|I Pre-Award – Proposal Development and Submission
||SPAdmin can assist you with many aspects of developing and submitting a proposal. Once you identify a funding opportunity to which you intent to apply, please notify SPAdmin so that we can prepare to answer any questions you may have, discuss any special considerations, and submit your application in a timely manner.
|A Funding opportunities
||A funding opportunity announcement (FOA) can take the form of a Broad Agency Announcement (BAA), program announcement (PA), PA with special referral guidelines (PAR), Request for Applications (RFA), or Request for Proposals (RFP). Generally, a FOA may be seeking PI-initiated projects (“unsolicited”) or sponsored-defined projects (“solicited”).
||A sponsor’s guidelines generally include an identifier (e.g., FOA number); due date and time; paper or electronic submission instructions; required content and format; award amount, including F&A; period of performance; and eligibility requirements. These may be program-specific or applicable to the sponsor as a whole. Care should be taken to be sure you are accessing the current version of the guidelines.
|2 Application forms
||A completed application generally is comprised of mandatory and optional forms, which are then submitted either in paper or electronically. Care should be taken to be sure you are accessing the current version of the forms.
|B Types of proposals
||A sponsor can require that proposal be submitted in one or two (or more) steps. Care should be taken to be sure your proposal will be accepted.
||A sponsor may require an applicant to initiate consideration of a project via the submission of a pre-proposal. The sponsor may use the pre-proposals in order to invite full proposals only from applicants who are evaluated to be more competitive. Alternatively, the sponsor may use the pre-proposals to provide a mechanism to all applicants to submit full proposals. A white paper can serve as a pre-proposal. A Letter of Intent allows a sponsor to gauge interests but generally does not function as a pre-proposal. Care should be taken to determine whether a pre-proposal is required or allowed.
|2 Unsolicited proposals
||If a sponsor does not require a pre-proposal, an applicant generally is welcomed to submit a full proposal without first receiving feedback from the sponsor.
|3 Solicited proposals
||If a sponsor requires a pre-proposal, an applicant generally should submit a full proposal only after it has received feedback from the sponsor.
|C Proposal development and submission
||This document focuses on the administrative aspects of developing and submitting a proposal.
|1 Institutional policies and procedures
||SPAdmin reviews the sponsor’s terms and conditions, the program guidelines, and the proposal to ensure compliance with UNMC’s policies and procedures. It is important to keep in mind that a proposal must comply with both sponsor and UNMC policy. In cases in which sponsor policy is more restrictive, UNMC must manage the project carefully (e.g., if the sponsor does not allow any budget variance). In cases in which UNMC policy is more restrictive, sponsor policy does not override UNMC policy (e.g., if the sponsor allows the direct charging of facilities and administrative costs). SPAdmin welcomes discussion about differences in policy.
|2 Budget development
||SPAdmin encourages you to use the internal budget form to calculate your budget and transfer the information onto sponsor budget forms. The internal budget form takes into account UNMC’s fringe benefits, inflation factor, and F&A rates and UNMC’s Institutional Base Salary and cost-sharing policies. Care should be taken to ensure that the requested amount is sufficient to complete the proposed project and is within sponsor parameters.
|3 Administrative data and sponsor forms
||Sponsors frequently request such institutional information as legal name, federal employer identification number, Data Universal Numbering System (DUNS) number, and federally negotiated facilities and administrative rates. This information is available on-line. If a sponsor asks for institutional information that is not on the on-line list, please feel free to contact SPAdmin for assistance.
|4 Proposal review and clearance
||SPAdmin is UNMC’s official signature authority for sponsored projects. SPAdmin is responsible for verifying UNMC’s eligibility and the accuracy, validity, and conformity with the most current institutional guidelines of all the administrative, fiscal, and scientific information in an application. SPAdmin’s Director’s ink signature on a paper application or electronic signature in an on-line system certifies that UNMC will be accountable both for the appropriate use of any funds awarded and for the performance of the grant-supported project or activities resulting from the application.
