Chapter 3342-10 University and Administative Policy on Research

3342-10-01 University policy regarding research and sponsored programs administration.

(A) Policy statement. In furtherance of the mission of the university to provide a foundation and support for research and collaboration, the division of research and sponsored programs shall serve as the coordinating office for sponsored programs administration, research compliance, and technology commercialization.

(B) The vice president for research and sponsored programs is responsible for developing and implementing policies and practices in furtherance of the university's research mission and strategic plan.

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04

3342-10-02 University policy regarding research compliance.

(A) Policy statement. The university, in the course of carrying out its teaching, research, and service missions, engages in research involving the use of human subjects and vertebrate animals, across a wide array of academic disciplines and administrative functions. To protect the rights, dignity and welfare of all human subjects participating in research conducted on behalf of Kent state, the university shall establish and maintain a human subjects protection program, and to ensure that vertebrate animals used in research, testing and teaching at Kent state are treated humanely, the university shall establish and maintain an animal care and use program.

(B) The vice president for research and sponsored programs is responsible for developing and implementing the human subjects protection program and the animal care and use program.

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04

3342-10-02.1 Administrative policy regarding research involving human subjects.

(A) Purpose. The university, in the course of carrying out its teaching, research, and service missions, engages in research involving the use of human subjects across a wide array of academic disciplines and administrative functions. In order to protect the rights, well-being, and personal privacy of individuals, to assure a favorable climate for the conduct of scientific inquiry, and to protect the interests of the university, the policies and procedures described in this policy have been established for the conduct of investigations and educational projects involving human subjects.

(B) Scope.

This policy shall apply to all activities conducted by. or under the auspices of the university, irrespective of the funding source, that meet the criteria for:

(1) "Research" involving "human subjects, " as defined in the department of health and human service (DHHS) regulations 45 CFR pt. 46 as such regulations may be amended, and/or

(2) A "clinical investigation" involving "human subjects" or "subjects, " as defined in U.S. food and drug administration (FDA) regulations in CFR Title 21, as such regulations may be amended. This includes graduate theses or dissertations.

(C) Implementation.

(1) All members of the university community, including all faculty, staff, and students engaged in research recognize and share in the responsibility for protection of the rights and welfare of human subjects.

(2) No research involving human subjects shall be initiated until approval or exemption has been granted by the institutional review board (IRB).

(3) Under the approved federal-wide assurance (FWA) provided by the university to DHHS. all research involving human subjects, and the oversight of such research shall be guided by the ethical principles set forth in the "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research." and performed in compliance with the regulations set forth by DHHS.

(4) For clinical investigations involving drugs, biologies, medical devices, and other test articles, the university shall comply with human subjects research regulations established by the FDA for clinical investigations.

(5) The university shall conform with other applicable federal, state and local laws and regulations germane to human subjects research.

(6) Investigations conducted by university students in connection with academic work must be supervised by a faculty member, who will refer such proposals to the IRB for review. For student research, the faculty advisor is assumed the principal investigator in regards to IRB applications.

(D) Authority and responsibility.

(1) The IRBs designated under the university's FWA are the principal mechanism by which the university reviews proposed research to ensure that it is planned and conducted in a manner consistent with applicable law and policy, and that the rights and welfare of human research participants are adequately protected. The responsibilities of the IRB include, but are not limited to:

(a) Reviewing, approving, exempting, requesting modifications to, or denying proposed research involving human subjects to ensure that it is planned and conducted in a manner consistent with applicable law and policy, and that the rights and welfare of human subjects are adequately protected. Notwithstanding the preceding, research that has been approved by the IRB may be subject to further review and approval or disapproval by the provost or the provost's designee. No university official, however, may approve research that has not been approved by the IRB.

(b) Conducting continuing review of research approved by the IRB, at intervals not less than once per year, including as necessary, observing, or having a third party observe, the consent process and investigational activity; or requesting and inspecting information related to human participant research activity.

(c) Suspending or terminating approval of research activity that is not being conducted in accordance with the requirements established by the IRB for a particular research activity, has been associated with serious harm to research participants, or that is not otherwise in accordance with federal human subject research regulations or university policy.

(d) Reporting to appropriate university and federal officials, and as applicable, any department or agency head:

(i) Unanticipated problems involving risks to research participants or others and serious or continuing noncompliance with this policy or the requirements or determinations of the IRB.

(ii) Any suspension or termination of IRB approval.

(e) Contributing to the development and implementation of administrative policies and procedures consistent with federal regulations and best practices.

(2) Sponsored projects involving human subjects are subject to rule 3342-3-04.1 of the Administrative Code.

(3) The institutional official, by appointment from the provost, shall represent the university in providing assurance to the federal government that the university will comply with federal human subject research regulations, and shall be responsible for ensuring that all regulatory and programmatic requirements for the conduct of human participant research at the university are met.

Replaces: 3342-3-03.2

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 3/11/1982, 7/19/1985, 5/5/1995, 12/20/2004, 6/1/2007, 9/1/2014, 3/1/2015

3342-10-02.2 Administrative policy regarding animal care and use.

(A) Statement of purpose. Recognizing a scientific and ethical responsibility to provide appropriately for the welfare of animals used for research and education, the university and its faculty and staff are committed to assuring humane care and use of these animals. To implement this commitment, an animal care and use (ACUC) committee under the direction of the provost or designee will be established. The animal care and use committee will operate in accordance with the United States public health service policy on humane care and use of laboratory animals and the public health service "Guide for the "Care and Use of Laboratory Animals, " the provisions of the United States Animal Welfare Act and other applicable laws and regulations.

(B) Responsibilities of the ACUC. The ACUC has the following responsibilities:

(1) To review at least semi-annually, the university's program for humane animal care and use for compliance with state and federal regulations.

(2) To review all research projects involving live, vertebrate animals to determine that the described care and use of animals are in compliance with university, state and federal policy and regulations.

(3) To review and approve proposed changes in on-going research which introduce significant change in use of animals or when animal studies not originally proposed and approved by the ACUC are added.

(4) Inspect all of the university's animal facilities at least semi-annually.

To provide assistance and advice in research involving live animals and to implement the guidelines and policies of the university through the division of research which has general administrative responsibility for animals used in research.

(C) General principles. The following general principles apply equally to all projects involving animals, whether carried out solely with university resources or with the assistance of outside funds. The university has responsibility for communicating and explaining these principles to university personnel, and for providing procedural guidelines to effect their observance.

(1) Experiments using live animals shall be conducted by, or under the immediate supervision of a qualified research scientist.

(2) Animal care and housing will be under the direction of a properly qualified veterinarian.

(3) Research will be conducted in a manner to ensure humane care and use of animals. Care will be taken to minimize the number of animals used and to avoid all unnecessary suffering and injury to the animals.

(4) Facilities will be maintained in accordance with standards prescribed by the United States department of agriculture and department of health and human services as well as relevant accrediting organizations.

(5) Transportation will be in accord with applicable standards to reduce discomfort, stress and spread of disease.

(6) Euthansia will be performed according to American veterinary medical association guidelines.

Replaces: 3342-3-03.3

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 10/26/1979, 7/19/1985, 8/7/1985, 5/5/1995, 7/5/1995, 6/1/2007, 3/1/2015

3342-10-03 University policy regarding extramural projects, grants, and contracts.

(A) Statement of purpose. It is appropriate to note some basic university policies and considerations which apply to soliciting and administering extramural support. All extramural support funds should assist and be consistent with the long-range goals of the university and should provide direct educational benefits to the university faculty, staff and students. With this statement in mind, it shall be university policy to encourage extramural support and to enter into agreements with extramural agencies for programs and projects in such areas as research, training, seminars, workshops, graduate fellowships, facilities and equipment, and institutes.

(B) General guidelines.

(1) Such projects should provide faculty or staff members the opportunity to gain experience and knowledge of value to their teaching and research or other university activity;

(2) Projects should be justified academically as having the potential for resulting in worthy contributions to knowledge;

(3) Facilities or equipment provided should complement the university's teaching, research or other aims;

(4) Research experience should be made available to students; and

(5) The projects should have public value.

(C) Additional policies and procedures. Because of the fact that the area of extramural support is complex, and the procedures for preparation, processing and administering proposals and programs vary by area of concern, more specific administrative policies and operational procedures have been provided for.

Replaces: 3342-3-03

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 1/25/1980, 6/1/2007, 3/1/2015

3342-10-03.1 Administrative policy and procedures regarding sponsored programs administration.

(A) Purpose. The sponsored programs office ("sponsored programs") resides in the division of research and sponsored programs and, together with grants accounting in the controller's office, is responsible for stewardship of external funds received for sponsored projects. Sponsored programs oversees submission of proposals to external sponsors, negotiation/acceptance of grant and contract awards, and other Sponsored programs-related matters. Sponsored programs shall assist faculty and staff with:

(1) Retrieval of funding source information;

(2) Preparation of proposal applications to include budgeting;

(3) Authorization and submission of proposals to federal/state/local/private sponsors;

(4) Negotiation/acceptance of grant/contract award agreements to include review of terms/conditions;

(5) Plans for spending awarded funds;

(6) Award modifications to include changes in scope of work or key personnel, re-budgeting, and/or no-cost extension requests; and

(7) Grant/contract personnel appointments.

