Northwestern University : Office for Research : The Guide for Research

Roles and Responsibilities Related to Research Projects

Northwestern University solicits and accepts contracts and grants for research, training, clinical trials, equipment acquisition, construction, public service, and other types of projects from a variety of federal and non-federal sponsors. Those sponsors include, but are not limited to, industrial and commercial entities, universities, governments, hospitals, and private foundations.

Fiduciary duty -- With the acceptance of these awards, the University agrees to provide technical and/or scientific expertise, as well as manage each award in conformance with various fiscal and administrative regulations.

Award Management -- Responsibility for managing these awards is shared by the principal investigator, the staff in the administering department or research center, the department chair or research center director, the dean, and various central offices, such as the Office of Sponsored Research (OSR) and Accounting Services for Research and Sponsored Programs (ASRSP).

Roles and responsibilities related to research projects reflects practices as of the release of The Guide. However, the University is conducting a project designed to assess and realign research and research administration roles & responsibilities. The Guide will be updated as the project's recommendations are adopted.

Responsibilities of PIs
Responsibilities of Administration Unit Staff
Responsibilities of Department Chairs/ Research Center Directors
Responsibilities of Deans' Offices
Responsibilities of the Office for Research
Responsibilities of the Office of Sponsored Research (OSR)
Responsibilities of Accounting Services for Research and Sponsored Programs (ASRSP)
Responsibilities of the Office for the Protection of Research Subjects (OPRS)
Responsibilities of the Office for Research Safety (ORS)
Responsibilities of the Technology Transfer Program (TTP)
Responsibilities of the Office for Research Integrity (ORI)

Responsibilities of the PI back to top ^

The principal investigator (PI) is the individual with the responsibility for the technical, administrative, and fiscal management of a project, including any applicable subcontracts. As a practical matter, PIs may leverage departmental and/or center staff members for assistance in carrying out many of the tasks associated with these responsibilities. However, delegation of tasks does not eliminate the responsibility of the PI.

PIs must fullfill the following roles and responsibilities.

Knowledge of rules and regulations - PIs must know, understand and comply with applicable agency and University guidelines and restrictions relative to the conduct of research, training, and public service programs
Proposal costs reflect University sanctioned costs and rates - PIs must ensure that the costs reflected in a proposal budget are based on University sanctioned costs and rates. Additionally, costs must represent full recovery to the University for the costs of the project,unless there is an express written agreement to the contrary. Note that salaries are commensurate with the effort expended on the project, fringe benefits, animal costs, facilities and administration costs, are consistent with approved rates
Sufficient proposal lead time - PIs must prepare and submit proposals, including Office of Sponsored Research (OSR) forms, cost-sharing commitments and sub-contractor information, with sufficient lead time to permit a meaningful review by the appropriate University officials prior to submission to the sponsoring agency
Effort not to exceed 100% of Northwestern University (NU) and Northwestern Medical Faculty Foundation (NMFF) time - PIs must ensure that sufficient participant effort is available to honor the effort committed to the project. Maximum effort by any one PI is 100% of their aggregate time spent on NU and NMFF activities. If not, ensure that necessary adjustments are made
No conflict of interest or conflict of commitment - PIs must ensure that no conflict of interest or commitment exists between the work associated with the project and any personal holdings or positions within other organizations. Disclose potential conflicts of interest or commitment and work with appropriate individuals or committees to ensure that the conflicts are managed. Please see /policies/faculty-conflict-of-interest.html for more information
Completion of grant - PIs must conduct the work supported by the grant or contract in a timely and professional manner
Compliance with grant terms and conditions - PIs must comply with:
- The specific terms and conditions of each award as stated in the contract or grant documents
- All administrative requirements as set forth in various sponsoring agency and campus policy statements
- Issues include, but are not limited to, conflict of interest, issuance of subcontracts, publication, patents, proprietary data, consultants, human subjects, animal subjects, equipment, recombinant DNA, or regulated substances
Grant expenditures are compliant - PIs must ensure that:
- Expenditures made prior to the receipt of a fully-executed contract or grant award are incurred only after obtaining specific authorized approval
- Expenditures during the approved period of the grant or contract do not exceed the total amount of funds awarded
- Adherence to specific budget category expenditure limits stipulated by the sponsor is maintained
Maintainance of budget control - PIs must maintain budgetary control through the use of departmental and central cost control systems and monthly reconciliation with the University financial system budget statements
Costs are compliant with OMB Circular A-21 - PIs must certify that all costs charged to each contract or grant specifically and proportionately benefit the project and are allowable, allocable, reasonable and treated consistently. This responsibility includes reviewing and approving payroll position forms to verify that individuals charged to a project are actually working on that project, providing quarterly certifications of effort expended by project personnel, initiating purchase transactions and approving vendor invoices for goods and services, approving subcontract invoices, travel vouchers and cost transfers, and any other charges to the project
Compliance with reporting requirements - PIs must comply with the reporting requirements of each contract and grant. This includes:
- Periodic progress reports
- Annual reports of project accomplishments
- Reports of inventions
- Reports of publications generated
- Reports of major items of equipment acquired
- Financial reports, or in the case of clinical trials, submission of 1572 forms and Case Reimbursement Forms (CRFs)
- Other reports detailed by the specific project
- Although Accounting Services for Research and Sponsored Projects (ASRSP) is responsible for the preparation and submission of reports of expenditures, the PI must assure that all financial transactions are properly recorded in a timely manner so that the reports of expenditures are accurate and can be submitted promptly
Budget statement and payroll expense reports - PIs must review the budget statements and payroll expense reports - available on VISTA - monthly and make any necessary adjustments to assure that the sponsored project is cleared of any expenses not applicable to the award upon expiration. Such adjustments may include correcting posting errors, transferring items of expense not allowable under that particular grant or contract, and transferring overdrafts to permissible non-sponsored accounts
Sub-contractor compliance - PIs must ensure that all sub-contractors comply with the terms and conditions of each award as stated in the contract and grant documents and with all administrative requirements, as set forth in various sponsoring agency statements
Commitments honored - PIs must ensure that all commitments are honored - commitments of effort, cost sharing, etc.
Sponsor Notification - PIs must identify any substantial changes in the project plan -- e.g., scope, personnel - and notify the sponsor as required
TPP Notification - PIs must disclose all inventions or discoveries to the Technology Transfer Program (TTP) office promptly
Technical Report Preparation - PIs must prepare all technical reports as required by the agreement terms and conditions in a timely manner

