Chapter 3349-20 | Research

Rule 3349-20-10 | Residual funds policy.

• Effective: June 11, 2017
• Promulgated Under: 111.15

(A) Purpose

This rule establishes the university's process for identifying unrestricted residual funds from sponsored programs and outlines the process for moving them out of their original restricted index. This rule is designed to assure that unrestricted residual funds from sponsored programs are used to advance the university's mission and is intended to help principal investigators avoid conflicts of interest.

(B) Scope

This rule applies to all sponsored programs proposed on or after July 1, 2011.

(C) Definitions

Consult rule 3349-7-01 of the Administrative Code.

(1) "Designated Residual Funds Index" refers to an index that is set up when there are residual funds related to a sponsored program. The fund manager of the index will be the principal investigator. The availability of these funds will not expire during the principal investigator's employment at university. This index will be subject to all university guidelines, policies and procedures.

(2) "Fixed Price Agreement" refers to an agreement in which the sponsor states that a set dollar amount will be given in exchange for a specific deliverable(s).

(3) "Principal Investigator" refers to the faculty or staff member designated by the sponsor to have the appropriate level of authority and responsibility to direct the project or program supported by the grant.

(4) "Restricted Index" an index set up to track revenue and expenses for a specific project or purpose that is funded by an external entity (sponsor) and is subject to terms and conditions set by said entity.

(5) "Sponsor" for the purposes of this rule, refers to an entity that awards funding for a specific purpose.

(6) "Sponsored Program" refers to an award funded via a grant, contract, cooperative agreement or subcontract from a federal, state or local government entity, the private sector, or an institution of higher education, whereby the university agrees to perform a certain scope of work, in accordance with terms and conditions set by the sponsor, for specific, budgeted monetary compensation.

(7) "Unrestricted Residual Funds" refers to an unobligated balance in a sponsored program award at the time of closeout that is not required to be returned to the sponsor. These funds are no longer considered funds of the sponsored program and as such will not follow sponsored program policies, but will still need to be spent in accordance with all applicable university policies and procedures.

(D) Body of the rule

Unrestricted residual funds resulting from a sponsored program award will be made available to the award's principal investigator by transferring the funds to a designated residual funds index when all of the following criteria are met:

(1) All terms and conditions of the award (including all deliverables) have been fulfilled;

(2) All expenses related to the project (except approved cost share) have been charged to the sponsored program;

(3) The sponsor has paid the university in full;

(4) The university has been reimbursed for the total maximum facilities and administrative ("F&A") (indirect) costs related to the project;

(5) Awards with unrestricted residual funds in excess of twenty per cent of the total amount awarded must be approved by the office of research and sponsored programs.

(E) Responsibilities

(1) Principal investigator ensures that all terms and conditions are met, all deliverables are provided and that all appropriate expenses are charged to the sponsored program index and that any funds transferred into a designated residual funds index will be spent to support the principal investigator's research or scholarly activities, teaching, or service as applicable.

(2) Grants accounting ensures that the sponsor has paid the university in full and that the university has recovered its maximum indirect costs. "F&A" (indirect) costs will be calculated based off of the total award budget at the residual funds rate determined by the office of research and sponsored programs when the fixed price of agreement was executed. Grants accounting will send a request of review to the office of research and sponsored programs when unrestricted residual funds are in excess of twenty per cent of the total amount awarded. If approved, grants accounting will initiate all necessary transfers. If not approved, grants accounting will return the remaining funds to the sponsor.

(3) Office of research and sponsored programs establishes the "F&A" rate at which indirect costs will be charged if there are unrestricted residual funds remaining at the end of the fixed price award. Reviews restricted indexes where unrestricted residual funds are in excess of twenty per cent of the total amount awarded to ensure that the university is complying with applicable regulations and internal procedures, which include consistency in budgeting costs, cost shared expenses, and possible changes in scope.

Supplemental Information

Authorized By: 111.15
Amplifies: 111.15

Rule 3349-20-12 | Cost transfer.

• Effective: June 11, 2017
• Promulgated Under: 111.15

(A) Purpose

To assure the integrity of the university's charges for salaries, wages, goods and services on sponsored programs and other restricted funding transferred to and/or from a sponsored program or other restricted funding after an initial charge elsewhere in the university's accounting system.

In accordance with 2 C.F.R. 200 it is necessary to explain and justify transfers of charges onto federally-funded sponsored programs, where the original charge was previously recorded elsewhere on the university's operating ledger. Timeliness and completeness of the explanation of the transfer are important factors in supporting allow ability and allow capability.

(B) Scope

This rule applies to cost transfers, including the transfer of payroll and other direct costs associated with sponsored programs and restricted funding.

(C) Definitions

Consult rule 3349-1-01 of the Administrative Code.

(1) "Cost Transfer" refers to the reassignment of an expense to or from a sponsored program or restricted fund after the expense was initially charged to another sponsored program or non-sponsored program. Cost transfers include reassignments of salary, wages, and other direct costs.

(2) "Sponsored Program" refers to an award funded via a grant, contract, cooperative agreement or subcontract from a federal, state or local government entity, the private sector, or an institution of higher education, whereby the university agrees to perform a certain scope of work, in accordance with terms and conditions set by the sponsor, for specific, budgeted monetary compensation.

(3) "Principal Investigator" refers to the faculty or staff member designated by the sponsor to have the appropriate level of authority and responsibility to direct the project or program supported by the grant.

(4) "Sponsor" for the purposes of this rule, refers to an entity that awards funding for a specific purpose.

(5) "Restricted Funds" refers to those funds provided by a sponsor for a specific purpose and subject to specified terms and conditions.

(D) Body of the rule

(1) The university is committed to ensuring that all cost transfers (either in the form of a labor redistribution or non-salary journal entry) are legitimate and are conducted in accordance with the terms and conditions of the sponsored program, regulations and university rule.

(2) All principal investigators ("PI") and their business managers are responsible for ensuring that transfers of costs to or from sponsored program and restricted funds which represent corrections of errors are made promptly.

(3) Cost transfers must be supported by documentation which contains a full explanation of how the error occurred and a correlation of the charge to the sponsored program to which the transfer is being made. Explanations such as "to correct an error" or "to transfer to correct project" are unacceptable.

(4) Cost transfers to any sponsored program account are allowable only where there is direct benefit to the sponsored program account being charged. An overdraft or any direct cost incurred in the conduct of one sponsored program may not be transferred to another sponsored program account merely for the sake of resolving a deficit or an allow ability issue. Cost transfers should not be used as a means of managing awards.

(5) Cost transfers that are initiated as a means to move expenses onto a sponsored program merely to spend the available balance are unallowable.

(6) Expenses that have been disallowed on one sponsored program or restricted fund are not to be transferred to a different sponsored program. Additional details can be found in the direct charging sponsored programs and unallowable costs rule.

(7) Cost transfers must be prepared and submitted within ninety days from the end of the calendar month in which the transaction appears on the award except in cases where the sponsor's (federal or non-federal) terms and conditions are stricter than those of the university. Any cost transfers that are initiated after ninety days will require the approval of the department or college head and will be reviewed by the controller; approval may be given on a case-by-case basis.

(E) Responsibility

The principal investigator is responsible for prompting the cost transfer form. Grants accounting is responsible for reviewing the form and completing the cost transfer process.

Supplemental Information

Authorized By: 111.15
Amplifies: 111.15

Rule 3349-20-15 | Direct charging sponsored projects and unallowable costs.

• Effective: March 29, 2025
• Promulgated Under: 111.15

(A) Purpose

The university is required to ensure that any costs charged to federally sponsored programs follow costing requirements set forth in the office of management and budgets ("OMB") uniform guidance (2 C.F.R. 200). This rule also provides a foundation for direct charging costs to other, non-federally sponsored programs.

(B) Scope

This rule applies to all individuals involved in the decision making process for direct charging costs to sponsored programs.

(C) Definitions

Consult rule 3349-7-01 of the Administrative Code.

(1) "Direct Costs" refer to those costs that can be identified specifically with a particular sponsored program. Direct costs must also be allocated to one or more sponsored programs on a reasonable basis, where those direct costs benefit multiple projects or activities. If a cost is already included in the indirect cost rate (example, facilities and administrative costs rate), then it should not be charged again as a direct cost.

(2) "Indirect Costs" or "Facilities and Administrative Costs (F&A)" refers to those expenditures that have been incurred for common or joint objectives and cannot be readily identified with a particular sponsored program or activity. These costs consist of overall support of sponsored research activities and are therefore recovered through the university's "F&A" rate. Some examples include depreciation of buildings and equipment, the costs of operating and maintaining facilities, utility costs, library costs and general, department, and sponsored programs administration.

(3) "Allowable Costs" are those costs that are necessary and reasonable to perform the scope of work of the sponsored program. Allowable costs must also conform to the terms and conditions of the sponsor, of the award, and of the university's policies and procedures, the award terms and conditions. Allowable cost should be substantiated, by proper documentation or justification, to support its allocation to the sponsored program(s) being charged.

(4) "Allowable Costs" are those costs that are necessary and reasonable to perform the scope of work of the sponsored program. Allowable costs must also conform to the terms and conditions of the sponsor, of the award, and of the university's policies and procedures, the award terms and conditions. Allowable cost should be substantiated, by proper documentation or justification, to support its allocation to the sponsored program(s) being charged.

(5) "Sponsored Program" refers to an award funded via a grant, contract, cooperative agreement or subcontract from a federal, state or local government entity, the private sector, or an institution of higher education, whereby the university agrees to perform a certain scope of work, in accordance with terms and conditions set by the sponsor, for specific, budgeted monetary compensation.

(6) "Allocable Costs" refers to costs incurred to benefit a sponsored program and charged based on the proportional benefit of that cost to the sponsored program. If a cost benefits multiple sponsored programs and/or other university activities, then the costs must be allocated accordingly.

(a) If a cost benefits two or more projects or activities, it must be charged in accordance with its benefits to each project respectively. Charges split between more than one grant must be split on the basis of proportional benefit or other reasonable method. The division of the expenditure cannot be split based on available funding or any other type of synonymous methodology. An expenditure that benefited two or more projects cannot be charged solely to one project because of funding constraints on another project.

(b) Any costs allocable to a particular project may not be shifted to other sponsored programs in order to meet deficiencies caused by overruns (deficits) or other fund considerations. Costs cannot be shifted to avoid restrictions imposed by law, by terms of the sponsored program, or for other reasons of convenience.