(8) Additionally, in cases of proposed or awarded projects, sponsored programs shall guide faculty and staff in interpretation of university/federal/state/other sponsor policies relative to cost principles; external sponsor-required university cost sharing; effort certification; university use/maintenance/sharing of equipment; intellectual property rights; use of human participants; animal care and use; use of high hazard chemicals, radioactive materials, recombinant DNA, bio-hazardous materials, select agents/toxins; matters related to export controlled data; and classified research/sensitive but unclassified research.

(B) Scope. A "sponsored project" is defined as any externally funded research or scholarly activity that has a defined scope of work or set of objectives, which provides a basis for sponsor expectations. This more specifically involves research, demonstration, professional development, instruction, training, curriculum development, community and public services, or other scholarly activity involving funds, materials, or other forms of compensation, or exchanges of in-kind efforts under awards or agreements.

(1) A project is considered a "sponsored project" if any one of the following conditions apply:

(a) The project is awarded based on a proposal request;

(b) The university commits to a statement of work for a specified project;

(c) The project involves a set of objectives which provides the basis for sponsor expectations;

(d) The proposal includes a detailed budget;

(e) There is a written agreement for a commitment of resources between a sponsor and the university, there is a specified period of performance, requires deliverables (such as reports, financial accounting, or intellectual property ownership);

(f) The award provides for the disposition of tangible or intangible property that may result from the project (such as equipment, records, formal activity reports, rights in data, software, copyrights, invention or research-related materials);

(g) The sponsor is involved in making decision regarding project performance; or

(h) The project involves the use of human subjects, laboratory animals, radioactive or hazardous materials, recombinant DNA, carcinogens, pathogens or proprietary materials.

(C) General principles.

(1) To generate proposals for external funding to the university, Sponsored programs will disseminate information on funding opportunities across all campuses.

(2) Compliance. Proposals must be consistent with the mission of the university and must be suitable to the unit in which the project is to be conducted. A proposal is a formal offer by the university to conduct a program under the direction of the principal investigator/project director who does so utilizing personnel and facilities of the university. Therefore, projects must comply both with university policies and external sponsor regulations. Authority for proposal submission resides in sponsored programs where the authorized organizational representative (AOR) or his/her designee is the legal signatory on submissions.

(3) Acceptance and contracting authority. A grant or contract award is an award to Kent state university and, as such, must be accepted by the university. Authority for acceptance resides in sponsored programs where the AOR or his/her designee serves as the legal signatory on grant or contract agreement documents.

(4) Principal investigators/project director role eligibility. Faculty members and professional staff who are full-time university employees may serve as principal investigators/project directors. It is the responsibility of the principal investigators/project directors to maintain academic and research integrity in the conduct of his/her sponsored project. A project may be carried out under the direction of one or more principal investigators/project directors within a single department, school, institute, center, regional campus or college or under the direction of such individuals from various cooperating units. In extenuating circumstances, an individual who is not a full-time employee may serve as principal investigator/project director; such cases must be sanctioned by the chair of the department/institute or center director, or regional campus dean from which the proposal is submitted. A full-time employee must assume both reporting and fiscal responsibility for the resulting award if granted.

(5) Approval process. Prior to the submission of the proposal to an external sponsor, a proposal must be approved electronically through the Coeus grant proposal and management system, or any subsequent system in place at the university as designated by sponsored programs. Though completion of the routing and approval process, the principal investigator/co-investigator/project director/co-director must accept responsibility for the proposal's content while also certifying compliance with the sponsoring agency and institutional requirements. Also prior to submission to an external sponsor, the proposal must be approved by the appropriate chair(s), director(s), regional campus dean(s), dean(s), or other university officer(s), as relevant, indicating to sponsored programs that the proposed project, its budget, and the level of effort committed by university personnel have the necessary university endorsements.

In reviewing the proposed project, the chair/director, dean or regional campus dean must ascertain that the proposed project is consistent with the goals of the department, college, school, or regional campus, that the faculty level of effort dedicated to the project is compatible with the unit's needs, and that any cost-sharing commitment is both possible and suitable. The college dean or regional campus dean shall review the proposed project to ascertain to what degree the project commits the college to long-term support of project personnel or program support beyond the award period.

(6) Budget. Sponsored programs staff shall determine the cost of a sponsored project in accord with principal investigator/project director needs and external sponsor program guidelines. The proposed project's budget shall include allowable direct costs, facilities and administrative costs, and, as needed, the appropriate, sponsor required university cost share whose source and amount has been approved by responsible chair, director, regional campus dean, or vice president.

(7) Cost sharing shall become part of a proposed project's budget when required by the external sponsor and only when authorized by the appropriate university official representing the unit providing the cost share. Cost sharing on one project precludes its use on another project. Sponsored programs shall ascertain that costs requested from an external sponsor as well as university cost sharing meet the cost principles (OMB A-21) of allowability, allocability, reasonableness, and consistency (with university financial practices). The university assumes the position that voluntary (not required by the external sponsor) cost sharing shall not ordinarily be offered, and that the university's negotiated facilities and administrative rate, an essential sponsored project cost, shall not be waived. When Kent state university project costs include subrecipient costs, in order to incorporate such costs into the Kent state university proposed budget, sponsored programs must receive adequate documentation from the subrecipient prior to proposal submission.

(8) Research projects involving use of human subjects must be reviewed by the university's institutional review board (IRB) prior to proposal submission or within thirty days after proposal submission if allowed by external sponsor guidelines (see rule 3342-3-03.2 of this Administrative Code). A project's human subjects must be protected in accord with federal regulations. A project that does not comply may not be conducted.

(9) Live vertebrate animals. Research projects involving use of live vertebrate animals must be reviewed by the university's institutional animal care and use committee (IACUC, as provided for in rule 3342-3-03.3 of the Administrative Code). No project involving animals may begin without approval by and adherence to recommendations by IACUC.

(10) Hazardous materials. Research projects involving use of high hazard chemicals, recombinant DNA, bio-hazardous materials, radioactive materials, or select agents/toxins must receive approval from the manager, research safety and compliance in research and sponsored programs. No project may begin without such approval.

(11) Export controls. The conduct of research projects involving export-controlled data must be approved by sponsored programs in concert with university legal counsel, with the aim of maintaining university exemption from export control restrictions based upon the university's position that it is (under "National Security Decision Directive 189") a fundamental research institution with publication rights which the university shall not waive. In such cases where export controlled information is a consideration, the university shall, as necessary, implement its master technology control plan accompanied by the annex appropriate to the specific project in question. Each project involving export-controlled information will comply with its specific annex.

(12) The university shall maintain its publication rights in all sponsored projects. The university shall not accept awards or enter into agreements for the support of research that permits another party the power to prohibit publication of or dissemination in any form of results of the sponsored research activities. The university shall permit short delays (thirty to sixty days) of publication or dissemination of results in order for sponsor review, not sponsor approval, in order for sponsors to remove inadvertently included, sponsor-provided proprietary information or for sponsors to seek patent applications; in such cases, these delay conditions will be specified in the initial grant/contract award.

(13) Classified research. At times, a government agency or an industry has need to contract with the university for a research project under conditions that do not permit free inquiry and disclosure of results. Such research is "classified research." Contracts for classified research may be considered on a case-by-case basis. The general purpose and method of such research shall be disclosed to pertinent faculty and administrators so that they can judge the appropriateness of the research and its contribution to human knowledge and well being. The funding agency shall not influence the selection or promotion of faculty members or the formulation of university academic policy. The study's results and conclusion shall be available for open discussion and/or publication after a reasonable period of time. To ensure adherence to these policies, faculty members shall submit any proposal responding to an external sponsor request involving classified research to the vice president of research and sponsored programs for review and consideration. The vice president of research and sponsored programs may consult with the university research council. The principal investigator or the granting agency may appeal the decision of the vice president to the provost. In order to facilitate the conduct of federal classified grants or contracts, the university shall continue to hold a "facility clearance." This involves providing the physical means to protect security data, perhaps requiring personal security clearance of certain university officers and other employees.

(14) Gifts. A solicitation for a gift (a donation that has no requirements attached and is not work for hire) is submitted through the office of institutional advancement and foundation. The office of institutional advancement and foundation is also responsible for submission of other proposed projects in such cases where the agencies/foundations require submission by that office. In these latter cases, sponsored programs shall assist the office of institutional advancement and foundation with accurate proposal budget development.

(15) Approving department. A proposal to an external sponsor is subject to approval of the department in which the sponsored project will reside. The proposal may be submitted only if the proposed project does not unduly disrupt the established research and teaching programs of the university and department, that is, if teaching obligations can be met or rearranged as needed; if appropriate space, equipment, and facilities can be made available to the project; and, if the university can provide for continuation of support for a project's new positions if required.