Generally, SPAdmin will submit the application on a department’s behalf to the sponsor after review. A department can make arrangements with SPAdmin to submit an application. Ideally, the department will provide SPAdmin with a review copy of the complete application, but SPAdmin will accept a subset of “key components.”
In cases in which a sponsor accepts proposals that are not signed and/or submitted by an institutional official, the department remains responsible for obtaining SPAdmin’s approval before submitting.
In addition to the application, SPAdmin requires a set of internal forms, signed by the appropriate parties. These forms provide SPAdmin with the information needed to understand your project and the documentation that your unit supports your application.
|5 Terms and conditions
||By submitting an application to a sponsor, UNMC is certifying to the sponsor that it will comply with the terms and conditions of the grant, if awarded. SPAdmin must review a sponsor’s terms and conditions prior to application submission.
|6 Signature authority and delegation
||The Director of SPAdmin is the official signature authority for sponsored project applications. If the Director is unavailable, other UNMC personnel are authorized to sign on the Director’s behalf.
|7 Deadline management
SPAdmin will make every effort to submit your application in a timely manner. To ensure successful submission, SPAdmin strongly encourages early actions, including:
- Notifying SPAdmin of a PI’s intent to submit an application at least two weeks before the deadline
- Submitting signed internal forms to SPAdmin at least three business days before the deadline
- Providing a review copy of the application to SPAdmin at least three business days before the deadline
- Planning to submit your application
- For electronic applications, at least one day before the deadline
- For paper applications, at least two days before the deadline
|II Pre-Award – Just in Time
|| “Just in Time” refers to the period after application submission and peer review and before selection for funding. During this period, the sponsor may request additional information that was not required to be submitted with the application. “Just in Time” balances the sponsor’s need for accurate, timely information with the desire to minimize the burden on the applicant.
|A Other Support
“Other Support” includes all financial resources available in direct support of an individual’s research endeavors. It is used by the sponsor to identify and resolve potential overlaps in the science, budget, or effort. For each active and pending project, the following information should be provided:
- Project number
- Project period
- Annual direct costs
- Effort (cannot exceed 12 person months)
- Overlap (if applicable)
ADIS can be used to generate NIH-compliant “Other Support.”
|B CITI Training
||If your project involves human subject research, personnel must be trained in the protection of human subjects. UNMC uses the web-based Collaborative IRB Training Initiative (CITI), which was developed by a consortium of ten research institutions, including UNMC. SPAdmin will provide a letter that certifies those personnel have completed CITI training, as tracked in the IRB’s database.
||If your project involves human subject research, an IRB protocol must be approved and active for the project.
||If your project involves research using live vertebrate animals, an IACUC protocol must be approved and active for the project. At “Just in Time,” SPAdmin initiates a “compare” of the application and the IACUC protocol; the IACUC office reviews both and certifies to SPAdmin that they match.
||If your project involves research using recombinant DNA molecules or select agents, an IBC protocol must be approved and active for the project.
|F Advance Accounts
||A “Just in Time” request is no guarantee that an award will be made. You may want to consider establishing an advance account, if your PI has received other indications that funding is likely.
|III Award – Set-up
||When a notice of award is received, SPAdmin and SPAcctng work with the department to set up the award in UNMC’s sponsored program systems.
|A Award process
||Typically, the notice of award is sent by the sponsor to SPAdmin. If you receive it directly from the sponsor, please forward it to SPAdmin for set-up. If the internal paperwork on file is complete and matches the award, SPAdmin can complete the set-up within one week. If the internal paperwork needs to be completed or revised to match the award, then set-up may be delayed. SPAdmin will contact you if internal paperwork is needed.
|1 Types of award
||Awards are generally categorized as follows:
- Research. Per OMB Circular A-110:
- "Research and development means all research activities, both basic and applied, and all development activities that are supported at universities, colleges, and other non-profit institutions. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function."
- Instruction. Per OMB Circular A-21:
- "Instruction means the teaching and training activities of an institution. Except for research training as provided in subsection b, this term includes all teaching and training activities, whether they are offered for credits toward a degree or certificate or on a non-credit basis, and whether they are offered through regular academic departments or separate divisions, such as a summer school division or an extension division. Also considered part of this major function are departmental research, and, where agreed to, university research."
