There are many steps to developing a research project and preparing a proposal for submission. The Office of Research aims to provide and identify services and resources to aid the researcher’s efforts in developing and preparing a project or proposal.
Graduate students employed on a sponsored project are entitled to have their fees or tuition remitted on their behalf by the University. To be eligible for tuition and fee remittance, the student must have at least a 25% appointment. This can be a combined total of appointments across all sponsored projects. The fees and tuition remitted must be charged to the contracts or grants on which the student is appointed. The fees and tuition must also be charged in proportion to the effort charged to the project. As of 2011, the Budget Resource Management office has approved an annual escalation of 10% for student fees and tuition. You should take this into account on multi-year budgets which involve graduate students.
For budgeting purposes, “Patient Care Costs” are the costs of routine and ancillary services provided by hospitals to individuals participating in research programs. The costs of these services normally are assigned to specific research projects through the development and application of research patient care rates or amounts.
The following are examples of what are not considered “patient care costs”:
- First doctor-patient visit
- Follow-up visits (Physician /Nurses)
- Physical Exam performed by the Physician
- Physical Exam performed by a Nurse
- Taking “patient’s history” by a Physician or a Nurse
- Any other services provided by a Nurse, or a Medical Technician
- Referrals to other doctors within the hospital or department
Projects with patient care costs always involve human subjects, so the project must have IRB approval.
Researchers need to account for applicable IRB Review Fee in their proposed budgets for industry-sponsored projects, as well as budgets for all subcontracts they expect to receive from such industry sponsors. For projects subject to IRB review, IRB Review Fees will be collected based on the following rates for all industry sponsored projects, regardless of the committee reviewing them:
- Initial Review: $3,400
- Each Annual Review: $1,600
The above listed IRB Review Fees apply to all research involving human subjects, fully, or in part funded by extramural funds, and conducted by UC Davis employees, students, or agents, except for any project for which the sponsor is one or more of the following entities, with no participation of any industry sponsors:
- Federal government
- State of California and its local governments
- Non-profit foundations
- UC Davis Departmental discretionary funds
Additionally, the following IRB reviews will not be assessed IRB Review Fee:
- Reporting adverse events;
- Annual review of investigator-initiated clinical trials (however these projects continue to be subject to IRB Review Fee for their initial review);
- Review of modifications and amendments of previously IRB approved projects;
- Projects that qualify as “Exempt Review”, as defined by the Code of Federal Regulations, Title 45, Part 46, Section 101(b)(1) through 101(b)(6),- (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm/l46.101(b)(1)#46.101(b)(1));
- Unfunded projects, such as projects conducted by undergraduates, as a part of their educational activities are also exempt from the application of IRB Review Fees;
- Medical records research that is not industry-sponsored;
- Reporting of noncompliance, potential unanticipated problems, or adverse events;
- Applications involving a non-research use of a Humanitarian Use Device;
- Application for emergency or one-time use of an investigational drug or device.
Consultants work out of their brain, bag, or brief case, and typically work on an hourly basis. They don’t use resources of an entity such as a university or company, and don’t own the resources of the entity for which they are consulting. If you are calling someone a “consultant” in your budget, but they will be utilizing University resources, you should evaluate whether they are, in fact, a subcontractor.
As a part of the budget, you will need to obtain a written scope of services and fee schedule from any consultants. Finally, you will need to determine whether there is any conflict of interest between the institution or PI and the consultant. In general, you’ll examine whether the consulting agreement is with a current or recent employee, their near relatives, or an entity in which an employee controls or owns a financial interest.
There are four standard items which Sponsored Programs will always need for a subaward: budget (broken down by year), scope of work, subrecipient monitoring form, and institutional approval from the receiving institution. Approval from the receiving institution generally consists of a short letter agreeing to the terms and conditions and any required cost share. It should come from an institution contact with signature authority. For example, at UC Davis, this would be the Sponsored Programs office.
Researchers at UC Davis often find that their research and other projects can be enhanced by partnering with other institutions on extramurally funded projects. When the partnering institution provides a significant portion of the programmatic effort and exercises independent responsibility for programmatic decisions, this partnership usually takes the form of a subaward.
A subaward is agreement between an award recipient and a third-party entity who partner to perform a portion of the work toward the research objectives. Principal Investigators may choose to work with institutions, public or private entities as long as the work is approved with the prime sponsor and complies with contractual terms of the award. There are various types of subawards and terms flowed down to subcontractors depend on the prime sponsor and are intended to align with the terms and conditions of the prime award.
When lease costs are charged directly to a sponsored project, you may use off-campus indirect cost rate for your budget calculations. Remember that the lease charges must still be allowable, allocable, and consistent. You must also be able to document the lease and other associated charges.
As of December 26, 2014, the Uniform Guidance provided institutions with flexibility in the direct charging of administrative and clerical salaries as compared to the previous guidance in OMB Circular A-21. The Uniform Guidance removed the requirement that only major projects are eligible for charging these administrative and clerical salary costs. These costs are now allowable if they are integral to the project and have prior approval from the awarding agency, as set forth further, below.
