Administration

IntroductionRequired Regulatory Review Processes

Do I need to complete regulatory review processes prior to grant submission?

TheNIH informationand most other sponsors allow applicants to submit grants prior to obtaining final approval of required regulatory processes. This process is called “Just in thisTime section(JIT).” appliesAfter the application is submitted and approved, but prior to sponsoredfinal projectsdetermination whoseof primaryfunding, fundingNIH sourceor other sponsors will request submission of regulatory approval documents. The request will be designated in eCommons using JIT next to the submitted application. However, a JIT request does not guarantee that an award is aforthcoming.

commercial,

When for-profitshould entityI complete and whosesubmit recipientregulatory isdocuments?

UNMC

If orregulatory UNeHealth. Funds may be received directly from the commercial entity or from another institution that receives commercial funds and then subcontracts to UNMC. The industry-funded projects may be clinical or nonclinical.

Internal Forms

What internal formsapprovals are required for industry contracts?

Internal forms document institutional support for the project and provide information related to decision and approvals. They are signed by the PI,grant, and they are not completed and approved prior to grant application, it is best to begin the application as soon after the grant submission as possible to prevent any delays in grant award once those documents are needed. These may include human studies review (IRB), animal welfare review (IACUC), and safety review (IBC). Human studies projects involving administration of any medication or therapeutic agent also require pharmacy and therapeutics (P&T) review, and any cancer-related project will require Scientific Review Committee (SRC) review and approval. For human studies projects, all personnel on the study budget who will also interact directly with patients or human subjects’ data should complete human subjects training on the CITI Web site. For more about CITI training, see unmc.edu/irb/citi.

Before I receive the Notice of Award, can I hire personnel and order equipment on the grant Budget?

If you have received indication that funding will be awarded you can request an Advance Account from SPAdmin. However, if an Advance Account is set up and the award is not made, the department covers the cost of any expenses incurred.

Access the Advance Account Request form in ADIS Internal forms. A guide is available at unmc.edu/spa/forms/forms-templates

You must have processed your proposal through SPAdmin prior to requesting an Advance Account.

Finalizing Grant Awards

As soon as you receive a Notice of Award, please notify and forward to Sponsored Programs Administration (SPAdmin) negotiator,to appropriateset Deans/Directorsup andyour Chairsgrant. (or designees), and UNMC’s official signatory.

At least two internal forms are required for all industry-sponsored projects:

• The Routing Form provides basic information about the project
• The Internal Budget calculates the budget based on institutional rates

Personnel costs are calculated as follows: Each participant and amount of effort (as a percentage) from that participant are entered. The salary requested is based on each participant’s Institutional Base Salary (IBS), which is comprised of:

• UNMC base salary
• Specified UNMC stipends
• UNMC Physicians base salary
• Children’s Specialty Physicians base salary

The benefits requested are based on UNMC’s federally-negotiated fringe benefits rate agreement.

Cost sharing by UNMC is discouraged for industry-sponsored studies but may be allowed in rare exceptions with proper justification. Cost share occurs when UNMC pays a portion of the project cost instead of the sponsor.

See UNMC’s Institutional Base Salary and Cost-Sharing Policies.

SPAdmin may request additional internal forms, depending on the nature of the project. Examples include:

• F&A Waiver (generated automatically byIf the internal forms whenon F&A is less than UNMC’s institutional rate). Access via ADIS Internal Forms.
• International Projects Questionnaire.

Howfile are complete and match the award, SPAdmin will prepare the award and send it to Sponsored Programs Accounting (SPAccting) for set-up within one week. If the total award or budget has been changed since the grant application was submitted, the internal forms accessedwill need to be revised to match the award. SPAdmin will contact you if changes to internal paperwork are required.

