Office of Research Integrity
The UAF Office of Research Integrity (ORI) facilitates the responsible conduct of research through educational, preventive, outreach, and service activities. ORI provides administrative support for the Institutional Official, IACUC, and researchers. Organizationally, the ORI is located in the Center for Research Services (West Ridge Research Building, Suite 212) and reports to the Vice Chancellor for Research (VCR). The VCR is the UAF Institutional Official charged with oversight of the animal care program.
ORI staff serve as subject area experts on institutional and regulatory requirements associated with the care and use of animals in research, teaching, and testing activities. ORI staff are available to meet with faculty, staff, and students on a variety of topics including, but not limited to, the following:
- State and Federal Laws, Regulations and Guidelines
- Permit Requirements
- Import or Export of Live Animals or Tissues
- Interstate Transfers of Live Animals
- Controlled Substances
- IACUC & UAF Institutional Policies
- IACUC Forms& Processes
- Preliminary Reviews (prior to distribution to the IACUC)
- Requesting Modifications
- Progress Reports
- IRBNet - the web-based submission and management system used by the UAF IACUC
- Compliance Concerns
- Training Requirements
- Occupational Health & Safety Concerns
Coordination with Pre- and Post-Award for Funded Activities
Most funding agencies do NOT require IACUC approval of animal activities at the time of proposal, but rather at the time of award. ORI works with the Office of Sponsored Programs (OSP) and Office Grants & Contracts Administration (OGCA) to ensure that sponsor requirements are met. ORI works with OSP to flag potential animal care issues at the proposal stage so that everyone is aware of what will be required if the proposal is funded. ORI works with OGCA to insure that IACUC approval is obtained before award funds are released and that approval is maintained for the duration of the work involving live vertebrates.
Coordination of IACUC Reviews with other Institutions/Investigators
IACUC review and oversight is the responsibility of the institution receiving the award; responsibility follows the money. That means that UAF subawardees or subcontractors are typically responsible for obtaining approval from their own IACUC. However, when the work will be performed jointly by researchers from two or more institutions ORI can often make arrangements (via an Inter-Institutional Agreement) for one institution's IACUC to take the lead which may prevent researchers from having to apply to multiple IACUCs for approval of the same work.
An Independent Investigator Agreement is required for non-UAF personnel working on an IACUC Protocol when there is no Inter-Institutional Agreement. In essence, this agreement formalizes the individual's willingness and intent to abide by all UAF policies, procedures, and the approved protocol(s).
The electronic submission system IRBNet sends email notifications to principal investigators related to approaching deadlines of their Protocols and SOPs (i.e. expiration dates and continuing review submission deadlines). Reminders are automatically issued 60, 30, and 7 days prior to the expiration date specified in the original approval letter. The ORI will also notify new personnel of training and occupational health and safety program requirements related to their specific assigned duties.
IACUC Support & Committee Administration
The ORI provides administrative support to the IACUC: setting meeting agendas, taking minutes, drafting inspection and program evaluation reports, managing IACUC correspondence, distributing and tracking all IACUC submissions, and maintaining IACUC files and databases. In addition, the ORI serves as the point-of-contact for faculty, staff, students, the public, and regulators for all questions and concerns associated with the care and use of live vertebrates at UAF or by UAF researchers at other locations.
Training Program Management
This online training program is designed and managed by the ORI on behalf of the IACUC. ORI personnel are responsible for enrolling new personnel in the training program, maintaining a training database, and for checking to ensure training has been completed prior to issuing approval letters.
Training in the care and use of animals is a required element of UAF's Assurance of Compliance with Public Health Service Policy on the Care and Use of Laboratory Animals (PHS Assurance), on file with the Office of Laboratory Animal Welfare.
Occupational Health & Safety Program Management
Participation in the Occupational Health & Safety Program (OHSP) for UAF Animal Facilities is mandated by UAF Policy #04-004 (Note: Research policies are accessible from the policy page on the Center for Research Services website. The ORI is responsible for management and oversight of this component of the UAF OHSP and works closely with the department of Environmental Health, Safety & Risk Management (website) which oversees rest of the UAF OHSP.
Participation in the OHSP is mandatory. Initial enrollment is accomplished by completing the Personnel Information Form (PIF). Further program requirements are determined based on administrative the review of PIF. More information about the OHSP is available from the link provided under Module 3 Topics or directly from the IACUC website.
The OHSP for UAF Animal Facilities, like the training program described above, is a required component of UAF's PHS Assurance.
Controlled Substances Program Oversight
The Anchorage Resident Office, Seattle Field Division, Diversion Control Office, Drug Enforcement Agency, is responsible for oversight and enforcement of controlled substances regulations in Alaska. The Anchorage Resident Office has determined that the UAF research institutes may hold research registrations for schedule II-V substances. Field offices in other areas have made other determinations. Each Institute Director holding a DEA research registration is responsible for approving and overseeing all uses of controlled substances under their institute's registration. Directors may only authorize individuals under their supervision; this means only faculty, staff and graduate students within their institutes, not non-UAF collaborators, contractors, or volunteers.
The Office of Research Integrity's role in overseeing controlled substances at UAF is primarily in the area animal research; however, ORI also provides advice on individual research registrations (typically for schedule I substances), drug storage lockers/safes, transport and export of controlled substances.
Quality Improvement Program
The Quality Improvement Program (QIP) is post-approval compliance monitoring program. The purpose of the QIP is to ensure that personnel are following the methods as described in the approved protocols and SOPs. QIP assessments are intended to identify potential issues so they can be dealt with BEFORE they become a non-compliance issue that must be reported to the sponsor and/or regulatory agencies. QIP assessments may be conducted randomly, in response to an allegation/report, or at the request of the IACUC.
QIP Report Forms for Animal Use, Human Subjects in Research, and Biosafety Issues are available on the ORI website. You may also make a report directly to a member of the ORI or IACUC.
The ORI provides administrative support to the Institutional Official (IO) by maintaining institutional registrations, certifications, and permits associated with the care and use of vertebrate animals. ORI drafts initial applications, renewal requests, and other required reports on behalf of the IO.
In addition to assisting the IO in maintaining required institutional registrations, certifications, and permits, the ORI makes required non-compliance reports to State and Federal regulatory agencies on behalf of the institution. Non-compliant activities and associated repercussions that may impact progress on funded awards must also be reported to the sponso, in most cases. The ORI coordinates sponsor reports with Grants & Contracts Administration.