Chapter 3341-7 Research

3341-7-01 Conflict of interest in sponsored programs and research.

(A) Policy statement and purpose

It is the purpose of this policy to set forth the principles for identifying potential for conflicts of interest and the assurance that they do not improperly affect university activities and the procedures for reviewing and addressing potential conflicts that occur.

(B) Policy

Bowling Green state university actively encourages and participates in interaction with both the public and private sectors as an important component of its research, education, and public service activities. The university encourages the recruitment, retention, and recognition of individuals with creative abilities who can contribute to technology transfer and interactions with external entities (both private and public) consistent with their primary commitment to the university. For the purpose of this policy, external entity means any corporation, partnership, sole proprietorship, firm, franchise, association, organization, holding company, joint-stock company, receivership, business or real estate trust, or any other non-governmental legal entity organized for profit, not-for-profit, or charitable purposes. Employees involved in such interactions may receive personal financial compensation in accordance with the principles and guidelines provided in this policy. Activities supported by grants and contracts from public and private entities provide a valuable source of funds and equipment for the university. Professional interactions, including consulting arrangements, between employees and public entities and private businesses advance the university's ability to provide a high quality research and educational experience for students and enhance employment opportunities for students. University licensing of technology, employee's consulting, assisting in new business start-ups, and other forms of technology transfer to both public and private entities are critical to meeting society's needs. The university is committed to fostering the welfare of the state of Ohio through interaction by the university with other public and private entities.

At the same time, the university and its employees are committed to conducting themselves and university activities in accordance with the highest standards of integrity and ethics. This includes the identification of the potential for conflicts of interest and the assurance that they do not improperly affect university activities. It is the purpose of this policy to set forth the principles for identifying such potential for conflicts and the procedures for reviewing and addressing potential conflicts that occur.

(1) A conflict of interest occurs when an employee compromises his/her professional judgment in carrying out university teaching, research, outreach, or public service activities because of an external relationship that directly or indirectly affects the significant financial interest of the employee, an immediate family member, or any associated entity. University employees are free to have financial interests in private companies. Modest holdings do not fall under the purview of this policy. Nevertheless, there is the potential for a conflict of interest when an employee, an immediate member, or an associated entity has a significant financial interest in a business. Thus, it is imperative that such interests be disclosed and, if necessary, appropriate steps taken to insure that the employee's professional judgment is not compromised.

A financial interest is an interest in an external entity consisting of: any stock, stock option, or similar ownership interest in such business, but excluding any interest arising solely by reason of investment in such business by a mutual, pension, or other institutional investment fund over which the employee does not exercise control; or receipt of, or the right or expectation to receive, any income from an external entity whether in the form of a fee (e.g., consulting), salary, allowance, forbearance, forgiveness, interest in real or personal property, dividend, royalty derived from the licensing of technology or other processes or products, rent, capital gain, real or personal property, or any other form of compensation, or any combination thereof. For the purposes of this policy, a financial interest is significant, and thus disclosure is required, when the interest in a business by an employee or by an immediate family member exceeds five thousand dollars in annual income of all types, or when there is any equity or ownership. Disclosure is also required when an extended family member holds a financial interest valued at ten per cent or more in an external entity.

There is also the potential for a conflict of interest when an employee, or any family member, serves on the board of directors or the advisory board of a business, or holds an executive position in a business. This does not mean that direct involvement in a company is necessarily precluded. Indeed, such involvement can be of important benefit to the research/instructional mission of the university by providing students with experience at the academic/industrial interface. But service on boards or in executive positions does create the potential for a conflict of interest. Thus, it is imperative that service in these capacities be disclosed and, if necessary, appropriate steps taken to insure that the employee's professional judgment is not compromised.

The potential for conflicts arises because of the nature and scope of employee's activities and responsibilities. The university assumes that potential for conflicts may occur in the normal conduct of activities. However, it is essential that the potential for conflicts be disclosed and reviewed by the university. After disclosure, the university can then make an informed judgment about a particular case and require appropriate oversight, limitations, or prohibitions on the activity in accordance with this policy.

Employees are encouraged to participate in technology transfer activities and other interactions with external entities. Such activities, referred to in this document as external relationships, may have the potential for conflicts of interest. This policy is predicated on the belief that disclosure of potential conflicts of interest itself will effectively address the vast majority of cases. In those few cases in which measures need to be taken to effectively manage potential conflicts of interest, the goal is to insure that the employee's professional judgment is not compromised while maintaining the benefits that result from entrepreneurial activities and external relationships.

(a) Significant combinations of activities and external relationships

The potential for a conflict of interest arises when certain behaviors on the part of the employee occur and are coupled to the existence of certain external relationships. Some combinations are assumed to not have potential for a conflict of interest. Other combinations represent sufficient potential for conflict of interest that they require review and prior approval by the university before the employee can engage in the activity.

The following is a representative, though not inclusive, list of activities and external relationships covered by this policy. The categories are general guidelines, and application of appropriate review and oversight will always be in accordance with maintaining the full integrity or reputation of the university and its employees within the context of academic freedom.

Any combination of activity and external relationship not specifically represented in paragraph (B) (1) and paragraph (B) (2) of this policy and that an employee reasonably believes constitutes a potential conflict of interest must be discussed with the vice president for research & economic development in order to determine whether or not it falls under the provisions of this policy.

(b) Category I-relationships that do not involve a conflict of interest. The following are not considered conflicts of interest and do not require disclosure. They are appropriate, if they are consistent with other policies of the university including the patent policy and copyright policy.

(i) An employee receiving royalties and honoraria for published scholarly works, occasional lectures, and other writings or creative works if less than five thousand dollars aggregate over the previous twelve months from a single entity.

(ii) An employee receiving honoraria for serving as a special reviewer or serving on review panels for academic or governmental entities.

(iii) An employee receiving royalties under the university's royalty-sharing policies, or another academic institution's royalty-sharing policies if less than five thousand dollars aggregate over the previous twelve months from a single entity.

(c) Category II-combinations of activities and external relationships that have the potential for conflict of interest. The following combinations range from those that are considered to have minimal to moderate potential for conflict of interest to those that have a moderate to high potential for conflict of interest. The activities in section A are ordinarily appropriate following disclosure and, where necessary, the implementation of oversight or other management procedures. The activities and external relationships listed in paragraph (B) of this policy equire case-by-case review and only some of the specific relationships may be approved. Special oversight or management procedures are likely to be required.

