CHAPTER ONE: General Information
This handbook provides assistance and guidance to faculty and staff who are involved in the preparation of proposals to and in the administration of awards received from external sponsors. Extramural support assists the University in fulfilling its mission of research, teaching and service. However, when the University of Louisville Research Foundation accepts such support as the limited agent for the University of Louisville (collectively referred to as the University), the Institution also accepts the responsibility of complying with the sponsor’s terms of agreement as well as various regulatory compliance requirements. The intent of this handbook is to define responsibilities for the preparation, review, management and reporting requirements of sponsored programs that will allow the Institution to comply with these agreement terms and compliance requirements. The responsibilities of principal investigators/project directors, chairs, deans, the Office of the Executive Vice President for Research, and the Office of the Vice President for Finance are outlined in the handbook.
The handbook includes links to other University policies and procedures, including the Red Book, relevant Board Policies and other guidelines important to those involved in sponsored programs. Suggestions for revisions or requests for clarification are welcome at the following address: email@example.com.
Sponsored Activities must be cleared through the appropriate unit within the Office of the Executive Vice President for Research to assure appropriate treatment in the University system. This policy provides guidelines to assist in determining which agreements fall into this category.
Sponsored agreements generally include two or more of the following characteristics:
· Investigator-initiated project that specifies proposals for research, training, or service activities to an outside entity;
· The proposed project binds the University to a specific scope of work;
· A formal agreement for a specified term is established, with the agreement between the University of Louisville Research Foundation and the sponsor. This agreement is signed by an authorized signatory of the Research Foundation and the sponsoring agency and may be a grant, contract, cooperative agreement, fee-for-service arrangement or other sponsored agreement;
· The project involves disposition of property, whether tangible or intangible, that may result from the project (e.g. equipment, records, inventions, copyrights, or rights in data);
· The sponsor has written policies concerning Facilities & Administration (F&A, also referred to as indirect or overhead) cost recoveries. Projects normally requiring F&A cost recovery must be established by either the Office of Sponsored Programs Grants Administration (formerly known as Grants Management) or the Office of Industry Contracts. The absence or prohibition of F&A costs does not automatically preclude the award from being considered a sponsored agreement;
· Progress, technical, final reports or other deliverables are required, excluding stewardship reports on gifts;
· Invoices and/or financial reports are required;
· Unexpended funds are returned to the sponsor or a fixed price contract has been negotiated;
· The proposed activity involves human subjects, laboratory animals, radiological hazards, biohazards, or recombinant DNA.
Numerous offices and individuals have responsibilities related to both the processing of proposals, and in conducting and reporting sponsored projects once they are funded. The following includes a high-level description of the primary offices and individuals responsible for the administration of sponsored programs. More detailed roles and responsibilities can be viewed in Appendix A or can be found on the Office of Sponsored Programs Grants Administration (OSPGA) or the Office of Industry Contracts web page.
1.2 Offices of the Executive Vice President for Research
The Mission of the Office of the Executive Vice President for Research (EVPR) is to:
· Promote and support research, scholarship, and creative activities;
· Assist faculty and staff in obtaining intramural and extramural support;
· Serve as an advocate for the value of research in an educational setting;
· Enhance the vitality of campus-based research and to encourage its use to enrich education, enhance technology transfer and serve the community.
The EVPR’s office contains the offices of Sponsored Programs Development, Sponsored Programs Grants Administration, the Human Subjects Protection Program, Industry Contracts, Technology Transfer and the Research Integrity Program. A complete listing of the SVPR’s staff can be found by selecting “Staff” on the web page of the link provided above. The individual units and their responsibilities are described below.
1.3 Office of Sponsored Programs Development
The Office of Sponsored Programs Development is responsible for identifying funding opportunities and providing support to faculty and staff during the proposal development process. The staff is trained to assist researchers in identifying potential funding sources, writing competitive proposals and submitting proposals to the sponsoring agency. The following is a list of the services the Office of Sponsored Programs Development provides:
· Train researchers in grant writing;
· Provide updates in legislative policies;
· Assist investigators in seeking funding for research;
· Provide individual seminars for academic departments;
· Assist with proposal editing;
· Coordinate multi-investigator proposals;
· Provide information on current sponsor guidelines and grant application forms;
· Provide contacts with federal funding agencies;
· Assist with cooperative activities with industry, government, and other institutions.