Administrative and clerical salaries should still (generally) not be direct charged, but the rules governing “major project or activity” exceptions have been dropped and replaced by the following criteria, all of which must be met:
- Administrative or clerical services are integral to a project or activity;
- Individuals involved can be specifically identified with the project or activity;
- Such costs are explicitly included in the budget or have the prior written approval of the federal awarding agency; and
- The costs are not also recovered as indirect costs.
If all of these requirements are met, PIs/departments should add a new statement to the budget justification section of proposals to facilitate the required agency approval.
Administrative/clerical salaries are different from programmatic salaries, as further described below. Programmatic salaries are not subject to the extra approval requirements set forth above for administrative and clerical salaries.
UNIFORM GUIDANCE made changes to rules regarding PROGRAMMATIC SALARY COSTS
Costs related to protocol development and maintenance, managing substances/chemicals, managing and securing project-specific data and coordination of research subjects are allowable direct costs when they are “contributing and directly related to work under an agreement.” Thus, these programmatic costs may be direct charged using the same underlying requirements as other types of direct costs, and are not subject to the prior approval requirements necessary for administrative and clerical costs.
Administrative costs such as phone, copying, and office supplies are not normally charged as a direct cost to a sponsored project supported with federal funds. There is, however, an exception to this policy that applies to both major projects and non-major projects. When the costs for office supplies, postage, memberships, and similar administrative costs meet the following criteria, the cost is allowable:
- The PI is able to show that these costs can be tracked, i.e., recorded so that they are directly associated or identified with the PI’s sponsored project, and
- The cost is necessary to carry out the project’s technical objectives, and
- The administrative support provided is above and beyond the normal support provided by the PI’s department.
For example, although postage is normally treated as an indirect cost, a particular program may have a special need for an extraordinary amount of postage because of mailing hundreds of survey questionnaires. In this case, it would be appropriate to charge that program directly for the postage related to the questionnaires, since the postage for the questionnaires would constitute “unlike circumstances” compared to routine postage requirements.
The judgment as to whether a direct charge for these types of costs is appropriate should be based on the needs of the project; accordingly, such a judgment should be made by the PI. However, this is only the first step.
The PI must also support his or her decision in the budget justification. The PI will need to indicate the item and the cost and provide a clear justification that describes how the administrative cost is critical to the success of the technical aspects of the project and how the cost exceeds routine administrative services provided by the department.
Note: NIH modular budgets do not allow detailed budget information on the types of charges that go into each module. In such cases, if the PI anticipates administrative costs to the NIH, UC Davis Sponsored Programs will require the PI to provide a detailed budget and a justification for these charges to keep with the file.
Charging Administrative Costs to Non-Federal Sponsors
The Uniform Guidance does not apply to non-federal sponsors. However, all charges to sponsored projects must be allowable and allocable no matter what type of sponsor is involved. Therefore, in the case of a non-federal sponsor, administrative costs may be charged only if:
- The sponsor does not prohibit such costs, and
- Such costs are not charged in place of allowable F&A costs, and
- It is possible to track these costs as belonging to a specific project. For example, if postage costs are to be charged to a specific project, there must be a way to document that the postage paid for by the non-federal sponsor is only being used to pay for the non-federal sponsor’s project.
In preparing a proposal that includes administrative costs, always follow the guidelines of the sponsor:
- If the sponsor does not require a budget or a budget justification, the PI is not required to provide these items to the sponsor. However, the PI/Department must provide an internal Excel budget to UC Davis Sponsored Programs for review to ensure that F&A costs have been accounted for and handled appropriately.
- When budget information is required by the sponsor, the PI/Department should follow these procedures:
- Administrative and clerical salaries charged to a non-federally sponsored project must be labeled as administrative/clerical in the project budget. These costs also must be supported by an “original” justification specific to the current project in the budget justification section.
Reminder: Justifications copied from other projects including previous sponsored projects carried out by the PI are not acceptable. This is because every sponsored project is unique and every segment of a sponsored project should show progress in achieving the project’s objectives.
- Other types of administrative costs (office supplies, postage, memberships, and similar costs related specifically to the technical substance of the project) must be clearly listed in the project budget. The budget justification should indicate how these costs relate to the programmatic, technical, or administrative needs of the project. The PI also must indicate how he or she will assure that costs associated with these items will be tracked and remain project specific.
Your budget may have other direct costs which don’t have their own budget categories. This may include items such as equipment repair and maintenance, computing time, publication costs, animal care, or other costs associated with completing the project. You should list these costs on your budget, and describe them in detail in your budget justification.
Memberships, Subscriptions and Professional Activity Costs
Under the Uniform Guidance, costs of membership in any civic or community organization are allowable with prior approval by the federal awarding agency or pass-through entity.