Review Process

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Key Guidelines

  • All proposals must be internally reviewed and signed by an authorized UNC official prior to submission to the sponsor. PIs do not have the authority to negotiate for and/or commit to the performance of a proposal on behalf of the University. OSR Policy 200.2
  • With the exception of non-competing renewals, no proposal should be submitted to OSR, SPO, or OCT without prior review and approval by the PI’s Department Head and Dean/Director/Chair. OSR Policy 200.6
  • Individual departments or units may have their own procedures that must be followed.

Details

Responsibilities

Principal Investigator (PI)

OSR Policy 200.4.I

The PI is ultimately responsible for the proposal and corresponding activities including scientific, administrative, fiscal and ethical performance. Day-to-day financial management may be delegated to administrative staff, but accountability for compliance with University and Sponsor requirements ultimately rests with the PI. All proposals are subject to University review and oversight, in accordance with all relevant state and federal regulations, University policies and contractual obligations. If the project involves Co-Principal Investigators from different schools, each school should follow its own policies for determining who will act as lead investigator.

OSR Policy 200.3 provides additional information regarding PI eligibility at UNC-CH.


Business Manager/Research Administrator

OSR Policy 200.5I

A Business Manager’s/Research Administrator’s expertise and input is important in preparing a proposal’s budget and reviewing the funding agency’s announcement for any special terms and conditions to assure that proposals are prepared accurately and completely. This person is also instrumental as an interface between PIs and OSR in assuring that completed proposals are routed through their Department and submitted to OSR in a timely fashion so that reviews and sponsor submission deadlines are met.


Department Head

OSR Policy 200.6I

Typically, while constructing a proposal, the PI consults the department head or laboratory director regarding the availability and use of space and personnel and secures his/her approval. If the research involves human subjects, animal subjects, or hazardous substances, approval of the relevant committees should be obtained prior to submission to the Dean or his/her designee. If research involves investigators from more than one department/unit, one department is selected to administer the award (admin department), but each department/unit must still provide approval for the use of space, personnel, and/or equipment to be used on a particular project.


Dean/Director/Chair

OSR Policy 200.6I

The Dean/Director/Chair of the lead unit reviews the application and agrees that the PI is appropriately qualified for performance of the project; that it is an appropriate activity within the Department/Center/Institute; and that the Department/Center/Institute has agreed to provide any resources identified in the application. When applicable, these resources could include cost sharing and the responsibility for reimbursement of costs to the University in the event that the sponsor is unable to pay the University for research expenses incurred during the period of performance of the project. In the event that signature authority has been delegated to another person for purposes of approving the Internal Processing Form, a copy of this delegation is kept on file in the department. However, ultimate responsibility for the Department/Center/Institute named on the application remains with the Dean/Director/Chair.


Office of Sponsored Research (OSR)

OSR Policy 300.1

The Office of Sponsored Research (OSR) is required to evaluate all proposals, awards, agreements, or contracts prior to submission in order to certify that commitments made can be honored, and verify the accuracy of the information supplied. Each application is evaluated for compliance with University policies, agency guidelines, and where applicable federal regulations (i.e., animal use, human subjects, conflict of interest). OSR works in concert with departmental offices and central administration to prepare and submit the application. Under a specific delegation of authority from the Vice Chancellor for Research (VCR), OSR has signatory authority to enter into legal commitments for the University for all proposals, grants, cooperative agreements, and contracts associated with research and training activities.


Sponsored Programs Office (SPO), School of Medicine

OSR Policy 300.1

SPO signs for UNC-CH SOM on proposals to NIH (R, K & F Series) and American Heart Association(AHA) and American Cancer Association (ACA) typically, single investigator awards. (Link)


Office of Clinical Trials (OCT)

OSR Policy 300.1

OCT negotiates and executes clinical trial agreements between the University and industry sponsored trials. OCT also processes clinical trial subcontracts, other types of agreements related to clinical research at UNC, and their associated IPFs. (Link)

Internal Processing Guidelines

General Guidelines

To assure that OSR properly executes the University’s responsibilities with adequate time to provide investigators with appropriate feedback on their applications and to ensure timely submission to the funding agency, it is necessary that applications with published and/or established agency deadlines be received by OSR at least 5 business days prior to the due date. Proposals that have no established deadlines will be processed as soon as possible depending on the circumstances and the urgency.