1.4 Office of Sponsored Progrmas Grants Administration
The Office of Sponsored Programs Grants Administration, (OSPGA), is the official authorized signature authority for sponsored program agreements from governmental and non-profit sponsors. The Office provides guidance and assistance relating to grants management from proposal development through award closeout. Responsibilities for the Office include the following:
· Provide guidance and assistance in completing external applications consistent with the policies and procedures of both the University and sponsors;
· Provide administrative support for budgetary matters related to sponsored programs activities including the review of budgets and approval of all applications for submission to outside sponsors;
· Negotiate final terms for government and not-for-profit grants, contracts. subagreements, and other agreements from governmental and non-profit sponsors;
· Administer and monitor the individual and departmental research incentive funds as well as the Executive Vice President for Research matching research funds;
· Establish chartfields and set up budgets for all government and non-profit awarded grants, contracts, subawards, cooperative and other related agreements.
· Process budget revisions and no-cost extension requests;
· Act as a reference for questions regarding cost allowability, cost sharing, indirect costs, and award transfers;
· Issue final patent and invention reports to federal agencies after review and approval from the project director and the Office of Technology Transfer;
· Maintain the official database of all proposals and awards for the University of Louisville and the University of Louisville Research Foundation;
· Monitor processing of proposals and awards;
· Assist and consult with other units under the SVPR, such as the Office of Industry Contracts
1.5 Office of Industry Contracts
The Office of Industry Contracts (OIC) is the official authorized signature authority for sponsored program agreements from for-profit/private industry sponsors and research involving human subjects such as clinical trials. OIC provides guidance and assistance for investigators/project directors obtaining funding from for-profit/industry sponsors. OIC works with faculty and staff in arranging contractual agreements with industry. OIC serves faculty and staff in the negotiation and approval of agreements associated with these sponsored activities. The Office is charged with the following responsibilities:
· Review, negotiate and approve industry-sponsored research agreements, service agreements and other research agreements, including clinical trial agreements;
· Assist coordinators and faculty investigators with the interpretation of obligations of sponsored agreements and applicable state and federal regulations;
· Establish chartfields and set up budgets for research projects involving human subjects (such as clinical trials)  and industry-sponsored and -awarded grants, contracts, subawards, cooperative and other related agreements;
· Process budget revisions and no-cost extension requests;
· Maintain the official database of all proposals and awards for the University of Louisville and the University of Louisville Research Foundation;
· Monitor processing of proposals and awards;
· Process and approve proposals for investigators submitting proposals to businesses submitting Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) proposals;
· Review, negotiate and approve confidentiality/non-disclosure agreements for confidential information being disclosed by sponsors to the Institution; 
· Assist and consult with other units under the EVPR, such as the Office of Sponsored Programs Grants Administration.
1.6 Office of Technology Transfer
The Office of Technology Transfer provides information, assistance and guidance to faculty, staff, students and academic units to nurture the development and disclosure of intellectual property. Its responsibilities include the following:
· Monitor and implement patent and licensing agreements to ensure that financial and administrative requirements are met;
· Manage the evaluation and protection of Intellectual Properties (patents, copyrights, inventions, technologies etc.) held by the University;
· Implement commercialization strategies and conduct subsequent licensing negotiations;
· Function as the liaison between the University and its inventors with patent counsel, government officials, companies, other institutions, licensees, etc;
· Review and negotiate material transfer agreements.
1.7 Research Integrity Program
The Research Integrity Program (RIP) responsible for maintaining broad oversight and knowledge of all integrity and compliance issues relating to the conduct of research at the University. The Research Integrity Program provides broad oversight, resources and education for integrity and compliance issues relating to the conduct of research at the University of Louisville. The Research Integrity Program carries out its responsibilities by:
· Monitoring and making recommendations concerning ethical, professional, federal, state and other (e.g. international) policies or requirements relating to research, whether proposed or in effect ;
· Creating and maintaining the University of Louisville’s research integrity and compliance infrastructure;
· Educating and training researchers in the responsible conduct of research and research compliance;
· Implementing policy and procedural requirements relating to research misconduct and the federal Office of Research Integrity.
