To provide exemplary stewardship of sponsored projects, the following Duke University offices oversee research policies and procedures and supply research administration services.
Policy, Administration and Compliance Offices
The Office of Animal Welfare Assurance (OAWA) assists researchers with animal care or use at Duke. Services provided by the OAWA include: protocol development, administrative and veterinary pre-review of protocols and amendments, assistance with laboratory preparation for Institutional Animal Care and Use Committee (IACUC) semiannual inspections, and coordinating or providing for the training needs of the research community at Duke. The OAWA also serves as the administrative support for the IACUC and the primary contact office with federal regulatory agencies. Under IACUC authority, OAWA is responsible for monitoring Duke’s overall compliance with regulations governing animal care and use.
Broader Impacts Resource Center (the BIRC) The mission of the BIRC is to support the Duke University research community in its individual and collective efforts to develop, implement, assess and disseminate broader impacts activities and initiatives.
- The BIRC offers broader impacts consulting at the preproposal stage to develop your impacts statement and advises at the award stage on implementation of those goals.
- Throughout the year, we run or contribute to workshops which provide researchers with an overview of Broader Impacts policy and best practices, as well as grant-writing strategies to ensure that your Broader Impacts ideas are communicated clearly and persuasively.
- The BIRC maintains a selection listing their “Broader Impacts Resources” page listing local (Duke, Durham, RTP) individuals or groups that are engaged in Broader Impacts/outreach activities and might serve as valuable partners for your proposed project.
Campus Compliance: The Campus Compliance Program is administered through the Office of Research Support (ORS) and is closely associated with the ORS grants and contracts section. In support of the responsible conduct of research at Duke, the compliance staff, headed by the Assistant Director for Compliance, works closely with the Campus Schools’ Conflict of Interest Committee, chaired by the Vice Provost for Research, in addressing potential conflicts of interest relating to all Duke individuals with faculty or PI status, all postdoctoral associates and some postdoctoral scholars, and other individuals who have a certain level of participation on sponsored projects. The Campus Compliance Program staff administers and monitors the online Conflict of Interest disclosure form for individuals whose primary affiliation is with one of Duke’s Campus Schools. Additionally, compliance staff work in the areas of potential conflicts of commitment, committed effort, subrecipient monitoring, past-due annual and final reports, monitoring responsible conduct of research (RCR) training, and other general compliance related projects. The Campus Compliance Program staff also conduct training presentations on compliance topics and are available for consultation regarding intellectual property relationships, external relationships (e.g.., business ownership, consulting, participation on a scientific board of advisors, etc.), and other potential overlaps of interest
The Office of Research Contracts (ORC) supports Duke University School of Medicine and School of Nursing research and educational efforts by drafting, reviewing, negotiating, signing, and performing certain administrative functions regarding agreements with external industry, non-profit/foundation, and government entities for the funding and conduct of clinical and non-clinical research and CME and non-CME educational programs. ORC additionally supports all Duke faculty in establishing appropriate documentation for exchanges of research materials, confidential information, data, technical know-how, and equipment in support of research across the University.
**To initiate a request for a Materials Transfer Agreement (MTA) or to get more information about the MTA process at Duke, please contact Dr. Curtis Bradney (Curtis.Bradney@dm.duke.edu) in Duke’s Office of Research Collaborations.
Division of Laboratory Animal Resources: The Division of Laboratory Animal Resources (DLAR) is responsible for the daily care and welfare of all vertebrate animals on the Duke campus. DLAR is committed to programs of excellence in veterinary care and laboratory animal management practices for all species used in Duke research endeavors. DLAR provides animal procurement, housing, veterinary care, assistance with experimental design, and technical services, etc. Further information for available services and support of research studies may be found on the DLAR website.
