Pre-award Administration

Pre-Award Negotiations

Award Negotiations

Award negotiations, as defined in this section, means the scope of activities between proposal submission and the acceptance of an award by the University. During this period, the award mechanism (grant, cooperative agreement or contract) and the sponsor will largely determine the length and complexity of the negotiation process. The end result of award negotiations is a mutually agreeable set of terms under which the University will conduct the proposed project.

Who Can Negotiate the Award?

The authority to negotiate an award on behalf of the University has been delegated from The Regents to the Chancellor and the Chancellor has redelegated this authority to Sponsored Projects Administration (SP). SP works in conjunction with the Principal Investigator to negotiate an award that is acceptable to the University, Principal Investigator, and sponsor.

Changes to the Scope of Work and/or Budget

Any time a sponsor requests or requires a change in the originally proposed budget or scope of work, the Principal Investigator should always notify and coordinate a response through their Grants or Contracts Officer before submitting a revised budget or scope of work to the sponsor.

Grants and Cooperative Agreements

Grants and cooperative agreements usually contain references to a sponsor's established grants management policies or in the case of government grants, government-wide regulations, laws or directives.

Clinical Trial Agreements

Contracts or Clinical Trial Agreements (CTAs) with clinical trial sponsors (e.g., pharmaceutical or medical device companies, clinical research organizations) cover human testing activities related to an investigational drug, compound or device leading to approval by the Food and Drug Administration for commercial distribution.  For further information, please see the Negotiation of Clinical Trial Agreements page.

Industry Research Contracts

Agreements with private sponsors cover many activities including basic, applied or developmental research, collaborative research, and various types of testing.

As a public, non-profit educational institution, the University is bound by certain policies and regulations regarding what it can and cannot accept in an agreement. These policies are designed to foster the University's basic mission of teaching, research and public service and to ensure the academic freedom of our faculty. Because for-profit private sponsors are motivated by different forces, they sometimes do not understand the ideals and principles behind our policies. Consequently, negotiations can take additional time while SP works with the sponsor to arrive at a mutually acceptable agreement.

Whenever possible, the University tries to negotiate an agreement using the appropriate standard University contract language for the activity proposed. These standard agreements address key concepts required by University policy. When a private sponsor prepares an agreement or insists on controlling the preparation of an agreement, these concepts may or may not be addressed and can lead to protracted negotiations.

Contract negotiations with private sponsors can be difficult and complex because the agreements must address a large number of issues such as budget, scope of work, intellectual property rights, publication rights, indemnification, termination and confidentiality.

Principal Investigators should discuss all aspects of the proposed project with their Contracts Officer prior to the start of negotiations. In particular, SP needs to know whether graduate students will be involved in the project, and whether existing University or sponsored-owned intellectual property will be used in conducting the project.

Federal/State Contracts

Contract negotiations with a government agency primarily focus on budget and scope of work issues.

The terms and conditions of the award are usually fixed by law or regulation. However, it is important to make sure that the terms and conditions imposed by the agency are appropriate for the work proposed and applicable to the University.

Required Documents

Background

When an award document is received in Sponsored Projects and negotiation of the award is complete, the Contracts or Grants Officer must ensure all administrative requirements are in place prior to acceptance of the award and notification to the campus. The most common delays in release of funding include lack of regulatory committee approvals, conflict of interest disclosure, and the award to protocol verification match.

Regulatory Committee Approvals

Most sponsors do not require proof of regulatory committee approval until the award stage. Any scope of work which requires approval from one or more of the regulatory committees, must have approval prior to the release of the award synopsis in most cases. Since most of the UCI regulatory committees only meet once per month, Principal Investigators should submit their protocol applications to the appropriate committee as soon as an award appears to be forthcoming.

If a scope of work includes animal research, approval from the Institutional Animal Care and Use Committee (IACUC) may be required. For more information, please visit the Animal Care and Use Program home page.

If a scope of work includes human subjects research, approval from the Institutional Review Board (IRB) may be required. For more information, please visit the Human Research Protections Program home page.

If a scope of work includes the use of pathogens or recombinant DNA, approval from the Institutional Biosafety Committee (IBC) may be required.

Conflict of Interest Disclosure

Depending on the sponsor of a project, Principal Investigators are required to disclose potential conflicts of interest, both financial and in obligation.

For the Public Health Service (PHS) and the National Science Foundation (NSF), as well as those sponsors who adopt the federal requirements, ORA must receive the appropriate disclosure form prior to the acceptance of the award.

For non-governmental sponsors, unless the sponsor is exempt, ORA must receive the appropriate disclosure form prior to acceptance of the award. For non-governmental sponsors, this is forwarded to ORA along with the proposal for review.

In cases where a positive interest is identified, the disclosure must be reviewed by the Conflict of Interest Oversight Committee (COIOC). The COIOC meets once per month. For more information, please visit the Conflict of Interest home page.

Award to Protocol Verification

ORA is responsible for verifying that all federally funded research procedures and activities are authorized by the applicable regulatory committee. This is done to protect both the institution and the investigator from inadvertently spending award dollars to perform unauthorized research procedures or activities in violation of funding agreements (contracts or grants) and/or regulatory requirements. As UCI is subject to unannounced audits by federal regulatory and granting agencies and by private sponsors, it is very important that award information is consistent with regulatory committee approval documentation.

The verification process is completed for federally funded awards within ORA. If any inconsistencies between the approved protocol and the scope of work in the award are identified, the Principal Investigator or Lead Researcher is contact by the Sponsored Research Analyst for resolution. The Sponsored Research Analyst must verify the match prior to release of funding.

