Ohio Administrative Code
Title 3364 - University of Toledo
Chapter 3364-70 - Research Protection and Practices
Section 3364-70-22 - Principal investigator's responsibilities on sponsored projects

Universal Citation: OH Admin Code 3364-70-22

Current through all regulations passed and filed through September 16, 2024

(A) Policy statement

The process of managing sponsored research awards is a shared responsibility between the principal investigator "PI," the staff of the office of research and sponsored programs "RSP," grants accounting, the PI's department head or chair, and dean of the respective college. Each has unique areas of primary responsibility. The university of Toledo "UToledo" recognizes that the principal investigator, referred to as PI in this policy, is the primary individual responsible for initiating a research grant proposal, cooperative agreement, training or public service project, contract or other sponsored project. RSP is responsible for approving the proposed budget, developing the award terms and conditions, authorizing and signing the agreement. The dean and department chair commit their units to support the projects through cost-sharing if needed, and to dedicate space, time, and effort to complete the project.

(B) Purpose of policy

The purpose of this policy is to outline the specific responsibilities of PIs and to present an overview of project management with special emphasis on the PI's role in sponsored projects management. The role of the RSP and grants accounting staff in helping the PI meet those responsibilities is outlined.

(C) Definitions

(1) Sponsored projects - Activities originated or conducted by UToledo faculty or staff supported wholly or in part by external restricted funds awarded to the university. Definitions of activities are found in rule 3364-70-23 of the Administrative Code (facilities and administration costs). Such activities include: sponsored instruction and training, organized research and other sponsored activities.

(2) Proposal - A response to a request for proposal (solicited or unsolicited) or work utilizing UToledo labor, equipment, facilities, supplies, or procurement.

(3) Principal investigator (PI) - The principal investigators (PIs) are individuals responsible for the design, conduct and reporting of the sponsored project including administrative and programmatic aspects (excluding financial reports). Financial reports, including cost share reports, must be completed by grants accounting. Some agencies refer to the PI as project director. PI will be used to refer to project directors.

(4) In the case of multiple PIs, the first PI listed on the proposal will be considered "primus inter pares" (first among equals) and will be the contact PI for RSP and grants accounting.

(5) Co-investigator (Co-I), co-principal investigator- Some funding agencies allow the submission of proposals with multiple PIs/co-PIs. Multiple PIs (including co-PIs, if so designated) on a project share the authority and responsibility for leading and directing the project, intellectually and logistically. Each investigator (PI, co-PI, co-I) is responsible and accountable to the grantee organization, or, as appropriate, to a collaborating organization, for the proper conduct of the project or program, including the preparation and submission of required reports and insuring that expenditures are made consistent with the planned budget. Sponsored research with PIs/co-PIs and co-Is who are not UToledo employees must include an executed subrecipient commitment form or other agreement with the PI/co-I institutions before the proposal is submitted.

(6) Joint appointee (JA) - The joint appointee is an employee of a U.S. national laboratory or other institution or organization whose joint appointment at both institutions has been approved by both their employer and UToledo through an inter-institutional agreement that facilitates such joint appointment.

(D) Applicability

(1) Sponsored programs

All grant, contract, clinical trial and other and internally or externally sponsored program applications (collectively, "sponsored projects ") that have a UToledo faculty/staff member as the PI and are part of that individual's UToledo responsibilities must name UToledo as the grantee/contractor, regardless of the performance site.

