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Related Offices for Research Administration and Services

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

Animal Welfare Assurance

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.

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

Corporate Research Collaborations

The Office of Corporate Research Collaborations (OCRC) drafts, reviews, and negotiates agreements for commercially supported research, both clinical and non-clinical, in the School of Medicine and related departments, and approves these agreements for institutional signature. These include clinical trial agreements, sponsored research agreements, data analysis agreements, network participation agreements, educational program support agreements (other than those for CME credit which are handled by the Office of Continuing Medical Education), subagreements under any of these, and an array of other similar contracts. Additionally, OCRC handles Confidentiality Agreements and agreements for transfers of research materials, data and equipment (**Material Transfer Agreements, Collaborative Research Agreements, HIPAA Data Use Agreements, Data Transfer Agreements, Research Equipment Loans), and other related documents for these research endeavors for all of the University, including commercial, government, and academic sources and recipients. OCRC sees that agreements are consistent with Duke policies, applicable federal and state laws, and applicable IRS regulations relating to Duke’s status as a not-for-profit organization making extensive use of facilities funded with tax-exempt bonds. OCRC advises faculty on matters arising from these agreements, particularly publication* rights, intellectual property rights, confidentiality obligations, human subjects protections, and liability issues. OCRC coordinates its activities with numerous other Duke offices, including the Office of University Counsel, Office of Research Administration, Office of Research Support, Office of Risk Management, Institutional Review Board, Clinical Research Support Office, and Office of Licensing and Ventures. OCRC advises the Office of Research Administration and the Office of Research Support on matters regarding intellectual property terms for foundation and government-sponsored research. OCRC advises the Duke University Health System (DUHS) Institutional Review Board on terms for IRB* Authorization Agreements in which external entities are seeking coverage from the DUHS IRB*.
 
**To initiate a request for an 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 Corporate 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 5.1.1.10 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 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:

Research Administration and Research Support

The Office of Research Administration (ORA) and the Office of Research Support (ORS) serve as the pre-award research administration offices for Duke University, and also have responsibility for certain post-award 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 and 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

Research Administration Continuous Improvement (RACI) Steering Committee 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 post-award 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

The Office of Research Costing Compliance (RCC) Research Costing Compliance (RCC*) 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

The 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

The Research Support Services Office 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.

Sponsored Programs

The Office of Sponsored Programs (OSP) exists to perform the post-award administration of sponsored projects at Duke University, for both Campus Schools* and Duke Medicine. OSP*’s mission is to safeguard project funds, maximize Duke’s cash flow position, maintain good relations with sponsors and Duke personnel, and to be viewed by principal investigators and departmental administrators as facilitating the progress of their sponsored projects. Specific responsibilities include:
  • Preparing financial and other non-scientific reports to sponsors on sponsored projects
  • Monitoring projects for compliance with sponsor and Duke requirements
  • Assuring reimbursement of project expenditures
  • Providing advice to departmental administrators
  • Coordinating award documentation and approval processes with the Office of Research Support, Office of Research Administration, and other Duke service departments
  • Answering questions and providing information to sponsors and Duke personnel

Vice Dean for Research

Within the School of Medicine, the Office of the Vice Dean for Research serves as a liaison between the Dean and the basic science and clinical faculty engaged in research. The Vice Dean for Research works with department chairs and faculty to implement the School of Medicine’s strategic initiatives concerning research and education, including the oversight of shared resources, and multiple regulatory/advisory committees. The Vice Dean is also the administrative head of the graduate program within the school, and is jointly responsible (along with the Vice Provost for Research) for the Office of Postdoctoral Services. The Vice Dean for Research is administratively responsible for several aspects of research operations at the School of Medicine. Areas of oversight include the Institutional Review Board (IRB*) for the protection of human subjects in medical research, the Clinical Research Support Office (CRSO), conflict of interest, and misconduct in research. The office can be of assistance in questions regarding institutional resources and “dry lab” (clinical research) space, and will be increasingly involved in faculty mentoring. One component of the office seeks to match investigators and funding opportunities, and is also a good place to start when investigators have a new research idea and are looking for collaborators. The office (through the Administrative Development Group) is also responsible for the institutional research databases, including the Faculty Research Directory (FReD), the Research Executive (REX), the Conflict of Interest (COI*) reporting system, and the Sponsored Projects System (SPS*).

Vice Provost for Research

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*).

Audit Offices

Office of Internal Audits

The objectives of the Office of Internal Audits (OIA) are to assist 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 OIA 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

School of Medicine Compliance Office

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.

Technology Transfer

Licensing & Ventures

The Office of Corporate & Venture Development (CVD) serves Duke University (Campus Schools* and Duke Medicine) and is responsible for commercially-sponsored research, patents and licenses, new venture activity, corporate gifts, and corporate vending relationships. CVD* includes:
  • Vice Chancellor Corporate & Venture Development
  • Office of Licensing & Ventures (see below)
  • Office of Corporate Research Collaborations (see above)
  • Corporate Alliances & Development
  • Corporate Programs

Sponsor Relations

Federal Relations

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.

Corporate & Foundation Relations

Duke University Corporate Relations  facilitates mutually-beneficial relationships with companies to achieve business objectives through research, recruiting, or employee development.

Foundation Relations  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*

Duke Medicine Foundation Relations

The Office of 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

Duke Medicine Government Relations

The Duke Medicine Office of Government Relations serves as the point of strategy development and implementation on health-related legislative and policy issues at the federal and state government levels for Duke University Health System, including Duke University Hospital, Durham Regional Hospital, Duke Raleigh Hospital, the Private Diagnostic Clinics (PDC), and Duke Medicine. The office is also responsible for all state-level legislative and policy issues affecting Duke University including the Campus Schools*.

Additional Offices

Office of Postdoctoral Services Office of Postdoctoral Services

Undergraduate Research Support Office Undergraduate Research Support Office

This information excerpted from the Duke Faculty Handbook.

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