Responsibilities of Administration Unit Staff back to top ^

Administrative Unit Staff at the departmental and dean's office levels provide administrative support for one or more sponsored projects. With respect to financial management of sponsored accounts, unit administrators prepare, complete and process financial, human resource and other electronic and paper transaction documents as well as approve and monitor documents prepared by others.

Administrative Unit Staff are responsible for:

Assisting and supporting PIs - Unit administrators support PIs' grants management activities by performing activities such as:
- Helping PIs develop proposal budgets
- Working with the PI and the Office of Accounting Services for Research and Sponsored Programs (ASRSP) to provide information and advice to resolve any invoicing or reporting problems
- Gathering information on the conduct of subcontracts and notify the Office of Sponsored Research (OSR) of their progress and of any problems that may have arisen
- Assisting the principal investigator, as needed, in negotiations with sponsors on project scope and budget in the pre-proposal stage
- Maintaining databases or files of sources of support for each principal investigator in the unit
- Assisting principal investigators develop small business plans
- Reviewing reports detailing progress towards goals contained in small business plans
Facilitating the grants administration process - Unit administrators facilitate the grants administration process by performing activities such as:
- Processing requests for matching/in-kind funds and off-campus space
- Verifying receipt of program income
- Removing overdrafts and unallowable charges
- Provide information to ASRSP for interim invoicing and financial reporting
- Preparing documents and provide information on issues including:
  - Effort certification
  - Re-budgeting
  - Internal and external purchasing
  - Program income
  - Cost transfers
  - Proposal budget justification
  - Project appointments
  - Overdrafts
  - Final invoices and reports

Department Chairs/ Research Center Directors back to top ^

The department chairs and research center directors are responsible for reviewing proposals submitted by principal investigators or other research staff under their direction as well as monitoring the resulting awards. Specifically, Department Chairs/ Research Center Directors are responsible for:

Consistancy with University Mission - Chairs and directors determine whether the project is consistent with the mission and objectives of the University, the school, and the department/center
Space validation - Chairs and directors ensure that the descriptions of space, facilities and resources listed as being available for the conduct of this project are accurate
Resource validation - Chairs and directors assess whether the work described in the proposal can reasonably be expected to be conducted within the resources stated, provided that the sponsoring agency funds the work at the proposed level
PI validation - Chairs and directors ensure that the individual designated as principal investigator is eligible to serve in this capacity
Effort commitment validation - Chairs and directors evaluate whether the time commitments made by the unit's faculty members and staff listed in the proposal are appropriate and consistent with their other commitments to teaching, sponsored projects, service, and administrative responsibilities
Cost sharing/matching funds validation - Chairs and directors confirm that any cost sharing and/or matching fund commitments set forth in the proposal are appropriate and can be met
Conflict of interest and conflict of commitment validation - Chairs and directors assess whether the project as proposed adheres to the institution's policies regarding conflict of interest and commitment
Staffing validation - Chairs and directors determine that the department or research center either has or will hire the necessary support staff to administer the project in accordance with sound financial and administrative practices and the requirements of the sponsoring agency
Financial and administrative commitment validation - Chairs and directors ensure that:
- Financial and administrative commitments are identified on OSR-1, OSR-2 and OSR-CT forms
- Changes in principal investigator time or effort, rebudgeting and approval of subcontracts, and payment of IRB fees are valid and can be met by the department or center
Manage department and center unrestricted funds - Chairs and directors confirm that appropriate unrestricted fund sources at the departmental and center level will be made available in the unlikely event of (1) funding agency non-payments, (2) audit disallowances, and (3) the principal investigator's inability to cover shortfalls with funds under their direct control. Please note: PIs are responsible for sponsored project finances. However, in the rare occurance of an overdraft, chairs and directors must confirm that unrestricted fund sources at the department and center level will be made avaliable.

Responsibilities of Deans' Offices back to top ^

Deans are accountable for all funds administered by units under their control as well as for the coordination of all programmatic elements within their school or college. Deans have the responsibility for:

Project objective(s) validation - Deans must review all proposals to assure that the proposed projects are consistent with the educational and professional objectives of the school or college
Cost sharing/matching funds approval - Dean must approve cost sharing and/or matching fund commitments contained in proposals
Managing department and center unrestricted funds - If a pre-spending account is established and the anticipated award is not received, expenditures incurred against the pre-spending account will be transferred to the designated departmental guarantee account. Please note: PIs are responsible for sponsored project finances. However, in the rare occurance of an overdraft, deans must identify and appropriate department and center unrestricted fund resources if department chairs within the school or college are unable to cover the overdraft with funds under their jurisdiction.

Various schools delineate the responsibilities differently between department chairs/directors and deans; check the policies of your school to determine the exact division of responsibilities.

Responsibilities of the Office for Research back to top ^

The Office for Research has general oversight responsibility for research at Northwestern University. The Office for Research will:

Coordinate compliance with federal and other research regulations in matters such as human subjects, animal welfare, and biohazards
Work with research administrative units to create, enforce, and update policies
Resolve disputes which arise concerning scientific propriety or academic policy
Establish and oversee the University's Conflict of Interest and Conflict of Commitment policies
Approve requests for reductions or waiver of Facilities and Administrative Cost Rates (F&A)
Approve exceptions to principal investigator eligibility

Responsibilities of the Office of Sponsored Research (OSR) back to top ^

The Office of Sponsored Research (OSR) provides administrative support over the life of a sponsored project. OSR is responsible for:

Information dissemination - OSR staff disseminate information about funding opportunities and significant changes in sponsor policies and procedures
Proposal validation and submission - OSR staff will review, endorse on behalf of the institution, and submit all proposals for sponsored research, training, clinical trials, equipment acquisition, construction, public service, and other programs at the University. Proposal review ensures that projects are consistent with University policy, agency terms and conditions, and application guidelines. OSR staff also assist with elctronic proposal submission
Negotiate, execute, and accept contract and grant awards - OSR staff ensure that grants and contracts are consistent with University policy and contain terms and conditions that minimize unnecessary administrative burdens and exposure to compliance problems
Award notification - OSR staff informs appropriate campus personnel of incoming awards and provides them with a copy of the requirements and obligations imposed by the grant or contract. OSR staff may elect to confer with a principal investigator in advance of acceptance of an award if the terms of the agreement involve unusual or potentially problematic commitments
Account establishment - in accordance with agency requirements and institutional practice, OSR staff establish accounts in the University financial system, appropriate funds, and provide project account summaries to PIs and account folders to ASRSP
Award terms and conditions interpretation - OSR staff will interpret award terms and conditions to assist principal investigators and their departments in the proper administration of awards
Provide other administrative support over the life cycle of a grant - OSR will perform the following activities:
- Draft, negotiate and endorse subcontracts following receipt of a request from the principal investigator. For example, OSR will send letters of intent to subcontractors on behalf of the institution and accept purchasing requests for small business' subcontracting plans for contracts in excess of $500,000
- Review and approve certain financial or administrative transactions, such as retaining consultants, rebudgeting of funds, carry over or forwarding of funds, absence of PI, proposal withdrawals and award relinquishments. OSR will ensure consistency of those transactions with award terms and conditions
- Manage the PHS and NSF conflict of interest policy
- Facilitate grant transfers into and out of the institution
- Develop policies and processes to comply with new regulations or changes in agency requirements
- Provide training in accordance with training, education and communication curriculum;
- Submit invention disclosure forms to sponsors
- Maintain a current, comprehensive website with useful information for the research community;
- Maintain a listserv in order to disseminate new or revised regulations/policies/procedures
- Collect and disseminate information and data files on proposal and award activity
Take action, as necessary, to protect the interests of the University - OSR staff will:
- Notify sponsors and ASRSP of expired protocol status
- Notify PIs and ASRSP of changes in PI effort