After the award is set up in UNMC’s accounting system, the PI and submitted?

department

Internal formsadministrator are generatednotified by email that the account is ready and that the project “bundle” may be accessed in ADIS. UserThe rightsbundle areincludes:

required

to
• Checklist, accesswhich lists the internalaccount forms.number SPAdmin/UNeHealth(known assignsas userthe rightsWBS), uponpersonnel, requesteffort, budget, regulatory requirements, and budget and award periods
• Internal budget
• Award document
• Routing form signed by the DepartmentPI
Administrator.

To learn more or access additional internal forms go to unmc.edu/spa/forms/forms-templates. For training, call SPAdmin at 402-559-7456 or UNeHealth at 402-559-7614.

Effort Reporting

What do you mean by “effort” on a sponsored project?

Per UNMC’s Effort Reporting Procedure “effort” is the proportion of time spent on any activity, expressed as a percentage of total time. Total effort for an employee must equal 100% of the employee’s appointment.

Office of Management and Budget's Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards requires that the salary charged to a sponsored project be certified as reasonable in relation to the effort expended on that project.

For more information,more, see UNMC’sAward Effort Certification Policy #6105Set-up.

How

Finalizing isSubcontracts effort tracked?

Responsibilities for effort tracking and reporting are as follows:

• Investigators assign effort to all personnel on sponsored project budgets
• Investigators monitor effort for all personnel on the budget
• Investigators or delegated staff with first-hand knowledge track effort for all departmental personnel and complete Effort Certification Reports in RSS (Research Support System) on the UNMC intranet
• SPAccting administers the Effort Reporting System and initiates Effort Certification reporting
• SPAdmin verifies effort availability prior to submission of new grants and subcontracts

Direct CostsOUT

What are direct costs?

Direct costs are those that can be specifically identified with a particular sponsored project or activity and can be assigned to that project or activity with a high degree of accuracy.

What is required to finalize a subcontract OUT?

After UNMC’s grant award is finalized, SPAdmin generates a subcontract OUT to any sub-recipient organizations based on the relationshipstatement betweenof fringe benefitswork and sponsored projects?

UNMC negotiates a Fringe Benefit Rate agreement with the federal government each year that identifies specific rates for each personnel group, such as faculty, post-docs, and staff. Fringe benefits at the appropriate rates should be included in the budget you requestcollected from the sponsor. UNMC’s fringe benefit rate agreement appears on page 3 of the Current Agreement posted on unmc.edu/spa/about/institutional

Indirect Costs

What are indirect costs?

Indirect costs, also known as overhead or FacilitiesPI and Administrative (F&A) costs, are costs that cannot be identified specifically with a particular project or activity. Examples include administration, accounting, office supplies, equipment, postage, lighting, heating, and refrigeration.

What indirect costs can I charge to the sponsor?

The F&A rate for industry-funded studies is 26 percent. This amount should be included in the budget total you request from the sponsor.

UNMC’s F&A Rate Agreement is posted on the SPAdmin Web page at unmc.edu/spa/about/institutional.

Conflict of Interest

Could my Conflict of Interest disclosure impact the conduct of my research?

All sponsored project proposals are revieweddepartment prior to grantsubmission. submissionThe orsubcontract contract negotiation to identify any real or perceived conflicts of interest. If a potential conflict is identified, itbudget may need to be eliminatedrevised orif managed.there Theis a significant variance between the budget request and budget award.

Finalizing Subcontracts IN

What is required to finalize a subcontract IN?

Once the prime recipient organization receives a notice of grant award, SPAdmin works with the organization to execute a subcontract IN based on the statement of work and budget provided by the UNMC Conflictinvestigator and department.

The subcontract from the prime recipient should contain:

• Statement of Interestwork
Committee
• Detailed establishesbudget
• Catalog of Federal Domestic Assistance (CFDA) number (if federally funded)
• Documentation of terms and conditions
• Copy of prime award

The budget and scope of work may need revisions if a significant variance exists between the COIbudget managementrequested plans.and the budget awarded to the prime recipient.