The Research Integrity Program (RIP) coordinates the SVPR Task Force Project (Refer to sections 1.15 – 1.24) which is comprised of eight task forces and two governing committees. Participants in the Task Force project are drawn from faculty, staff and administration and provide recommendations to the governing committees related to research integrity and human studies; research standards and procedures; conflict of interest; monitoring, auditing and response; animal welfare; biological and environmental safety and Health Insurance Portability Accountability Act (HIPAA) regulations as related to research and award administration.
The Research Integrity Specialist is Allison Griffin Ratterman, Ph.D. The RIP Office is located in Jouett Hall, Room LL05, Louisville, Kentucky 40292. Telephone: (502)-852-2454.
1.8 Human Subjects Protection Program
The Human Subjects Protection Program (HSPP) is responsible for protecting the rights, dignity, and welfare of human research subjects by adhering to the principles of the Belmont Report and the regulations of the Common Rule and the Food and Drug Administration. The Program is committed to advancing responsible conduct in research, promoting ethical treatment of human research subjects, and ensuring that the right of every human being to voluntary, informed consent to research is respected.
The program’s responsibilities include the following:
· Reviewing all research involving human research subjects before it is initiated;
· Working to protect the rights and welfare of human research subjects by fostering and advancing the ethical and professional conduct of persons and organizations that engage in research with human participants;
· Providing education to researchers, research staff and the public;
· Conducting periodic reviews of research involving human subjects.
The staff of the Human Subjects Protection Program Office (HSPPO) is responsible for providing administrative support for the University Institutional Review Boards (IRBs) and HSPP. The Director of Human Subjects Protection Program Office is Becky Higgins. The Office is located in MedCenter One, Suite 200, Louisville, Kentucky 40202. Telephone: (502) 852-5188. E-mail: Becky Higgins.
1.9 Principal Investigator/Project Director
The Principal Investigator (PI) or Project Director (PD) is ultimately responsible for the effective and compliant management of all scientific, fiscal and programmatic aspects of the sponsored research project. These responsibilities include, but are not limited to the following:
· Preparing proposals and ensuring that all information provided is accurate and correct;
· Ensuring that reviews by compliance committees are completed as appropriate during the proposal clearance/pre-award process;
· Ensuring the accuracy of information submitted as a part of the proposal clearance/pre-award process and completing the appropriate transmittal forms (e.g. PCF, MIRA) for processing proposals and other sponsored activities;
· Justifying any special support costs, as well as costs normally charged as F&A but included as direct costs in the original proposal. Please see Section 6.1 for direct charging guidelines;
· Ensuring that anyone involved in the design, conduct or reporting of the project has complied with the University Disclosure of Significant Financial Interest Form and Guidelines prior to incurring costs on an award;
· Adhering to the policy regarding the Responding to Allegations of Research Misconduct (PDF);
· Making certain that all charges on sponsored projects are reasonable, allocable, allowable and consistent with University cost accounting practices via a monthly reconciliation process;
· Requesting timely approvals for budget changes in compliance with the sponsor’s policies and making certain of the consistent application of direct costs;
· Submitting all sponsor-required project deliverables and reports in a timely manner.
· Monitor the work of any subcontractors.
1.10 Qualifications for Principal Investigator/Project Director Status
The University of Louisville will allow anyone who has a formal relationship with the University to act as a PI/PD on an extramurally funded project. That relationship can be as a faculty, staff, postdoctoral fellow or adjunct faculty. The individual must also meet all of the agency guidelines for eligibility. In addition, the individual must meet all of the University of Louisville eligibility requirements in order to serve on any IACUC, IRB, and/or IBC approved protocols. The IACUC and IBC require a faculty member to serve as Project Director and the IRB permits faculty or staff to serve as Principal Investigator. In instances where a conflict of interest in research exists, an individual may be restricted from serving on an approved IRB, IACUC and/or IBC protocol depending upon the nature of the conflict and its required management.