(d) Section A-combinations of activities and external relationships in which there is a minimal to moderate potential for conflict of interest

(i) An employee participating in research on a technology, process, or product developed in whole or in part by that employee in which the employee, a member of his/her immediate family, or an associated entity is entitled to receive royalties from an existing agreement with an external entity under the university's or another academic institution's royalty-sharing policies, but has no other financial interests in the project.

(ii) An employee assigning students, postdoctoral fellows, or other trainees to research projects in which the employee, a member of his/her immediate family, or an associated entity is entitled to receive royalties from an existing agreement with an external entity under the university's or another academic institution's royalty-sharing policies, but has no other financial interests in the project.

(iii) An employee assigning students or other trainees to instructional projects, for example, design projects, for an external entity in which the employee, a member of his/her immediate family, or an associated entity has a significant financial interest.

(iv) An employee receiving reimbursed or sponsored travel related to their institutional responsibilities from an external entity. Excluded is travel that is reimbursed or sponsored by a federal, state, or local government agency, and institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education.

(e) Section B-combinations of activities and external relationships in which there is a moderate to high potential for conflict of interest

(i) An employee participating in clinical trials or evaluation or development of a technology, process, or product owned or controlled by an external entity in which the employee, a member of his/her family, or an associated entity has a significant financial interest.

(ii) An employee assigning students, postdoctoral fellows, or other trainees to projects supported by an external entity in which the employee, a member of his/her family, or an associated entity has a significant financial interest, other than royalty income or the entitlement to future royalty income under university royalty-sharing policies.

(iii) An employee receiving university-supervised sponsored project support (whether in dollars or in kind) for research from an external entity in which he/she, a member of his/her family, or an associated entity has a significant financial interest, other than royalty income or the entitlement to future royalty income under university royalty-sharing policies.

(iv) An employee receiving sponsored project support from an external entity in which the employee or a member of his/her family serves on the board of directors or advisory board.

(v) An employee holding an executive position in an external entity engaged in commercial or research activities directly related to his/her university responsibilities.

(vi) An employee taking administrative action on behalf of the university with respect to the university or any university-affiliated organization that is beneficial to in which he/she, a member of his/her family, or an associated entity has a significant financial interest.

(vii) An employee taking administrative action on behalf of the university with respect to any supported research activity (a sponsored project) for an external entity in which the employee, a member of his/her family, or an associated entity has a significant financial interest in the sponsor or donor.

(viii) An employee while acting in the context of his/her university duties making professional referrals to an external entity in which he/she, a member of his/her family, or an associated entity has a significant financial interest of which the employee is aware or reasonably should be aware.

(2) Disclosure requirements and responsibilities

Disclosure of significant financial interests and other external relationships falling under this policy is intended to protect the integrity of the design, conduct, and reporting of project activities by effectively managing, reducing, or eliminating those significant financial interests which cause or appear to cause a conflict of interest on the part of an investigator. Disclosure is accomplished by submitting a conflict of interest (COI) disclosure form. This form indicates either that the employee is not involved in any activities that have the potential for conflict of interest as defined by category II of this policy or that such potential does in fact exist. In the latter case, a description of the potential conflict of interest must also be provided. For the purposes of this policy, disclosure is required when the interest in a business by an employee or by an immediate family member exceeds five thousand dollars in annual income of all types, or when there is any equity or ownership interest; or when an employee or a member of his/her family has an executive position in a business or serves on a board of directors or advisory board; when an extended family member holds an executive position in a business, or holds equity or ownership interest valued at ten per cent or more in a business.

(a) Disclosure at the time of submitting a proposal for a sponsored project

All principal investigators (PIs) and co-PIs must disclose significant financial interests and other external relationships falling under this policy at the time of their application for external sponsored project support or technology transfer. It is also the responsibility of all PIs and co-PIs to inform and explain the provisions of this policy to all persons employed on a sponsored project, and to report any potential conflicts (relationships falling under category II of this policy) to the director of sponsored programs and research. Funding for the project will not be accessible to the employee until the disclosure of financial interests is reviewed and approval is given, and other appropriate measures have been implemented in accordance with this policy. In the case of multi-year applications that receive funding, employees must update the disclosure annually.

(b) Disclosure when involved with technology transfer

When employees are involved with transferring technology through patents or copyrights covered by the copyright policy, or licensing to a business in which the employee has a significant financial interest, or other external relationships covered by this policy, the employee must disclose the financial interest to the vice president for research & economic development. For disclosure when an employee is involved with review or advisory activities: All employees must temporarily excuse themselves from any university committee or review process that is considering an activity in which they have a significant financial interest or other external relationships covered by this policy.

(c) Disclosure to external entities

Employees must disclose relevant significant financial interests or other external relationships covered by this policy to sponsors of projects and in reporting by either written or oral communication project results. Disclosure must also be made by any employee who makes an appearance, either in person or by way of a written communication, before any public body, commission, group, or individual, to present facts or to give an opinion respecting any issue or matter under consideration, discussion, or action.

(i) Prior to engaging in sponsored research and at least every four years, and immediately under the following circumstances:

(a) University financial conflict of interest policies change in a manner that affects investigator requirements

(b) An investigator is new to the university

(c) The university finds that an Investigator is not in compliance with the university's financial conflict of interest policy or management plan.

(3) Review of potential conflict of interest

The general purpose of the review process is to assist employees and the university in avoiding or controlling risks to integrity and reputation engendered by external relationships, while at the same time protecting and furthering the interests of employees, the university, and society in the activities supported by consulting, technology transfer and sponsored projects.