- Public service. Otherwise fits UNMC’s mission:
- "To improve the health of Nebraska through premier educational programs, innovative research, the highest quality patient care, and outreach to underserved populations"
How a project is categorized has ramification for administration, including application of F&A rates, WBS numbering in SAP, and institutional reporting.
|2 Award document
||Award documents are generally categorized as follows:
- Grant: Financial assistance for the conduct of a program in which the sponsor anticipates no substantial programmatic involvement
- Cooperative agreement: Financial assistance for the conduct of a program in which the sponsor will have substantial programmatic involvement
- Contract: Mechanism for procurement of a product or service with specific obligations
How a project is categorized has ramification for administration and negotiation of terms and conditions.
|3 Award review
||To accept external funding, UNMC must agree to the sponsor’s terms and conditions for spending funds, conducting the project, and reporting on outcomes. Careful review of the sponsor’s requirements is needed to ensure UNMC can meet them.
Note: Some sponsors require an applicant at the time of application to agree to accept their terms and conditions, should an award be made.
|4 Award acceptance
||Once SPAdmin has determined that the award terms and conditions are acceptable, UNMC accepts the award, by:
- Signing an agreement
- Accessing funds (e.g., cashing a check)
|5 Authorized official
||The Director of SPAdmin is the official signature authority for sponsored project agreements. If the Director is unavailable, other UNMC personnel are authorized to sign on the Director’s behalf.
|6 Documentation and notification of project requirements
||UNMC uses “checklists” and “halfsheets” to communicate between offices about new projects and changes to existing projects.
Checklists are used when the award amount is being changed:
- New project set-up
- Non-competing continuations
- Closeouts with adjustments
Halfsheets are used if the award amount is not being changed:
- No-cost extension
- Approval to charge administrative costs directly to a project
- Subcontract-out being executed
- Subcontract-out being modified
- Closeouts with no adjustments
Once SPAdmin and SPAcctng have completed award set-up or modification, departments can access the checklist and halfsheets in ADIS.
|B Basic agreements
||SPAdmin reviews every agreement to ensure that UNMC can comply and is protected. Agreements can be categorized broadly as follows.
||Typically, UNMC receives Notices of Award (NOAs) or Notices of Grant Awards (NGAs or NOGAs) from federal sponsors, including NIH and HRSA. An NOA (or NGA or NOGA) typically provides project-specific details about funding commitments, start and end dates, and any special restrictions. It also incorporates the sponsor’s grants policy by reference.
UNMC also receives Contracts/Agreements from federal sponsors, including DOD. A Contract/Agreement typically provides more specific details about applicable regulations, including Federal Acquisition Regulations (FAR) clauses.
||The NE DHHS uses a standard template with all NU campuses.
||Many national non-profit foundations use a standard template with universities and refer to posted policies and procedures. Some smaller organizations may issue very detailed or very brief award documents. Although many of UNMC’s non-profit sponsors tend to follow the NIH’s general award process, others may have unique requirements. For example, many sponsors allow UNMC to rebudget up to 25%; some sponsors limit rebudgeting to 10% or lower.
||SPAdmin’s Contracts team handles industry-sponsored agreements.
|C Terms and conditions
||At a minimum, a sponsored project agreement should address:
- Scientific, administrative, financial, and reporting requirements
- Identification of the key personnel, with roles and responsibilities
- Compensation, including dollar ceiling, method and schedule of reimbursement, type of supporting documentation required, and timing
- Ownership and disposition of intellectual property and real property
- Applicable public policy requirements
Terms and conditions that may require negotiation are described below.
|1 Choice of law and venue
||“Choice of law” refers to the legal jurisdiction. “Venue” refers to the physical location.
||“Indemnification” refers to a guarantee to compensate another party for any loss or damage that occurs in the future.
||“Copyright” refers to the intellectual property right granted to an author.