If an individual is not a permanent employee of the University of Louisville, the term of appointment must be sufficient in length to complete the proposed project. Such individuals must obtain formal approval by the appropriate chair and dean to submit the application in the name of the University with assurances that adequate resources and supervision will be available for the project to be successful should it be funded.
1.11 Unit Business Manager (or Designee)
While ultimate responsibility for the financial oversight of any sponsored research agreement remains the responsibility of the Principal Investigator/Project Director, the person in charge of the business aspects of the PI/PD’s home unit, such as a unit business manager, may provide assistance with budgetary and compliance issues. The following list includes responsibilities this individual may have:
· Preparing the proposal budget by providing accurate information about the status of the PI/PD and his/her salary and stipend levels, and related fringe benefits;
· Reviewing proposal documentation to ensure that purchasing regulations are being met;
· Providing budgetary oversight for the project;
· Assisting the PI/PD in managing the financial compliance aspects of the project;
· Ensuring that charging practices within the unit are consistent with university and sponsor guidelines;
· Reviewing sponsored project proposals for justification of direct charges;
· Examining, confirming and justifying costs normally charged as indirect when proposed as direct charges;
· Preparing financial documents such as rebudgeting forms, cost transfers or salary distribution;
· Documenting cost sharing;
· Recording program income;
· Monitoring effort certification;
· Assisting the Office of the Controller to resolve overdrafts;
· Providing information for financial reports;
· Reviewing expenditure statements on a monthly basis to ensure that only appropriate charges are posted to sponsored project accounts and working to make timely corrections to charges made in error.
1.12 Department Chair/Dean
Department chairs and deans both play a role in the research function of the University.
The department chair’s responsibilities include the following:
· Assuring departmental personnel are available to support PIs/PDs as addressed in Section 1.11;
· Approving proposal items such as the technical aspects and the budget;
· Reviewing all proposals to confirm consistency with the mission of the department and compliance with the policies and procedures of the University and the sponsor;
· Encouraging, supporting, and attesting to appropriate education in proper conduct of research by departmental personnel.
The dean’s responsibilities include the following:
· Ensuring proper oversight by the department chair;
· Approving all funding proposals prior to submitting them to the Office of Sponsored Programs Grants Administration.
The following are responsibilities shared by both the department chair and dean:
· Assisting in identifying and developing plans to manage significant conflicts of interest;
· Ensuring that departmental resources necessary to carry out the project have been identified;
· Indicating commitments and approvals on the appropriate transmittal forms (e.g. Proposal Clearance Form [PCF] and Multi-Institutional Research Application [MIRA]}
· Certifying that adequate budgetary oversight is in place to ensure that funds are allocated properly to the project to prevent cost overruns and inappropriate charges that would be assessed back to the University.
1.13 Office of the Controller
The Office of the Controller, reporting to the Vice President for Finance, is responsible for the following:
· Financial monitoring of sponsored research accounts;
· Preparing financial and other non-technical closeout reports;
· Preparing periodic billings and reports, including working with those departments conducting clinical trials which need to invoice sponsors with more detailed information or special formats;
· Assessing cash position on cost reimbursable accounts;
· Drawing federal funds to reimburse research expenditures;
· Obtaining the annual A133 or alternate documentation;
· Distributing and collecting effort reports;
· Closing completed accounts.
1.14 Department of Audit Services
The Department of Audit Services is charged with the following:
· Independently evaluating compliance with federal regulatory policies and institutional practices;
· Periodically reviewing account transactions in order to identify potential high-risk compliance areas within the University;
· Ensuring that proper internal controls are in place at the departmental and institutional level;
· Recommending actions to reduce risk to a reasonable level.
Numerous committees and individuals have responsibilities related to research compliance. The following includes an overview of Environmental Health and Safety & Radiation Safety compliance committees at the University. Other committees and offices responsible for research compliance including the Institutional Review Board (IRB) and the Institutional Animal Care and Use Committee (IACUC) are discussed in Chapter 9, Section 2.