(a) Technology transfer

All patent disclosures, copyright requests covered by the copyright policy, or efforts to license a product owned by the university to an external entity in which the employee has a financial interest, must be accompanied by a completed conflict of interest (COI) disclosure form when submitted to the vice president for research & economic development. This form indicates either that the employee is not involved in any activities that have the potential for conflict of interest as defined by category II of this policy or that such potential exists. In the latter case, a description of the potential conflict of interest must also be provided. If the vice president for research & economic development determines that a potential for conflict exists, the matter shall be handled in accordance for the provisions for the review of sponsored projects presented in this policy

(b) Sponsored projects

All proposals for external support must be accompanied by a completed conflict of interest (COI) disclosure form. The director of the office of sponsored programs and research shall review the COI disclosure form. If the form does not indicate any potential for conflict of interest as defined by category II of this policy, and there is no other evidence of a potential conflict of interest, then the director shall process the proposal in accordance with university procedures. If the director determines that a potential for conflict of interest as defined by category II of this policy exists, the vice president for research and economic development shall be notified immediately.

(c) Review process

The vice president for research and economic development (or his/her designee) shall consult with the employee's contracting officer (in most cases this will be the dean of the college). Together they shall review the disclosure, consult with the employee, and seek any additional information needed to determine whether the potential conflict of interest is of such a nature that it warrants institutional restrictions designed to manage, reduce, or eliminate the potential for conflict of interest. Either of their own accord, or upon the request of the employee, the vice president for research and economic development and the contracting officer may establish an acfnoc committee to review the situation and recommend a course of action.

Examples of the conditions or restrictions that might be imposed include:

(i) Public disclosure of the financial interest;

(ii) Monitoring of the project by independent reviewers;

(iii) Modification of the project plan;

(iv) Disqualification of the investigator from participation in all or a portion of the project;

(v) Withdrawal of the proposal or declination of an award;

(vi) Divestiture of the financial interest;

(vii) Severance of the relationship(s) that create actual or potential conflicts; or

(viii) Notification to the sponsor that the financial interest exists.

If the employee, contracting officer and vice president for research and economic development are unable to agree on a mutually acceptable method for managing, reducing, or eliminating the potential conflict of interest, then the vice president for research and economic development shall refer the case to the vice president for academic affairs for a final determination.

Employees engaged in multi-year sponsored projects shall update the COI disclosure form at least annually to the director of the office of sponsored programs and research. If an employee acquires a new potential for conflict of interest as defined by category II of this policy, the employee shall submit a revised or new COI disclosure form to the director of the office of sponsored programs and research within thirty working days after acquisition. When a conflict of interest is disclosed by an employee at the time of an application, the vice president for research & economic development shall review, consult with the employee, seek any additional information needed, document the result in writing, and disclose the existence of the conflict and the plan for mitigating the conflict to the sponsoring entity as may be required, before accepting an award or the expenditure of funds.

When a conflict of interest is discovered or disclosed post-award, and for identification for an Investigator who is newly participating in a project, within sixty days of discovery/disclosure the vice president for research & economic development shall review, consult with the employee, seek any additional information needed, document the result in writing, and disclose the existence of the conflict and the plan for mitigating the conflict to the sponsoring entity.

Additionally for conflicts of interest discovered, not previously disclosed, or not reviewed post-award, with the exception of an Investigator who is newly participating in a project, a retrospective review shall occur within one hundred twenty days of the discovery or disclosure for non-compliance, and documentation required by 42 CFR Section 50.605 shall be gathered and reported as applicable.

All records pertaining to conflicts of interest for sponsored projects shall be retained by the office of sponsored programs and research and the vice president for research and economic development for a minimum of three years after the submission of a final expenditure report (FER). Records for proposals which are not funded by sponsoring agencies will be retained for a period of at least one year after the decision of the sponsoring agency. All records shall be retained in a manner to protect confidentiality as allowed by law.

(4) Compliance

The university expects employees to comply fully and promptly with all the requirements of this policy. Breaches of this policy are considered forms of research misconduct and will be handled in accordance with the provisions of the research misconduct policy. Breaches include, but are not limited to, failure to file, intentionally filing an incomplete, erroneous, or misleading disclosure form, or failing to provide additional information as required by the approving authority. The potential sanctions may include, but are not limited to, the following:

(a) Letter of admonition;

(b) Ineligibility of the employee for grant applications, institutional review board (IRB) approval, or supervision of graduate students;

(c) Suspension;

(d) Nonrenewal of appointment; and

(e) Dismissal

Date: November 1st, 2013

Effective: 3/20/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-02 Copyright.

(A) Policy statement and purpose

The purposes of this copyright policy are to: identify the proprietary rights of personnel and of the university in respect to copyrightable materials; establish procedures for clarifying and negotiating proprietary rights when those of the university intersect with those of its personnel; establish procedures for licensing use of university copyrighted materials; and establish an income distribution schedule for royalties resulting from licensing agreements or other marketing arrangements for university copyrighted materials.

(B) Policy definitions

(1) Written materials - all literary, dramatic, musical materials or works, all pantomimes, and choreographic works, pictorial, graphic, and sculptural works, and all other materials or works including computer programs published or unpublished, copyrighted or copyrightable at any time under the federal copyright act as now existing or hereafter amended or supplemented.

(2) Literary materials-works expressed in words, numbers, or other verbal or numerical symbols or indicia, regardless of the nature of the material object, such as books, periodicals, manuscripts, phone records, film, tape, disks, or cards in which they are embodied.

(3) Recorded materials-all sound recordings, visual, audio-visual, and television films, tapes, or disks, video tapes, kinescopes, computer tapes or disks containing electromagnetic representations of written materials or computer programs.

(4) Works-written or recorded materials.

(5) Publication-distribution of copies or recordings of a work to the public by sale or other transfer of ownership, or by rental, lease or lending.

(6) University personnely part-time and full-time members of the faculty, administrative staff, classified staff, all students, postdoctoral fellows; and any other employees or consultants to the University or persons being trained in university sponsored programs.

(7) Work for hire-work created under the circumstances set forth in Section 101 of The Copyright Act of 1976.

(8) Substantial assistance-University salary, above and beyond the academic year or contract year salary; assignment of university-salaried staff other than author(s) or creator(s) to creation or production of the materials above and beyond clerical assistance; or use of university facilities and equipment in creation or production of the materials above and beyond use of assigned office space, libraries, personal use of computing resources, and word processing equipment. Faculty improvement leave with pay does not constitute substantial assistance in the creation of material subject to copyright.