||“Patents” refers to the intellectual property right granted to an inventor.
||Board of Regents Policy on Ownership of Intellectual Property states that "the prompt and open dissemination of the results of research undertaken at the University of Nebraska and the free exchange of information among scholars are essential to the fulfillment of the University's obligations as an institution committed to excellence in research, education, and service."
|6 Payment schedules
||Typically, payment to UNMC by a sponsor is made:
- In response to a quarterly invoice from UNMC SPAcctng office for reimbursement of actual expenses
- In response to an invoice from the department based on deliverables met
- On a set payment schedule
|7 Incorporated by reference
||Some agreements may not specifically state every term or condition but instead refer to other documents.
|8 Federal Acquisition Regulations
||Federal Acquisition Regulations (FAR) clauses define how to do business with the federal government in a procurement environment.
|D Sub-award set-up
||Once an award is received and an agreement is signed by both parties, SPAdmin sets up the award in the SPAdmin database. SPAdmin then sends data electronically to SPAcctng to set up in SAP. When this is complete, a “checklist” (or “halfsheet”) with project information is posted to ADIS for the PI and department to access.
|IV Post-Award – Project Implementation
||After an award is set up and the PI begins implementation, you will continue to work with SPAdmin on non-financial post-award administration and will work with SPAcctng on financial post-award administration.
||Most sponsors require that UNMC report progress at regular intervals, which could be:
||The PI is responsible for preparing the technical report. Either the PI or SPAdmin is responsible for submitting the report, via an electronic system and/or in paper. SPAdmin’s review of a technical report is focused on whether it contains the required elements and is in the proper format.
||SPAcctng is responsible for preparing and submitting the financial report, via an electronic system and/or in paper, based on the information in SAP. Financial reporting and invoicing often occur simultaneously.
|B Changes to plan
In general, UNMC is allowed some flexibility to implement a project differently than was proposed. Depending on the sponsor’s guidelines and the nature of these changes, they may be made:
- At the PI’s discretion
- With approval from SPAdmin
- With notification to the sponsor
- Only with approval from the sponsor
Changes are formalized as a revised Notice of Award or amendment.
||It is understood that an investigator will make adjustments as new information is received throughout the project. These adjustments are often reported to a sponsor via the next progress report. Should the investigator take the project in a new direction, it may be necessary to involve the sponsor earlier. Potential indicators of a change in scope include:
- Change in the specific aims approved at the time of award
- Change from the approved use of live vertebrate animals or involvement of human subjects
- Shift of the research emphasis from one disease area to another
- Application of a new technology
- Adding a new subcontract or an international component
- Change in other senior/key personnel not specifically named in the NOA
||It is understood that actual costs might not equal what was anticipated on a proposal budget. Actual expenditures are reported to a sponsor via the next financial report. Should the actual costs differ significantly from what was anticipated, it may be necessary to involve the sponsor. “Significant rebudgeting” generally refers to:
- An expenditure in a single direct cost budget category that deviates (increases or decreases) from the categorical commitment level established for the budget period by 25 percent or more of the total costs awarded
Sponsors may set lower thresholds or set line-item restrictions (e.g., equipment). Also, any funding restrictions contained in the funding opportunity announcement would still apply (e.g., if the FOA did not allow salaries, one could not re-budget into the salary line-item).
||When a certain level of effort is stated in a proposal, either in terms of Person Months or percent effort, UNMC has made a commitment to the sponsor that that individual will spend that time on the project, either paid for by the award or cost-shared by UNMC. It is understood that month to month time may fluctuate, but the individual must spend the stated average over the project period.
Generally, if the PI or other key personnel will:
- Withdraw from the project entirely
- Be absent from the project during any continuous period of 3 months or more
- Reduce time devoted to the project by 25 percent or more from the approved level
We must seek prior approval by the sponsor.
It is important to monitor incremental effort changes in order to engage sponsors when the threshold is crossed.
||Most NIH (and NIH-style) awards are funded in one-year budget periods as part of a five- (or less) year “cycle.” Treatment of funds that remain at the end of each year vary by sponsor and program.