(D) Implementation: proposal preparation and submission.

(1) Individual faculty/staff members prepare proposals in accord with external sponsor guidelines.

(2) Sponsored programs staff shall review the proposal and provide project proposal support including but not limited to the following services:

(a) Sponsored programs staff shall review the proposal for adherence to university policy and sponsor regulations.

(b) Sponsored programs staff shall assist with development of the budget, ensuring its adequacy for the proposed work, allowability (meets cost principles as delineated in OMB A-21 and external sponsor cost requirements), and consistency with university financial procedures; and shall ascertain that the university is not cost sharing unnecessarily or unduly.

(c) Sponsored programs staff shall review the level of effort committed and the indicated current and pending support.

(d) Sponsored programs staff shall ensure that the principal investigator/project director follows university-required procedures (involving as necessary the institutional review board, the institutional animal care and use committee, the manager, research safety and compliance, university legal counsel) when human subjects, animals, export controlled data, high hazard chemicals, recombinant DNA, bio hazardous materials, radioactive materials, select agents/toxins, or new use of space (obtaining approval from the relevant university official) are involved in the project's conduct.

(3) Sub-recipient institution. When a sub-recipient institution serves as a partner in the university's proposed project, sponsored programs staff shall coordinate the proposal submission with the subrecipient. Sponsored programs staff shall obtain, prior to submission of the proposal, the necessary subrecipient documents. This documentation shall be in the form of a letter of commitment to the project, an officially authorized budget for subrecipient costs and cost sharing if applicable, the sub-recipient's statement of work substantiating what that institution will do for its proposed costs, and verification of the sub-recipient's facilities and administrative rate.

(4) AOR authorization. Every proposal must be authorized by the AOR for submission and submitted by sponsored programs staff to the external sponsor.

(5) Endorsement. Prior to its submission to an external sponsor, the proposal must be approved electronically through Coeus by the appropriate chair/director and dean or regional campus dean. In reviewing the proposed project, the chair/director, dean or regional campus dean and executive dean for regional campuses must ascertain that the proposed project is consistent with the goals of the department, college, school, or regional campus, that the faculty level of effort dedicated to the project is compatible with the unit's needs, and that any cost sharing commitment is both possible and suitable. The college dean or regional campus dean shall review the proposed project to ascertain to what degree the project commits the college to long-term support of project personnel or program support beyond the award period.

(6) Conflict of interest. Prior to its submission to an external sponsor, all potential conflicts of interest must be disclosed (see rules 3342-3-07 and 3342-3-07.1 of the Administrative Code) by the project's key personnel (those who have a role in the design, conduct, or reporting of the project). Each investigator must complete the "investigator certification" in Coeus, which incorporates the financial conflict of interest screening form questions, while key personnel must complete the financial conflict of interest screening form.

(7) Time for submission. Sufficient time shall be allowed for sponsored programs to process the proposed project. University principal investigators/project directors submitting proposals must follow the established timelines to ensure efficiency, expediency, and quality of the proposal process.

(a) Sponsored programs should be notified of intention to submit a proposal at least ten working days before the submission deadline.

(b) A complete proposal with the final budget must be entered into Coeus and routed for internal approval no later than five working days prior to the due date.

(c) If narrative proposal documents will be revised after submission for internal approval, all files must be finalized in Coeus no later than two working days before the due date of the proposal to the external agency or source.

(E) Procedures: Grant/contract acceptance, initiation, and administration.

(1) The grant or contract award to Kent state university is issued as a document that must be reviewed by sponsored programs staff, often in concert with university legal counsel; prior to acceptance, unacceptable clauses are modified or struck from the agreement. Acceptance is evidenced by the AOR's signature on the award agreement document. The university does not make funds available to the principal investigator/project director until he/she has met all compliance requirements (e.g., financial conflict of interest, IRB, IACUC).

(2) When an award to the university includes subrecipient collaboration, the university shall issue the subaward agreement that includes the external sponsor's award terms and conditions. The subaward agreement will require the subrecipient's certification of compliance with federal regulations and/or other external sponsor requirements. The agreement is then executed between Kent state university and the subrecipient. Ongoing monitoring of subrecipient technical performance is documented by the principal investigator/project director and of administrative requirements by sponsored programs and grants accounting.

(3) In the administration of grant or contract awards, sponsored programs shall abide by: The award instrument issued by the particular funding agency; OMB circulars A-21, A-133, A-1 10; Other federal regulations; and university policies.

(4) When an external sponsor selects a proposal for an award, the sponsor commonly requests additional budgetary or technical information. Such budgetary information may be provided only by sponsored programs staff

(5) Any award negotiation that takes place between Kent state university and an external sponsor must be conducted by sponsored programs. If an external sponsor contacts a principal investigator/project director directly, he/she shall advise sponsored programs. Prior to finalizing negotiations, sponsored programs staff shall work with the principal investigator/project director to ensure that his/her needs are met and that the university is protected. Sponsored projects are subject to facilities and administrative costs (F&A) at the university's current federally-approved F&A cost rate agreement applicable to the type of project being conducted. If the sponsor has a published policy, uniformly applied, prohibiting or restricting the payment of F&A costs, the university may accept the reduced F&A rate in accordance with the sponsor's policy. This does not apply to for-profit sponsors that are expected to provide full F&A recovery.

(6) The principal investigator/project director shall operate within university policy and external sponsor requirements and shall be responsible for day-to-day direction and financial and administrative management of his/her awarded project. Sponsored programs staff shall guide the principal investigator/project director in the interpretation of university policy and external sponsor requirements. University policy and external sponsor terms and conditions shall be followed for all sponsored program activities including but not limited to travel, equipment acquisition, employment and committed effort of personnel, participation of human participants, and/or use of animals. The principal investigator/project director shall fulfill the requirement for review and certification of salaries, assuring that salaries charged to sponsored projects correspond to effort expended on those projects.

(7) Equipment as defined by the university that is purchased with grant/contract funds shall be subject to university equipment inventory control procedures regardless of whether title vests in the university or the funding agency. The principal investigator/project director shall be responsible for such equipment, shall purchase the equipment in due time (well before an award end date), and shall account for all items periodically as well as at the project's end. Retention and disposal of equipment at project termination falls into three categories:

(a) equipment purchased by the university with university funds (deemed to be cost share) remains in the department, school, or regional campus of the principal investigator/project director and cannot be removed from the university by a resigning principal investigator/project director;

(b) special purpose equipment purchased by the university with grant or contract funds with title vested in the university by a sponsor remains in the principal investigator/project director's department, school, or regional campus and may be transferred with the approval of the appropriate chair/director/regional campus dean to a principal investigator/project director's new institution upon his/her resignation, only if the department/school/regional campus has no use for the equipment (final approval for transfer rests with the provost or his/her designee; and

(c) equipment purchased with grant/contract funds that remains vested with the external sponsor shall be tagged appropriately to identify the sponsor and grant/contract number and shall be disposed of in accord with external sponsor instructions and as coordinated between the controller's office and sponsored programs.

(8) Kent state university considers that cost sharing included in proposal budgets and accepted by the sponsoring agency is an award condition and university obligation. Cost sharing is subject to audit; the external sponsor will require repayment of a portion of grant funds if the proposed cost sharing is not obtained/documented and could terminate an active award. Cost sharing obligations, including both mandatory and voluntary-committed investigator effort, are appropriately recorded by project in the university's accounting records and substantiated by documentation (e.g., effort certification, vendor letters stating equipment value). Cost sharing is monitored for timeliness and adequacy as well as for allowability, allocability, reasonableness, and consistency with other university charging procedures. Cost sharing expenditures like expenditures subsidized by the grant/contract award must comply with federal cost principles and sponsor award terms and conditions. Where cost sharing is a requirement of a university-issued subaward, the cost sharing commitment that the university requires from the subrecipient is included in the university-issued subaward document. The subrecipient's compliance with the required cost sharing commitment is then monitored by both the principal investigator/project director and grants accounting and appropriately reported to the external sponsor.

(9) Throughout an externally funded project's course, the principal investigator/project director shall inform his/her chair/director, or regional campus dean as well as sponsored programs staff if there is or will be (a) any deviation from the project's sponsor-approved scope of work, budget, and/or level of personnel effort; or (b) any other change necessitating external sponsor approval. Sponsored programs staff should be informed about any such proposed deviations prior to discussions that might occur between the principal investigator/project director and the external sponsor. The principal investigator/project director shall not communicate directly with the external sponsor about such deviations without approval from sponsored programs.

(10) A separate university-restricted index with its own number shall be established for each externally sponsored project. All project-related expenditures shall be charged directly to this index. All expenditures must occur during the period of the grant/contract award. Principal investigators/project directors shall be responsible for reviewing the project expenditures (as documented in the university system-generated reports) on a monthly basis, correcting any errors, and staying within the sponsored programs-approved budget. Costs allocable to a particular sponsored agreement may not be shifted to other sponsored agreements in order to meet deficiencies caused by overruns or other fund considerations, or to avoid restrictions imposed by law, by terms of the sponsored agreement, or for other reasons of convenience.