Additional requirements apply to all externally sponsored programs (including non-research programs) for which there are a written application, agreement or contract with the sponsor which binds UToledo to terms and conditions set forth by the sponsor, and for which any one of the following applies:

(a) The agreement obligates the principal investigator/program director to sponsored activity that follows a plan or work scope set forth in the proposal, protocol, or agreement, provides for systematic evaluation, or seeks to meet stated performance goals, or other activities to meet the obligations of the sponsored activity (i.e. training grants);

(b) There is a requirement for UToledo to provide technical or programmatic reports;

(c) There is a requirement for UToledo to provide financial accountability, as evidenced by the submission of financial reports to the sponsor, an audit provision, or for return of unexpended funds;

(d) There is a requirement that something of value be provided to the sponsor or that the sponsor is promised any rights, or option thereto, to intellectual property discovered/developed during the program;

(e) There is a requirement for an institutional commitment to maintain confidentiality of information provided by the sponsor;

(f) There is a requirement for UToledo to define and/or track personnel effort devoted to the program;

(g) There is a requirement for UToledo to cost-share any portion of the program costs;

(h) There is a requirement that a portion of the program be subcontracted to another entity; or

(i) There is a requirement for assurance of regulatory compliance (e.g., institutional review board "IRB" or institutional animal care and use committee "IACUC" protocol approval).

(2) Gifts for research and involvement of UToledo foundation

Some awarding agencies may restrict their funding to a 501(C)(3) organization. In those cases, the university of Toledo foundation will assist in preparation, submission and acceptance of those awards. Financial awards or requests to philanthropic foundations and other entities for gifts to support faculty research will be subject to formal endorsement by appropriate UToledo officials, including RSP and the UToledo foundation if a 501(C)(3) organization is required to accept the award. Any gift supporting research programs which include human subjects, clinical trials, vertebrate animals, radioisotopes, radiation-generating equipment, lasers, nanotechnology or hazardous materials, must have approved protocols through the appropriate review committees. The RSP office must review and approve all such projects before proposals are submitted on behalf of the UToledo foundation. Upon award, funds are transferred to UToledo with oversight by grants accounting for all expenditures.

(3) Restrictions
(a) UToledo may refuse to enter into agreements which define study results as confidential information not to be published or which convey to the sponsor the right to veto publication or to censure the content of publications.

All proposals for sponsored projects will be reviewed by RSP prior to submission to any funding source to determine compliance with national security, export control restrictions and other sponsor or UToledo regulations and policies. If RSP determines that any component of such research may violate federal, state or local law of UToledo policies, then UToledo will decline to accept such award.

(b) It is UToledo policy that sponsored program funding will not be accepted from tobacco companies.

(c) Faculty and staff are not permitted to conduct research for third parties that utilize university facilities and equipment.

(d) Faculty members or staff are not to engage in any sponsored activities using UToledo facilities without the formal involvement of the office of research and sponsored programs.

(E) PI eligibility

(1) Each project must have a PI, authorized by the university, who will execute the project as outlined in the funded proposal, using sound management techniques. The PI(s) must have the skills, knowledge and resources necessary to carry out the proposed research. Approval of PI(s) must be made prior to proposal submission via the RSP proposal approval form (RSP100).

(2) Salaried university faculty members or other qualified salaried university contract employees having at least a fifty per cent appointment (or signed contract) may serve as PI on sponsored programs agreements. The PI must be in a position to provide direct, personal, day-to-day oversight of activities and personnel associated with the sponsored program. University-designated emeritus faculty may serve as PIs on sponsored program agreements, provided they hold less than a fifty per cent appointment/employment with another (non-UToledo) institution or company.

(3) Research assistant professors, research associate professors, research professors, and post-doctoral fellows (with a letter of approval from their department chair) are entitled to submit proposals as PI or co-PI for the support of research that may include the faculty member's own salary.

(4) JAs at UToledo are entitled to submit proposals and receive awards as PI/co-PI/PD or key personnel for sponsored research through UToledo under the specific conditions as described herein. A JA may act in his/her university role and lead/participate in a proposal submitted by UToledo when all of the following conditions are present:
(a) The primary location for the work described in the proposal is UToledo;

(b) There is a sufficient basis for the proposal to be submitted by UToledo, including the need for university facilities, capabilities, expertise, field site proximity to the university or ongoing experiments;

(c) The JA (and associated students) will perform the work under the proposal at UToledo;

(d) The research budget includes partial salary support for the JA in their role as lead/participant in the sponsored research; and

(e) The JA must have assigned office and/or laboratory space at UToledo to perform work associated with their effort, as outlined in the proposal. Any alternative work place must be approved by both the JA's primary employer (i.e., a U.S. national laboratory or other institution) and the university's RSP, including space in any dedicated collaborative facilities, such as a U.S. government laboratory joint institute facility.