(C) Policy

The university encourages and supports the creation, development, expression and publication of written and recorded materials by university faculty, staff and students. Such activity furthers the broad university goals of excellence in knowledge creation, communication, and dissemination. Publication, a common means for communication and dissemination, is also a common indicator of scholarly productivity and quality because publication per se is often preceded by external evaluation of the quality and significance of the work. Therefore, publication is an important activity for the university to encourage and support, both because of its scholarly significance and its role in the communication of knowledge.

An important corollary of publication is copyrighting, which secures for a limited time an exclusive right of ownership to authors or creators for their work.

Owners of copyrighted material may transfer or grant license to use their protected work usually in return for some fee or other benefit. Thus, copyrighting protects these proprietary and financial interests while encouraging publication. Many works developed for publication by university authors or creators are undertaken at their own initiative. The university clearly recognizes the longstanding norms of academic freedom and legal tradition that university personnel through their own initiative may prepare materials that may be copyrighted by and generate income for the author(s) or creator(s). The university has no interest in restricting the ability of its personnel to produce copyrightable materials and to receive royalties therefrom.

The university does recognize however, a proprietary interest in some materials prepared with its support, by its personnel or under its auspices for which copyrights are requested. University support of the scholarly activities leading to creation, development, expression, and publication of written or recorded materials takes many forms, including: clerical and research assistance; supplies, equipment, and use of university facilities and services; specifically assigned time for the work; graphics and computer services.

Therefore, the purposes of this copyright policy are to: identify the proprietary rights of personnel and of the university in respect to copyrightable materials; establish procedures for clarifying and negotiating proprietary rights when those of the university intersect with those of its personnel; establish procedures for licensing use of university copyrighted materials; and establish an income distribution schedule for royalties resulting from licensing agreements or other marketing arrangements for university copyrighted materials.

(1) Publication rights of university personnel

The policy of the university with regard to copyrighted materials is intended to foster and support the traditional freedoms of the university's faculty, staff, and students in matters of publication. It is also intended to ensure that the university's legitimate ownership interests in certain classes of materials are adequately protected and that commercial development is conducted in a manner consistent with the university's public mission.

The ownership of materials initiated and produced by authors who are university staff members shall remain with the authors, except for the classes of works identified below. This policy follows the principle that ownership of copyright generally vests in the author(s) or creator(s) of the copyrighted work. When ownership vests in the author or creator, she/he is entitled to all rights and privileges associated with commercial development of the work including (but not limited to) copyrighting the work, registering the copyright, licensing the use of the work, publishing, marketing, paying fees and expenses associated therewith, and receiving royalties therefrom.

(2) Principles of university ownership

There are, however, exceptions to the "author/creator as owner" principle. These arise in cases of "works for hire," works substantially assisted by the university, works done under a sponsorship agreement between the university and an external agency, and works contributed to the university. The university desires to publish, copyright, and license the use of only those materials which fall into one of these categories and have a potential for royalty return. The potential for royalty return indicates that there is economic value to their dissemination requiring copyright protection. Other university-owned materials should be placed in the public domain by publishing them with copyright protection and a corollary permission clause allowing general "not for profit" use. Thus, the principle of author or creator as owner applies to all but the following categories of copyrightable materials or works.

(a) "Works for hire."

Copyrightable materials produced by university employees as the result of direct work assignments to meet specific objectives or as an assigned university duty other than general academic research and normal teaching assignments are "works for hire" for which the copyrights belong to the university. Such materials are usually not initiated by the author, although they may result from performance of a general assigned duty (e.g., a staff member may prepare a manual, instructional materials, or computer programs as a general assignment of his/her job). Such materials also include works commissioned by the university which fit within any of the categories of "specially ordered or commissioned" works enumerated in Section 101(2) of The Copyright Act of 1976. The university supports the primary cost of the work and all income derived from the work accrues to the university, to be shared.

(b) Works substantially assisted by the university

There are some instances in which copyrighted materials are substantially assisted by university support, such as (but not limited to): salary awards above and beyond the normal academic year salary; other staff salaries and effort; use of facilities and equipment; university computing and graphic services. Where such assistance goes beyond the author's academic year salary, use of office space, personal use of library and computing resources, or use of word processing equipment and clerical assistance, resulting in additional costs to the university, then the work was created with the substantial assistance of the university. It is correspondingly reasonable to review the rights to ownership and equities for that work in consideration of the magnitude and importance of university assistance in its creation.

Therefore, for works that are created with substantial university assistance, the rights and equities of ownership shall be negotiated and agreed upon in writing by the author(s) or creator(s) of the work and the vice president for research and economic development prior to release of university copyright privileges. It is desirable in most cases to negotiate agreements prior to the commitment of the university assistance for the work. The university may agree to: assign all rights of ownership to the author or creator; assign joint ownership rights, sharing in all income derived from the work; negotiate a royalty-free non-exclusive license to reproduce and use the work for university activities in return for sole ownership by the author or creator; negotiate a value of the university's assistance and receive payment of no more than fifty per cent of royalties accruing to the author or creator up to the value of the university assistance, in return for sole ownership by the author or creator; or any combination of the above that adequately reflects the university's level of support. Whatever arrangement is negotiated, the author or creator shall acknowledge in writing in the work the support of Bowling Green state university in producing the work.

The vice president for research and economic development shall utilize the assistance of the copyright advisory committee in negotiating the ownership rights and equity. If no arrangement can be mutually agreed

upon, the copyright advisory committee and the vice president for research and economic development shall make independent recommendations regarding ownership and equity to the/resident who shall assign the rights of ownership and equity and whose decision will be final.

(c) Externally sponsored works.

The ownership of copyrightable materials prepared either wholly or partially with the support of grants or contracts from an external agency shall be determined according to the terms and conditions of the applicable grants or contracts. Where the applicable grant or contract is silent on rights to and income from copyrightable materials or where the agency has no policy pertaining thereto, rights to ownership shall be determined as if the materials were "substantially assisted by the university."

(d) Works contributed to the university.

University personnel may choose to contribute copyrightable materials to the university and thereby assign all rights of ownership to the university. The university may choose to accept or not to accept such works for university ownership. In accepting such works for university ownership, the vice president for research and economic development may negotiate a limited license for personal use by the author or creator as well as a share of any royalties earned by the university from commercial development in return for contribution of the copyrightable work. Nothing in this paragraph shall be construed to be contrary to the policies of Bowling Green state university publications in regard to ownership rights or equities.