(7) "Consistent Treatment" means that each item of cost incurred for the same purpose must be treated consistently in like circumstances either as a direct or an indirect "F&A" cost in order to avoid possible double-charging of federal awards.

(8) "Reasonable Costs" refers to costs incurred that reflect the judgment a prudent person would have used under the circumstances prevailing at the time of the decision. Costs must be reasonable relative to the nature or type of cost incurred and the price paid for the items in relation to the benefit received.

(D) Body of the rule

Costs to sponsored programs must meet the following criteria:

(1) Be adequately documented.

(2) Must be charged accordingly as either a direct cost or an indirect cost "F&A."

(3) Must be a reasonable costs, allocable costs, allowable costs, be accorded consistent treatment in order to be charged to the grant.

(4) Must not be included as a cost or cost-sharing requirement of any federally-funded sponsored program unless allowed under specific statute and sponsor approval.

(5) May include unlike circumstances where costs that are normally "F&A" types of costs (such as administrative and clerical salaries, computing devices, memberships, office supplies and postage) may be directly charged, when all of the following criteria have been met:

(a) The costs are integral to a project or activity;

(b) The costs can be specifically identified with the project or activity;

(c) The costs are explicitly included in the budget or have the prior written approval of the federal awarding agency; and

(d) The costs are not also recovered as indirect costs.

(6) May allow a typically unallowable costs in special circumstances with prior written approval from the sponsor.

View Appendix

Last updated March 29, 2025 at 7:38 PM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12
Prior Effective Dates: 11/4/2019

Rule 3349-20-18 | Effort reporting.

• Effective: November 29, 2021
• Promulgated Under: 111.15

(A) Purpose

The university must ensure payroll costs, example, salary, wages, stipends and fringe benefits, that are charged to sponsored programs adhere to the effort reporting standards in the office of management and budgets ("OMB") uniform guidance 2 C.F.R. 200 Section 200.430.

(B) Scope

This rule applies to all faculty, staff, students, and fellows with payroll charges or effort commitments on sponsored programs if they are paid directly by the sponsored award or cost shared from other funding sources.

(C) Definitions

Consult rule 3349-7-01 of the Administrative Code.

(1) "Actual Effort" is the actual effort expended on a sponsored program; and is usually expressed as a percentage of total effort.

(2) "Cost Sharing of Effort" is the portion of total effort not paid by the sponsor. For example, twenty per cent effort commitment with a request for fifteen per cent salary support results in a five per cent cost sharing commitment.

(3) "Effort Commitment" is the proportion of effort proposed by faculty, staff, students or fellows to carry out their stated role on a sponsored program. This can be expressed as a percentage or in person months. The terms "effort commitment" and "committed effort" are interchangeable.

(4) "Institutional Base Salary" is the annual compensation paid by the university for an individual's appointment, whether that individual's time is spent on research, instruction, administration, or other activities. Institutional base salary excludes any income that an individual earns outside of duties performed for the university.

(5) "Principal Investigator" refers to the faculty or staff member designated by the sponsor to have the appropriate level of authority and responsibility to direct the project or program supported by the grant.

(6) "Person Months" is a method of expressing effort percentage by normalizing an individual's effort percentage compared to their appointment length, which may be a partial year appointment. For example, an individual with a twelve month appointment devoting twenty per cent effort would be working 2.4 person months (calculated by multiplying twenty per cent times twelve months equals 2.4 person months). Many federal sponsors require effort commitments to be proposed in person months.

(7) "Significant Reduction in Committed Effort" is defined as a variance greater than twenty-five per cent between committed effort and anticipated actual effort. For example, a personal investigator with a twenty per cent effort commitment who anticipates only being able to devote ten per cent effort would have a significant reduction in committed effort, calculated by the following: (effort commitment less anticipated effort) divided by effort commitment or numerically: (twenty per cent - ten per cent)/twenty per cent equals fifty per cent reduction in effort, which is greater than twenty-five per cent and may require sponsor approval prior to reducing effort.

(8) "Total Effort" is the sum of all effort expended or planned to be expended for a period; this includes all activities for which an individual is paid their institutional base salary. The total effort calculation is based on the time necessary to fulfill one hundred per cent of activities for which an individual is compensated, regardless of the number of hours worked; it is not based on a forty hour work week.

(D) Rule statement

(1) The OBM uniform guidance standards state that effort reporting must:

(a) Be supported by a system of internal control which provides reasonable assurance that the charges are accurate, allowable, and properly allocated.

(b) Be incorporated into the official records of the university.

(c) Reasonably reflect the total activity for which the employee is compensated by the university, not exceeding 100% of compensated activities.

(d) Encompass both federally assisted, and all other activities compensated by the university.

(e) Comply with the established accounting policies and practices of the university.

(f) Support the distribution of the employee's salary or wages among specific activities or cost objectives if the employee works on [multiple] award[s] or activities regardless of the source of funding.

(g) Correspond to the actual charges for salaries and wages rather than be based upon budget estimates alone which do not qualify as support for charges to federal awards.

(2) Effort commitments are expressed in percentages or person months when proposed to the sponsor. Once the proposal is awarded, those effort amounts become effort commitments that must be met within a reasonable variance (example, +/- twenty-five per cent change between committed effort and actual effort).

(3) Key personnel, which includes the principal investigator, co-principal investigator, or other individuals named in the notice of grant award or contract, are typically required to request prior written approval from the sponsor when they anticipate a significant reduction in effort (example, a twenty-five per cent reduction in effort or a twelve week absence).

(4) University employs an electronic after-the-fact effort certification method which requires payroll distributions to be updated on a continual basis to account for new awards or changes in effort with actual effort being certified on a semi-annual basis on time and effort certification reports.

(5) Sponsored programs will be separately identified on the time and effort certification reports with payroll charges expressed as percentages of payroll charged to the sponsored program in relation to the institutional base salary during the certification period.

(6) Time and effort certification reports must list all cost sharing of effort for the certification period. The sponsored program and cost sharing effort are listed as payroll charges, the total of the two combined funding sources is representative of the total effort for the project requiring certification.

(7) Time and effort certification reports must be certified by an appropriate individual.

(a) Faculty who are principal investigators may certify their effort for their own awards.

(b) All other individuals must have their effort certified by

(i) The named employee on the time and effort certification report;

(ii) The principal investigator(s) for the sponsored program(s) that appear on the time and effort certification report.

(c) In special circumstances where an individual has terminated employment, is on an extended leave of absence, or not accessible, the following individual(s) may be appropriate to certify that individual's time and effort certification report:

(i) The principal investigator(s), or

(ii) Named employee's supervisor, or

(iii) Department chair, or

(iv) Another responsible institutional official who has suitable means to verify the work was performed during the certification period. Proper documentation must accompany the time and effort certification report to justify the appropriateness of the alternate certifier.

(8) The certifier is responsible for reviewing all payroll lines on the time and effort certification report and certifying that the payroll percentages charged to each sponsored program (paid and cost-shared) and all other activities reasonably agree with how the employee devoted their actual effort during the certification period. Department administrators who support the certifier(s) in the financial management of their sponsored programs may be granted "viewing access only" to assist certifiers with the review process.

(9) Supplemental earnings for duties outside of an individual's primary appointment (or job duties) for which they are paid an institutional base salary are not included on the time and effort certification report.

(10) All sponsored program activities must be reported on the time and effort certification report. This includes all cost sharing commitment and situations where the notice of award has not been issued, an index number has not been established, or payroll distributions have not been updated in time to be reflected on the time and effort certification report.

(11) An individual's payroll distribution must be directly correspond to the time and effort certification report before certification.

(12) Effort expended may exceed the amount charged to an award. However, the amount charged cannot exceed the effort expended nor the effort committed to the sponsor in accordance with the terms of the sponsored programs.

(13) The time and effort certification report cannot be adjusted once certified, unless the adjustment is to reduce overstated effort.

(E) Responsibility

(1) Principal investigator is responsible for adhering to this rule in its entirety.

(2) Office of research and sponsored programs is responsible for evaluating effort commitments at the proposal and award stages.

(3) Grants accounting is responsible for generating and tracking time and effort certification reports.

Last updated October 10, 2024 at 10:16 AM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12

Rule 3349-20-30 | Financial conflict of interest in research.

• Effective: November 30, 2020
• Promulgated Under: 111.15

(A) Purpose

The university is committed to ensuring that the financial interests of investigators do not affect, or appear to affect, the design, conduct or reporting of research or compromise the welfare of human or animal subjects.

The purpose of this rule is to promote objectivity in research by establishing standards to ensure there is no reasonable expectation that the design, conduct, or reporting of research will be biased by an investigator's conflicting financial interest. This rule establishes procedures for the disclosure, evaluation, management, reduction, and/or elimination of investigator's significant financial interests. This rule complies with the following federal regulations:

(1) Title 42 code of federal regulations (CFR), part 50, subpart F, responsibility of applicants for promoting objectivity in research for which public health service "PHS" funding is sought

(2) Title 45 code of federal regulations (CFR), part 94, responsible prospective contractors.

(B) Scope

(1) This rule applies to all investigators applying for, conducting, supervising, or reporting research at the university. This rule acknowledges that individual financial conflicts of interest may be inherent in the research process and does not preclude research in which a financial conflict of interest exists. This rule applies only to financial conflicts of interest in research.

(2) This rule applies to any investigator who is planning on participating in or is participating in research funded by the public health service "PHS" and any other funding agency that has adopted the "PHS" regulations or requires a conflict of interest rule. The research contemplated under this rule includes a research grant, contract, cooperative agreement, sub grant, subcontract, or sub-cooperative agreement which is funded in whole or in part by "PHS" funds (with the exception of phase I small business innovation research/small business technology transfer research applications).

(3) For purposes of determining the existence of a significant financial interest, this rule extends to the financial interests of the investigator and the investigator's immediate family.

(C) Definitions

(1) "Conflict of Interest Management Plan" is a written plan developed by the institutional officials in collaboration with the investigator to address the management, reduction or elimination of a financial conflict of interest.

(2) "Financial Conflict of Interest" refers to situations in which the university determines that an investigator's significant financial interests related to a externally funded research project could directly and significantly affect the design, conduct or reporting of the externally funded research.

(3) "Financial Interest" refers to anything of monetary value, whether or not the value is readily ascertainable.

(4) "Immediate Family" refers to the spouse (including individuals who are recognized as lawfully married under the law of any state) and dependent children of an investigator.