(11) Costs allocable to activities sponsored by industry, foreign governments or other sponsors may not be shifted to federally sponsored agreements. If a cost transfer is made due to discovery of an error, the transfer must be supported by documentation that fully explains how the error occurred and a certification of the correctness of the new charge. sponsored programs staff must approve any cost transfer that exceeds ninety days from the original erroneous charge.

(12) External sponsors and Kent state university expect principal investigators/project directors to manage the funded grant/contract project both within the sponsor-approved budget and project period. Unanticipated developments can, however, necessitate modification of the budget, scope of work, personnel effort, project period, or, in some cases, all of these. Principal investigators/project directors who need a modification must submit the request to sponsored programs for approval. The university has established procedures to implement the federal expanded authorities and documents actions taken under such federal expanded authorities. Exercising this authority, the university's AOR is able to approve certain budget and time frame modifications, to include pre-award costs, expeditiously without contacting the funding agency. When required, the university seeks external sponsor prior approval for modifications and maintains records of the approvals granted.

(13) As recipients of external funds, principal investigators/project directors must exercise appropriate responsibility in reporting performance on the funded project to the sponsor. Technical progress (e.g., quarterly, annual) and final reports shall be submitted by the principal investigator/project director to the external sponsor as required and in timely fashion. The principal investigator/project director shall provide a copy of any submitted report (to include electronic reports) to sponsored programs. At the project period's end, the project work ceases; after the termination date, no additional expenditures may be charged to the grant/contract index. A period of thirty to ninety days is usually allowed to pay previously committed financial obligations prior to grant accounting's preparation of the final financial report based on expenditures recorded in the grant index. Grants accounting shall certify the accuracy of the final fiscal report to the external sponsor. Final technical reports, invention disclosure reports, subrecipient reports (property, patent, technical, and fiscal) if applicable, and other reports as required by the external sponsor shall be submitted by sponsored programs to the external sponsor (the principal investigator/project director may have submitted the final technical report as required). The university shall not pay the subrecipient's final invoice until the reports and deliverables required from the subrecipient have been received and accepted. The principal investigator/project director shall certify that the subrecipient has adequately completed the technical aspects of the work. Upon acceptance of these closeout reports, grants accounting shall close the index.

(14) Considered an integral part of a department/center/institute, school, or regional campus program and resources base, grant/contracts/other sponsored agreements must be monitored not only by the principal investigator/project director but also by the chair, director, and college dean or by the regional campus dean. Project over-expenditures and audit disallowances are, ultimately the responsibility and burden of the home department/center/institute, school, or regional campus.

(15) Records of sponsored project activities (financial and programmatic records, supporting documents, statistical records, lab books, records for real property and equipment) shall be retained for the active years plus five years.

Replaces: 3342-3-04.1

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 10/26/1979, 7/19/1985, 8/7/1985, 5/5/1995, 6/1/2007, 5/15/2009, 11/3/201, 3/1/2015

3342-10-04 University policy regarding financial interest in sponsored projects.

(A) Purpose. University faculty and some staff members have taken on new and different functions in addition to the traditional roles of teaching, research, and public service. Spin-off companies transferring technology developed in the laboratory, extensive consultative activities, and various types of public service involvement are encouraged by both federal and state agencies, and by the university as necessary for the public good. Governmental agencies have become more concerned about the extent and type of these activities as they relate to funded and proposed research and scholarly activities of faculty and have issued regulations that require the establishment of standards and procedures to ensure that the design, conduct, or reporting of funded research will not be biased by any conflicting financial interest of the investigator.

The regulations require universities to develop, publish, and enforce institutional policies which comply with the requirements for regular, timely, and full disclosure of actual or potential conflicts of interests as they relate to significant financial interests which could reasonably be seen by an impartial observer as affecting the design, conduct, or reporting of research or educational activities funded or proposed for funding by an external sponsor.

(B) Procedure.

(1) Each investigator involved in sponsored activities whether proposed, pending or funded is required to disclose to a designated university official a list of significant financial interests (including that of his/her spouse and dependent children) that could compromise the objectivity of the proposed and/or supported activities.

(2) The university official will review these disclosures and determine whether any reported significant financial interests could directly and significantly affect the design, conduct or reporting of the research and, if so, such conflicts must be resolved by an administrative process.

(3) The vice president for research and sponsored programs is responsible for administering the policy in accordance with existing present and future applicable governmental regulations.

Replaces: 3342-3-07

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 3/22/1996, 9/30/2005, 6/1/2007, 3/1/2015

3342-10-04.1 Administrative policy on financial interest in sponsored projects.

(A) Purpose. In accordance with state and federal regulations, the university is required to manage, reduce or eliminate any actual or potential conflicts of interest that may be presented by a significant financial interest of an investigator. Thus, the university requires that investigators disclose all significant financial interests that may present an actual or potential conflict of interest in relation to a sponsored project, as defined in rule 3342-3-04.1 of the Administrative Code. These requirements apply to all recipients of subawards.

(B) Definitions.

(1) "Conflict of interest" occurs when the relationship between an individual's private interests and his or her professional obligations to the university is such that an independent observer might reasonably question whether the individual's professional actions or decisions are determined by considerations of personal gain, financial or otherwise. An "actual" conflict of interest depends on the situation and not on the character or actions of the individual.

(2) "Investigator" means the principal investigator/project director, co-principal investigator, and any other person who is responsible or involved in the design, conduct, or reporting of research, instructional or service activities funded, or proposed for funding, by an external sponsor. For the purposes of the requirement relating to financial interest, investigator includes spouses and dependent children.

(3) "Project" means any externally funded scholarly activity such as basic, applied, or developmental research, instructional or curricular activities, student aid, career development, or other activity conducted by faculty or staff members on behalf of the university.

(4) "Significant financial interest" means anything of monetary value or potential monetary value held by an investigator (and by the investigator's spouse and dependent children), and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:

(a) With regard to any publicly traded entity, remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds ten thousand (for PHS funded research, this amount is five thousand). For purposes of the definition of significant financial interest, remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship), equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.

(b) With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds ten thousand (for PHS funded research, this amount is five thousand), or any equity interest (e.g., stock, stock option, or other ownership interest); or

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

(d) A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.

(e) For investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available) related to the investigator's institutional responsibilities. Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.

(5) "Financial conflict of interest "(FCOI) means a significant financial interest that is related to proposed university research (i.e., the interest reasonably appears to be affected by the research or is in an entity whose financial interest reasonable appears to be affected by the research) and that could directly and significantly affect the design, conduct, or reporting of research.

(C) Requirements.

(1) Disclosure requirements. All investigators must submit a listing of the following significant financial interests: Any significant financial interest that would reasonably appear to be affected by the research, instructional or service activities funded, or proposed for funding, by an external sponsor; or any significant financial interest in an entity whose financial interest would reasonably appear to be affected by the research, instructional or service activities funded, or proposed for funding, by an external sponsor.

(2) Regardless of the above minimum requirements, a faculty or staff member, in his or her own best interest, is encouraged to disclose any other financial or related interest that could present an actual conflict of interest or be perceived to present a conflict of interest. Disclosure is a key factor in protecting one's reputation and career from potential embarrassing or harmful allegations of misconduct.

(D) Procedures.

(1) Special requirements/disclosures for PHS-funded research. Pursuant to public health service (PHS) regulations ( 42 CFR 50 ) institutions receiving funds from any PHS agency [PHS agencies include NIH, SAMHSA, OPHS, IHS, HRSA, FDA, CDC, AHRQ] or other agencies adopting PHS financial conflict or interest policies, must comply with the following requirements:

(a) Each investigator who is planning to participate in PHS-funded research is required to disclose to Kent state university officials the investigator's significant financial interests (and those of the investigator's spouse and dependent children) no later than the time of application for PHS-funded research. Each investigator must complete the appropriate certification process required by the university.

(b) Each investigator who is participating in PHS-funded research is required to complete an updated certification either within thirty days of discovering or acquiring a new significant financial interest, or at least on an annual basis during the period of the PHS funding award.

(c) Disclosure of all externally-funded travel reimbursements: PHS-funded investigators must disclose all travel reimbursements that are either sponsored by (that is paid by an outside entity directly to the investigator) or reimbursed directly to the investigator from an outside entity for travel that occurs after August 24, 2012, with some exceptions. Exception include: travel reimbursements from an institution of higher education, a federal/state/local government, an academic teaching hospital, a medical center, or a research institute affiliated with an institution of higher education. This disclosure requirement does not apply to funding provided to the investigator by the institution (for example as part of sponsored research projects, paid from departmental discretionary or gift funds). Travel reimbursements must be reported within thirty days of its occurrence.

(d) Mandatory training requirements: All PHS-funded investigators must complete online FCOI training provided by Kent state university prior to the expenditure of funds of any newly-funded projects, including noncompeting continuation awards. This applies to all PHS-sponsored research projects as of August 24, 2012. Training must be completed at least every four years. Online training is available for KSU personnel. Current PHS awards are not subject to these new requirements until the noncompeting continuation award. For these purposes, the term "investigator" includes the principal investigator (PI) and any other person (regardless of title or position) that the PI identifies as independently responsible for the design, conduct, or reporting of the research.