(e) Student works

Unless subject to the provisions within this policy, copyrightable works prepared by students as part of the requirements for a degree program are deemed to be the property of the student, but are subject to the following provision. The university shall have, as a condition of the degree award, a non-exclusive royalty-free right to retain and use a limited number of copies of the copyrightable work and the right to secure its publication for archival use.

(f) Responsibilities and administration

(i) The vice president for research and economic development shall be responsible for promoting general awareness of this policy by university personnel and for answering any specific questions having to do with its terms or implementation.

(ii) University personnel agree to abide by this policy and by procedures for its implementation as a condition of their employment.

(iii) The vice president for research and economic development shall appoint a copyright advisory committee consisting of three members of the faculty, one administrative staff member, and one classified staff member for terms of three years. Initial appointments shall be for staggered terms to avoid disruptive member changes every third year. The committee shall meet at least once a year.

(iv) The vice president for research and economic development shall develop and approve agreements about and assignments of copyright to authors or creators, to the university, or to both, in regard to works which are produced with substantial university assistance.

(v) The vice president for research and economic development shall provide assistance in securing the^ copyright to any works in which the university has proprietary rights and equity.

(vi) The vice president for research and economic development shall provide assistance in licensing or distributing any copyrightable works in which the university shares rights and equities with the author or creator or external sponsor.

(vii) The vice president for research and economic development shall establish appropriate accounts and" procedures for receiving and distributing income accruing to the university as the result of licenses to use copyrighted works in which the university has proprietary rights and equities or for which there are other agreements assigning income to the university.

(g) Distribution of income

Net income accruing to the university from the commercial licensing or development of wholly university-owned copyrights resulting from works for hire shall be distributed as follows:

Thirty-three per cent to the author(s) or creator(s), with the balance sixty-seven per cent to the university. Net income is gross income less expenses for copyright registration, marketing, or other requirements for use and sale of materials outside the university.

Although this is the norm for university copyright agreements, the distribution formula is subject to negotiation for works substantially assisted by the university, externally sponsored works, and works contributed to the university. The distribution formula in these instances should reflect the level of university support or assistance.

Date: November 1st, 2013

Effective: 3/20/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-03 Patent policy.

(A) Policy statement purpose

The purpose of this policy is to establish the rights and procedures for all discoveries or inventions, including patents resulting from any research or investigation conducted in whole or in part in any laboratory or facility of Bowling Green state university.

(B) Policy

(1) Pursuant to section 3345.14 of the Revised Code and as a condition of university employment, all right, title and interest in discoveries or inventions, including patents thereon resulting from any research or investigation conducted in whole or in part in any laboratory or facility of the Bowling Green state university, (BGSU) shall be the sole and exclusive property of BGSU. Assignments or waivers of such rights, titles, and interests may be made by BGSU to external sponsoring agencies or others, as provided in subsequent clauses of this policy.

(2) Promptly upon the conception of a potentially patentable invention or discovery and before either filing for patent or reducing the invention or discovery to practice, the inventor shall disclose to BGSU such invention or discovery and shall assign, in writing, all rights to the invention or discovery to BGSU. Such disclosure shall contain a general description of the field of the invention or discovery, a specific disclosure of the invention or discovery, any prior part of which the inventor(s) is aware, a general statement (if possible) of the economics of the invention or discovery, a listing of the notebooks or other records containing the first description of the invention or discovery, the name of the person to whom the invention or discovery was first disclosed, and the date of such disclosure. Such disclosure shall also contain an election as to the method for payment of patenting and/or licensing and related costs and schedule of distribution of net income received as provided in subsequent clauses of this policy.

(3) All information which may reasonably be related to inventions or discoveries shall be held confidential by the inventor and shall be disclosed only to BGSU or others directed by the officers and agents of BGSU.

(4) All information as described in paragraph above shall be maintained in confidence unless such information is, or becomes, publicly available through no fault to the inventor or unless written permission is obtained from an authorized officer or agent of BGSU to disclose such information.

(5) Whenever requested by BGSU, the inventor shall make, sign, execute, and deliver all applications, assignments, and other papers which, in the opinion of BGSU or its counsel, are deemed necessary, proper, or desirable for obtaining letters patent of the United States and any other countries, and for transferring all such discoveries, inventions, improvements, patentable ideas, methods, processes, trade secrets, and letters patent and applications therefore to BGSU, its successors, and assigns.

(6) Royalty distributions shall be made in accordance with article 25, section 4.9 of the collective bargaining agreement.

(7) Net income from any invention or discovery shall consist of earnings received by BGSU from the invention or discovery after payment of all costs incurred by the BGSU or the inventor(s) as applicable in connection with the invention or discovery and beginning at the moment of invention. Such costs shall include the cost of pursuing patent protection, and developing, marketing, and licensing the invention.

If there is a plurality of joint inventors, that part of the net income accruing to the inventors will be distributed equally among the inventors unless some other distribution is specifically requested in writing by the inventors. If a plurality of institutions is involved in an invention, an agreement will be negotiated by the institutions in consultation with the inventors.

(8) All income received pursuant to an invention or discovery shall be deposited in a separate university account from which shall be deducted an amount equal to the sum of all BGSU or inventor (whichever is applicable) costs paid or billed for obtaining a patent, license, or related activities. After such deductions have been made and distributed, net income distribution according to the elected schedule shall be made on an annual basis.

(9) The president or designee shall appoint a patent advisory committee consisting of three or more faculty members and two or more administrative staff members of BGSU. Such committee shall:

(a) Review all applicable inventions and discoveries and determine and advise in each individual case whether a discovery or invention resulted from research, investigation, or activity conducted in any laboratory or facility of the BGSU and is the property of BGSU.

(b) Determine and advise the president whether or not the discovery or invention, which is the property of BGSU, has a sufficient value or is of a sufficient interest to BGSU to warrant its retention; or, if the same should be relinquished to the inventor or otherwise dealt with.

(c) Advise the president about acquiring on behalf of BGSU, by agreement, on such terms and conditions as it deems appropriate, an interest in such patentable discoveries and inventions in those situations in which it shall have been determined that the discovery or invention does not otherwise belong to BGSU.