(5) "Investigator" refers to the project director or principal investigator and any other person, regardless of their title or position, who is responsible for the design, conduct, or reporting of research that is "PHS" funded, which may include, for example, collaborators or consultants. For the purposes of this rule, the term investigator includes financial interests held by the investigator's immediate family.

(6) "Institutional Responsibilities" refers to an investigator's professional responsibilities on behalf of the university and set forth in this rule. Institutional responsibilities include research, research consultation, teaching, professional practice, university committee membership and service on panels such as the institutional review board.

(7) "Institutional Officials" refer to the collaborative efforts of the chief technology transfer officer and the vice president for research.

(8) "Public Health Service Awarding component" is the organizational unit of the "PHS" that funds the research, e.g., national institute of health.

(9) "Principal Investigator" refers to the individual who is the project director or investigator who has primary responsibility for the design, conduct or reporting of the proposed research.

(10) "Research" is a systematic investigation designed to develop or contribute to generalizable knowledge relating broadly to public health, including behavioral and social-sciences research. The term encompasses basic and applied research and product development and includes any such activity for which research funding is available from an external source, including a "PHS" awarding component, through a grant or cooperative agreement.

(11) "Significant Financial Interest" is a financial interest consisting of one or more of the following interests held by the investigator or the investigator's immediate family that reasonably appears to be related to the investigator's institutional responsibility:

(a) Remuneration received from a publicly traded company that, when aggregated for an investigator and the investigator's immediate family for the past twelve months, or expected over the next twelve months, exceeds five thousand dollars. Remuneration includes:

(i) Salary or other payments for services (e.g., consulting fees, honoraria, paid authorship).

(ii) Equity interests (e.g., stocks, stock options or other ownership interests);

(iii) Intellectual property rights (e.g., patents, copyrights and royalties from such rights).

(b) Remuneration received from a non-publicly traded company that, when aggregated for an investigator and the investigator's immediate family for the past twelve months, or expected over the next twelve months, exceeds five thousand dollars or when the investigator or the investigator's immediate family holds any equity interest in the company;

(c) Intellectual property rights and interests (e.g., patents, copyrights) upon receipt of income related to such rights and interests.

(d) Any reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and not reimbursed to the investigator), related to the investigator's institutional responsibilities, except for travel that is reimbursed or sponsored by a United States (U.S.) government agency, a U.S.-based institution of higher education or a teaching hospital, a medical center, or a research institute that is affiliated with a U.S.-based institution of higher education.

(e) The term "significant financial interests" does not include:

(i) Salary, royalties, or other remuneration paid by the university, including intellectual property rights assigned to the university and agreements to share in royalties related to such rights;

(ii) Income from investment vehicles, such as mutual funds and retirement accounts, as long as the investigator does not directly control the investment decisions made in those vehicles;

(iii) Income from seminars, lectures, or teaching engagements sponsored by a U.S. government agency, a U.S.-based institution of higher education or a teaching hospital, medical center, or research institute affiliated with a U.S.-based institution of higher education;

(iv) Income from service on certain advisory committees or review panels by a government agency, an institution of higher education or a teaching hospital, medical center, or research institute affiliated with an institution of higher education.

(12) "Small business innovation research" refers to highly competitive programs that encourage domestic small businesses to engage in federal research/research and development with potential for commercialization.

(D) Body of the rule

(1) University employment is a trust conferred by a public authority for a public purpose. Such status forbids employees from placing themselves in a position in which a private interest would conflict with a public duty. This principle applies to all research conducted on the university campus or supported by university resources.

(2) A financial conflict of interest exists if the institutional officials conclude that an investigator's significant financial interest could directly and significantly affect the design, conduct, or reporting of the externally funded research.

(3) Training for investigators. All investigators who engage in "PHS" funded research must complete conflict of interest training prior to engaging in the "PHS" funded research; at least every four years; and immediately upon obtaining employment as a university employee or as required by modifications to this rule.

(4) Disclosure requirements and management plans.

(a) Investigators are required to submit a financial conflict of interest in research disclosure form to university's institutional officials with each new grant application (and to update it annually during the period of the award, or within thirty days of discovering or acquiring (e.g., through purchase, marriage, or inheritance) a new significant interest financial interest.

(b) Within sixty days of the disclosure, whether the disclosure was timely or not, the university's institutional officials or their designee(s) will review the significant financial interest disclosed by the investigator and determine, with or without consultation with the investigator, whether the significant financial interest is related to "PHS" funded research and whether a financial conflict of interest exists. If the significant financial interest was not timely disclosed, the intuitional officials shall further conduct a retrospective review within one hundred twenty days of the untimely disclosure to determine if the research was biased during the period of nondisclosure and report any such finding of bias according in accordance with this rule.

(c) If it the institutional officials determine that a financial conflict of interest exists, they shall work with the investigators to develop a management plan that specifies the actions that have been, or will be, taken to manage the financial conflict of interest. The university will submit a financial conflict of interest report to the "PHS" awarding component within sixty days of the disclosure.

(d) The conflict of interest management plan shall include the following information, at a minimum:

(i) The role and principal duties of the conflicted investigator in the research project;

(ii) Conditions of the management plan;

(iii) How the management plan is designed to safeguard objectivity in the research project;

(iv) Confirmation of the investigator's agreement to the management plan;

(v) How the management plan will be monitored to ensure investigator compliance throughout the duration of the award; and

(vi) Other information as needed.

(e) The conflict of interest management plan may include the following limitations or restrictions to manage the financial conflict of interest:

(i) Public disclosure of financial conflict of interests;

(ii) Disclosure of financial conflict of interests to participants;

(iii) Appointment of an independent monitor;

(iv) Modification of the research plan;

(v) Change of personnel or personnel responsibilities, or disqualification of personnel from participation in all or a portion of the research;

(vi) Divestiture of significant financial interest; or

(vii) Severance of relationships that create actual or potential conflicts.

(f) Disclosure of any reimbursed or sponsored travel requires detailed information on the purpose of the trip, the identity of the sponsor/organizer, the destination, the duration, and the estimated expense of the travel.

(g) If a significant financial conflict of interest arises during the term of the grant, the investigator must immediately notify institutional officials in writing within thirty business days of obtaining such interest.

(5) Reporting financial conflict of interests to the "PHS" awarding component.

(a) University 's institutional officials will manage and timely report financial conflict of interest reports to the "PHS" awarding component as required by 42 C.F.R. 50.604(h) and 605(b).

(b) Institutional officials will promptly notify the "PHS" awarding component when a financial conflict of interest has been disclosed by the investigator and that a plan to manage, reduce or eliminate the financial conflict of interest is in place to protect the research from bias.

(c) Reporting by the institutional officials will further include a finding as to whether any bias was found with respect to the design, conduct, or reporting of the "PHS" funded research and a mitigation report where any bias has been identified.

(d) If the PHS awarding component determines that research designed to evaluate a drug, medical device or treatment was conducted by an investigator with an undisclosed or unmanaged conflict of interest, the investigator must disclose the conflict in any public presentation of the research.

(6) Records. University's institutional officials will maintain all financial conflict of interest records for at least three years from the date the final expenditure report is submitted to the "PHS" awarding component, unless otherwise required by regulation or the university's record retention schedule.

(7) Enforcement. Failure to complete the requisite training, file the annual research conflict of interest disclosure form, provide information required by this rule or to comply with any conditions or restrictions imposed by the institutional officials regarding financial conflict of interests may result in disciplinary actions being taken against the investigator.

(8) Confidentiality

(a) The financial disclosure forms and the decisions of the institutional officials will be kept confidential to the extent permitted by law.

(b) University will make its financial conflict of interest in research rule publicly accessible on its website. University will respond to written requests for financial conflict of interest information within five days of receipt of the request.

(9) Subrecipient compliance. University will take reasonable steps to ensure that subrecipient investigators also comply with the terms of this rule, which will include, but is not limited to, incorporating conflict of interest compliance requirements as set forth in this rule into any written subrecipient grant agreements in which it is a party.

(E) Responsibilities

Investigator

(1) Complete a financial conflict of interest in research disclosure form for each new proposal submitted to the office of sponsored research programs. The office of sponsored research programs will not submit grant proposals if an investigator's disclosure forms are not included with the application.

(2) Update the disclosure form within thirty days after acquiring a new financial interest and at the time of annual review of each approved proposal.

(3) Identify all individuals who are responsible for the design, conduct or reporting of the proposed research and to ensure that all such individuals complete and submit a disclosure form.

(4) Investigators conducting research under food and drug administration regulations related to applications for a human drug, biological product or device must update the financial conflict of interest in research disclosure form during the study and for one year following completion of the study.

(5) Comply fully and promptly with all conflict of interest management plans put in place.

Last updated October 2, 2024 at 9:06 AM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12
Prior Effective Dates: 3/1/2019

Rule 3349-20-50 | Intellectual property.

• Effective: September 19, 2025
• Promulgated Under: 111.15

(A) Purpose

Under Ohio law, all discoveries or inventions resulting from research or investigations conducted in any Ohio public college or university are the sole property of the university. The purpose of this rule is to establish a framework for university intellectual property protection and development that will transfer the benefits of its innovations to society, and at the same time, obtain appropriate financial gains for the university and its inventors as appropriate.

(B) Scope

(1) This rule applies to all discoveries, innovations, or inventions, made by any university employee if such discovery, invention, or innovation was:

(a) The result of scholarly activity by, or under the direction of, any university employee, supported by funds, equipment or resources provided by or through the university, including but not limited to sponsored research, grant funding, or departmental support. This includes all grant funds under the control of a university employee regardless of the source; or

(b) The discovery, innovation, or invention resulted from efforts by any university employee that utilized more than a de minimus amount of university facilities or resources.

(2) Inventions not involving any university funds, equipment, facilities, or personnel (or a de minimus amount) are the property of the inventor, so long as the discovery, innovation, or invention is not in a substantive area of research in which the inventor is customarily engaged on behalf of the university.

(a) Students generally retain ownership of intellectual property (IP) they create in their capacity as students, except in the following circumstances:

(i) The student receives compensation from the university for the work;

(ii) The work makes use of more than a de minimis amount of university resources; or

(iii) The work arises from a sponsored research project or other university-administered activity that is subject to a preexisting agreement requiring assignment of IP.

(b) Students will not be required to participate in courses, projects, or activities where assignment of IP to the university is a condition of participation, unless they are given prior notice and a reasonable opportunity to decline participation without academic penalty.