(2) Review by conflict of interest review committee. The vice president for research, or official designee, will conduct an initial review of all disclosure statements submitted to determine whether a financial conflict of interest (FCOI) exists and, if so, determine what actions should be taken by the university to manage, reduce, or eliminate the FCOI. If a determination is made that there may be a potential or actual FCOI, the investigator, in cooperation with his/her dean, chair or director, will develop and present to the vice president for research a plan to manage, reduce or eliminate any potential or actual FCOI presented by the disclosed significant financial interest.

(3) The proposed plan shall be referred to the university conflict of interest review committee (CIRC) which will advise the vice president for research. The CIRC shall contain, at a minimum, faculty members representing a cross section of academic disciplines. Committee members are appointed by the vice president for research.

(4) The CIRC shall review the plan and recommend it as presented, or suggest conditions or restrictions which may include the following:

(a) Modification of the research plan;

(b) Disqualification from participation in all or the portion of the funded research that would be affected by the significant financial interest;

(c) Divestiture of significant financial interests; or

(d) Severance of relationships that create conflicts.

(5) If the CIRC determines that imposing conditions or restrictions would be inequitable, or that the potential negative impacts that may arise from a significant financial interest are outweighed by interests of scientific progress, technology transfer, or public health and welfare, then the CIRC may recommend that the research go forward without imposing such conditions or restrictions.

(6) The plan, if approved by the vice president for research, will be incorporated into a memorandum of understanding that details the conditions or restrictions imposed upon the investigator in the conduct of the project and/or the relationship with the business enterprise or entity. The memorandum of understanding shall be signed by the investigator and the investigator's cognizant university official (usually a dean, chair or director) and the vice president for research. Actual or potential conflicts of interest must be satisfactorily managed, reduced, or eliminated in accordance with these guidelines prior to expenditure of any funds under the award. If actual or potential conflict cannot be satisfactorily managed, the sponsoring agency must be informed.

(7) Non-compliance. When an investigator is found to have violated this policy or the terms of the memorandum of understanding, the CIRC may recommend to the appropriate vice president that sanctions be imposed consistent with procedures established by university policy and/or an applicable collective bargaining agreement affecting the employee and his/her employment relationship with the university. Disciplinary action may range from a letter of reprimand to dismissal and termination of employment. If the violation results in a collateral proceeding under university policies regarding misconduct in science, the CIRC shall defer a decision on sanctions until the misconduct in science process is completed. In cases of violation, the vice president for Research will notify the appropriate funding agency.

(8) Reporting. The university will provide initial and ongoing reports of its management of FCOI to external sponsors of university research as required by law and in accordance with this policy.

(9) Records. Records relating to all investigator disclosures of significant financial interests and the university's review and management of such disclosures, will be maintained by the university in the case of externally-funded research for (a) three years from the date of submission of the final expenditures report (in the case of grants and cooperative agreements); or (b) three years from the final payment (in the case of research contracts), or (c) resolution of any government action involving the records, or (d) as otherwise required by law.

Replaces: 3342-3-07.1

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 03/21/1996, 06/01/2007, 8/22/2012, 3/1/2015

3342-10-05 University policy regarding faculty participation in companies commericalizing university research.

(A) Purpose. Faculty are encouraged to develop discoveries and inventions with commercial potential; however, they should do so with due regard to the broader teaching and research mission of the university. Faculty should not allow their interest in a financial opportunity arising out of their research efforts to influence their teaching or research, or to interfere with their relationships with other faculty. Specifically, research assignments for students must be selected solely on the basis of the students' interests and academic development. Faculty should respect and promote the cooperative nature of the academic environment by sharing information and participating in joint research efforts with their colleagues.

(B) Eligibility. This policy applies only to faculty who:

(1) create intellectual property owned by the university; and

(2) desire to hold an interest, whether vested or not, in a firm, corporation, or other association (hereinafter "company") to which the board of trustees has assigned, licensed, transferred, or sold the university's interests in discoveries or inventions made or created by that faculty or in patents issued to that faculty commercializing their research. This policy serves as exceptions to the Ohio ethics law and related statutes (Chapter 102. and sections 2921.42 and 2921.43 of the Revised Code), which might otherwise apply. Matters outside the scope of these rules will be subject to such laws to the extent applicable.

(C) Procedures and guidelines.

(1) Faculty responsibilities. While faculty are permitted by these rules to engage in specified private business activities relating to their institutional positions, they continue to be responsible for the performance of all their teaching, research and service obligations. Authorized private business activities must not be allowed to interfere with the performance of any of their institutional responsibilities and must be undertaken in accordance with university rule 3342-6-23 of the Administrative Code and pursuant to formal consulting and conflict of interest management plans between the faculty, company and Kent state university, which plan must be approved by the vice president for research and sponsored programs.

(2) Reporting business activities. Prior to requesting participation in the commercialization of university technology, private business activities that may relate to a faculty member's scope of employment shall be reported in writing to the vice president for research and sponsored programs.

(3) Determining applicability of guidelines. Decisions concerning the relationship between a faculty member's private business activities and his or her scope of employment shall be made by the vice president for research and sponsored programs. The faculty member may appeal the decision of the vice president for research and sponsored programs to the provost. The decision of the provost will be final.

(4) Activities not related to research. Private business activities that are not subject to these rules because they are unrelated to the faculty member's scope of employment may be subject to other institutional policies on outside enterprises (rule 3342-6-24 of the Administrative Code), conflicts of interest and commitment (rules 3342-3-01.6 and 3342-6-23 of the Administrative Code), and patents and copyrights (rule 3342-5-09.1 of the Administrative Code).

(5) Approval process. A faculty member who wishes to participate in the commercialization of technology must first obtain approval from his or her department chair or school director and academic dean as appropriate. The faculty member, in consultation with his/her academic dean, chair or director, shall develop and present to the vice president for research and sponsored programs, a plan to manage, reduce or eliminate conflict of interest or commitment arising out of the faculty member's business activity. The vice president for research and sponsored programs shall refer the proposed plan to the university patent and copyright board, which will advise the vice president for research and sponsored programs as to the acceptability of the plan. Faculty may not enter into any agreements relating to their proposed business activities until the plan has received final written approval from the vice president of research and sponsored programs.

(6) Responsibilities of academic deans, chairs and/or directors. Academic deans, department chairs and directors have the responsibility of ensuring that faculty participating in approved business activities continue to perform all of their teaching, research and service obligations. Academic deans, department chairs and directors are also responsible for enforcing the university rules 3342-3-07.1 and 3342-6-23 of the Administrative Code and for reviewing and making a recommendation as to the propriety of business activities reported by their faculty in written disclosures required by those policies.

(7) Annual review. Prior to the start of each academic year, the vice president for research and sponsored programs, in consultation with the academic dean, department chair or director will conduct an assessment of the employee performance under conflict of interest management plan.

(a) The academic dean, department chair or director will provide a written assessment of the employee's performance of their teaching, research and service obligations as outlined in the conflict of interest management plan.

(b) A review of the company's performance focused on the achievement of milestones set forth in the plan including but not limited to the reduction of management responsibilities for the employee, the dilution of employee equity interests, patents filed, etc., will be a part of the annual assessment.

(c) The vice president for research and sponsored programs shall consult with the patent and copyright board at its next regularly scheduled meeting for advice and counsel in the assessment of the performance of the faculty member to meet his/her obligations under the conflict of interest management plan.

(d) Failure to meet the goals outlined in the conflict of interest management plan will result in defined actions prescribed by the vice president for research and sponsored programs in consultation with the academic dean, department chair or director that may include but are not limited to revisions in the management plan, changes in the sponsored research or licensing agreements, or other remedies to ensure that faculty meet commitments to Kent state university.

(8) Agreements with start-up companies. A "start up" company is defined as a legal entity in the early stages of commercializing intellectual property or technology licensed by the university.

(a) Companies may not enter into any agreements with the university relating to the commercialization of a faculty member's research until final written approval from the vice president for research and sponsored programs is obtained.

(b) Faculty who wish to participate in a start-up company may discuss initial company formation matters with the vice president for research and sponsored programs; however, they should not participate in the ongoing negotiation of option and licensing terms between the company and vice president for research and sponsored programs.

(c) As soon as possible, third parties, such as company management and/or legal counsel should perform this function. A company wishing to obtain an exclusive license to the university technology may be required to provide the vice president for research and sponsored programs with a viable business plan including, at a minimum, the following:

(i) A capitalization plan addressing the acquisition of additional capital and the equity dilution of the faculty member's ownership interests;

(ii) A proposed management team; and

(iii) Milestones for capitalization, product development, and commercial sale.

(9) Use of university facilities. Institutional facilities, equipment and other resources may be used for research benefiting a company in which a faculty member has an interest only pursuant to a sponsored research agreement, facilities use agreement or other appropriate contractual arrangement in accordance with institutional policies.