(d) Determine and advise the president whether or not to pursue the patentability and development of a discovery or invention that is the property of BGSU.

(e) Recommend to the president appropriate courses of action, including prospective purchasers or licensees of inventions or discoveries, and advise the president on the terms and conditions of any agreements.

(10) The president of BGSU is hereby empowered and authorized, after receiving the advice of the patent advisory committee, and after reporting to the board of trustees, to act on or reject the patent advisory committee's determinations, and to sell, assign, convey, or grant on behalf of BGSU any such discoveries and inventions or any rights or shares in such discoveries and inventions, including patent rights, to such persons, firms, or governmental agencies for such consideration or upon such terms and conditions, including dedication to the public, as shall be deemed by the president, after consultation with the inventors, to be in the proper and best interest of BGSU.

(11) Within six months after disclosure of an invention, the president of BGSU shall

(a) Elect whether to apply for a United States patent and shall initiate the patent search;

(b) Relinquish all rights to the invention to the inventor(s); or

(c) Indicate how the invention shall be otherwise dealt with.

(12) The president or designee is authorized by the board of trustees to make arrangements with external sponsors of research to obtain research funding from such sponsors. Such arrangements may include, but are not limited to, assigning all rights to inventions or discoveries to the sponsor, or granting an exclusive or nonexclusive license to the sponsor with or without royalties to be returned to BGSU. Any such agreement must be in writing and signed by an authorized officer or agent of BGSU. Such agreements will be in consultation with the investigator(s).

Effective: 11/14/2017
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345
Prior Effective Dates: 3/20/2015

3341-7-04 Research faculty administrator research stipend.

(A) Policy statement and purpose

The purpose of this policy is to establish who is eligible for a research stipend.

(B) Policy

Research faculty administrators on full year contracts who are principal investigators (PIs) or co-PIs on externally funded, on-going research grants and who have requested one month released-time calculated at one twelfth of the full year contract salary, may qualify to receive a research stipend of 8.4 per cent of salary during the fiscal year. The out-of-base stipend will be provided' by the college and will be paid out over a fiscal year or its equivalent. Released time approved both in the grant and by the college will be charged appropriately to the grant in the university's established manner. The research faculty administrator is released the time-equivalent of one month to perform grant related research.

Research faculty administrators on full year contracts who are not PIs or co-PIs but are budgeted for the equivalent of one-month salary on someone else's grant, may not receive a research stipend or additional salary in the form of supplemental compensation from that grant. Released time approved in the grant will be charged appropriately to the grant in the university's established manner. The research faculty administrator is released the time-equivalent of one month to perform grant related research.

Date: November 1st, 2013

Effective: 3/20/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-05 Research misconduct.

(A) Policy statement and purpose

(1) To communicate to all members of the university community what constitutes misconduct, that misconduct is inimical to the values of pursuit of truth and open inquiry; and that it seriously harms public confidence in research;

(2) To establish university procedures that accord with federal regulations for reporting, investigating, responding to, disposing of, and appealing allegations of misconduct; and

(3) To establish principles and procedures that maximizes the privacy and confidentiality of, and protects the reputations of, members of the university community (a) who make allegations of misconduct, or (b) against whom allegations of misconduct are made.

Nothing in this policy displaces or precludes integrated procedures under this policy and other applicable policies, including the academic honesty policy.

(B) Definitions: Nothing in these definitions shall be deemed to include honest error,honest omission or oversight, or honest differences in interpretations or judgments of data.

(1) Misconduct in research, scholarly inquiry, or other forms of creative scholarly endeavor (hereinafter referred to as "misconduct" for convenience of reference) means (a) fabrication, falsification, plagiarism or other practices that violate accepted standards of honesty within the academic and scientific communities for proposing, conducting, presenting, or reporting the results of research, scholarly inquiry, or creative scholarly endeavors; (b) material failure to comply with federal, state, or local laws or regulations for protection of researchers, human subjects, or the public, or for ensuring the welfare of laboratory animals; or (c) failure to comply with other material legal requirements governing research.

(a) "Fabrication" means the creation of nonexistent or fictitious data or results.

(b) "Falsification" means the manipulation or alteration of data for the creation or reporting of false results.

(c) "Plagiarism" means representing the words, ideas, or methods of another person as one's own.

(d) Other practices that violate accepted standards of honesty include but are not limited to:

Selective reporting or omission of conflicting data;

Gross negligence in collecting or analyzing data;

Improper use or release of ideas or data that have been received with the expectation that confidentiality will be preserved;

Stealing, destroying, taking or using without permission the property of others or products of research produced by others, such as data, equipment, supplies, computer programs or software, notes and records, manuscripts, or specimen collections.

Federal regulations for the protection of researchers, human subjects, and the public include but are not limited to:

Protection of human subjects; use of recombinant DNA; use of radioactive material; use of hazardous chemicals or biological material.

(2) Inquiry

"Inquiry" means information gathering and initial fact finding to determine whether an allegation or apparent instance of misconduct warrants an investigation.

(3) Investigation

"Investigation" means the formal examination and evaluation of all relevant facts to determine if misconduct occurred.

(C) Policy

(1) It is a violation of university policy for any member of the faculty, administration, contract or classified staff, temporary employee, or student body (including post-doctoral appointees) to engage in misconduct.

(2) It is a violation of university policy for any member of the faculty, administration, contract or classified staff, temporary employee, or student body (including post-doctoral appointees) to make other than in good faith allegations of misconduct.

(3) It is a violation of university policy for any member of the faculty, administration, contract or classified staff, temporary employee, or student body (including post-doctoral appointees) to retaliate against anyone making a good faith allegation of misconduct.

(4) Except as required by this policy or by Federal, State, or local law or regulation, it is a violation of university policy for any member of the faculty, administration, contract or classified staff, temporary employee, or student body (including post-doctoral appointees) to breach the confidentiality of any proceeding or action taken under this policy by publicly disclosing (a) the names or other personally identifying information of persons making, or persons the object of. an allegation of misconduct, or (b) the contents of written, oral, or electronic communications made pursuant to procedures indicated in paragraph (E) of this policy.