Should there be any question regarding the routing of a proposal or contract for signature, contact the Director of Proposal Management in OSR for guidance.


Specific Guidelines

  1. Proposal drafts may be provided to OSR for review and comment in advance of the final proposal and based on the availability of time, OSR will provide feedback. However early submission of proposal drafts does not guarantee a reduction to the 5 working days required for final review and approval.
  2. In order to expedite the review process of proposals that include Intellectual Property issues, an advance copy of the agreement should be sent to OSR who will forward it to appropriate departments (i.e. University Counsel, Office of Technology Development) for review and identification of issues requiring negotiation with the sponsor. Upon completion of the negotiations and legal review, OSR will provide copies of the agreement to the Development Office when appropriate and fulfill its reporting requirements to UNC General Administration.
  3. Proposals are to be submitted with all required documentation. Please refer to the appropriate office’s guidelines:

  4. All proposals submitted electronically must be approved by OSR at least 5 business days prior to the submission deadline. Additionally, if the electronic submission requires files to be uploaded, either by OSR or by the PI/department, those files must be ready and available for uploading no later than 5 business days prior to the submission deadline. Program/project announcements should accompany the hard copy of the proposal to facilitate submission. Because many of the electronic submission systems have gone down or become extremely slow on deadline day, OSR cannot guarantee submission by the imposed deadlines for proposals that are not received and approved within the time periods above. Go here for more information regarding electronic submissions (link)
  5. If a proposal budget is revised after it has been submitted to the sponsor and the proposal is still pending final action by the sponsor, the following routing procedures should be followed:
    • For proposal budgets with increased cost sharing commitments or increased faculty effort devoted to the proposed project
      • route to OSR with an IPF approved by departmental and school officials from those departments in which the financial or personnel commitments are being increased
      • the originating department is responsible for notifying and providing copies of revised budgets to participating departments
    • All other revised proposal budgets
      • IPF is NOT required
      • department prepares a transmittal letter addressed to the sponsor and signed by the PI with a signature line for the appropriate contract specialist and routes the letter to OSR
    • If the department receives an agreement from the sponsor in response to a submitted proposal, the agreement should be forwarded to OSR for further processing. If changes have occurred since the proposal was submitted to the sponsor please include updated human subject approvals and lab animal or radiological materials approvals.
    • An agreement for which a proposal was previously routed that does not require University signature in order to be accepted should be forwarded directly to OSR for account establishment.

Just-In-Time (JIT) Guidelines

JIT Information is provided at the request of the granting agency and as applicable, includes a request for the following documentation: Active/Pending Support for all Key Personnel named in the grant proposal; IRB Approval; IACUC Approval; Certification of Human Subjects Education** for Key Personnel. JIT request may also require other information such as a detailed budget and/or other information deemed necessary by the agency.

A signing official of the University must approve all JIT documentation prior to providing the information to the granting agency.

  • Hard copy submissions via mail or FAX:

A cover letter to the agency should accompany the JIT documentation to the Office of Sponsored Research (OSR) or the Sponsored Programs Office (SPO) as applicable for SOM proposals, with the signature of the principal investigator and a countersignature line for Terry Magnuson, Vice Chancellor for Research.

Should an IRB Approval or IACUC Approval not be available at the time other hard copy JIT documentation was provided to the NIH or other granting agency, the approval(s) should NOT be forwarded to the agency prior to obtaining the approval of an authorized University official in the OSR or the SPO.

Note: this reflects a deviation from the NIH JIT instructions which permit for the approval(s) to be provided up to two weeks following the submission of other JIT information previously provided with University approval.

  • Electronic submissions: To submit JIT Information electronically through the NIH eRA Commons, all documentation requested must be uploaded, i.e., current IRB and/or IACUC Approval is required when applicable. Important: You must notify the OSR or the SPO that the JIT information has been uploaded and is ready for review and submission by a signing official.

Please provide OSR/SPO a copy of the notification from the agency requesting the JIT info.

**University Policy requires that all personnel named in a proposal using human subjects complete the Human Subjects Education Training. Please print and include the Training Certification Letter.

Link to Human Subjects Protection Required Education

Contacts

OSR Pre-Award Assignment by Department