For most NIH awards (“SNAP”), UNMC has been granted “expanded authorities” to carry “forward” (or carry “over”) funds from one budget period to the next, without prior agency approval. For these awards, if the amount remaining is greater than or equal to 25% of the amount awarded for that year (exclusive of any other funds), then UNMC must explain in the progress report why there is a significant balance and how those funds will be used in the next budget period.
For some NIH awards (non-“SNAP”), UNMC must request prior agency approval to carry “forward” (or carry “over”) any funds from one budget period to the next, by:
- Submitting a request that explains why there is a significant balance and how those funds will be used in the next budget period
- Reporting the balance on the financial report
Other sponsors’ policies may:
- Be similar to NIH
- Be more restrictive (e.g., no movement of funds between budget years)
- Be less restrictive (e.g., no segregation of funds between budget years)
In order to manage cash flow, it is important to understand a sponsor’s carry-forward policies. Some investigators may think it is prudent to conserve funds during the award, in order to have sufficient funds on hand for unforeseen emergencies or to extend the project period (see No-Cost Extension below), but they run the risk of the sponsor determining the funds are not needed and pulling them back.
||For most NIH awards (“SNAP”), UNMC has been granted “expanded authorities” to extend the project end date once for up to one year in order to complete the project. To extend the end date a second time and/or beyond one year, UNMC must require approval from the sponsor.
Other sponsors’ policies may:
- Be similar to NIH
- Be more restrictive (e.g., end date cannot be changed)
- Be less restrictive (e.g., end date can be changed multiple times)
|V Post-Award – Continuation
||After the initial award is made, the project may continue with additional funding from the sponsor.
|A Non-competitive (progress report)
||A sponsor may initially commit to several years of funding, contingent on satisfactory progress. Most NIH (and NIH-style) awards are funded in one-year budget periods as part of a five- (or less) year “cycle.” A non-competitive continuation of the project may be triggered by the submission of a progress report. It does not have to be peer reviewed again.
|B Competitive (renewal)
||A sponsor may consider funding a project again. Most NIH (and NIH-style) awards can be renewed. A competitive continuation of the project takes the form of a complete application. It has to be peer reviewed again.
|VI Post-Award - Close-out
||After the funded project is complete, UNMC must administratively close out the project with the sponsor and internally.
|A Technical reporting
||In general, a final technical report should include:
- Summary of progress made toward the achievement of the originally stated aims
- List of significant results (positive or negative)
- List of publications
- Report on the inclusion of study subjects (gender, minority, children)
- Description of any data, research materials (such as cell lines, DNA probes, animal models), protocols, software, or other information resulting from the research that is available to be shared with other investigators and how it may be accessed
Please see your notice of award for project- and sponsor-specific requirements, due date, and submission mode.
|B Financial reporting
Sponsored Programs Accounting will work with you to reconcile the SAP account and submit the final financial report to the sponsor. In order to close the account,
- All financial activity must be recorded
- All funds due to UNMC must be received
- Any unexpended funds must be returned to the sponsor or moved to a non-sponsored account, as allowed by sponsor policy
UNMC typically has 90 days to submit the final financial report, covering activity since the last report and all cumulative activity.
|C Invention reporting
If any inventions were conceived or first actually reduced to practice during the project:
- UNeMed must report them to the federal government via the iEdison system (if federally funded) or the sponsor’s Intellectual Property office
- SPAdmin must report them to the sponsor’s Grant Management office, using the:
- HHS 568
- DD 882
- Other form
||After a project is completed and closed out, UNMC’s reporting responsibilities continue for a period of time, including:
- Sponsored Programs Accounting including the award (if federal) on UNMC’s A-133 audit
- Sponsored Programs Accounting makes the results of the audit available to sponsors (e.g., other universities that have subcontracted to UNMC)
- Sponsors can choose to examine UNMC’s financial records
|E Record retention
||UNMC must retain financial and programmatic records and supporting documents after the close of the project. Disposition schedules vary by NU and sponsor policy and by document type. UNMC’s Director of Business Services serves as UNMC’s records retention officer.