(10) Management of start-up companies. Faculty for a limited period of time may hold management positions in start-up companies commercializing their research. While they may initially find it necessary to play a management role in a newly formed company, it is expected that their management responsibilities will decrease as the company develops. Professional management should be brought in at the earliest opportunity. Agreements between the university and faculty owned start-up companies will specify milestones for the reduction of these management responsibilities.

(11) Management positions in existing companies. A faculty member who acquires interest in a previously established company that contracts with the university to commercialize his or her research should not serve as a director, officer or employee of that company.

(12) Leave to pursue private business activities. Faculty should not allow their management activities with newly formed companies commercializing their research to consume a disproportionate amount of their professional attention. Faculty engaged in approved private business activities who are unable to perform all of their institutional responsibilities are encouraged to consider a full or partial leave of absence without pay. Professional improvement leave available under section 3345.28 of the Revised Code shall not be used for private business purposes.

(13) Student research within the university. Graduate and undergraduate students may use institutional facilities, equipment and other resources to perform research benefiting a company in which a faculty member has an interest only pursuant to a sponsored research agreement.

(14) Student employment with the company. Except as provided in paragraph (C)(15) of this rule, students may be employed by companies in which faculty members hold an interest. Prior to such employment, the student, the faculty member, the chair of the student's department, the chair of the graduate studies committee and a company representative must sign an agreement that clearly sets forth the roles, rights, and responsibilities of the respective relationships.

(15) Employment of students academically involved with faculty owners of the company. A student may not be employed by a company in which a faculty member has an interest if:

(a) The student is enrolled in a course taught by the faculty member;

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

(c) The faculty member is the student's advisor or the director of his or her thesis or dissertation research. Such students may perform research benefiting a faculty owned company only pursuant to a sponsored research agreement or formal internship agreement through the university.

(16) Contracts unrelated to technology development. Companies in which faculty hold an interest may enter into agreements with the university unrelated to research or technology development for the purchase, sale or rental of equipment, supplies, or services only to the extent not prohibited by Chapter 102. and sections 2921.42 and 2921.43 of the Revised Code.

(17) Investments by faculty 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.

(18) Regulatory review boards. Institutional regulatory review boards, including for example, institutional review board and animal care and use committee, may be utilized for research benefiting a company in which a faculty or staff member has an interest only pursuant to institutional policies.

(19) Limitation of equity ownership. While significant faculty equity ownership may be inherent in a newly formed company, it is expected that faculty ownership interests, as a percentage of the total outstanding shares or membership interests of the company, will decrease as the company develops and attracts additional equity.

(a) Agreements between the university and faculty owned start-up companies shall specify milestones for the dilution of these equity interests. In most cases, the faculty's ownership interest should decrease to no more than twenty-five per cent of the total equity in the company.

(b) Failure to comply with or renegotiate these agreed-upon milestones may result in a renegotiation or in the company's inability to engage in sponsored research, employ students and the other commercialization agreements and/or activities allowed for under this policy.

(20) Principal investigators. Faculty may assume the role of principal investigator in sponsored research projects funded by companies in which they have an interest only pursuant to rules 3342-3-07 and 3342-3-07.1 of the Administrative Code.

(21) Intellectual property. Faculty participating in start-up companies approved pursuant to these guidelines continue to be bound by all institutional policies on patents and copyrights. New inventions and/or discoveries made as a result of a faculty member's research efforts for the company must be disclosed in writing to the vice president for research and sponsored programs. New inventions and/or discoveries developed by the faculty for the company will be owned by the university, unless the patent and copyright board determines that the invention or discovery is wholly unrelated to the research and teaching responsibilities of the faculty member.

Replaces: 3342-3-08

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 3/14/2002, 9/19/2005, 6/1/2007, 3/1/2015

3342-10-05.1 Administrative policy regarding staff participation in companies commercializing institutional research.

(A) Purpose. Staff are encouraged to develop discoveries and inventions with commercial potential; however, they should do so with due regard to the broader teaching and research mission of the university. Staff should not allow their interest in a financial opportunity arising out of their research efforts to influence their teaching or research, or to interfere with the relationships with others in their department.

(B) Eligibility. University rules apply only to staff members and/or student employees who:

(1) Are specifically assigned to engage in research and development activities;

(2) Create intellectual property owned by the university; and

(3) Desire to hold an ownership interest in any firm, corporation, or other association to which the board of trustees has assigned, licensed, transferred, or sold the college or university's interests in discoveries or inventions made or created by that employee or in patents issued to that employee (hereinafter "company") commercializing their research.

(4) This policy serves as exceptions to the Ohio ethics law and related statutes (Chapter 102., sections 2921.42 and 2921.43 of the Revised Code), which might otherwise apply. Matters outside the scope of this chapter will be subject to such laws to the extent applicable.

(C) Responsibilities.

(1) Institutional responsibilities and personal financial interests. Staff members may pursue research projects as authorized by their supervisors. Supervisors must take extra care to monitor the entrepreneurial activities of their staff employees. They should authorize only those staff research projects that will advance the missions of the university and the employing unit, without regard to the financial interests of individual employees.

(2) Staff responsibilities. Staff members may not perform private business activities of any kind during institutional working hours. Staff who wish to perform activities for companies commercializing their institutional research shall do so on their own time. These activities must not interfere with the performance of any of the employee's institutional responsibilities and must be undertaken in accordance with rule 3342-6-23 of the Administrative Code and pursuant to a conflict of interest management plan between the staff member, company and university and approved by the vice provost and dean of research and graduate studies.

(3) Staff supervisors. Staff supervisors are responsible for ensuring that their employees participating in approved entrepreneurial activities continue to perform all of their institutional responsibilities. They are also responsible for enforcing rules 3342-03-07.1 and 3342-6-23 of the Administrative Code and for reviewing and making a recommendation as to the propriety of private business activities reported by staff in written disclosures required by that rule.

(D) Procedures and guidelines.

(1) Reporting business activities. Private business activities that may relate to a staff member's scope of employment shall be reported in writing to the vice president for research and sponsored programs.

(2) Determining applicability of guidelines. Decisions concerning the relationship between a staff member's private business activities and his or her scope of employment shall be made by the vice president for research and sponsored programs.

(3) Activities not related to research. Private business activities that are not subject to these rules because they are unrelated to a staff member's scope of employment are nevertheless subject to the policy on conflicts of interest and commitment, the policy on patents and copyrights and the rules of the employing unit.

(4) Approval process. Staff must obtain approval from the vice president for research and sponsored programs and a conflict of interest management plan must be in place before any business agreements related to their university research are finalized. Staff may not enter into any agreements relating to commercialization of their research until final written approval from the vice president for research and sponsored programs is obtained.

(5) Annual review. Each year on the anniversary of the agreement, the vice president for research and sponsored programs in consultation with the staff supervisor will conduct an assessment of the employee performance under conflict of interest management plan.

(a) The staff supervisor will provide a written assessment of the employee's performance as outlined in the conflict of interest management plan.

(b) A review of the company's performance focused on the achievement of milestones including but not limited to the reduction of management responsibilities for the employee, the dilution of employee equity interests, patents filed, etc., will be a part of the annual assessment.

(c) At the discretion of the vice president for research and sponsored programs, a staff advisory committee may be convened to provide advice and counsel to the vice provost to assist in the assessment of the performance of the staff member to meet his/her obligations under the conflict of management plan.

(d) Failure to meet the goals outlined in the conflict of interest management plan will result in defined actions prescribed by the vice president for research and dean of graduate studies in consultation with the staff supervisor that may include but are not limited to revisions in the management plan, changes in the sponsored research or licensing agreements, or other remedies that ensure the staff meets their commitments to Kent state university.

(6) Agreements with start-up companies. Companies may not execute any agreements relating to the commercialization of a staff member's research until final written approval from the vice president for research and sponsored programs is obtained. While they may find it necessary to do so initially, staff members should not participate in the ongoing negotiation of option and licensing terms between the company and the vice president for research and sponsored programs. When available, third parties, such as company management and/or legal counsel shall perform this function.

A company wishing to obtain an exclusive license to the university technology may be required to provide the vice president for research and sponsored programs with a viable business plan including, at a minimum, the following:

(a) A capitalization plan addressing the acquisition of additional capital and the equity dilution of the staff member's ownership interest;

(b) A proposed management team; and

(c) Milestones for capitalization, product development, and commercial sale.

(7) Use of university facilities. University facilities, equipment and other resources may be used to conduct research benefiting a company in which a staff member has an interest only pursuant to a sponsored research agreement, facilities use agreement or other appropriate contractual arrangement in accordance with rule 3342-3-08 of the Administrative Code and this rule.

(8) Management of start-up companies. Staff for a limited period of time may hold management positions in start-up companies commercializing their research. While they may initially find it necessary to play a management role in a newly formed company, it is expected that their management responsibilities will decrease as the company develops. Professional management should be brought in at the earliest opportunity. Agreements between the university and staff owned start-up companies should contain enforceable milestones for the reduction of these management responsibilities. Failure to comply with these agreed-upon milestones may result in the company's inability to engage in sponsored research, utilize student employees and the other commercialization agreements and/or activities allowed for under these guidelines.