(5) It is a violation of university policy for any member of the faculty, administration, contract or classified staff, temporary employee, or student body (including post-doctoral appointees) to aid or abet misconduct, or to obstruct the inquiry or investigation of allegations of misconduct.

(D) Responsibilities

(1) The vice president for research and economic development is responsible for the coordination and timely implementation of this policy, as well as for maintaining all documents and records relating to this policy and to any actions taken pursuant to it.

(2) Each vice president, dean, director, department chair, and administrative head of an operational unit is responsible for informing their constituents of this policy, of the importance of complying with this policy and related procedures, and for referring questions about misconduct or allegations of possible misconduct to the vice president for research and economic development.

(3) The vice president for research and economic development is responsible for obtaining and keeping current any and all assurances of compliance with federal regulations pertaining to misconduct as well as for reporting information about allegations of misconduct and related actions taken by the university to Federal agencies as required by federal regulations.

(4) Upon receiving an allegation of misconduct, the vice president for research & economic development is responsible for taking immediate and appropriate action under this policy.

(5) Each member of the university community is responsible for complying with the principles and procedures of this policy, including full cooperation in the conduct of inquiries, investigations, hearings or appeals made pursuant to this policy.

(6) Area vice presidents are responsible for making and implementing any disciplinary decisions arising from recommendations made pursuant to this policy consistent with the different disciplinary and grievance policies and procedures governing the various employee and student constituency groups.

(7) It is the responsibility of the university community to discourage misconduct, to report misconduct where there is reasonable cause to believe it has occurred and to cooperate in any inquiry or investigation.

(E) Procedures for handling allegations of misconduct

The following procedures are required in part by 42 Code of Federal regulations 50(103.d).

(1) Making allegations.

Any member of the university community, upon observing or having evidence of suspected misconduct or believing specific actions, activities, or conduct constitutes misconduct (as defined in paragraph(A)(1)of this policy may make an allegation of misconduct. Any person confemplating making an allegation may, and is encouraged to. first discuss the contemplated allegation in absolute confidence and privacy with the vice president for research and economic development, who will advise the person or persons contemplating the allegation about

(a) The appropriate written form for the allegation.

(b) Their rights and responsibilities under this policy, and

(c) The procedures that must be followed under this policy once an allegation is made. An allegation of misconduct is not made unless and until it is received in writing by the vice president for research and economic development.

The vice president for research and economic development is responsible for protecting, to the maximum extent possible, the privacy of those who in good faith report apparent misconduct.

(2) Conducting inquiries.

Upon receiving a formal allegation of misconduct, the vice president for research" and economic development will notify the person(s) against whom an allegation is made about the allegation. The person(s) about whom an allegation is made may have legal assistance at his/her expense in any subsequent proceeding in which he/she may be asked or required to be involved.

Upon notifying the person(s) against whom an allegation is made, the vice president for research and economic development will conduct an inquiry (as defined) in order to determine whether or not an allegation or apparent instance of misconduct warrants an investigation. In conducting this inquiry, the vice president for research and economic development shall be responsible for gathering information and conducting initial fact finding to justify his/her decision about the need for a formal investigation. The vice president for research and economic development is responsible for preparing a written report that states what evidence was reviewed, summarizes interviews conducted, and includes the conclusions of the inquiry. The individual(s) against whom the allegation is made shall be given a copy of the report of the inquiry. They may respond in writing with comments about any part of the inquiry report within a reasonable period of time to be specified by the vice president for research and economic development and if they choose to make written comments, those comments shall be made part of the formal inquiry report.

An inquiry must be completed within sixty calendar days of its initiation unless circumstances clearly warrant a longer period. If the inquiry takes longer than sixty days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the sixty day period.

The vice president for research and economic development shall maintain sufficiently detailed documentation of inquiries to permit later assessment of the reasons for determining that an investigation was not warranted. Such records shall be maintained in a secure manner for a period of at least three years after the termination of the inquiry, and shall, upon request, be provided to authorized federal personnel having a valid reason to review the records.

The vice president for research and economic development is responsible for affording the affected individuals

(a) Confidential treatment to the maximum extent possible

(b) A prompt and thorough investigation if one is warranted, and

(c) An opportunity to comment on the allegations and findings of the inquiry and/or any investigation.

(3) Conducting investigations.

If the inquiry provides sufficient evidence that an investigation is warranted, the vice president for research and economic development shall commence an investigation within thirty days of the completion of the inquiry.

The vice president for research and economic development shall appoint an ad hoc committee of not less than three and not more than five tenured university faculty having appropriate substantive expertise to carry out a thorough and authoritative evaluation of the evidence bearing on alleged misconduct. The vice president for research and economic development shall also be responsible for obtaining individuals from outside the university community having appropriate substantive expertise to thoroughly and authoritatively evaluate evidence if such expertise is not present within the university community or if a conflict of interest could arise from using a member of the university community to evaluate the evidence.

The investigation shall include examination of all documentation, including but not necessarily limited to relevant research data and proposals, laboratory or field notes, manuscripts, publications, correspondence, and memoranda of telephone calls. Whenever possible, interviews should be conducted with not only individuals involved in making the allegation and individuals against whom the allegation is made, but also any other individuals who might have information regarding key aspects of the allegation. Complete summaries of these interviews should be prepared, provided to the interviewed party for comment and suggested revision, and included as part of the investigation record. Persons being interviewed pursuant to an investigation may have legal counsel present to advise them.

The ad hoc committee shall participate in the interviews of all parties involved in the investigation and shall report its findings concerning evaluation and assessment of the evidence to the vice president for research and economic development in a written report.

Using all available information, the vice president for research and economic development shall prepare a written report of the investigation, which shall include an assessment of the extent to which the allegation of misconduct is substantiated by the evidence. If an allegation of misconduct is substantiated in whole or in part, the vice president for research and economic development shall include in the written investigation report a recommendation concerning appropriate sanctions, discipline, or corrective actions, including without limitation:

(a) Removal from involvement or activity on a particular project;

(b) Orderly termination of the entire research project;

(c) Suspension of privileges to submit external proposals for research support;

(d) Suspension of privileges to submit proposals for BGSU research support;

(e) Special monitoring of future work.