|VII Special cases
||In general, all sponsored projects follow a common process from application to award to close-out. Depending on project-, program-, and sponsor-specific factors, special handling may be required.
|A Grant transfers-in
||A sponsor makes an award to an organization. Should a PI transfer from another university to UNMC, the university may relinquish its interest in the award (or application) to UNMC. In this case, UNMC would submit a transfer application to the sponsor. In addition to the standard forms, SPAdmin requires a copy of:
- Relinquishment statement
- Final Invention Statement
- Financial Status Report
- Funded Proposal
- Notice of Award
- Progress Report/Work Statement
In order to have the award set up at UNMC as close as possible to the PI’s start date, early submission of the transfer application is encouraged.
|B Grant transfers-out
||A sponsor makes an award to an organization. Should a PI transfer to another university from UNMC, UNMC may:
- Relinquish its interest in the award (or application) to the other university
- Propose a new PI at UNMC
In order to have the award set up at the new organization as close as possible to the PI’s start date, early submission of the relinquishment statement is encouraged. Sponsored Programs Accounting can assist with estimating the unobligated balance. Sometimes, the new organization subcontracts a portion of the project back to UNMC.
|C Training grants
||Training grants support pre-doctoral and post-doctoral education for:
- Groups of students selected by UNMC
- Individual applicants
||Federal agencies set aside fund for Small Business Concerns (SBC) to work with Research Institutions (RI) on Innovative Research and Technology Transfer. The SBC is the applicant / recipient, and the RI is the subrecipient.
||UNMC’s goals include expanding work done globally. Sponsored projects with an international component require special considerations, including:
- Approval of international travel
- Export control
- Understanding the laws of another country
- Different regulations on human subject research
- Registering as an agent in a foreign country
- Ability to monitor project activities
- Banking infrastructure
- Currency exchange
- Risk assessment
- Foreign country stability, including State Department and CDC advisories
- Vetting NGOs
Early notification to SPAdmin of an investigator’s intent to submit a proposal for work done in another country is critical for timely completion of proposal review by multiple units on campus, including:
- Business Services
- Legal Counsel
||Construction grants require closer coordination with the sponsor, including:
- Sponsor approval of design documents
- Architectural drawings, specifications, construction schedule, and cost estimates
- Perpetual reporting of facility use and disposition
- Sponsor site visits
|G Cost share
||Cost share (or “matching”) is the portion of a sponsored project that is not funded by the sponsor. It can be:
- Mandatory – Explicitly required by award terms, for example:
- Cash - Actual expenditure of funds (e.g., for salaries, equipment, travel), which follow the same allowability rules as the grant-funded expenses
- Non-Cash (AKA “in-kind”) - Contributions to a project other than cash (e.g., effort of non-employee volunteers)
- Voluntary Committed - Cost associated with project, identified in a proposal, but not requested from the sponsor, for example:
- Effort - Stated in the proposal, for which compensation is not requested
- Voluntary Uncommitted - Cost associated with project, not funded by sponsor, and not identified in proposal, for example:
- Effort - Beyond what was committed in the proposal and not included in the budget
Cost-sharing may be appropriate:
- For certain types of programs
- If a program won’t pay for faculty salaries, because the PI must commit some level of effort
|H Program income
||A sponsored project might generate program income for UNMC by:
- Income from fees for services performed
- Charges for the use or rental of real property, equipment, or supplies acquired under the grant
- Sale of commodities or items fabricated under an grant
- Charges for research resources
- Registration fees for grant-supported conferences
- License fees and royalties on patents and copyrights
Program income is reported to sponsors on financial reports. The sponsor may require UNMC to treat program income using one of three alternatives or a combination thereof:
- Additive: Added to funds committed to the project or program and used to further eligible project or program objectives
- Deductive: Deducted from total allowable costs of the project or program to determine the net allowable costs on which the Federal share of costs will be based
- Matching: Used to satisfy all or part of the non-Federal share of a project or program
|VIII Public Responsibility
||By accepting external funds to support its projects, UNMC assures its sponsors and the public in general that it:
- Minimizes the opportunity for improper financial or other gain
- Limits the potential for project results to be tainted
- Provides safe and healthful working conditions
- Fosters work environments conducive to high-quality results
|A Project Integrity
||UNMC is expected to uphold high ethical, health, and safety standards in both the conduct of our sponsored projects and and the expenditure of external funds.