(9) Management positions in existing companies. A staff member who acquires an interest in a previously established company that contracts with the university to commercialize his or her research should not serve as a director, officer or employee of that company.

(10) Leave to pursue private business activities. Staff who wish to perform management activities for newly formed companies commercializing their university research during university working hours may do so only if they take approved leave. Staff who are unable to perform all their institutional duties because of management responsibilities in their private companies are encouraged to consider a reduction of appointment or other approved leave mechanism.

(11) Student research within the university. Graduate and undergraduate students may use university facilities, equipment and other resources to perform research benefiting a company in which a staff member has an interest only pursuant to a sponsored research agreement.

(12) Student employment with the company. Companies in which staff members hold an interest may employ students. Prior to such employment, the student, the staff member, the chair of the student's department, the chair of the graduate studies committee and the company must sign an agreement that clearly sets forth the roles, rights and responsibilities of the respective relationships.

(13) Contracts unrelated to technology development. Companies in which staff hold an interest may enter into agreements with the university unrelated to research or technology development for the purchase, sale or rental of equipment, supplies or services only to the extent not prohibited by Chapter 102., and sections 2921.42 and 2921.43 of the Revised Code.

(14) Investments by staff not involved with development of the technology. Staff who are not directly involved with research and development of technology licensed to a faculty or staff owned start-up company may hold equity interests in that company only to the extent not prohibited by Chapter 102., and sections 2321.32 and 2921.43 of the Revised Code).

(15) Regulatory review boards. University regulatory review boards including, for example, IRBs and animal care and use committees, may be utilized for research benefiting a company in which a staff member has an interest only pursuant to university policies.

(16) Limitation of equity ownership. While significant staff equity ownership may be inherent in a newly formed company, it is expected that their ownership interest, as a percentage of the total outstanding shares or membership interests of the company, will decrease as the company develops and attracts additional equity.

(a) Agreements between the university and staff owned start-up companies should contain enforceable milestones for the dilution of these equity interests.

(b) In most cases, the staff's ownership interest should decrease to no more than twenty-five per cent of the total equity of the company.

(c) Failure to comply with these agreed upon milestones may result in the company's inability to engage in sponsored research, employ students and the other commercialization agreements and/or activities allowed for under this chapter.

(17) Principal investigators. Staff may assume the role of principal investigator in sponsored research projects funded by companies in which they have an interest only pursuant to university policies.

(18) Intellectual property. Staff participating in start up companies approved pursuant to these guidelines continue to be bound by the university policy on patents and copyrights. New inventions and/or discoveries made as a result of a staff member's research efforts for the company, must be disclosed in writing to the vice president for research and sponsored programs. New inventions and/or discoveries developed by the staff member for the company will be owned by the university, unless the invention or discovery is wholly unrelated to the research responsibilities of the staff member.

Replaces: 3342-3-08.1

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 07/16/2001, 9/19/2005, 6/1/2007, 3/1/2015

3342-10-06 University policy regarding patents.

(A) Preamble. According to the section 3345.14 the Revised Code, "All rights and interests in discoveries or inventions, including patents thereon, which result from research or investigation conducted in any experiment station, bureau, laboratory, or research facility of any state college or university shall be the sole property of such college or university." Thus, the university has the right to license, sell, or otherwise dispose of the rights to inventions in which the university has an interest. The board of trustees of the university will determine the final disposition of these rights.

(B) Purposes. Patents and licenses provide an appropriate means for developing and using inventions. This statement of policy has been adopted to ensure that those creative developments in which the university has an interest will be used in a manner most beneficial to the public interest. The purposes of the university patent policy are as follows:

(1) To promote the progress of the arts and sciences through research and scholarship and the professional development of the university's faculty, students, and staff;

(2) To make inventions resulting from the efforts of university faculty, students, and staff available to business and industry, as well as the general public after applying section 3345.14 of the Revised Code;

(3) To obtain revenue for the university for use in furthering its educational and research goals;

(4) To provide appropriate compensation in accordance with the university policy on distribution of license and royalty income, for university faculty, students, and staff who invent.

Replaces: 3342-5-09

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 2/8/1980, 4/5/1991, 5/29/1991, 9/2/1992, 6/1/2007, 3/1/2015

3342-10-06.1 Administrative policy regarding patents.

(A) Definitions. As used in this statement of policy, the following terms have the meaning indicated:

(1) Inventions. All discoveries, methods, uses, products or combinations whether or not patented or patentable at any time under the Federal Patent Act as now existing or hereafter amended or supplemented.

(2) University personnel. Part-time and full-time (paid or unpaid) faculty, staff, and student appointees of Kent state university.

(3) Inventor(s). University personnel who have developed inventions.

(4) Disclosure. A reporting of an invention or creation.

(5) University funds and facilities. Funds and facilities provided by governments, commercial, industrial or other public or private organizations which are administered and controlled by the university shall be considered to be funds and facilities provided by the university.

(B) Rights to inventions.

(1) Domestic and foreign rights to inventions developed by university personnel through their use of facilities or funds provided by the university shall vest in the university and be subject to the distribution of license and royalty income policy. Rights of university personnel in invention(s) are provided in subsequent sections of this statement of policy.

(2) The university may elect to waive ownership under this policy. If the university asserts ownership, but elects not to seek a patent or otherwise pursue commercial development for an invention to which it has vested rights, it will release its rights to such invention to the inventor subject to third party rights to such invention. These actions shall apply only where the inventor(s) has disclosed fully said invention under this policy.

(3) The rights of the university and its personnel to ownership and disposition of inventions are defined in terms of the following summarized categories:

(a) Sponsored work. Rights to inventions which are subject to the terms of a sponsored research agreement between the university and a third party are subject to the terms of the applicable agreement, or, in the absence of such terms, the rights to the inventions shall be vested in the university and be subject to the distribution of license and royalty income policy.

(b) Unsponsored work. Rights to inventions developed by university personnel in university research facilities, through research support provided by the university or with the use of research support facilities or services also shall be vested in the university and subject to the distribution of license and royalty income policy.

(C) Disclosure and disposition of inventions.

(1) Any invention shall be disclosed in confidence by the originator(s) by completing and filing an "Invention Disclosure Form" with the vice president for research and sponsored programs or designee. Such forms are available from the office of technology transfer.

(2) The originator(s) shall work closely with the division of research and sponsored programs and/or any organization to whom the university assigns rights to such inventions and creations in pursuing applications for patents as well as in the pursuit of licensing.

(3) The university has the sole right to license, sell, or otherwise dispose of the rights to inventions which are owned by or have been assigned to the university.

(4) The president, provost, or their designee, may request an audit and report on any university-sponsored or supported research program where patent or copyright issues are involved.

(D) Administration. Administration of this policy regarding patents is the duty of the president and the provost and their designees, who are charged with the execution of the policy and administrative procedures, as well as recommended changes for policy revisions.

(1) University patent and copyright board.

(a) Membership. To assist in the administration of the policy there shall be a university patent and copyright board consisting of ex officio members including the vice president for research and sponsored programs; the director of technology transfer; and the university counsel; four faculty members appointed by the provost; and such outside members with expertise in patent and licensing matters as deemed appropriate by the president or provost. The term of faculty members shall be four years. All members shall be voting members.

(b) Chairperson. The university patent and copyright board shall be chaired by the provost or designee.

(c) Duties. The duties of the university patent and copyright board are to advise on the application of this policy to the specific facts surrounding the development or discoveries and inventions, to recommend appropriate action to the provost, and to study and recommend suitable changes in the patent policy, as the need arises.

(2) Procedures.

(a) The vice president for research and sponsored programs shall establish appropriate procedures for the disclosure of possible discoveries and inventions and shall inform university personnel of such procedures through suitable means.

(b) Employees shall promptly notify the vice president for research and sponsored programs, or designee, of possible discoveries and inventions by filing an invention disclosure form.

(c) Upon the recommendation of the vice president for research and sponsored programs, the provost or designee shall convene the university patent and copyright board for consideration of invention disclosures and any other matters requiring consideration by the university patent and copyright board.

(d) The university patent and copyright board shall promptly consider all disclosures of inventions and creations and requests for a determination of rights and shall make the determinations required within a reasonable time.

(e) The university personnel involved shall be entitled to appear before the university patent and copyright board and present evidence with respect to the disclosure.

(f) The university patent and copyright board's determination shall be made in writing and shall contain a statement of its findings and grounds for decision. The university patent and copyright board may obtain legal and other advice necessary to perform its function.

(g) Actions of the patent and copyright board may be appealed in writing to the provost.

(E) Publication and publicity.

(1) To fulfill the university's obligation as a publicly assisted educational institution, university research should serve a public rather than a private purpose and the results should be broadly disseminated, where the same does not breach any confidentiality agreement to which the university is a party or violate any government law or rule requiring secrecy. The university encourages studies whose results can be freely published.