Export Controls: Compliance with export control regulations for both the Campus Schools and Duke Medicine is managed by the Director of Export Controls in the Office of Export Controls. The Director assists faculty, staff, and students with compliant exports from the United States. This includes the transmission or shipment of items out of the United States AND the release of technology, data, or software to a foreign national, even if it occurs in the United States. The Director will determine if goods and/or technology are controlled under the Export Administration Regulations or the International Traffic in Arms Regulations for the intended destination and/or recipient. The Director will also determine the applicability of exemptions or licenses for the export. In addition, the Director assists faculty, staff, and students planning to travel to any of the embargoed or sanctioned countries on the Treasury Department’s Office of Foreign Assets Control lists. The Director will evaluate the controls as they apply to Duke funded travel. Faculty, staff, and students may wish to consult the Director of Export Controls when giving speeches overseas or conducting research abroad in any country, as certain types of activities may be proscribed by various government regulations. Faculty, staff, and students should consult with the Director of Export Controls prior to conducting business or research with foreign governments. Commercially available goods may be export controlled and visual exposure of controlled articles to a foreign national may be regulated. This particularly applies to goods and technology that were designed, developed, or modified for military or space application. The Director prepares and submits, on behalf of faculty, staff, and students, any applications for export or travel licenses.
Institutional Review Boards: Duke University has two distinct Institutional Review Board (IRB) offices. The Duke University Health System (DUHS) IRB reviews all research with human subjects that is sponsored by DUHS, involving as key personnel any employee or agent of DUHS, including students, residents or fellows, utilizing any DUHS property or facility, or utilizing any DUHS non-public information. The DUHS Institutional Review Board Office coordinates the activities of the nine convened boards assigned to review medical research projects involving human subjects, as well as the expedited reviews conducted by the IRB Chairs and Vice Chairs. The DUHS IRB also reviews non-medical research projects involving human subjects, if those projects meet any of the definitions above. All other non-medical research projects involving human subjects are reviewed by the Institutional Review Board for the Protection of Human Subjects in Non-medical Research, coordinated by the Human Subjects Protection Program within the Office of Research Support (see 220.127.116.11 below).
Occupational & Environmental Safety Office: The Occupational & Environmental Safety Office (OESO) is committed to supporting the mission of Duke University (Campus Schools and Duke Medicine) to provide excellence in patient care, research, and teaching. In support of this mission, OESO ensures that the environment is in balance with all regulatory requirements, relevant community standards, and institutional resources. This balance is accomplished by identifying hazardous conditions, developing appropriate control measures, implementing controls through specialized training, and monitoring the effectiveness of the controls.
Ombudsman: The Offices of the Ombudsman address concerns about how and when to approach existing resources (Office of Institutional Equity, course directors, advisory deans, practice faculty, faculty mentors) if or when an individual feels mistreated or has a conflict with another member of the University community. Three ombudsman offices offer support to faculty, students and postdoctoral associates/fellows at Duke University:
- The Faculty Ombudsman
- The Student and Postdoctoral Associate Ombudsman
- The Medical Student Ombudsman, Allied Health, Medical School Post docs
The responsibilities of the Office of the Ombudsman include:
- Providing neutral safe and confidential environment to talk
- Listening to concerns and complaints and discussing appropriate options
- Helping to evaluate those options
- Assisting faculty and students to resolve those options
- Mediating conflicts, convening meetings, and engaging in “shuttle diplomacy”
- Referring people to appropriate Campus or Medical School resources
- Providing information about University or Medical School resources
The ombudsperson does not constitute notice to the institution with regard to grievances or complaints and does not:
- Adjudicate or participate in formal University grievances
- Determine guilt of any party in a dispute
- Get involved in any formal litigation or testify in court
- Provide legal advice
- Assign sanctions on individuals
- Replace any official University office, department or process
To contact any of the ombudspersons with a concern you would like to discuss, you may simply:
- email the Faculty Ombudsperson at firstname.lastname@example.org or call 919-613-7811 or 919-257-0982
- email the Duke Student Ombudsperson at email@example.com or call 919-673-2261 or 919-684-4039
- email the Medical Student Ombudsperson at firstname.lastname@example.org or call 919-668-3326
Research Administration and Research Support: The Office of Research Administration (ORA) and the Office of Research Support (ORS) serve as the preaward research administration offices for Duke University, and also have responsibility for certain postaward functions, as detailed below. ORA is responsible for the institutional review and approval of externally sponsored research for Duke Medicine, while ORS has this responsibility for the Campus Schools. Specific functions of both ORA and ORS include the following:
- Reviewing and approving proposals to assure that they comply with both sponsor and Duke guidelines; that budgets are accurate and consistent, with clear and concise justifications; and that both direct and indirect costs are appropriately recovered. All Duke proposals fall under their purview, with the following exceptions: construction and endowment proposals, which are handled by the Office of Corporate or Foundation Relations; fellowship proposals, which do not require review or approval by any University office, if the funds are awarded directly to an individual and they do not require any University involvement during the proposal or award processes.