|1 Promotion of Responsible Conduct in Research
||To conduct research in a responsible manner, a researcher must understand:
- Conflict of interest (personal, professional, and financial)
- Policies regarding human subjects, live vertebrate animal subjects, and safe laboratory practices
- Mentor/mentee responsibilities and relationships
- Collaborative research, including collaborations with industry
- Peer review
- Data acquisition and laboratory tools (management, sharing, and ownership)
- Research misconduct and policies for handling misconduct
- Responsible authorship and publication
- The scientist as a responsible member of society, contemporary ethical issues in biomedical research, and the environmental and societal impacts of scientific research
|2 Conflict of Interest
||In an academic health sciences center setting, an individual’s private interests may conflict or create the appearance of conflicting with the center’s public interests. Potential conflicts of interest include:
- Receipt of significant consulting fees, honoria, speakers’ bureaus fees, and other payment or remuneration from commercial sponsors of research
- Payments related to recruiting or enrolling research subjects
- Financial interests in commercial sponsors of research
- Royalty interests resulting from publications, products, or technology
- Philanthropic support from commercial sponsors of research
- Serving as a director of a company that sponsors research
- Employing research subcontractors in which an immediate member of one’s family has a substantial financial interest
In order to maintain the public’s trust in UNMC’s mission, we identify, manage, and, when needed, reduce potential conflicts of interest.
|3 Research Misconduct
||Research misconduct includes:
- Fabrication: Making up data or results and recording or reporting them
- Falsification: Manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record
- Plagiarism: Appropriation of another person’s research ideas, processes, results, or words without giving appropriate credit
Research misconduct does not include:
- Honest error or differences of opinion
- Authorship disputes
- Misallocation of resources
|4 Protection of Human Subjects
||UNMC’s Institutional Review Board (IRB) assure the protection of all human subjects in research projects conducted by anyone on the premises of the University of Nebraska Medical Center/The Nebraska Medical Center/UNO and conducted elsewhere by faculty, students, staff, or other representatives of the University of Nebraska Medical Center in connection with their institutional responsibilities.
In accordance with Health and Human Services Regulations for Protection of Human Subjects (45 CFR 46), an institutional review board committee, composed of members from a variety of scientific disciplines as well as community members, assists investigators in the protection of the rights and welfare of human subjects. All human research projects must be reviewed and approved by the IRB prior to initiation and then conducted in full compliance with the IRB guidelines.
During proposal review, a sponsor will ask for documentation of IRB approval. Also, before award set-up and during the project period, SPAdmin links projects to IRB protocol and monitors the status. A PI cannot conduct human subjects research without an active IRB protocol (or determination by the IRB that the project is exempt from HHS regulations).
|5 Humane Care and Use of Animals
||UNMC’s Institutional Animal Care and Use Committee (IACUC) assure the protection of all live vertebrate animals used in research, research training, teaching and biological testing conducted by anyone on the premises of the University of Nebraska Medical Center and UNO and conducted elsewhere by faculty, students, staff, or other representatives of the University of Nebraska Medical Center in connection with their institutional responsibilities.
In accordance with Public Health Service (PHS) policy on Humane Care and Use of Laboratory Animals, an institutional committee competent to oversee the institution's animal program, facilities, and projects involving the use of animals is devoted to the principle of carrying out meaningful scientific research through the use of laboratory animals in accordance with humane standards. The primary function of the IACUC is to assist our faculty, students and staff in upholding UNMC and UNO's determination to assure the finest care and most humane utilization of our laboratory animals. To this end, every research, testing, and teaching project involving the use of a live vertebrate animal must be reviewed and approved by the IACUC prior to initiation.
