CHAPTER FOUR: Proposal Review, Approval, and Processing
4.1 Review and Approval Responsibilities
Proposals must be reviewed and have the appropriate approvals prior to submission to an outside funding agency. The review process includes review by the chair/unit head, the unit dean or designee and reviews by University compliance committees such as Human Subjects and Animal Use. The Office of Sponsored Programs Grants Administration (OSPGA), (formerly Grants Management), or Office of Industry Contracts (OIC) (dependent upon the sponsor) is the final step in the review process.
All proposals being submitted to outside funding agencies must list the “University of Louisville Research Foundation, Incorporated” as the grant recipient unless the submission is required from a university or there is required security clearance. Prior to submission to the funding agency, the proposal is submitted to the Office of Sponsored Programs Grants Administration (OSPGA) or the Office of Industry Contracts (dependent upon the sponsor) for final review and signature. A completed and signed Proposal Clearance Form (PCF) or Multi-Institutional Research Application (MIRA) must accompany the proposal. The PCF/MIRA enables a review of administrative, policy and fiscal issues affecting the proposal. It consists of a series of information items and questions to assist the PI/PD and University reviewers in assessing potential risks and obligations if the proposal is funded. In addition to the signatures of the PI/PD and co-PIs/PDs, the department chair or appropriate unit head and dean or appropriate unit head are required. Certain other pre-submission approvals that may also be required are detailed in Section 4.3.
The MIRA is used for all clinical trials, sponsored research which requires approval by the Biomedical IRB and any other project/study that uses the facilities of Jewish Hospital Healthcare Services (JHHS), Norton Healthcare (NHC), or University Hospital (ULH) sites or resources to conduct the research. The information on the MIRA is shared with the respective hospital/study sites and is used by the respective hospital/study site to give approval for the research study to occur at their facilities.
Proposals or other sponsored research projects in which the sponsor is a for profit or industry entity go to Industry Contracts (OIC). Proposals or other sponsored research projects in which the sponsor is a governmental or non-profit entity go to the Office of Sponsored Programs Grants Administration (OSPGA). (Note: OSPGA sends proposals that are clinical trials or use the facilities of JHHS, NHC or ULH to OIC after proposal is submitted to the sponsor which then handles the agreement/award documents when the proposal is funded.)
When there are faculty from more than one academic department participating in the proposed project, all appropriate department chairs and deans must indicate approval by signing the PCF/MIRA prior to submitting the proposal to the Office of Sponsored Programs Grants Administration/Office of Industry Contracts for approval.
The PCF/MIRA must also be executed if an agreement or contract is received but no proposal was submitted. PIs/PDs and administrators are obligated to complete a PCF/MIRA when requested by the Office of Sponsored Programs Grants Administration/Office of Industry Contracts.
4.3 Other Pre-Submission Approvals and Requirements
University and funding agency policy requires certain other approvals prior to the submission or award of a proposal. These are indicated on the Proposal Clearance Form/MIRA and include:
Institutional Review Board (IRB)
All faculty members, students and staff members at the University of Louisville are required to have any research involving human subjects reviewed and either approved or exempted from approval. The University is guided by three basic ethical principles regarding all research involving human subjects, regardless of whether the research is subject to federal regulation or with whom it is conducted, or the source of support. Those principles are:
· Respect for persons
· Beneficence: the obligation to do no harm, maximize benefits and minimize risks
· Justice, equal opportunity for subjects to receive the benefits and bear the risks of research, regardless of gender, race and socioeconomic status
A human subject is defined as any living individual. Research is defined as the collection of data by an investigator by means of:
· Data through intervention or interaction with the individual
· Data from identifiable private information
Any collection of data for publication or other dissemination is considered research and needs some action by the IRB. The status of IRB review must be indicated on the PCF. Please remember that sponsors differ in whether they will accept a “pending review” status.
The Institutional Animal Care and Use Committee reviews all proposals involving the use of animals. The status of IACUC approval as either “complete” or “pending” must be indicated on the PCF. Some sponsors will not accept “pending review” status.
For more information concerning the IACUC, please refer to Chapter 9, Section 2.
Federal regulations require approval by this Committee when research involves the use of replicating agents or recombinant DNA, whether funding is required or not.
For information concerning Recombinant DNA Research, please refer to Chapter 9, Section 3.
Approval by this Committee is required when research involves the use of radioactive material.
For information concerning Radiation Safety, please refer to Chapter 9, Section 4.
4.4 Proposal Review
All applications for external funding must be reviewed for consistency with agency guidelines and University policies prior to submission.
The Office of Sponsored Programs Grants Administration (OSPGA)/Office of Industry Contracts (OIC) reviews the budget for accuracy and proper format, to ensure the correct application of fringe benefit and F&A (indirect cost) rates, and to verify University cost-sharing commitments. Draft copies of the budget may be submitted in advance of the proposal due date for review. This is especially helpful for budgets involving multiple years, sub-agreements and/or cost sharing commitments.
The Director of the OSPGA/OIC and designated Grants Management/Contract Specialists have been delegated signature authority for all proposals submitted to external sponsors by the University of Louisville Research Foundation, Inc. and the University of Louisville. In no case is a PI/PD allowed to sign for the University or ULRF.
The Office of Sponsored Programs Grants Administration/Office of Industry Contracts must have the following items to sign-off for the institution:
· Completed and signed Proposal Clearance Form/MIRA
· Indication of IRB approval status
· Indication of Animal Subjects status
· General Disclosure of Significant Financial Interests form for each PI/PD, co-PI/PD, and all other U of L participants the PI/PD determines are responsible for the design, conduct and reporting of research
· Approval in writing of all University cost sharing or match requirements indicated in the proposal
A final copy of the proposal for OSPGA/OIC files should either be submitted at the time of proposal review or within two weeks after submission.
4.5 Pre-Award Audits
If the budget proposed to a federal agency exceeds $500,000 per year, the agency may do a pre-award audit, known as a Field Pricing Report, before an award is issued. If this is required, the federal sponsor generally requests a review of the proposal budget to ensure that it is adequately documented and that all rates are current.
These audits may be conducted in person or via telephone and fax. Audits should be coordinated through the OSPGA. The PI/PD and the academic department will need to assist as requested on specific cost or pricing issues.
4.6 Unfunded Proposals
Upon receipt of notification that a proposal will not be funded, the PI/PD should inform the Office of Sponsored Programs Grants Administration/Office of Industry Contracts. OSPGA/OIC retains copies of unfunded proposals for a year following notification that the proposal will not be funded.