Pre-Award Spending

Background and Contingencies

Under limited circumstances, Principal Investigators (PIs) may request authorization to spend funds in support of a sponsored project in advance of receiving a notice of an award from a sponsor. Authorization of pre-award spending is contingent upon the following:

  • An essential need to advance or commit funds prior to the receipt of an award;
  • Approval of human subjects, animal and/or biosafety protocols, as applicable;
  • Successful completion of the human subject tutorial by the PI and all key personnel participating on the project, if human subjects are involved;
  • Approval of financial disclosures on the Federal Financial Disclosure form and/or the State Financial Disclosure form 700-U, as applicable;
  • Approval of Exception to Principal Investigator Eligibility, as applicable;
  • Certification by the Principal Investigator that the level of effort, scope, and objectives of the project as proposed or negotiated will not change;
  • Certification by the chair/director of the unit responsible for administering the anticipated award, along with the appropriate dean or vice chancellor, that any monetary loss to the campus resulting from the sponsor's failure to make the award, or from costs incurred but disallowed by the sponsor, shall be the responsibility of that unit or school; and
  • Receipt of a firm commitment by an authorized representative of the sponsor to the Office of Research Administration (ORA) that an award is forthcoming.

Pre-Award Spending - Risks, Liabilities and Limitations

The risks, liabilities and limitations associated with pre-award spending must be carefully considered prior to requesting authorization to spend funds in advance of receiving the award.

Risks: Whenever the University authorizes pre-award spending, the University is risking monetary loss. Other funding must be available to cover the risk of a delayed start date, costs disallowed by the sponsor or failure of the sponsor to make an award as anticipated.

Liabilities: Special care must be exercised in assessing the impact of pre-award spending on the legal obligations of the University prior to requesting or approving a RAS. The University must consider the impact of not having a fully executed grant or contract agreement on its legal obligations regarding intellectual property rights, subject injury, indemnification, etc.

To minimize the legal liabilities, approval of pre-award spending is prohibited for agreements with for-profit entities and agreements for clinical trials.

Limitations: A sponsor's policies, the terms and conditions of the anticipated award, and campus policies and practices determine whether or not pre-award spending or pre-award activities are allowable. Restrictions differ depending on the funding agency and the type of award anticipated (i.e., grant, cooperative agreement, or contract).

Submission and Routing of RAS

Requests for pre-award spending are routed on the Request for Approval to Spend Funds ("RAS") form.

The PI should complete the RAS, explaining the essential need, the amount of funds and the period of time requested for pre-award spending. The PI must also sign and date the RAS; thereby certifying that the level of effort, scope and objectives of the project as proposed or negotiated will not change.

The Department Chair/Director and the Dean/Vice Chancellor each must sign the RAS and place a check mark in the appropriate boxes indicating who will provide funding for any losses incurred as a consequence of the approval of this request.

Once the RAS is completed and signed, it may be submitted to Sponsored Projects (SP) to secure a firm commitment from the sponsor's authorized representative. SP will analyze the request to verify all administrative requirements have been met. If such requirements have been met, SP will secure a firm commitment from the sponsor's authorized representative.

If the sponsor provides a firm commitment, SP will then approve the RAS and forward it to Contract and Grant Accounting for account/fund number assignment.

If the sponsor cannot provide a firm commitment, pre-award spending will not be approved, unless the department chair/director or dean, as appropriate, is willing to accept the increased risk.

Form

Request for Approval to Spend

Revised Cost Sharing Agreements

Background

As a recipient of Federal funds, UCI is required to propose cost sharing in a manner consistent, and in accordance, with federal regulations. Therefore, it is important to understand UCI Research Policy - Cost Sharing on Sponsored Projects, which defines cost sharing and describes when cost sharing is appropriate and permitted. In addition, principal investigators, department administrators, chairs, directors, deans and vice chancellors should be aware that cost sharing commitments may arise during pre-award discussions with extramural sponsor representatives regarding project funding.

Please note that these guidelines do not supersede UCI Research Policy - Cost Sharing on Sponsored Projects.

Definitions

UCI Research Policy - Cost Sharing on Sponsored Projects defines certain terms, including the following, which are restated below for the convenience of the reader:

  • Cost sharing is any portion of the total costs of a project or program not borne by the sponsor. Cost sharing typically takes the form of in-kind resources (e.g., contributed project personnel effort) or cash.
  • Cost sharing commitment means any cost sharing that is offered and quantified anywhere in a proposal.

Changing and Revising Cost Sharing Commitments

Once UCI accepts an award that contains a cost sharing requirement or receives an award in response to a proposal that offered a cost sharing commitment, the cost sharing becomes a binding obligation on UCI. Therefore, when discussing project funding with extramural sponsors, principal investigators must take care not to increase cost sharing commitments previously offered or create cost sharing commitments where none existed.

Generally, when a sponsor is willing to fund at least 90% of the originally proposed project costs, the principal investigator is able to conduct the project as originally proposed, and within the funds awarded, without modifying any existing cost sharing commitment or creating a new cost sharing commitment. However, whenever a principal investigator agrees to conduct the proposed scope of work, but the sponsor is only willing to fund less than 90% of the originally proposed project costs, the principal investigator must decide whether to:

  • reduce the scope of work to coincide with the level of funding;
  • increase the cost sharing commitment or offer cost sharing as a means to make up the difference between the required project costs and the level of funding offered; or
  • pursue both a and b.

Any change to a previously offered cost sharing commitment or any new offer of cost sharing made to a sponsor, at any time, should be submitted in writing to the sponsor through UCI's Sponsored Projects Office.