1.15 Executive Oversight Committee for Research Integrity
The Executive Oversight Committee for Research Integrity (EOCRI) guides the University in the changing regulatory environment and will provide uniform direction regarding the development or enhancement of the compliance infrastructure necessary to promote compliance with federal guidelines related to research. The responsibilities of the EOCRI include:
· Determining and authorizing appropriate responses to incidents of non-compliance;
· Monitoring the Research Integrity Committee in determining compliance priorities and strategy;
· Approving compliance procedures and strategies as recommended by the Research Integrity Committee;
· Confirming the availability of resources necessary to implement approved strategies;
· Acting as the ultimate approval authority for finalizing research policies, procedures and training activities;
· Determining and authorizing appropriate responses to incidents of non-compliance.
1.16 Research Integrity Committee
The Research Integrity Committee (RIC) evaluates the effectiveness of the compliance infrastructure and proposes structural and operational enhancements to the EOCRI. This Committee helps to ensure that compliance is maintained at a high priority level in all aspects of research activities. Specific responsibilities of the RIC include the following:
· Advising, on and monitoring research compliance activities throughout the University via the Research Integrity Program;
· Approving and implementing policies and procedures established by the Research Integrity Task Forces;
· Recommending enhancements to compliance polices and training programs;
· Reviewing and approving training programs created by the Research Integrity Forces.
The mission of the Task Forces is to ensure that the University has mechanisms in place to identify compliance issues and requirements, communicate compliance concerns to management, and recommend enhancements to research policies and procedures, roles and responsibilities, systems, and training with respect to research activities in the specific areas assigned to the Task Force. The Task Forces advise the Executive Oversight Committee for Research Integrity and the Research Integrity Committee about key compliance risks and the status of compliance activities. Specific responsibilities of the Compliance Task Forces include:
· Maintaining current knowledge of federal and other sponsor regulations and the impact of any changes in the requirements on the University;
· Developing policies and procedures designed to communicate compliance requirements and limit compliance risk;
· Preparing training content and curricula, conducting compliance training, monitoring the delivery of the training and assessing the effectiveness of the training.
1.17 Human Subjects Task Force
The Human Subjects Task Force monitors external compliance requirements and develops policies, communication and training related to research involving human subjects.
1.18 Research Standards and Training Task Force
The Research Standards and Training Task Force monitors external compliance requirements related to expectations for conduct in research and develops policies, communication, and training to help ensure the responsible conduct of research at the University.
1.19 Conflict of Interest Task Force
The Conflict of Interest Task Force monitors external compliance requirements and develops policies, communication and training related to actual and potential conflicts of interest in research.
1.20 Animal Welfare Task Force
The Animal Welfare Task Force monitors external compliance requirements and develops policies, communication and training related to research involving animal subjects.
1.21 Biological and Environmental Safety Task Force
The Biological and Environmental Safety Task Force monitors external compliance requirements and develops policies, communication and training related to research involving recombinant DNA, infectious agents or biological toxins.
1.22 Award Administration Task Force
The Award Administration Task Force monitors external compliance requirements and develops policies, communication and training to communicate financial and other award administration compliance requirements.
1.23 Monitoring, Auditing and Response Task Force
The Monitoring and Response Task Force develops and recommends compliance monitoring steps that may be performed to assist in the identification and assessment of potential compliance risks.
1.24 HIPAA Research Task Force
The HIPAA Research Task Force monitors compliance relating to the implementation of the Health Information Portability and Accountability Act (HIPAA) in respect to research activities, especially those involving human subjects.
 The Office of Sponsored Programs Grants Administration (OSPGA) processes proposals for research projects involving human subjects (such as clinical trials) for research sponsored by governmental and non-profit entities. Upon notification of award, OIC handles the contractual agreements and budget setups.
 The Office of Technology Transfer typically handles confidentiality/nondisclosure agreements when University confidential information is being disclosed to sponsors; however, either Industry Contracts or Technology Transfer will handle the agreement when it is associated with a project handled by their respective offices.