During proposal review, a sponsor will ask for documentation of IACUC approval. Also, before award set-up and during the project period, SPAdmin links projects to IACUC protocol and monitors the status. A PI cannot conduct animal subjects research without an active IACUC protocol.
|6 Biohazards and Radiation Safety
||UNMC’s Institutional Biosafety Committee (IBC) ensures the health and safety of all personnel working with biohazardous agents on the premises of the University of Nebraska Medical Center and UNO.
In accordance with NIH Guidelines for Research Involving Recombinant DNA Molecules and the Select Agent Rule, the IBC plans and implements the campus Biosafety Program, drafts campus biosafety policies and procedures, and reviews individual research proposals for biosafety concerns.
During proposal review, a sponsor will ask for documentation of IBC approval. Also, before award set-up and during the project period, SPAdmin links projects to IBC protocols and monitors the status. A PI cannot work with biohazardous agents without an active IACUC protocol.
|B Intellectual Property
||Central to UNMC’s mission is the creation and dissemination of knowledge.
||UNeMed researches the patentability and marketability of UNMC inventions before deciding whether to seek patent protection. To be patented, an invention must: 1) be novel, 2) have utility, and 3) be non-obvious.
||Per long-standing academic tradition, faculty own the copyright to academic, scholarly, and educational works resulting from their research, teaching, and writing. Exceptions may result from contractual or other obligations.
|3 Publication Rights
||In general, PIs retain the right to publish the results of their sponsored projects. Sponsors may ask to review or to be acknowledged as a funder. A PI is generally not obligated to seek sponsor approval or make sponsor requested changes. One possible exception is confidential information.
PIs may be required to make the results of their sponsored project publicly available. For example, NIH-funded investigators are required by Federal law to submit to PubMed Central an electronic version of the final, peer-reviewed manuscript upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication.
|4 Data Ownership
||In general, PIs own rights in data resulting from sponsored projects. Sponsored projects are not works for hire, and thus the sponsor does not own the data.
Data sharing is essential for expedited translation of research results into knowledge, products, and procedures to improve human health. Sponsors generally endorses the sharing of final research data. One exception is personal health information.
|C Technology Transfer
||If the ultimate goal of a UNMC sponsored project is to improve the health, then transferring UNMC intellectual property from the academic laboratory to the marketplace is a key step. UNeMed is the technology transfer arm of UNMC.
|1 Bayh-Dole Act
||The Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212) provides incentives for the practical application of research supported through federal funding. It strikes a balance between ensuring the timely transfer of the technology to the private sector and protecting the limited rights of the Federal government. Per the Bayh-Dole Act, UNMC must:
- Report all subject inventions to NIH
- Make efforts to commercialize the subject invention through patent or licensing
- Formally acknowledge the Federal government’s support in all patents that arise from the subject invention
- Formally grant the Federal government a limited use license to the subject invention
|2 Invention Reporting
||To meet Bayh-Dole requirements, UNeMed reports federally funded inventions to the federal government via the iEdison system.
In addition to Bayh-Dole requirements, grant applications and progress reports must indicate whether or not any subject inventions were made and, if inventions were made, if whether they were reported.
|3 Export Control
Federal laws prohibit the unlicensed export of certain items when:
- The item has actual or potential military applications
- The item is covered by economic protections
- The Government has concerns about the destination country, organization, or individual
- The Government has concerns about the declared or suspected end use or the end user
An export is any oral, written, electronic or visual disclosure, shipment, transfer or transmission of commodities, technology, information, technical data, assistance or software codes to:
- Anyone outside the U.S. including a U.S. citizen
- A non-U.S. individual wherever they are (deemed export)
- A foreign embassy or affiliate
Most exports do not require government licenses. However, licenses are required for exports that the U.S. government considers "license controlled" under:
- Department of Commerce's Export Administration Regulations
- Department of State's International Traffic In Arms Regulations
- Treasury Department's Office of Foreign Assets Control