- Negotiating and accepting grants and contracts on behalf of the University
- Issuing subcontracts
- Serving as the principal liaison between the University and its sponsors
- Approving programmatic and budgetary changes to sponsored projects (including the establishment of new fund codes and extending existing codes)
- Reporting Financial Conflict of Interests to Federal sponsors
- Facilitating closeout documentation
- Working with the Vice Provost for Research and the Research Policy Committee to develop and implement research policies and procedures
ORS, for its part, has the following additional responsibilities:
- Coordinating submissions for institutionally limited funding opportunities for both Campus Schools and Duke Medicine
- Administering the Institutional Review Board (IRB) for the Protection of Human Subjects in Non-medical Research (as noted below, Duke’s medical-research IRBs are administered by a dedicated IRB Office)
- Administering the Campus Compliance Program for conflict of interest, committed effort, subrecipient monitoring and training programs in the responsible conduct of research
- Disseminating funding information to both Campus Schools and Duke Medicine
Research Administration Continuous Improvement Steering Committee (RACI): The goal of the Research Administration Continuous Improvement Steering Committee is to enhance Duke's research support structure to provide efficient and effective grant administrative support systems, befitting our faculty's national and international status in research. The committee develops clear roles and responsibilities for administrative procedures for each organizational area, including pre and postaward offices, departments, centers and institutes, and research support units. The procedures are to be as efficient as possible and consideration for compliance and safety are first level requirements. The committee also reviews the University’s job structure for research administrators and the status of IT tools necessary to ensure efficiency and compliance.
Research Costing Compliance (RCC): The Office of Research Costing Compliance serves as the primary resource for financial research compliance management. Through the collaborative functions of monitoring, integration, and remediation, RCC provides oversight and guidance to the university research community in the management of sponsored projects funding and the interpretation and communication of policy.
Monitoring: The RCC Monitoring Program constantly monitors the state of financial research compliance at Duke University. Through analysis of financial data and with input from the Management Centers, RCC Monitoring provides both targeted input and assistance in remediation of risk issues.
Education and Training: RCC provides financial/grant administrators with effective and efficient training designed to support compliance with Federal regulations. RCC offers a variety of mandatory, certificate, and optional training and education programs for grant managers, business managers, and faculty.
Research Integrity Office supports the responsible conduct of research in Duke Medicine. It has administrative responsibility for the conflict of interest reporting and management process, and the research misconduct process.
Research Policy Committee: Chaired by the Vice Provost for Research, the Research Policy Committee is a standing committee of the University with representatives from the administration, faculty, and Legal Counsel. It is responsible for:
- Writing Duke University’s research policies
- Reviewing existing institutional research policies and procedures on a regular basis and proposing modifications, as necessary
- Ensuring that the research community is educated in the standards for the design, conduct, reporting, and supervision of research
School of Medicine Research Support Services provides operational oversight within the Office of the Vice Dean for Research for the Human Subject Protection Program (Institutional Review Board), Animal Care and Use Program, Clinical Research Support Office, conflict of interest and research misconduct. The Research Support Services Office serves as an institutional resource on the regulatory and ethical requirements for the responsible conduct of human and animal research. The Office also assists investigators in navigating the human and animal research process.