(c) If a student makes a discovery or develops an innovation or invention as part of a class project or a university-sponsored competition using only resources available to all participants, and the project is not subject to a separate research or sponsorship agreement, the resulting IP shall belong to the student.

(d) A student who owns the rights to IP created as set forth above, may request the university's assistance in protecting or commercializing an invention. The university will consider such requests using the criteria set forth in this rule.

(C) Definitions

(1) "Confidential information" refers to all proprietary or confidential information of the university, the affiliated entities of the university, research sponsors, foundations, governmental agencies, or others, whether provided or made available verbally, in writing, electronically, by observation or through any other means, as well as all information generated during the review of such information or concerning the existence, scope or terms of any past, present or potential future research project, study, collaboration, grant, contract or other agreement. Confidential information includes, by way of example, but without limitation, the following: all business, financial, or scientific information; contractual arrangements and methods of operating; lab notes, graphic materials, work papers; patent applications and trade secrets; research protocols or other information; biological materials; reagents; software or documentation; prototypes; mask works; information pertaining to any directors, officers, medical staff members, employees, consultants, representatives, or agents of university affiliates or relating to actual or potential sponsor, patient, supplier, customer, or licensee identities, accounting and patient records; and any other information or materials not specifically mentioned in this rule that is designated as confidential, that affiliated entities have an obligation to keep confidential; that the university designates as confidential or designate as requiring permission to release; or that would constitute a trade secret under applicable law.

(2) "Composition of matter" generally, refers to chemical compositions and can include mixtures of ingredients as well as new chemical compounds per se.

(3) "Copyright" refers to the protection that is accorded to original works of authorship fixed in tangible media of expression. Copyright protects the owner of the work if others copy, present, or display the work without the permission of the owner.

(a) "Works of authorship" include but are not limited to scholarly articles, literary, musical, dramatic, audiovisual, architectural, pictorial, graphic, and sculptural works, and video and sound recordings.

(b) "Tangible media of expression" include physical, digital, and other formats now known or later developed from which copyrightable works may be stored, reproduced, perceived, or otherwise communicated, either directly or with the aid of a machine or device.

(c) Copyright may be used to protect software source codes from being copied or infringed.

(4) "Direct and significant use of university resources" refers to an allocation of university resources that is not routinely provided to members of the employee's unit and that entails a material commitment of institutional support. Such resources include but are not limited to: (i) dedicated staff support beyond ordinary administrative assistance; (ii) specialized or restricted equipment or laboratory facilities; (iii) university, college, departmental, institute or center, and grant funds allocated specifically for the project; (iv) substantial computer resources not ordinarily available for general academic use; or (v) release time from assigned teaching or administrative duties.

(5) "Disclosure" refers to printed publication, or in public use, or sale, or otherwise made available to the public. An invention disclosure to the university is a confidential reporting of an invention or discovery in sufficient detail to communicate an understanding of the invention or discovery to the university personnel responsible for evaluating and protecting the discovery, innovation or invention.

(6) "Discovery" refers to the process of finding out about substances, mechanical devices, improvements, or applications not previously known. It is something less than invention and may be the result of industry, application, or may be merely fortuitous.

(7) "Employee" refers to all full-time and part-time faculty, staff, administrative personnel, postdoctoral fellows, volunteers, and any individual who receives compensation from the university. This definition expressly includes clinical faculty at affiliated hospitals or institutions when the university pays any portion of their salary, stipend, or professional compensation, regardless of their formal appointment or employment status. This definition includes any visiting scholars/researchers who are working or studying within the university, students who are paid for rendering services, shared or leased faculty.

(8) "Gross income" refers to all income received by the university from royalties, option payments, license issue fees, milestone payments, or any other consideration of monetary value arising from the licensing or other commercial exploitation of an invention, without deduction of any fees, costs, or expenses.

(9) "Intellectual property (IP)" refers to any and all rights resulting from endeavors of the mind including those that protect the application and/or expression of ideas, inventions, creations, works, developments, improvements products, processes, procedures, techniques, devices, software, designs, materials and compositions of matter, as well as the embodiments of all such rights, whether in tangible or intangible form, including but not limited to, those items specifically referred to in the definition of confidential information. Intellectual property rights may be protected under federal law under patents, trademarks, service marks, copyrights, and trade secrets.

(10) "Innovation" refers to a new model, idea, or product. A useful application of new inventions or discoveries.

(11) "Invention" refers to, but is not limited to, products, methods, or uses, even if not patentable.

(12) "Inventor" refers to one who, alone or with others, first invents a new and useful process, machine, composition of matter, or other patentable subject matter. An Inventor conceived of, not just contributed to the reduction-to-practice, of at least one claim to a patent.

(13) "Manufactured" refers to all manufactured articles.

(14) "Net Income" refers to the gross income received by the university from royalties, option payments, or other payments arising from the licensing of an invention, less only those fees and costs directly attributable to that invention, including but not limited to patent filing fees, patent search fees, external legal fees, consulting fees incurred in litigation, necessary travel expenses, marketing costs, and patent maintenance fees. Indirect overhead, administrative expenses, and other costs ordinarily associated with the university's general operations shall not be deducted in determining net income. Net income shall constitute the amount distributable under this rule.

(15) "Patent" refers to the grant of a property right to the inventor issued by the united states patent and trademark office. Generally, the term of a utility is twenty years (fifteen years for design patents) from the date on which the application for the patent was filed in the United States, subject to the payment of maintenance fees. U.S. patent grants are effective only within the United States, U.S. territories, and U.S. possessions. The right conferred by the patent is the right to exclude others from making, using, or selling the invention (as defined in the patent claims).

(16) "Publication" refers to a published article or abstract in a technical journal, bulletin, newspaper, textbook, or any other tangible medium which gives sufficient information about the discovery, innovation, or invention to permit one skilled in the art to practice the invention.

(17) "Software" refers to computer instructions, data, and accompanying documentation. To be patent-eligible, software must perform features that are novel and proprietary. Computing code itself isn't patentable; the patent application must be directed to the process of execution of the software code on a computer. This is commonly referred to as a "software-implemented invention."

(18) "Trade secret" refers to information, including a formula, pattern, compilation, program, device, method, technique, or process that derives independent economic value, actual or potential, from not being generally known to the public or to other persons who can obtain economic value from its disclosure or use, and is the subject of efforts that are reasonable under the circumstances to maintain its secrecy.

(19) "Unobvious" refers to a characteristic that is not obvious to a person having ordinary skill in the art to which said subject matter pertains.

(20) "Work made for hire" refers to a specific type of relationship in which ownership of the work belongs to a third party, not the creator of the work. For purposes of this rule, there are two situations in which a work made for hire is produced; when the work is created by an employee as part of the employee's duties and when work is undertaken or created because of an express written agreement, such as a grant or sponsored research agreement, to the university. When a work is produced under these conditions, the university or the party sponsoring the work is considered the owner. A faculty member's general obligation to produce traditional academic and scholarly works does not constitute a specific responsibility as set forth in this definition.

(D) Body of the rule

(1) General considerations

(a) The university education and research missions are preeminent over that of the transfer and commercialization of research results.

(b) The university is committed to active engagement and support of innovation, technology development, and entrepreneurial activities through the efficient and effective deployment of its resources for the betterment of society and the generation of unrestricted revenue to support its mission.

(c) University resources may be used for non-university purposes so long as they are appropriately serving the public interest. Any such use must conform to university rule and be set forth in appropriate agreements between the parties.

(d) The university will respect the intellectual property of its partners and collaborators.

(e) When the university owns intellectual property under this rule, the inventor or creator may play an active role in the entire licensing process unless such participation is inconsistent with conflict-of-interest regulations or university rules.

(f) Any atrifical intelligence-generated outputs, datasets, or models developed using university resources or within the scope of employment shall be subject to the same ownership and disclosure, requirements as other discoveries, innovations, inventions and copyrights. Employees must ensure that data used in AI research complies with applicable laws and ethical standards. The university reserves the right to review and approve any agreements involving AI technologies, especially where such research may implicate export controls, national security concerns, or reputational risk.

(2) Patents

(a) Under this rule and in accordance with section 3345.14 of the Revised Code, all rights to and interests in patents that result from research or investigation conducted in any experiment station, bureau, laboratory, research facility, or other facility of the university, or by employees acting within the scope of their employment or with funding, equipment, or infrastructure provided by or through the university, shall be the sole property of the university. The university will distribute net income generated by the property in accordance with this rule.

(b) No person, firm, association, corporation, or governmental agency which uses the facilities of the university in connection with such research or investigation and no employee of the university participating in or making such discoveries or inventions shall have any rights to or interests in such discoveries or inventions, including income therefrom, except as may, by determination of the university's board of trustees, be assigned, licensed, transferred, or paid to such persons or entities in accordance with the terms of this rule.

(c) The board has delegated to the president of the university, unless the president is an inventor of the invention, the authority on behalf of the board of trustees, to retain, assign, license, transfer, sell, or otherwise dispose of, in whole or in part and upon such terms as the board of trustees has set forth in this rule, or may otherwise direct from time to time. Such dispositions may be to any individual, firm, association, corporation, or governmental agency, or to any employee, as the president or in the case where the president is an inventor, the board of trustees may direct. All income or proceeds derived or retained from such dispositions shall be distributed in accordance with this policy.

(d) The university has established these rules within the scope of academic freedom, consistent with its goal to provide incentives and institutional support to those employees whose research and scholarly activities lead to discoveries, innovations, or inventions, or that might be patented for societal use and to provide for equitable distribution of income resulting from discoveries, innovations, and inventions between the university and the inventor.

(3) Publications

It is well understood that publication of research results is an essential part of the activity of a university researcher. While this rule recognizes this need, the timing of the publication of research results can be of critical importance when considering patent activity. Failure to take timely steps to patent can result in a possible reduction in, or the entire loss of, adequate patent protection in the United States or abroad.

The safest course is to file a United States patent application before any public use, publication, disclosure or sale of the invention occurs. There is a period of one year from the date of publication to file an application for a United States patent; however, in most foreign countries, the publication itself bars valid patent protection with no grace period.

(4) Government grants under the Bayh-Dole Act or Patent and Trademark Law Amendments Act, Pub. L. 96-517, (1980).

The university generally can obtain title to inventions and patents arising under United States government contracts/grants, subject to certain rights reserved by the government, if invention reporting requirements and formalities are followed.

