval certifying to NIH that the activity as conducted at the foreign performance site is acceptable to the Yale. Clearly such reviews and assurances can add to the time for approval and release of grant funding. Investigators are advised to plan ahead. For assistance contact Yale IACUC at iacuc.yale
Ban on NIH Funding of Human Embryo Research
Investigators are reminded that the legislative prohibitions established in federal year 2006 have not changed in 2007. NIH funds may not be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) (2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The legislation defines the term “human embryo or embryos” to include any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells. (Yale's policy on the conduct of Human Stem Cell Research may be found at http://www.yale.edu/provost/html/escropolicy.html
Acknowledgement of Federal Funding
Institutions and investigators are reminded that the federal Appropriations Act contains specific requirements for the data to be included in an acknowledgement of federal funding.
“When issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money, all grantees receiving Federal funds included in this Act, including … recipients of Federal research grants, shall clearly state:
(1) the percentage of the total costs of the program or project which will be financed with Federal money;
(2) the dollar amount of Federal funds for the project or program; and
(3) percentage and dollar amount of the total costs of the project or program that will be financed by non-governmental sources."
Continued Salary Limitation
Funds appropriated for the National Institutes of Health, the Agency for Healthcare Research and Quality, and the Substance Abuse and Mental Health Services Administration may not be used to pay the salary of an individual, through a grant or other extramural mechanism, at a rate in excess of Executive Level I. Executive Level I of the Federal Executive Pay Scale effective January 1 through December 31, 2006 was $183,500. Effective January 1, 2007, this amount increased to $186,600 or $15,500 per month. Please refer to NIH Guide Notice, (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-051.html) and to Yale procedure http://www.yale.edu/ppdev/Procedures/gc/1315PR.03SalariesaboveCap.pdf for proper management of this restriction.