The Office of Sponsored Programs (OSP) exists to perform the postaward administration of sponsored projects by:
- preparing financial and other non-scientific reports to sponsors on sponsored projects,
- monitoring for compliance with sponsor and Duke requirements,
- assuring reimbursement of project expenditures,
- providing training and support to departmental administrators,
- coordinating award documentation and approval processes with two preaward offices and other Duke service departments, and
- answering questions and providing information to sponsors and Duke personnel in a prompt, accurate and cordial fashion.
OSP performs these duties and responsibilities in order that it may safeguard project funds, maximize Duke's cash flow position, maintain good relations with sponsors and Duke personnel, and be viewed by principal investigators and departmental administrators as facilitating the progress of the sponsored project.
The Offices of the Vice Dean for Basic Research and Vice Dean for Clinical Research within the School of Medicine, serve as liaisons between the Dean and the basic science and clinical faculty engaged in research. The Vice Dean for Clinical Research serves as a liaison between the Dean’s office and the Clinical Department Chairs and faculty. His duties include implementation of programs to support the clinical research mission, and oversight of the Institutional Review Board (IRB), conflict of interest (COI), and clinical research administration activities. Vice Dean of Basic Research duties include oversight of the biomedical graduate programs in the School of Medicine, the postdoc office, animal care and compliance programs, School of Medicine core facilities, and research lab space utilization.
The Office of the Vice Provost for Research (VPR) has overall responsibility for facilitating the research enterprise for Duke University’s campus components (Trinity College of Arts & Sciences, Divinity School, The Fuqua School of Business, School of Law, Nicholas School of the Environment, Pratt School of Engineering, Sanford School of Public Policy, and University Centers and Institutes). The VPR works closely with the Provost Office, its staff, and the deans on research policy. The VPR supervises the offices of Research Support (ORS), Export Controls, Postdoctoral Services (OPS), and Licensing and Ventures (OLV). The VPR oversees the University Committee on the Use of Human Subjects in Non-Medical Research, the Committee on Conflict of Interest, the Research Policy Committee and also manages the Instrumentation Fund. Other areas of oversight include misconduct in research involving non-medical personnel (however, please note that the Misconduct Review Officer for non-medical personnel is the Vice Provost for Academic Affairs). In addition, the VPR participates in the management and allocation of research funds allocated by the Provost. The VPR oversees Campus-wide research planning efforts. This includes working with the OLV to encourage and support the development and marketing of Duke’s intellectual property. The VPR (through the Administrative Development Group) is also responsible for the institutional research databases, including Conflict of Interest (COI) reporting system, and the Sponsored Projects System (SPS).
The Office of Audit, Risk and Compliance assists Duke University faculty and staff in the effective discharge of their responsibilities by furnishing them with analyses, appraisals, recommendations, counsel, and information concerning the activities it reviews, and by promoting effective control at a reasonable cost. The office has authorization for full and complete access to any of Duke University’s records, either manual or electronic, as well as physical properties and personnel relevant to a review. The scope of work of OARC is to determine whether Duke’s network of risk management, control, and governance processes, as designed and represented by management, is adequate and functioning in a manner to ensure:
- Risks are appropriately identified and managed
- Interaction with the various governance groups occurs as needed
- Significant financial, managerial, and operating information is accurate, reliable, and timely
- Employee’s actions are in compliance with policies, standards, procedures, and applicable laws and regulations
- Resources are acquired economically, used efficiently, and adequately protected
- Programs, plans, and objectives are achieved
- Quality and continuous improvement are fostered in Duke’s control process
- Significant legislative or regulatory issues impacting Duke are recognized and addressed properly
The School of Medicine Compliance Office serves as a resource to help ensure that the School’s practices are consistent with federal and state laws and regulations as well as Duke policies and procedures. The Office provides general oversight and guidance for research financial compliance, clinical trials billing, human subjects research, conflict of interest, and HIPAA privacy as well as other regulatory risk areas. The Office provides advice and consultation for the research community and administration on compliance issues. The Office also proactively reviews compliance risk areas to identify areas of needed improvement and partners with operational entities and the Research Community to address any identified deficiencies. It maintains a Compliance Integrity Hotline available 24 hours a day, which provides for anonymous reporting of compliance concerns. The Office works cooperatively with the Duke University Health System Compliance Office on the development of compliance training materials. The Chief Compliance Officer of the School of Medicine reports to the Audit Committee of the Board of Trustees through the Chancellor for Health Affairs.