(5) Technology commercialization activity

Inventions disclosed to the university will be evaluated to determine scientific and technical merit, the likelihood of patentability or other protection, the potential for societal benefit, market potential, barriers to market, and other criteria concerning commercialization potential.

(6) Rights and obligations of the parties

(a) In accordance with section 3345.14 of the Revised Code, unless otherwise modified by contract, all rights, title and interest in discoveries or inventions made by employees, as defined herein, shall be the sole property of the university. Rights to inventions arising during government sponsored research must be assigned to the to protect the government's interest against competing claims. Inventions arising from privately sponsored research must be assigned to the university unless otherwise agreed to in writing at the time the research commences. The university is required to report federally sponsored research discoveries to the federal government.

(b) Inventor rights and obligations

(i) Confidential disclosure of the invention to the general counsel must precede an inventor's public disclosure, publication of information concerning a discovery, innovation, or invention. Once a discovery, innovation, or invention is reduced to practice, an invention disclosure form shall be promptly submitted by the inventor to the general counsel. The invention disclosure form is available through the office of general counsel and on the university website.

(ii) The university requires that researchers maintain adequate laboratory notebooks documenting critical information about the discovery or invention. Notebooks and other materials pertaining to research activities leading to a patent application are the property of university and will remain at university even after termination of employment.

(iii) The inventor shall assign title to the invention, discovery, or innovation to university.

(iv) The inventor shall cooperate in the following:

(a) Executing applications and legal documents;

(b) Any litigation arising out of the patent application; and

(c) Reasonable marketing efforts related to the discovery or invention.

(v) The inventor has a right to receive a share of any royalties or licensing fees received for the discovery, invention, or innovation according to the schedule contained in paragraph (D)(10) of this rule.

(vi) If the general counsel and the vice president for research recommend that university surrender all rights in the discovery or invention, and the president agrees that this recommendation is in the best interests of the university, the president will have the authority to surrender the rights of the university with respect to the discovery, invention, or innovation unless the president is an inventor, in which case, the board must approve the surrender. After surrender, the inventor shall have the option to pursue a patent application in the inventor's own name at the inventor's expense, in which case, any royalties or licensing fees received would be the sole property of the inventor; however, the inventor will reimburse the university for its out of pocket expenses, if any, and grant to university a royalty-free, irrevocable, perpetual, non-exclusive license to make and use the invention for its own research and educational purposes.

(vii) The inventor has a right to timely publication of his or her findings as required by the principles of academic freedom, subject to the university's right to protect its interest in the intellectual property.

(7) The university's rights and obligations

(a) The university has the sole right to license, sell, assign, or otherwise dispose of the rights to discoveries, innovations, or inventions that are owned by or have been assigned to university.

(b) The university shall timely determine whether it chooses to retain or assign title, submit to an external source for evaluation of patentability, file a patent application, or surrender title to the inventor.

(c) Should the university choose to file a patent application, it shall file, in a timely manner, any documentation necessary to prosecute a patent and shall pay all filing fees, maintenance fees, attorney fees, and other costs related to prosecuting and maintaining the patent. These costs will be recovered by the university before any payments are made in accordance with this rule.

(8) Administration

The general counsel and the vice president for research shall have overall responsibility for administration of the university's patent program, including assuring valuable property rights are not lost. Specific responsibilities shall be to:

(a) Function as points of contact and resources with regard to this rule and procedure;

(b) Receive reports of all discoveries or inventions that are subject to this rule;

(c) Conduct or cause to be conducted due diligence studies to determine patentability, market potential, barriers to market, and other criteria deemed necessary to determine commercial potential;

(d) Act upon the due diligence conducted to promote the interests of the university and to the extent appropriate to the university inventors.

(9) The general counsel and the vice president for research may utilize university funds to engage appropriate consultants and legal and business professionals to evaluate all discoveries and inventions disclosed to university for potential patentability and commercialization. These reports will be sent directly to the general counsel and will be protected from disclosure under attorney-client work product.

(10) Income, including royalties and other payments

(a) For all intellectual property which the university receives gross income, the net income will normally be distributed as follows:

(i) Fifty per cent to the inventor(s);

(ii) Ten per cent to the inventor's department(s) or centers;

(iii) Twenty per cent to the university research office; and

(iv) Twenty per cent to the technology transfer office.

(b) All monies received by the departments, the university research office, or university technology transfer office are considered university funds and will be administered in accordance with established accounting policies and procedures.

(c) If multiple inventors are involved, the royalties as specified in this rule shall be distributed equally among the parties set forth in paragraph (D)(10)(a) of this rule unless a written proposal for an alternate distribution is jointly presented by the inventors and approved by the general counsel and the vice president for research.

(d) In accordance with section 3345.14 of the Revised Code, inventors or creators who make a timely and complete disclosure of a discovery or invention arising from university research or investigations shall remain eligible to receive their share of net proceeds, even after their employment or enrollment with the university ends, provided that:

(i) The discovery or invention was conceived or reduced to practice during the period of the individual's employment, appointment, or enrollment at the university;

(ii) The university has asserted ownership rights in the discovery or invention pursuant to this rule and applicable law;

(iii) The discovery or invention generates net proceeds through commercialization, licensing, or other authorized means; and

(iv) The former university-affiliated individual provides, upon reasonable request, cooperation as is necessary to assist the university in securing, protecting, licensing, or enforcing its legal rights in the discovery or invention.

(e) Royalty-sharing shall be subject to any ongoing obligations set forth herein and in any inter-institutional agreements, joint ownership arrangements, or contractual terms with external sponsors, as applicable.

(f) The university reserves the right to withhold or suspend payment of any royalty share if the individual materially fails to fulfill required duties in connection with the protection or commercialization of the intellectual property.

(g) It is the responsibility of the inventor to notify the general counsel in writing of the inventor's address. In the event of the inventor's death, royalties due and payable under this rule will be paid to the inventor's estate for the remainder of the royalty period if the person responsible for the administration of the estate provides written authority and instructions from a court of competent jurisdiction concerning the payments. The inventor's department(s) shall continue to receive the royalties specified in this rule as long as the inventor is affiliated with said department. Should the inventor leave the department or the university, all departmental royalties shall become the sole property of university and will be shared equally by the university research office and technology transfer office, unless otherwise agreed to in writing.

(11) Research agreements between collaborators and industry involving patent rights

It is not uncommon for university employees to receive funding from private industry to support their research activities. Likewise, collaborative research with colleagues at other academic or research institutions is a regular and valuable aspect of academic life. The university acknowledges that the continuation and success of these external relationships may require flexibility in accepting a range of contractual terms and conditions. To preserve the principles of academic freedom, support employees in evaluating and entering into external research arrangements, and safeguard the university's interests in any resulting discoveries, innovations, or inventions, the following policies shall govern such relationships:

(a) All written agreements with private industry or with other institutions utilizing university resources to conduct research must first be reviewed by the general counsel and the vice president for research. The general counsel and the vice president for research will only approve those agreements which assure that the rights of the university are appropriately protected. Only designated university officials may authorize or execute agreements that obligate university intellectual property.

(b) In dealing with inventions that are conceived or developed during research sponsored by a third party and/or pursuant to an agreement with another institution, the university will abide by the terms of the agreement with that third party. Where an option exists, the university will seek agreements and contracts, or waivers thereof, that will allow patent rights to remain with university.

(c) University will not waive the right to publish results of research. University will only agree to delay publication for reasonable periods of time so appropriate action can be taken to protect patentable discoveries or inventions. In agreeing to delay publication for a reasonable period, university will not agree to delays that effectively inhibit a student's timely completion of a course or degree or impair a faculty member's application for promotion or tenure.

(d) Title to all documents, records, biological materials, software, databases, notebooks, and other repositories of information from research shall be held by university unless otherwise provided in a written agreement with the private research sponsor. Those materials must remain at university should the inventor's employment at university be terminated for any reason unless specifically authorized by the university.

(e) The university will agree that confidential information remains the property of private industry sponsors and will agree to protect the trade secrets of third-party research sponsors. Written agreements with the third party must clearly define what information is proprietary in nature. Trade secrets will be kept confidential and will not be subject to disclosure under the provisions of section 149.43 of the Revised Code. If a request for such information is received, the university will notify the owner of the confidential information of the request and mutually agree to the appropriate response.

(12) Visiting scholars and researchers

(a) For the purposes of this rule, visiting scholars and researchers will be treated as employees (as defined in this rule) and are required to adhere to the provisions of the visiting scholar/researcher agreement, which is available through the office of general counsel.

(b) The faculty member hosting the visiting scholar/researcher is responsible for, and expected to, ensure the following:

(i) The visiting scholar/researcher agreement has been properly executed with the office of general counsel;

(ii) That a copy of this rule has been provided to the visiting scholar/researcher; and

(iii) That all departments have been properly notified of visiting scholar/researcher's presence at the university.

(13) Copyright

(a) For the purposes of copyright, the university seeks the following:

(i) To maximize academic freedom and creative expression for the public good;

(ii) To preserve traditional academic practices and privileges with respect to the publication of scholarly works;

(iii) To apply uniform principles and procedures that provide allocation of income resulting from commercial publication;

(iv) To apply funds accruing to university from copyrighted materials to advance and encourage scholarly endeavor;

(v) To disavow any claims by university in an individual's copyrightable work simply because of the individual's membership in the university community; and

(vi) To protect university's assets and preserve its reputation of excellence.

(b) Copyright ownership

(i) The general rule under United States copyright law, is that the author of a work is the initial owner of the copyright. However, when a work qualifies as a work made for hire consistent with the categories enumerated in 17 U.S.C. 101, or the work was created within the course and scope of an employee's employment, the university shall be deemed the copyright owner, regardless of who created the work.

(ii) Without a written agreement to the contrary, a work is considered to be made within the scope of employment when the creation of the work is among the duties or responsibilities for which the individual is employed or appointed by the university; it is prepared during working hours or using university-provided facilities, equipment, or it requires the substantial use of university resources beyond what is commonly made available to all employees for routine academic activity; or it involves the use of proprietary university information, patient data, protected research findings, or other confidential university assets. The university will retain title to all copyrighted software developed by, or substantially with, university resources unless prior written waiver of university rights is issued.