(2) The university recognizes that in some cases of industry sponsored applied research the legitimate proprietary concerns of private research sponsors and the effective commercialization of research outcomes may require limited delays in publication. Where appropriate, publications can be deferred for a negotiated period of time in order to protect patent rights. Similarly, on those occasions in which the university has accepted a sponsor's proprietary information as necessary background data for a research project, the sponsor may review proposed publications in order to identify any inadvertent disclosure of those specific data.

(3) Because of the potential for delay in publication, the involvement of graduate students in industry sponsored applied research will be governed by the appropriate policies of the graduate schools.

(4) The name of or reference to Kent state university shall not be used in any form of publicity by a sponsor without prior written approval from the university.

Replaces: 3342-5- 09.1

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 11/4/1977, 8/31/1979, 4/5/1991, 4/28/1992, 9/2/1992, 5/5/1995, 10/6/2000, 6/1/2007, 3/1/2015

3342-10-07 University policy regarding misconduct in research and scholarship.

(A) Purpose. One of the major responsibilities of faculty and staff at Kent state university is research and scholarship. Given the importance and influence of research on both the academic community and on society, the university faculty and administration want to assure that all scholarship and research is of the highest possible quality. It is the policy of the university to respond to allegations of misconduct in scholarly and research activities, and to do so with concern for all university processes which protect the rights of all parties involved.

(B) Policy. Although scholarly practices vary greatly, all are built upon a foundation of commonly accepted standards. When planning, proposing, and conducting research and scholarship, and disseminating the results thereof, the following standards shall apply:

(1) All members of the university community share a responsibility to adhere to standards of integrity in their scholarly work and to report fraudulent and other substantial acts of misconduct when they are known or are suspected to have occurred.

(2) Each unit engaged in scholarship and research has the responsibility to maintain an atmosphere that fosters integrity and to follow university procedures for dealing expeditiously and fairly with allegations of misconduct and fraud.

(3) All supervisors of research and scholarship have the responsibility to monitor carefully the activity being conducted under their supervision and to subject procedures and findings to rigorous evaluation.

(C) Scope. No university employee shall engage in misconduct or fraud in the performance of research and scholarly activities or in deviation from accepted standards and practices in any phase of such activities. This shall include violations of applicable federal and state laws and regulations as well as university rules, regulations, and policies.

Replaces: 3342-3-05

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 6/29/1989, 9/19/2005, 6/1/2007, 3/1/2015

3342-10-07.1 Administrative policy and procedures regarding allegations and instances of misconduct in research and scholarship.

(A) Purpose. Recognizing a responsibility for the proper and ethical conduct of research and scholarship by all its personnel, and further recognizing that allegations or instances of conduct inconsistent with accepted standards may occur, the university is committed to providing maximal opportunity for fairness and due process. Toward this end the procedures stated herein shall be applied when misconduct is alleged.

(B) Requirement. As a recipient of federal grants and contracts, particularly from the national science foundation (NSF) and the public health service (PHS), including the national institutes of health, the university is bound by regulations requiring that procedures be established for inquiry into and investigation of alleged or apparent misconduct in scientific activities conducted, funded, or regulated by these agencies. In order to establish a consistent and comprehensive procedure for the university, the procedures set forth below will apply to all instances of alleged or apparent misconduct in research, scholarly and creative activities regardless of funding or source.

(C) Definitions. The following key definitions apply to the implementation of the requirement in paragraph (B) of this rule.

(1) "Misconduct" is defined as deception, fabrication, falsification, plagiarism, or other serious deviation from accepted practices in proposing, carrying out, or reporting results from research and scholarship; material failure to comply with federal, state and/or university requirements for protection of researchers, human subjects, or the public, or for ensuring the welfare of laboratory animals; or failure to meet other material legal requirements governing research and scholarship.

(2) "Inquiry" is defined as information-gathering and preliminary fact-finding to determine whether an allegation or apparent instance of misconduct warrants an investigation, or other measure, such as referral to the faculty senate ethics committee when appropriate.

(3) "Investigation" is defined as a formal examination and evaluation of relevant facts to determine whether misconduct has taken place or, if misconduct has already been confirmed, to assess its extent and consequences or determine appropriate action. An investigation may be conducted simultaneously with an inquiry if circumstances warrant.

(D) Procedures.

(1) If a university employee is accused of misconduct in research or scholarship, the complaint shall be lodged by the accuser in writing with the chairperson/ director/dean of the accused's department/school. Any accusation of misconduct must be presented with what is perceived by the accuser as supporting evidence; the accused must have the opportunity to review any materials supportive of the complaint as soon as such accusations are made. Chairpersons and directors will immediately notify the research dean, the appropriate undergraduate and graduate dean(s), and the provost. Should the chairperson/director be the accused, the dean of the college will be the first point of contact and that dean will notify the research dean, the appropriate graduate dean, and the provost. Should an independent school or collegial dean be the accused, the first point of contact will be the dean for research and graduate studies.

(2) The research dean, (after appropriate consultation with the chairperson/ director/dean, and the faculty advisory committee) will select an inquiry committee of no less than three persons from among the tenured members of the faculty who have no direct interest in the case but who are otherwise closest in specialty to the area of work of the accused. The inquiry committee will be impanelled to discuss the seriousness of the charges and will be charged to conduct all procedures in the strictest confidence.

(3) Should the majority of the inquiry committee agree that serious misconduct in scholarly pursuits is clearly plausible, then the provost in consultation with the dean for research, and other appropriate members of the university community, shall inform the accused, shall alert appropriate granting agencies as to the possibility of irregularities and shall form an investigation committee from within, and if necessary and/or appropriate, from without the university to give considered opinion as to the gravity and validity of the accusations under consideration and, if appropriate, recommend sanctions. The investigating committee may, if it deems necessary, interview the accused and/or the accuser (separately). The accused and the accuser both have the right to appear before the investigating committee if either so desires. Utmost confidentiality is to be maintained during the investigation. The committee of investigation will consist of at least five full-time university employees of faculty or administrative rank, one of which will be the dean, research and graduate studies as convener; one of which will be a representative of the undergraduate and graduate dean(s) of the individual to whose activities the investigation applies; and at least two of which will be ordinarily chosen from the membership of or upon the recommendation of the university research council. Additional members will be appointed to provide scientific, legal, or other scholarly expertise required by the nature of the research or scholarship under investigation. The university may invite outside consultants or experts to participate in an investigation.

(E) Sanctions. Upon the completion of its deliberations and in accord with article V of the collective bargaining agreement, the investigating committee may recommend sanctions against the employee(s) found guilty of research misconduct.

(1) Recommendations of sanctions and a summary of its findings are to be made in writing by the investigating committee to the provost, with a copy provided to the faculty or staff member(s) to whom the recommended sanctions would apply.

(2) Possible sanctions recommended by the investigating committee may include:

(a) A letter of concern;

(b) Censure;

(c) Direction to the dean for research and graduate studies to:

(i) Terminate a research grant or contract involved in the misconduct;

(ii) Withdraw research grant or contract proposals connected with the research misconduct;

(iii) Suspend academic year or summer research/creative activity appointments to the faculty member;

(iv) Deny, permanently or temporarily, access to the services and facilities of the office of research and graduate studies;

(v) Deny, permanently or temporarily, access to the university computing facilities, the university library, and similar research tools;

(vi) Deny access for the purposes of university approved research to human subjects or laboratory animals;

(vii) Notify appropriate federal, state and local agencies;

(viii) Notify journal editors, book publishers, etc., as appropriate and necessary.

(d) Direction to the dean of the appropriate graduate school to conduct an immediate review of the faculty member's graduate faculty status;

(e) Direction to the dean of the appropriate collegial/independent school/campus unit to:

(i) Place the employee(s) on appropriate probation;

(ii) Reduce pay and/or benefits;

(iii) Suspend the employee(s):

(iv) Initiate termination of employment.

(3) If adopted, all of these recommended sanctions are to be carried out in accord with article V sanctions for cause, of the current collective bargaining agreement between the university and the local chapter of the American association of university professors and the appropriate paragraphs of this policy register and the Administrative Code.

(F) Appeals. Subjects of investigation who are found guilty of research misconduct may appeal the findings of the committee of investigation to the provost within ten working days of receipt of the decision and recommendations of the investigation. Upon completion of the appeals proceedings, the dean, research and graduate studies will report the final results to any relevant agency and the provost will take final action in the case, as appropriate.

(G) Reports. Upon completion of the investigation and appeal, if any, a report of findings and actions taken will be distributed to committee members, relevant administrators, and the parties involved. Further distribution will be made if needed to preserve the reputation of the person(s) alleged against.

Replaces: 3342-3-05.1

Effective: 10/15/2016
Promulgated Under: 111.15
Statutory Authority: 3341.04
Rule Amplifies: 3341.01, 3341.04
Prior Effective Dates: 6/29/1989, 5/5/1995, 5/28/1997, 2/27/1998, 6/1/2007, 3/1/2015