Responsibilities of Accounting Services for Research and Sponsored Programs (ASRSP) back to top ^

Accounting Services for Research and Sponsored Programs (ASRSP) is responsible for administrating and facilitating the financial administration of sponsored research grants. ASRSP is responsible for:

Document preparation - ASRSP will:
- Prepare and submit quarterly financial cash managemet reports, interim financial reports, final financial reports, property reports, and other required reports to funding agencies in coordination with administrative units
- Prepare invoices and letter of credit draws to sponsors on a timely basis
Transaction and invoice review - ASRSP will:
- Review service and supply transactions over $500, travel, consulting, and equipment transactions in conformance with University and agency guidelines
- Review subcontract invoices for (1) consistency with the terms of the prime agreement and (2) evidence of departmental approval
- Process payments for subcontract invoices
Other financial related administration activities - ASRSP will:
- Provide training and assistance to departments in the management of sponsored project funds in accordance with the training, education and cirriculum
- Coordinate with other administrative units to perform award close-out activities, such as resolving overdrafts, non-payments by the funding agency, and unallowable expenditures
- Disseminate, collect, and review quarterly Professorial and Professional Personnel Activity Reports (PARs)
- Coordinate sponsored projects audits and responses to audit findings
- Maintain records for sponsored projects expenditures, such as budget statements-

Responsibilities of the Office for the Protection of Research Subjects (OPRS) back to top ^

OPRS assists investigators in fulfilling their obligation to plan and conduct experiments using human or animal subjects in accordance with the highest scientific, humane, and ethical principles and in conformity with all laws, regulations, and rules governing research subjects. OPRS facilitates the work of the institutional oversight committees five Institutional Review Boards (IRBs) and the Animal Care and Use Committee (ACUC) and serves as a liaison between investigators and the federal government, interpreting the guidelines and regulations that govern research involving human or animal subjects. OPRS will:

Help ensure compliance - OPRS will:
- Serve as an institutional resource regarding regulatory issues
- Help identify and communicate required training courses to PIs and all research staff
- Help ensure consistency with scientific, humane, and ethical principles and all laws, regulations, and rules governing research subjects
Provide support for the review of projects involving human and animal subjects - OPRS will:
- Provide guidance to ensure the completion of the appropriate forms from the IRB and the ACUC
- Pre-review submissions
- Distribute materials to IRB members
- Document meetings and actions
- Prepare decision notifications, including approval letters, and communicate with PIs
- Track protocols submissions and send out reminders for protocol expirations
- Present protocol for review/approval by appropriate external peer review group if necessary
- Coordinate and schedule facilities inspections and laboratory site visits
Communicate and coordinate compliance efforts with other administrative offices - OPRS will:
- Conduct ad hoc research reviews and inquiries
- Provide review and inquiry information to the Office for Research and the Office of the Dean for any of Northwestern's schools
Educate IRB and ACUC panel members - OPRS will educate panel members on all federal, state, and University regulations and guidelines governing research with human subjects or animals
Take action as necessary to protect the interests of the University - OPRS will:
- Serve as a liaison between investigators and the federal government by interpreting the guidelines and regulations that govern research involving human or animal subjects
- Take actions in instances of non-compliance with IRB and ACUC standards, including placing restrictions on a study, suspending a study or terminating a study
- Initiate non-compliance reviews and inquiries if faculty, staff or students engage in research involving human subjects or animals without prior IRB or ACUC approval