(F) Multiple principal/co-investigators

It is strongly recommended that a leadership plan is created for proposals that name multiple investigators.

(1) In the event that the PIs cannot resolve conflicts over an administrative issue, the issue will be presented to the vice president for research or his/her designee who will rule on the issue after receiving input from all sides (including department chairs and deans) or refer the issue to an appropriate board such as an ad hoc conflicts management committee.

(2) Any appeals will be resolved by the provost.

(G) Roles and responsibilities

(1) Proposal preparation
(a) All proposals for extramural funds, contracts, or a commitment of work must be reviewed and approved by all investigators, department/unit chair(s) or head(s) and RSP prior to submission using the proposal submission form (RSP100).

(b) The PI is responsible for completion and assembly of all proposal components as required by the sponsor. This includes the following:
(i) Preparation for the technical proposal including: scope of work, biosketches, facilities and resources and other sponsor requirements.

(ii) Identify all PI(s), co-PI(s), co-Is and senior personnel.

(iii) Provide contact information for any subcontractors/subrecipients to RSP prior to final budget development.

(iv) Prepare proposal budget and submit a draft to RSP with as much time in advance as is reasonably possible to allow for adjustments by RSP staff.
(a) Identify personnel requirements (i.e. students, post-doctoral fellows, technicians) in conformance with UToledo policies.

(b) Include core facility costs (i.e. animal care, instrumentation centers, etc.).

(c) In support of strengthening the interface between faculty research and graduate education, the college of graduate studies will provide instructional fees for graduate students supported by external grants. In cases where the external sponsor supports graduate student tuition, matching support of graduate student tuition may be provided at the discretion of the college of graduate studies.

(v) Identify and address space/facilities requirements with endorsement/approval by chair(s) and dean(s).

(vi) Prepare and submit human and animal research protocols, as needed. Some sponsors require this prior to submission.

(c) RSP responsibilities in proposal preparation include the following:
(i) Contact the sponsored program office at subcontractors/subrecipients institution to request administrative materials including subrecipient commitment form, budget and scope of work.

(ii) Prepare proposal budget from PI's draft in conformance with UToledo policies and sponsor requirements.

(iii) Provide information and assistance in completing administrative information.

(iv) Commit RSP cost sharing funds if appropriate and approved by the vice president for research.

(v) Determine if PIs are in compliance with conflict of interest requirements.

(vi) Provide institutional signature and submit/release completed proposal to sponsor.

(vii) Prepare and submit human and animal research protocols, as needed. Some sponsors require this prior to submission.

(2) Award acceptance
(a) Grants or agreements for research, including clinical trials or any other programs involving UToledo faculty must be made between the university of Toledo and the sponsor pursuant to rule 3364-40-08 of the Administrative Code (delegation of signatory authority for documents that bind the university). The vice president for research is designated as the signing authority for accepting and approving all sponsored program awards on behalf of the university. Investigators are not authorized to accept awards or funds on their own behalf or on behalf of UToledo.

(b) All contracts/agreements issued to UToledo by a funding sponsor, including those which involve a contract or a subcontract to another institution or other organization must be reviewed, negotiated and signed by RSP pursuant to rule 3364-70-23 of the Administrative Code (facilities and administrative "F&A" costs for sponsored research and programs).

(c) If the award is utilizing an outside consultant, the consultant agreement must follow rule 3364-25-44 of the Administrative Code (independent contractor status).

(d) All procurement of goods, equipment or outside purchased services must follow rule 3364-40-15 of the Administrative Code (procurement policy), which includes compliance with uniform guidance procurement requirements for sponsored programs.