(iii) Traditional academic and scholarly works notwithstanding the foregoing, the university does not claim ownership of certain traditional academic works that are created by employees for the primary purpose of scholarship, authorship, or teaching; or are developed independently and without substantial use of university resources beyond those ordinarily provided to similarly situated individuals. Examples of such works include scholarly publications, research articles, and classroom materials such as slides, videos, and syllabi. In the case of a dispute concerning copyright ownership the general counsel will review information concerning the work with the employee's department chair or supervisor, and in consultation with the vice president for research, make a recommendation to the president. The president's decision will be final.

(iv) The following notice is to appear on all university-owned material:

Copyright (year) Northeast Ohio medical university

Rootstown, Ohio. All rights reserved.

The date in the notice should be the year in which the work was first fixed in any tangible mode of expression.

(v) The general rule of the university is to register only those of its works that have the potential for royalty return. University copyright ownership may be relinquished only upon the recommendation of the vice president for research and the general counsel to the president, who is authorized by the board to surrender such rights if it is in the best interest of the university to do so. If such rights are relinquished, the university will retain a non-exclusive, royalty-free license to use these works.

(vi) Sponsored works

The disposition of copyrights of works created with support from an outside sponsor shall be governed by an agreement.

(c) Rule administration

The general counsel with the vice president for research will:

(i) Determine, promote and protect the rights of the university in any copyrightable works created or to be created with university resources;

(ii) Develop and approve agreements for the use of university resources in the creation of copyrightable works;

(iii) Distribute royalties to the author or others as set forth in pertinent agreements.

Last updated September 19, 2025 at 8:17 AM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12
Prior Effective Dates: 8/28/2025

Rule 3349-20-90 | University personnel relationships with industry (vendor conflict of interest).

• Effective: July 29, 2024
• Promulgated Under: 111.15

(A) Purpose

The purpose of this rule is to ensure that the university maintains ethical working relationships with vendors in accordance with state of Ohio ethics laws, federal regulations and the ethical standards of the health professions of which our faculty, staff, residents and students are a part.

(B) Scope

This rule applies to all sites owned or operated by the university and university personnel as defined herein. This university strongly encourages all faculty who are appointed by but not employed by the university or who practice at sites that are not owned or operated by the university, to adhere to this rule.

(C) Definitions

(1) "Continuing medical education" ("CME" or "continuing education"): In this rule, the use of the terms "continuing medical education" and "continuing education" relate to a certified or accredited continuing professional education activity that provides credit toward maintenance of licensure for a healthcare professional. For example, CME in this document means a program that has been certified to provide category one CME credit by an accreditation council or continuing medical education (ACCME) accredited CME provider.

(2) "University" as used in this rule, refers to the northeast Ohio medical university, and/or its successor entity.

(3) "Department" - as used in this rule refers to an academic unit under the control of the university.

(4) "Off-site and after-hours activities" - as used in this rule, applies equally to on-campus activities as well as off-site, out of town, or after-hours (e.g., evening, weekend, etc.) activities.

(5) "University foundation" - as used in this rule, refers to the NEOMED foundation and/or its successor entity.

(6) "University personnel" - as used in this rule applies to:

(a) All tenure and non-tenure track faculty members, who are employed full time by the university or one of its colleges, and all employees (including clinical, administrative, clerical and other support staff members) working in any facility owned or operated by the university.

(b) The term also applies to any student, intern, resident, clinical fellow, postdoctoral fellow, or other trainee enrolled in an educational program through the university or one of its colleges.

(c) This rule does not apply to auxiliary or volunteer faculty (e.g., those with a "no salary" appointment) who are not working at a site owned or operated by the university. However, those individuals are strongly encouraged to abide by this rule in their respective practices, especially when university trainees are rotating in that setting.

(7) "Vendor corporations" are those non university owned, operated or affiliated businesses, corporations or other entities that supply or wish to supply equipment, goods, services or other clinically related products to the university or university personnel. This also includes organizations to which university patients are referred for clinical services (e.g., extended care facilities, skilled nursing facilities, etc.).

(8) "Vendor representatives" are those individuals who are employed by or who represent any vendor corporation. Vendor representatives are guests of the university and, as such, must provide their services in accordance with acceptable rules of conduct as determined by this rule and in a manner that provides the greatest benefit to the university and to our patients.

(D) Policy statement

(1) Gifts to individuals

(a) University personnel are prohibited from accepting any gifts from vendor representatives or vendor corporations regardless of the value of the gift. This includes items of minimal value like pens, mugs, notepads, etc. that have been commonly distributed by vendors in the past.

(b) University personnel may receive marketing, instructional, warning or other educational information from a vendor about the vendor's products.

(c) Any gifts that are delivered directly to an individual who meets the definition of university personnel at any site must be either:

(i) Returned directly by the individual to the vendor,

(ii) Forwarded to the office of the general counsel or the office of faculty affairs who will return the gift to the vendor.

(iii) In either case, a standard letter will be sent with the gift that explains that individuals can no longer accept any gifts from vendors.

(2) Gifts to the university, the university foundation, individual colleges or departments.

(a) The university, university foundation, individual colleges or departments may accept cash donations, gifts or other items of value that support the education, clinical or research missions of the university from a vendor corporation in accordance with this rule.

(b) Any donations or gifts accepted by the university, university foundation should remain the property of the university, university foundation, or an individual college or departments.

In the case of a cash donation, funds may be used to:

(i) Purchase items that may be used by university personnel in relation to their professional duties, or

(ii) To further the mission of the university or an individual college department.

(c) Samples of equipment for non-patient care related activities (e.g., research equipment, teaching laboratory suppliers, textbooks for evaluation for use in a course, etc.) may be accepted by the universities, individual colleges or departments in accordance with the rules of the purchasing department. These non-patient care related sample equipment must remain the property of the university, individual college or department.

(d) When working with vendors who would like to provide a donation, gift, or other item of value to the university, one of its colleges or departments, the vendor must work with the leadership of the university, individual college or department and with university I\institutional advancement personnel to ensure that the gift is appropriate before finalizing plans for the gift. University institutional advancement personnel and leadership personnel are responsible for properly processing the gift.

(i) If the gift is provided to support a research project or program, the office of the vice president for research must be consulted concerning conflict of interest and other research related polices prior to accepting any research related gift.

(ii) If the gift is provided to support a CME education program, the office of continuing professional education must be consulted prior to accepting any funds to support a CME education program.

(iii) If the gift is for another purpose beyond those listed above, the department accepting the gift must work with appropriate university leadership or administrative oversight entities to coordinate the gift based on the gift's purpose.

(e) All donations and gifts from vendors to the university an individual college or department should be documented in writing. Although no specific form is required, at a minimum, this documentation should include:

(i) The total amount of the gift.

(ii) The time frame over which the gift will be given (e.g., lump sum, quarterly, annually, etc.), and

(iii) The intended use of the funds or the gift.

(f) All gifts of ten thousand dollars or more, either in individual or cumulative gifts from one vendor to one department over the course of a fiscal year must be reviewed by the general counsel's office to ensure that they are being documented and conflicts are being managed appropriately. It is the responsibility of the department chair to forward documentation of such gifts to the office of the general counsel.

(3) Meals

(a) Vendors are prohibited from directly supplying meals, food, snacks or other food items to university personnel. The exceptions to this rule are:

(i) A modest meal as part of an event that grants CME or other continuing education credit when the event is sponsored by the vendor. This does not include departmental grand rounds or other university sponsored CME/CE events that are officially sponsored by a department but that may have some funding support from a vendor corporation.

(ii) A meal in conjunction with an individual's role as an advisor or consultant to a vendor corporation.

(b) The university, an individual college or department is allowed to provide meals, food, snacks or other food items to university personnel at any time in accordance with applicable university rules. The source of funding for such food may be a donation from a vendor or vendor representative but the university, college or department must be responsible for providing and paying for the food.

(4) Vendor sponsored events

(a) University personnel are permitted to attend, participate in and/or lead any off-site event that offers CME or other continuing education credit regardless of the sponsor of the event.

(b) University personnel are prohibited from receiving payment or gifts in exchange for attendance as an audience member at any event.

(c) University personnel are permitted to accept an item with a vendor logo on it in conjunction with an educational conference (e.g., a tote bag, a water bottle, etc.) if;

(i) The item has the name of the conference or sponsoring organization on it,

(ii) The item is provided by the educational conference, and

(iii) The item is provided to all conference attendees.

(d) Meetings with vendors regarding the potential purchase, lease or rental of equipment or services from the vendor and any meals provided at such a meeting must be in accordance with the rules of the university and the laws of the state of Ohio. In general, all costs for meals, travel, lodging, etc. for these meetings should be covered by a university department and not by the vendor.

(e) Vendor sponsorship

(i) If a vendor is interested in providing support to the university and individual college or department to underwrite an educational event or conference (including the purchase of food), the vendor should make a monetary donation to the university, individual college, or department to facilitate the event.

(a) The planning and coordination of the event must remain under control of the university; individual college or department that is sponsoring the event.

(b) The donated funds must remain under the control of the university, individual college or department that is sponsoring the event.

(c) The university, individual college or department is required to provide appropriate recognition of the vendor support for the event especially when the activity is granting CME or other continuing education credit.

(d) At the discretion of the leader of the administrative unit responsible for the event, vendor representative(s) from the entity providing support for the event may:

(i) Attend the event;

(ii) Be introduced/recognized at the event;

(iii) Set up a table in an area adjacent to but separate from the educational event where he/she may distribute marketing or scientific literature.

(e) Vendor representatives from the entity providing support may not:

(i) Distribute any gifts or meals, beverages, snacks, candy or other food items;

(ii) Conduct any marketing or commercial activities within the room where the educational event is occurring.

(f) Vendors are prohibited from providing funds directly to any university personnel to attend any CME or other continuing education event (with the exception of paragraph (G) of this rule). Vendors wishing to provide support for a specific CME or other continuing education event or program should make a donation to the university's individual college or department that is the sponsor of the event to reduce the cost for all attendees.

(ii) In the case of students, and other trainees, a vendor may provide support for one or more individual trainees to attend an educational conference with the following stipulations:

(a) The individual(s) chosen to attend the event must be chosen by the associate dean of academic affairs or other official designated by the university in which the student is enrolled.

(b) The associate dean of academic affairs or other official designated by the university in which the student is enrolled must approve the educational conference that is being attended to ensure that the conference is of substantial value to the trainee's education.

(c) The student chosen and the program must also be approved by the chief student affairs officer.

(d) The funding support must be directed to the university's office of student affairs which will then either pay for the expenses or reimburse the individual(s) for the expenses related to attending the event.