Responsibilities of the Office for Research Safety (ORS) back to top ^

ORS develops, implements, and coordinates the radiation, chemical, and biological safety programs for all research laboratories and other areas of the University. In addition to providing health and safety services, ORS is responsible for ensuring University compliance with federal, state, and local regulations. ORS will:

Promote and ensure safe research protocols - ORS will:
- Present proposal for review/approval by appropriate external peer review group
- Coordinate activities of the Chemical and Biological Safety Committee
- Coordinate hazardous waste disposal and waste minimization
- Coordinate and provide laboratory safety programs and training
Help ensure compliance - ORS will help ensure compliance with the National Institute of Health (NIH) and the Occupational Safety and Health Administration (OSHA) safety regulations
Help facilitate the grant administration process involving research safety issues - ORS will:
- Help identify and communicate required training courses to PIs in order for them to be eligible to submit proposals
- Provide oversight to ensure the completion of the appropriate forms from the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUC), Chemical and Biological Safety, or Radiation Safety Committee
- Conduct laboratory surveys
- Approve all radioactive material orders
Provide research safety training - ORS will:
- Train and monitor faculty, staff, and students who perform or participate in certain research related activities
- Coordinate and conduct laboratory safety programs, including:
  - Laboratory surveys
  - Training
  - Consulting on selection and use of personal protective clothing and equipment
  - Evaluating safety equipment and engineering controls
  - Assessing hazards
  - Air monitoring and other industrial hygiene investigations
  - Emergency response
- Oversee all aspects of the University's radiation safety program, including:
  - Encompasses radiation worker registration
  - Training
  - Laboratory surveys
  - Purchasing and inventory control
  - Bioassay
  - Personnel dosimetry
  - Radioactive waste disposal
  - X-ray inspections
  - Survey instrument calibration
  - Policy enforcement
  - Emergency response
- Coordinate the worker safety and compliance program under the OSHA standard for occupational exposure to human blood, blood products, and other potentially infectious materials
- Provide investigators with the required forms and plans for the various research safety programs

Responsibilities of the Technology Transfer Program (TTP) back to top ^

The Technology Transfer Program assists faculty, students, and staff in moving academic innovation from the bench to the market. TTP will:

Execute and log all material transfer agreements (MTA's) - TTP will:
- Review all inbound materials for undue restrictive language and potential conflicts with specific requirements of funding agencies
- Monitor and log outbound materials
- Review and execute MTA protocols received by PIs in lieu of materials exchange or transfer from an outside party
Convert research innovation into market opportunities - TTP will:
- Assist faculty, students and staff to determine market opportunities for their ideas and technologies
- Assist entrepreneurs in creating start-up companies
- Structure and negotiate license deals to generate revenue
- Reward inventors, departments, schools, and centers by sharing license revenue under University policies
Administer innovation opportunities - TTP will:
- Educate faculty, students and staff on what constitutes intellectual property and its timely protection
- Protect the inventors' and University's rights in novel technologies, copyrights, software, and private sector marketing
- Review and agree to proposal or application terms and conditions, as well as agency rules and regulations

Responsibilities of the Office for Research Integrity (ORI) back to top ^

ORI is dedicated to encouraging responsible and ethical research throughout Northwestern's research community. As a part of the Office for Research, ORI's commitment to supporting innovative research is founded on the principles of integrity and honesty. ORI will:

Manage and support research compliance - through partnership with Northwestern's research community, ORI will:
- Identify, minimize, manage and communicate compliance risks to the University's research community
- Respond to, coordinate and conduct scientific misconduct investigations
- Work with University personnel to promote and implement new guidelines related to research administration while minimizing additional administrative burden
- Monitor and correct non-compliance in accordance with University and federal guidelines
Coordinate training, education and communication - ORI will coordinate and help conduct research and research administration training, education and communication activities
Support and partner with the research community - ORI will:
- Partner with the research community to help identify and promote innovative methods to improve Northwestern's research administrative processes
- Assist the research community in understanding and complying with laws, regulations and policies
- Emphasize a culture of ethical conduct and integrity in research, including the establishment of research misconduct principles
- Promote trust and accountability in the research community
Promote excellence - ORI will strive to improve research at Northwestern through innovation and participation