The Office of Licensing & Ventures (OLV) is the licensing and new venture creation arm of Duke University and the Duke University Medical Center. It's where Duke innovations meet industrial, entrepreneurial, legal and investment markets to create the partnerships necessary to create value and benefit society.
Establishing and maintaining strong working relationships with policymakers is top priority for Duke. The Office of Public Affairs and Government Relations oversees the interests of the University and Health System in Washington, D.C., North Carolina, and the region. The Duke University Office of Federal Relations and the Duke University Health and State Government Relations office offer valuable resources for the Duke community and lawmakers on a range of topics including funding for scientific research and student aid, technology transfer and intellectual property law, healthcare policy and regulatory issues, faculty expert lists, legislative updates, breaking news and more.
The Office of Federal Relations (OFR) represents the University in Washington, D.C., on legislative and regulatory matters of interest to Duke. These issues include the federal budget, research and student aid funding, the reauthorization of relevant statutes (such as the Higher Education Act), visa and immigration matters, tax issues, technology transfer, intellectual property law and other areas of institutional interest. Additionally, the Office of Federal Relations coordinates Duke advocacy efforts, positions the University as a resource for policymakers in Washington and assists Duke faculty members who are interested in applying their expertise to policy development. OFR also provides many resources to faculty, staff, and policymakers on its website.
Duke University Corporate Relations facilitates mutually-beneficial relationships with companies to achieve business objectives through research, recruiting, or employee development.
Duke University's Office of Foundation Relations initiates and coordinates relationships that support Duke's teaching, research, and service mission. Working with administrators, faculty, and development staff, our staff provides expertise, services, and tools to successfully connect the university with foundations and corporate philanthropy.
- Developing strategies for working with foundations
- Identifies potential funders
- Advises on the development of program concepts and proposals
- Reviews construction and endowment proposals to foundations submitted by Duke University Campus Schools
NOTE: The University has development strategies which include seeking support from foundation and corporate sponsors, and it is important that individuals do not send proposals which would conflict with, or jeopardize, these strategies. Also, the development staff have cultivated relationships with potential sponsors, know what their expectations are, and seek to facilitate these relationships by sending only appropriate submissions. Advice from Duke University's Offices of Corporate Relations or Foundation Relations can be very helpful in the preparation and presentation of proposals to many foundation or corporate sponsors.
Duke Medicine Foundation Relations supports priority Duke Medicine initiatives by serving as the interface between Duke Medicine faculty programs and projects and the grant-making organizations and foundations that support medical research, education, and healthcare delivery. It works with the full spectrum of private foundations, from small family-based entities, to corporate philanthropic offices, to the nation’s largest philanthropic organizations. As a component of Duke Medicine’s Development and Alumni Affairs office, it works closely with its colleagues, the major gift officers and development directors, who serve the clinical, research, and educational missions of Duke Medicine. Services include:
- Identification of potential foundation resources
- Foundation background research
- Contact with, introduction to, and follow-up stewardship with foundations
- Proposal development and/or guidance
- Proposal review
- Office of Postdoctoral Services Office of Postdoctoral Services
- Undergraduate Research Support Office Undergraduate Research Support Office
This information excerpted from the Duke Faculty Handbook.