(iii) Consulting, speakers' bureaus and other business arrangements

(a) University personnel may serve as paid consultants or advisors to vendor corporations in accordance with this rule and other applicable university rules, on work outside the university.

(i) University personnel may receive complimentary meals from a vendor only in direct relation to their work for the vendor as a paid consultant or advisor (e.g., a lunch or dinner at an advisory committee meeting). This does not include meals or gifts from a vendor not in conjunction with their work as an advisor or consultant (e.g., one-on-one lunch with a vendor representative unrelated to their paid position).

(ii) Any paid advisory or consulting relationships must be disclosed by university personnel in the course of leading any educational activity for university students, faculty, or other employees if the topic being discussed relates to products or services that they provide consultation on to the vendor. This includes both CME/CE and non-CME/CE educational activities.

(iii) Any paid consulting relationship with a vendor corporation must be disclosed by university personnel through the annual university research conflict of interest disclosure process and should be discussed directly with the individual's unit leader.

(iv) Consulting or advisory relationships should be entered into by university personnel carefully. The work that will be done for the vendor corporation must be:

(A) Generally commensurate with the amount of compensation provided by the vendor; and

(B) The compensation must approximate fair market value.

(v) There should be a signed agreement that outlines, at a minimum, the work to be done for the vendor corporation and the compensation to be provided by the vendor.

(A) If this agreement is between the vendor and the individual, all aspects of the university consultation and conflict of interest rules apply.

(1) The agreement with the vendor must be produced by university personnel if requested by a department chair or university senior administrator.

(2) The individual must report to the university vice president for research and the university general counsel if any intellectual property will be created as a part of this activity.

(B) If this agreement is between the vendor and the university, the document should be reviewed and approved in advance by the office of the university general counsel.

(C) University personnel serving as a paid consultant, advisor, etc. for a vendor should comply with university rules regarding the requirement to use appropriate leave time for these activities when required.

(f) Speakers' bureau and educational events

(i) University personnel are permitted to participate in a vendor-sponsored speakers' bureau or other educational events only:

(a) When the presentation is to be made in an academic setting (e.g. grand rounds, visiting professor, guest lecturer etc. at an academic medical center or other teaching hospital); or

(b) At any event granting CME/CE credit regardless of the location, or

(c) When the presentation is an educational or training activity for a vendor's employees.

(ii) When presenting at a vendor-sponsored speakers' bureau or other educational event, any slides and other information presented by university personnel must have been prepared by the university personnel. Use of slides or other vendor-prepared educational materials by the university personnel is not permitted with the exception of FDA-approved slides that are mandated for use when discussing a specific product.

(iii) University personnel may receive an honorarium or speaker fee for lecturing in a permitted vendor sponsored or supported educational event as defined in this rule.

(a) If the event occurs in an academic setting (i.e., an academic medical center, teaching hospital, etc.), the honorarium or speaker fee must be from the academic institution.

(b) If the event occurs as a part of a CME/CE event, the honorarium or speaker fee must be from the organization sponsoring the CME/CE event.

(iv) University personnel are prohibited from receiving a retainer or other similar payments simply for being a member of a speakers' bureau. Any payments for involvement with a speakers' bureau must be in relation to actually performing a service as a speaker, lecturer, etc.

(v) University personnel are prohibited from participating in and receiving an honorarium for a vendor sponsored "speakers' bureau" event when the goal of the activity is marketing of the vendor's products.

(g) Token consulting arrangements are strictly forbidden.

(i) Token consulting arrangements are agreements to pay university personnel for consulting or advising a vendor corporation when either:

(a) No substantive work is done on behalf of the vendor, or

(b) The work done for the vendor is not commensurate with the amount of compensation provided by the vendor, or

(c) When the compensation is not at fair market value as determined by acceptable benchmarks (e.g., AAMC faculty or MGMA practicing physician salary benchmarks).

(d) If there are any concerns that a consulting arrangement could be considered token consulting, please consult the office of the university general counsel for further review.

(ii) Ghost-writing of publications, abstracts, case reports or other scholarly work by vendor representatives on behalf of university personnel is strictly prohibited. University personnel should be aware of published guidelines in the medical literature regarding taking credit for authorship of an article, abstract, or other scholarly work.

(h) Promotional materials

(i) Vendor corporations and vendor representatives are prohibited from directly placing any promotional materials or educational materials in any patient care area or waiting area of any university owned or operated in patient or outpatient site.

(ii) University personnel are permitted to distribute or display high-quality patient education materials produced by a vendor corporation in patient care areas or waiting rooms of any inpatient or outpatient site provided that the materials are unbiased and are not product-specific.

(iii) Promotional materials that are product-specific or that directly market a vendor's products may be distributed to patients:

(a) Only after they have been reviewed specifically by the university department to ensure that they are generally complete and accurate regarding the vendor's product, and

(b) Only after it is determined that the patient needs or potentially needs to use the product or medication covered in the promotional material, and

(c) By university personnel and not directly by vendor representatives.

(iv) This rule should not be construed in any way to limit the distribution of accurate and complete instructions for use or safety warnings for any product or medication regardless of the source of the information after an item has been ordered or prescribed for use by a patient.

(i) Samples

(i) Industry sales representatives are not permitted in university facilities without approval from the respective college deans or designees. If approved, vendor sales representatives are escorted to the proper venue by a member of the university staff.

(ii) In order to ensure patient safety and the appropriate storage and distribution of medication samples, the distribution of medication samples will be prohibited except as noted:

In an attempt to minimize the need for samples:

(a) vendors are encouraged to provide vouchers to clinical units or clinics within the university that may be distributed to patients. These vouchers, in addition to a valid prescription, will allow a patient to receive free or discounted medications at a retail pharmacy.

(b) Prescribers are encouraged to prescribe generic medications for those patients who cannot easily afford prescription medications and in those clinical situations when a generic medication is appropriate for the patient's condition.

(iii) If members of a clinical department in a facility owned or operated by the university believe that their clinical practice requires the continued use of medication samples for a specific medication or for a special patient population, they may apply to the dean of the college in which the department is located for an exception to this rule. As a part of that approval, the department will be required to annually report the following to the dean:

(a) The medication samples that are routinely stocked in the clinic,

(b) The process for ensuring the proper storage, security and distribution for samples,

(c) The process for monitoring the expiration dates on medication samples, and

(d) The process for the documentation of distribution to patients.

(iv) For non-medication product samples, the unit or clinic should ensure that any samples provided to patients are appropriately packaged, in good condition and have not expired.

(j) Conflict of interest in purchasing decisions

(i) Any university personnel involved in the evaluation of a product, selection of a vendor, negotiation with a vendor, or the decision to purchase a product must fully disclose any equity positions, consulting agreements, or other compensation relationships between him/herself or a member of his/her family (as defined by applicable university rule) with a vendor under consideration.

(ii) This conflict of interest should be disclosed in writing to the university personnel's immediate supervisor, and department chair as well as to the applicable staff from the purchasing department.

(a) The individual's immediate supervisor is required to review the conflict of interest with the department chair. If the conflict of interest is significant or cannot be managed appropriately in the opinion of the immediate supervisor or the department chair or the purchasing department, the individual must remove him/herself from the process.

(b) Individuals must report existing conflicts on an annual basis to the immediate supervisor, department chair and dean as part of the annual evaluation process.

(c) If additional assistance is needed to evaluate the conflict of interest, the university general counsel, the vice president for administration and finance and the vice president for research are additional resources that can be utilized.

(iii) If university personnel are in any position to materially benefit from the university relationship with the vendor or if the conflict is deemed too significant by either the purchasing department or the individual's immediate supervisor to be managed appropriately, the individual must immediately remove him/herself from any further discussions, meetings or negotiations.

(iv) Any university personnel who are involved in the evaluation of a product, selection of a vendor, negotiation with a vendor, or the decision to purchase a product should be generally familiar with all purchasing department rules regarding their role in the process.

(v) Communication between university personnel and vendor representatives related to selection of a vendor, negotiation with a vendor or a decision to purchase a product should occur only in accordance with purchasing department rules.

(vi) All costs related to meals, travel, lodging, etc. for meetings, site visits, or other activities related to a purchasing decision must be covered by university department and not the vendor unless explicitly approved by a senior administrator at the university.

(k) Conflict of interest in research

(i) Individual medical center staff members involved in any form of research should be generally familiar with and compliant with any applicable university rules that govern conflicts of interest in research.

(ii) Funding or other support for research from vendors may be received in accordance with applicable, university rules that govern industry-funded research.

(iii) As a part of the IRB approval process, university personnel must disclose to the IRB any financial conflicts regarding the research they are undertaking according to applicable university rules.

(iv) As a part of the IRB approval process, university personnel must disclose to prospective research subjects any substantial conflicts of interest regarding the research they are undertaking when required to do so by the IRB.

(l) Non-compliance

(i) Department chairs are charged with ensuring that all university personnel (e.g., faculty, staff, trainees, etc.) in their departments are educated about this rule.

(ii) Reporting of potential non-compliance with this rule may be done through a variety of mechanisms.

(a) Report directly to the vice president for research;

(b) Report directly to the vice president for administration and finance;

(c) Report directly to the university general counsel.

(iii) Determination of non-compliance and disciplinary action: determination of non-compliance will be done with the cooperation of the applicable administrative, academic, research and/or clinical department leadership where the alleged issue(s) occurred. For faculty members, this should also include the department chair for the individual involved. Additional assistance in any investigation, determination of non-compliance with this rule, or determination of disciplinary action can also be provided by the dean, the vice president for administration and finance, vice president for research, or university general counsel.

(iv) Vendor non-compliance: each issue of non-compliance with this rule will be dealt with on an individualized basis taking into account the actual events that occurred and any previous non-compliance with university rules. Non-compliance may result in actions including, but not limited to:

(a) A warning;

(b) A temporary suspension of access to the university;

(c) Permanent revocation of the individual vendor corporation; or

(d) Complete termination of business with the vendor corporation.

(v) University personnel non-compliance: each issue of non-compliance with this rule will be dealt with on an individualized basis taking into account the actual events that occur, any previous non-compliance with university rules, and the individual's overall applicable work or academic record. Any disciplinary action will be consistent with regard to existing disciplinary rules that apply to the individual in question. Non-compliance may result in disciplinary action, including but not limited to:

(a) A warning;

(b) Probation;

(c) Suspension;

(d) Removal from a position where duties include vendor interaction; or

(e) Termination.

