non-institutional performance sites for UK or the Lexington VAMC, domestic or international, shall also comply with the Department of Health and Human Services (DHHS) Code of Federal Regulations (CFR) 45 CFR 46 and, as applicable, Food and Drug Administration (FDA) 21 CFR Parts 50 and 56, Veterans Affairs (VA) 38 CFR Part 16, and the Health Insurance Portability and Accountability Act of 1996 (HIPAA) 45 CFR 160 and 164 Subparts A and E. In addition, research shall comply with all applicable federal and state laws and regulations. The institution applies additional regulations/policies on a case-by-case basis for projects funded by or covered by federal agencies such as the U.S. Department of Education, U.S. Department of Defense, National Science Foundation, or U.S. Bureau of Prisons, as appropriate to the sponsor. University officials shall develop and implement policies and procedures related to human research protection in alignment with this ethical and regulatory framework.
A1.0225 ACCREDITATION STANDARDS
Following a rigorous, three-year evaluation process, the UK HRPP prepared for and achieved full accreditation by the Association for the Accreditation of Human Research Protection Programs, Inc., (AAHRPP) in June, 2007. AAHRPP standards exceed federal regulations in two ways: the protections required by the federal government for federally sponsored or regulated research are extended to all research, and AAHRPP requires additional protections, such as conflict of interest rules and community education. Achieving accreditation demonstrates UK’s commitment to the highest ethical standards in conducting human research. This accreditation signals to research volunteers that UK puts their safety first and embraces standards that are higher than required by law. It also indicates to sponsors and investigators the efficiency and quality of the UK research program. Maintaining the HRPP at this distinguished level involves ongoing evaluation, training, documentation, annual reporting, and completing the reaccreditation process every three years.
A1.0250 ACTIVITIES COVERED UNDER THE UK HRPP
In accordance with federal and institutional regulations, any undertaking in which any UK/VAMC faculty, staff, or student investigates and/or collects data on human subjects for research purposes is subject to the UK HRPP and review by the appropriate Medical or Nonmedical Institutional Review Board (IRB) regardless of the funding source. Specific institutional procedures which correlate with the assurance and cooperative research guidance of the Office for Human Research Protections (OHRP) govern data collection occurring at “off- site” locations, including criteria for engagement in research by the organization.
Any UK/VAMC activity that meets the federal Department of Health and Human Services (DHHS) definition of both “research” and “human subjects” or the Federal Drug Administration (FDA) definition of both “human subject” and “clinical investigation” is subject to all provisions of the institution-wide HRPP. As appropriate, UK applies relevant definitions from other sponsor agencies (e.g., Veterans Health Administration or Department of Defense).
Research: “A systematic investigation designed to develop or contribute to generalizable knowledge” [45 CFR 46.102 (d)]
Human Subjects (DHHS): “A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) through identifiable private information” [45 CFR 46.102 (f)]