(e) Clinical trial agreements must be negotiated by staff in the jacobson center for clinical and translational research "JCCTR."

(f) All awards must be set up in UToledo restricted, sponsored program accounts monitored by UToledo grants accounting.

(3) Project performance and management

The university and PI is legally and financially responsible and accountable to the sponsor for the performance of the activity funded and the proper use of funds. The sponsored programs process is a joint effort between the PIs and the university. The PIs' responsibilities may be divided into two related but distinctly different sets of activities: those activities involving the management of the work of the project, and responsible spending of project funds. While the work of the project should drive the financial activities, sound management practices in both arenas are required. The financial stewardship of sponsored research funds is a shared responsibility with other areas of the university, among them the RSP office, grants accounting, and the PIs' and co-investigators' departments.

(a) It is the shared responsibility of the PI and department to ensure sponsor required progress reports are submitted in a timely fashion. It is the PI's responsibility to ensure that expenditures are allowable, reasonable, necessary and reimbursable by the sponsor. Any expenses not reimbursed by the funding agency, determined as unallowable, over expended, or for non-performance, will be moved to the department account.

(b) The PI is responsible for all actions required to manage and complete the scientific and programmatic aspects of the sponsored project and is responsible for project performance as designated in sponsor agreements/contracts.

(c) The PI must comply with all the terms and conditions of all awards and ensure that project funds are managed efficiently and effectively within approved budgets.

(d) The PI is responsible for managing the project in compliance with the most restrictive of the award requirements, UToledo policies and state of Ohio ethics laws.

(e) The PI initiates hiring or assignment processes and approves the selection or appointment of individuals to the project consistent with the statement of work (or other proposed research plan) and budget of the project. Hiring of personnel is a shared responsibility with the PI, the department and university of Toledo human resources department. Appropriate university of Toledo hiring policies must be followed in seeking or presenting offers to personnel for work on the project.

(f) All invoicing is the responsibility of the office of grants accounting and not the PI, the PI's department or the PI's college.

(g) When necessary, the PI initiates programmatic changes to the project in consultation with all faculty investigators, and, working with RSP office obtains sponsor approval, as required.

(h) The PI ensures the responsible conduct of the research pursuant to rule 3364-70-02 of the Administrative Code (responsible conduct of scholarship and research). This includes data management as required by sponsoring agencies, publishers, and as consistent with practices within the discipline.

(i) The PI ensures the completion, accuracy and timeliness of interim and final programmatic (technical) reports.

(j) Subcontract document(s) must be prepared and approved by the RSP office. The PI monitors performance of subcontractors and collaborators at non-UToledo entities.

(k) The PI agrees to abide by current UToledo policies on the use of human subjects/vertebrate animals in research, recombinant DNA, infectious agents, radioactive materials, controlled substances and hazardous materials. The PI adheres to research subject protocols and policies, and notifies the appropriate office if changes are made to protocols.

(l) The PI is responsible for the initial and annual filings of financial disclosures for all participants on the project as defined in C.F.R. 42 part 50, subpart F. The PI is responsible for notification to RSP (coi.utoledo.edu) when there are changes in the status of his/her financial interests or conflicts of interest.

(m) The PI is responsible for the ensuring completion of effort reporting for project participants as required by UToledo policy or sponsoring agencies.

(n) After completion of project ownership of capital equipment will be assigned according to sponsor agreements/contracts.
(i) Grants accounting will notify general accounting/asset management, working with the PI, to assemble a final inventory of equipment paid for or contributed to the award by the sponsor.

(ii) Grants accounting will validate final award documents with the sponsor and determine the appropriate process for disposition of equipment (vested to UToledo, retain for future award work by the PI, transfer to another department at UToledo, or return equipment to sponsor).

If the sponsor requires equipment return, grants accounting will notify the PI and general accounting/property management who will ensure proper shipping to the sponsor.

Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.