(f) Any disciplinary action may be appealed in accordance with applicable university HR rules and through a process that is based on the individual's status within the university (i.e., student, faculty, administrative staff, trainee, etc.).

Last updated July 29, 2024 at 8:26 AM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12

Rule 3349-20-175 | Participation in companies commercializing university research.

• Effective: July 29, 2024
• Promulgated Under: 111.15

(A) Purpose

Northeast Ohio medical university has determined that the interests of the university will be served if faculty, staff and students are afforded an opportunity to hold a personal, financial interest in companies commercializing their university research. Participation in technology licensing transactions will facilitate the university's strategic plan by making its intellectual property available for use in the private marketplace. Activities permitted under this rule will enhance the university's ability to recruit and retain high quality faculty researchers. These procedures and guidelines are intended to protect the integrity of the educational, research and service missions of the university, through compliance with university rules and procedures, as well as federal and state laws and regulations while enabling the university to realize the benefits of entrepreneurial activities.

(B) Scope

This rule applies to all staff engaged in research at the university (as that term is defined in paragraph (C)(18) of this rule).

(C) Definitions

(1) "Activity not related to research" refers to activities which are unrelated to scientific or scholarly investigation are not subject to this rule. However, they may be subject to other university rules.

(2) "Business activity" refers to activities directed toward the commercialization of university intellectual property.

(3) "Business plan" refers to a written proposal explaining a new business or business idea that usually includes financial, marketing and operational plans.

(4) "Conflict management plan" refers to a plan designed to manage, reduce or eliminate conflicts of interest in accordance with the university's conflict of interest rule.

(5) "Conflict of commitment" refers to external commitments which burden or interfere with the individual's primary obligations and commitments to the university.

(6) "Conflict of interest" refers to the ability to improperly influence the university's business, administrative, academic, research or other decisions in ways that could lead to personal gain or advantage of any kind.

(7) "Conflict of interest administrator" refers to the university official, appointed by the president, responsible for monitoring compliance with conflict of interest plans as approved by the conflict of interest committee.

(8) "Conflict of interest committee" refers to the committee appointed by the president that reviews disclosure statements regarding significant financial interest in a technology commercialization venture. This committee assists the faculty, staff and students in the development of a plan to manage, reduce or eliminate conflicts of interests in accordance with the university's conflict of interest rule.

(9) "Equity" refers to an interest or ownership in a commercial entity.

(10) "Faculty" refer to individuals appointed to that status by the board of trustees.

(11) "Intellectual property" refers to a category of intangible rights protecting a commercially valuable product of the human intellect. This category includes, but is not limited to, trademark, copyright, patent rights and trade secrets.

(12) "Intellectual property committee" refers to the committee appointed by the president that evaluates all discoveries and inventions disclosed to the university for patent potential and marketability.

(13) "Investigator" refers to individuals responsible for the design, conduct or reporting of a project whether in whole or part. This includes all personnel involved in a research project.

(14) "Milestones" refer to specific markers measured in terms of events, time or both.

(15) "Individuals" refer to as used in this rule, individuals include faculty, staff and students.

(16) "Research" refers to scientific or scholarly investigation.

(17) "Significant financial interest" refers to anything of monetary value including, but not limited to, salary or other payments for services, equity interests and intellectual property rights.

(18) "Staff" refers to any individual who is a part time or full time employee at the university whether paid or not qualified volunteers are included in this definition.

(19) "Start-up company" refers to a corporation, association, partnership or other commercial enterprise which is in its formative or developmental stage.

(20) "Students" refer to individuals who is enrolled full-time or part-time in approved university educational programs and/or individuals enrolled in other joint instructional programs who are under the direction of college of medicine faculty. This includes medical students, graduate students, graduate assistants, postdoctoral fellows and student employees.

(21) "Technology commercialization venture" refers to a commercial entity owned in whole or in part by a university faculty, staff member or student that has as its purpose the development and commercialization of university owned, assigned, licensed, or transferred intellectual property.

(D) Body of the rule

(1) Applicability

(a) This rule applies to individuals that are engaged in research and development activities or create intellectual property owned by the university in accordance with section 3345.14 of the Revised Code and desire to hold and own equity interest in a technology commercialization venture generated by the aforementioned commercialization activities.

(b) The conflict of interest administrator is responsible for ensuring that individuals within the university who participate in technology commercialization activities comply with this rule and the university's external and financial professional commitments, conflict of interest and intellectual property rules.

(c) The conflict of interest administrator, in consultation with the individual's immediate supervisor, is responsible for reviewing the conflict management plan and making recommendations to the conflict of interest committee.

(d) The conflict of interest committee is responsible for notifying the faculty member and his or her immediate supervisor upon approval of a conflict management plan.

(e) The supervisor is responsible for monitoring compliance with the conflict management plan and reporting deviation to the conflict of interest administrator.

(f) The conflict management plan will be reviewed annually by the conflict of interest administrator and the president or other university official designated by the president to assure compliance with the plan and all other university rules.

(2) Approval process

(a) Individuals who plan to participate in a technology commercialization venture must present a business plan to the general counsel and the chief technology transfer officer who will consult with the vice president for finance and administration. Such individuals must also submit a conflict management plan to the conflict of interest committee after consultation with the conflict of interest administrator and the immediate supervisor.

(b) The intellectual property committee is responsible for ensuring that the interests of the university are served by the technology commercialization venture through a review of all pertinent information relating to the venture.

(c) A technology commercialization venture requesting a license to university owned technology must provide a viable business plan to the general counsel and chief technology transfer officer including, at a minimum, the following:

(i) A capitalization plan demonstrating access to funds necessary for venture growth;

(ii) A proposed management team; and

(iii) Milestones for product development and commercial sale.

(d) The conflict of interest committee will be responsible for reviewing and approving the conflict management plan.

(e) The conflict of interest administrator or an immediate supervisor who has a financial interest or is a co-participant in a technology commercialization venture is not able to provide effective oversight of that activity. In these situations, an objective administrator will be appointed by the president to perform responsibilities of the conflict of interest administrator or the immediate supervisor

(3) Faculty obligations to the university

(a) Faculty are encouraged to develop discoveries and inventions with commercial potential; however, they shall not allow their interests in a financial opportunity to interfere with or detract from the teaching, research and service missions of the university.

(b) Faculty advisors shall base research assignments for a given student on the student's interest and academic development.

(c) Faculty shall respect and promote the cooperative nature of the academic environment by sharing information and participating in joint research efforts with their colleagues.

(d) Authorized private business activities must be undertaken in good faith, with due care and must be consistent with the university's best interests. These activities must not conflict with university rules and procedures or any federal and state law.

(4) Conflict of interest management standards

(a) University facilities, equipment and other resources shall be used for research benefiting a technology commercialization venture only pursuant to an appropriate contractual agreement.

(b) Faculty or staff shall not hold management positions in technology commercialization ventures without the express consent of the conflict of interest committee and the university president. It is expected that professional management shall be brought in at the earliest opportunity and that faculty or staff management responsibilities will decrease as the venture develops.

(c) Agreements between the university and a technology commercialization venture shall contain enforceable milestones for the reduction of faculty and staff management responsibilities. Failure to comply with these milestones will result in cessation of the faculty and staff management activities permitted under this rule unless specifically authorized by the conflict of interest committee.

(d) Faculty engaged in approved private activities, who are unable to perform all of their university responsibilities, must reduce those activities or request a reduction of appointment or other approved leave. Faculty improvement leaves may not be used for private business purposes and are subject to the faculty improvement program rule.

(e) A perceived failure to adhere to these guidelines shall be reported to the conflict of interest administrator.

(f) University regulatory review boards including, for example, the institutional review board and the institutional animal care and use committee, may be utilized for research benefiting a technology commercialization venture only pursuant to a written agreement with the university.

(g) While significant faculty or staff equity ownership may be inherent in a newly formed venture, it is expected that their ownership interests, as a percentage of the total outstanding shares or membership interests of the venture will decrease as the venture develops and attracts additional equity. Agreements between the university and technology commercialization companies shall contain enforceable milestones for the dilution of these equity interests.

(h) A faculty or staff member, who is a principle investigator for a project involving human subjects or live animals which is funded by a technology commercialization venture, must comply with the rules and regulations of the institutional review board or the institutional animal care and use committee.

(i) Agreements for sponsored research projects funded by technology commercialization ventures must include, at a minimum, a requirement for appropriate university publication rights and full cost recovery. The office of the vice president for administration and finance and the office of the general counsel must approve exceptions to these conditions.

(j) Faculty and staff participating in technology commercialization ventures approved pursuant to this rule continue to be bound by the university rule on intellectual property. New inventions and/or discoveries made as a result of a faculty or staff member's research efforts for the venture, will be owned by the university unless other arrangements are made in advance. New inventions and/or discoveries developed by the faculty or staff member for the venture must be disclosed to the dean for research and the general counsel as required by the intellectual property rule.

(5) Guidelines for students participating in commercializing technology

(a) Students may use university facilities, equipment and other resources to perform research benefiting a technology commercialization venture only pursuant to a contractual agreement between the university and the technology commercialization venture and approved by the conflict of interest committee.

(b) Research benefiting a technology commercialization venture may not be used to satisfy the criteria for a thesis or dissertation if the material is restricted from publication or public disclosure. Students shall be informed by their NEOMED faculty advisor in writing of this restriction prior to the start of their research.

(c) A student shall not be employed by a technology commercialization venture in which a faculty member has an ownership interest if:

(i) The student is enrolled in a course taught by the faculty member, or

(ii) The faculty member is a member of the student's thesis or dissertation committee, or

(iii) The faculty member is the student's advisor or the director of his or her thesis or dissertation research.

(d) Students may perform research benefiting a technology commercialization venture only pursuant to a sponsored research agreement or other formal internship agreement through the university.

(6) Specific guidelines on investments by faculty, staff and students not involved with development of the technology.

Faculty who are not directly involved with research and development of technology licensed to a faculty owned start-up company may hold equity interests in that company only to the extent not prohibited by Chapter 102. and sections 2921.42 and 2921.43 of the Revised Code.

(7) Board authorization

The board of trustees authorized the administration to establish and implement the provisions related to the commercialization of university research as necessary to carry out this rule without further ratification or action required by the board of trustees.

Last updated July 29, 2024 at 8:26 AM

Supplemental Information

Authorized By: 111.15
Amplifies: 3350.12