TERMS AND CONDITIONS
GRANT ADMINISTRATION REGULATIONS
Regulations from several entities guide the management of your grant. If you have any questions about regulations and how they apply to your grant, contact your grantee organization.
- Ahrens, T. (2005). Evidenced-based practice: Priorities and implementation strategies. AACN Advanced Critical Care, 16(1), 36-42.
- Cook, D. (1998). Evidence-based critical care medicine: A potential tool for change.New Horizon, 6(1), 20-25.
- Kelley, P. (2002). Research to practice in the military health care system. TSNRP grant N02-P18.
- Nieva, V., Murphy, R., Ridley, N., Donaldson, N., Combers, J., Mitchell, P., et al. (2005). From science to service: A framework for the transfer of patient safety research into practice. In Advances in patient safety: From research to implementation(vol. 2, pp. 441-453). Rockville, MD: Agency for Healthcare Research and Quality.
- Sackett, K. L., Straus, S. E., Richardson, W. S., Rosenberg, W., & Haynes, R. B. (2000). Evidence-based medicine; How to practice and teach EBM. London: Churchill Livingstone.
- Titler, M. G. (2006). Developing and evidence-based practice (6th ed.). St Louis, MO: Mosby, Inc.
Grant Management Regulations
- DoD Directive 3210.6-R, Department of Defense Grant and Agreement Regulations (DoDGAR), 13 April 1998.
- 2 Code of Federal Regulations (CFR) Part 215, Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations, 19 November 1993, amended 30 September 1999. Formerly known as OMB Circular A-110.
- 2 Code of Federal Regulations (CFR) Part 230, Cost Principles for Non-Profit Organizations, 10 May 2004. Formerly known as OMB Circular A-122.
- 2 Code of Federal Regulations (CFR) Part 220, Cost Principles for Educational Institutions, 10 May 2004. Formerly known as OMB Circular A-21.
Human Subjects Protection
- DoD Instruction 1100.13, Surveys of DoD Personnel.
- DoD Directive 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD Supported Research.
- DoD Directive 6000.8, Funding and Administration of Clinical Investigation Programs.
- HA Policy 05-003, Policy for Protection of Human Subjects in DoD Sponsored Research, Health Affairs Under Secretary of Defense for Personnel and Readiness, 28 Mar 2005.
- Title 10 U.S. Code 980, Limitations on Use of Humans as Experimental Subjects.
- DoD Directive 6200.02, Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs.
- Title 21 Code of Federal Regulations (CFR) 50, Protection of Human Subjects.
- Title 21 Code of Federal Regulations (CFR) 56, Institutional Review Boards.
- Title 21 Code of Federal Regulations (CFR) 312, Investigational New Drug Application.
- Title 21 Code of Federal Regulations (CFR) 812, Food and Drugs Chapter I: Food and Drug Administration Department of Health and Human Services, Subchapter H: Medical Devices, Part 812. Investigational Device Exemptions.
- Title 21 Code of Federal Regulations (CFR) 600, Biological Products, General.
- Title 21 Code of Federal Regulations (CFR) 314, Applications for FDA Approval to Market a New Drug.
- Title 32 CFR 219, Human Subjects Protection.
- Title 45 CFR 46, Subparts A, B, C, and D, Protection of Human Subjects.
- Title 5 U.S. Code 5536, Extra Pay for Extra Services Prohibited.
- Title 24 U.S. Code 30, Payment to Donors of Blood for Persons Undergoing Treatment at Government Expense.
- Health Affairs Policy 97-033, Policy for External Peer Review for Defense Health Program Extramural Medical Research Involving Human Subjects.
U.S. Army Regulations
- AR 40-38, Clinical Investigation Programs, 1 September 1989.
- AR 70-25, Use of Volunteers as Subjects of Research, 25 January 1990.
- AR 40-7, Use of Investigational Drugs in Humans and the Use of Schedule 1 Controlled Drug Substances, 4 January 1991.
U. S. Navy Regulations
- SECNAVINST 3900.39D, 6 Nov 2006, Human Research Protection Program.
- Summary of Significant Changes SECNAVINST 3900.39C to 3900.39D, 22 June 2007.
Non-Human Animal Subjects
- NIH, Office of Laboratory Animal Welfare.
- DoD Directive 3216.1, The Use of Animals in DoD Programs.
- Title Code of Federal Regulations (CFR) Subpart A-D, Animals and Animal Products.
- Public Law 99-158, Animals in Research, November 20, 1985.
- International Guiding Principles for Biomedical Research Involving Animals (1985), Council for International Organizations of Medical Sciences (CIOMS).
- American Veterinary Medical Association (AVMA), AVMA Guidelines on Euthanasia, June 2007.
- USUHSINST 3203, The Care and Use of Laboratory Animals in DoD Programs, incorporates Army Regulation 40-33, SECNAVINST 3900.38, AFMAN 40-401(1), and DARPAINST 18 (Defense Advanced Research Projects Agency Instruction).
- DoD Instruction 3210.7, Research Integrity and Misconduct, May 14, 2004.
- Title 42 Code of Federal Regulations (CFR) 93, Research Misconduct, 17 May 2005 (Federal Register).
- Title 45 Code of Federal Regulations (CFR) 689, Research Misconduct.
Public Affairs Policies and Procedures
- U.S. Army Regulations 360-1, Army Public Affairs Program, 165 September 2000.
- U.S. Navy SECNAV M-5720.44B, Public Affairs Policy and Regulations, 1 November 2005.
- U.S. Air Force AFI35-101, Public Affairs Policies and Procedures, 29 November 2005.
You must request prior approval from TSNRP before instituting any of the changes listed below. Forward a written request with adequate justification from the grantee organization to TSNRP for consideration.
- Change of objective or scope of the grant.
- Change in an essential person specified in the grant and/or absence for more than 3 months or a 25% reduction of the principal investigator's time and effort.
- Transfer of funds between budget categories when the cumulative amount is greater than 10% of total approved budget.
- Transfer of funds budgeted for indirect costs to absorb increases in direct costs or vice versa.
- Transfer of funds allotted for training allowances.
- Sub-grant or subcontract not specified in approved budget.
- Expenditures of more than $5,000 for equipment not specified in approved budget.
- Expenditures for foreign travel unless specified in approved budget.
- Extension of the budget or project period of award.
- Need for additional federal funding.
- Provision of "Cash Awards."
When your research project ends, what happens to the equipment you purchased with grant funds? Office of Management and Budget (OMB) circulars guide equipment disposition, which depends largely on how your grantee organization views, or defines, equipment.
Definition of Equipment
The OMB circulars define "equipment" as nonexpendable personal property having a useful life of more than one year and an acquisition cost that equals or exceeds $5,000 (or a lesser value established by your organization). If you purchased items with funds awarded in the "Equipment Budget" category, they may have a dollar value equal to, greater than, or less than your organization's defined value.
There are no disposition regulations on equipment that has a value less than your organization's defined value. Your organization may decide what to do with the equipment when your research ends.
There are several disposition options for equipment with a value equal to or greater than your organization's defined value. Your organization can:
- Use the equipment for other activities sponsored by TSNRP or other federal awarding agencies.
- Retain the equipment and compensate TSNRP or request disposition instructions from TSNRP for equipment that is no longer needed.
- Request that the equipment be gifted to a specific institution. (Items cannot be gifted to individuals.)
To request equipment gifting, send a formal written request to TSNRP through your grantee organization. The request should detail the item(s) to be gifted, their value, and the institution that will receive them. The request should also indicate if the gift is intended for a specific department within the receiving institution (e.g., Nursing Research Service).