The vice president for research and economic development shall provide copies of this report to the individual(s) against whom the allegations are made for comment and to the vice president of the area in which these individuals are employed. If they can be identified, the persons who raised the allegations should be provided with those portions of the report which address their role and opinions in the investigation. The vice president for research and economic development shall maintain all documentation to substantiate the investigation's findings.

The investigation should be conducted and completed within one hundred twenty calendar days of its initiation, including report preparation, review and comment by subjects of the investigation, and submission of the report to required university and federal officials. If the report cannot be completed within one hundred twenty days, and the report must be submitted to a cognizant federal funding agency (as in paragraph (F) (F)(2) of this policy of rule), then the vice president for research and economic development shall submit a written request for extension of the one hundred twenty days to the cognizant federal agency that includes an explanation of the delay, an interim progress report on the investigation, and an estimated completion date of the report and other necessary steps.

(4) Disciplinary actions.

Upon receiving a misconduct investigation report from the vice president for research. and (economic development in which the allegation of misconduct is in part or in whole substantiated, the area vice president shall be responsible for initiating the appropriate disciplinary proceedings and/or sanctions. In so doing, the area vice president shall give great weight to the recommendations of the vice president for research and economic development. Since disciplinary procedures vary across the major employee and student groups, this policy does not spell out specific disciplinary penalties, sanctions, procedures or appeals, but incorporates by reference the relevant governance and conditions of employment documents that pertain to infractions of university policy for (a) faculty, (b) administrative staff, (c) classified staff, and (d) students, including without limitation:

(a) Faculty - the academic charter, parts B.I.C. B.I.D. and B.I.E.

(b) Administrative staff (including post-doctoral appointees) -

Administrative staff handbook, parts on:

Contract information, (pp. 27-29)

Grievance procedures, (pp. 38-43)

(c) Classified staff- classified staff handbook, parts on:

Sanction policy and procedure (pp. 10-14)

Grievance procedures (pp. 18-28)

(d) Students - the academic charter, parts on: B.II.H - academic honesty

(F) Notifications to federal agencies when federal funds are involved

When alleged misconduct involves employees or students conducting research supported by federal agency sponsors, additional agency notification requirements apply, as follows.

(1) When, on the basis of an inquiry, it is determined that an investigation is warranted, the vice president for research and economic development shall notify the cognizant federal funding agency in writing on or before the date the investigation begins that an investigation is being commenced. The notification should inform the cognizant federal agency at a minimum of the name of the person(s) against whom the allegation(s) have been made, the general nature of the allegation(s). and the federal grant application(s) or award(s) involved.

(2) The vice president for research and economic development must submit the final report of an investigation to the cognizant federal funding agency if the investigation concerns research being supported by federal funds. This report to the cognizant federal agency must describe the policies and procedures under which the investigation was conducted, how and from whom information relevant to the investigation was obtained, the findings, and the basis for the findings. It must include the actual text or an accurate summary of the views of any individual(s) found to have engaged in misconduct, as well as a description of any sanctions or corrective actions taken by the university.

(3) The vice president for research and economic development shall notify the cognizant federal finding agency if at any time during an inquiry or investigation conducted under this policy it is determined that any of the following conditions exist:

(a) There is an immediate health hazard involved:

(b) There is an immediate need to protect federal funds or equipment:

(c) There is an immediate need to protect the interests of the person(s)making the allegations or of the individual(s) who is the subject of the allegations as well as his/her co-investigators and associates, if any:

(d) It is probable that the alleged incident is going to be reported publicly:

(e) There is a reasonable indication of possible criminal violation. In that instance, notification of the cognizant federal agency must occur within - twenty-four hours of obtaining that information.

(G) Resolution

(1) Absence of misconduct.

If the results of the inquiry and/or investigation reveal that allegations of misconduct are not supported, then any party making an allegation or against whom an allegation is made and previously notified about the possibility of misconduct or the need to conduct an investigation should be informed of those findings in writing. In announcing a finding that the allegations are not supported, the vice president for research and economic development should consult with the person(s) who were the subject of the allegations to determine (a) whether the announcement should be a public announcement or a selective announcement and (b) what organizations beyond those initially informed should receive the information about the findings of no misconduct as a means to restore, repair, or reassure the reputation of those involved. The vice president for research andeconomic development should normally be guided by whether or not a public announcement will be helpful or cause further harm in restoring the reputations of those against whom the allegations were made and should give weight to their views in determining which additional organizations, if any, should be notified.

Irrespective of the results of any inquiry or investigation, if allegations were made in good faith, the vice president for research and economic development will ensure that no disciplinary actions are brought against the person(s) making the allegations and will monitor the situation and will make diligent efforts to prevent any retaliatory actions. If, however, during the course of reaching a finding that no misconduct occurred, it is determined that allegations of misconduct were not made in good faith, the vice president for research & economic development shall initiate disciplinary actions against the person(s) making such allegations.

(2) Presence of misconduct.

If the results of the inquiry and/or investigation reveal that allegations of misconduct are supported, then the vice president for research andeconomic development shall notify all organizations and agencies initially" informed about the inquiry and/or the investigation. The vice president for research & economic development shall also inform all organizations or agencies previously notified about the outcome of any disciplinary action taken by the university.

References updated 11/1/93

Date: November 1st, 2013

Effective: 3/20/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-06 Commercialization.

(A) Policy statement and purpose

Bowling Green state university is a state institution of higher education that holds undergraduate and graduate education as its number one priority, and, the primary responsibility of the university professor is "to educate." As part of the education process. BGSU encourages its faculty, staff and students to conduct research. By virtue of what they do. certain university faculty, staff or students may produce commercial opportunities based on their research work. The university is obligated by state of Ohio law to protect resulting intellectual property and to promote its full development and public use. In doing so. it also has an obligation to the faculty member, staff or student and to the public interest, to provide the flexibility needed to advance the research, attract investors and to achieve commercialization of the product. That flexibility is defined by this policy.

(B) Policy

(1) Pursuant to Section, of the revise code and Bowling Green state university's (BGSU) board of trustees has determined that employees of the institution may be afforded the opportunity to hold personal financial interests in companies commercializing technology developed in conjunction with their BGSU research and development activities. The board recognizes that participation by employees of BGSU in the ownership and commercialization of technology and other intellectual property may increase the transfer of discoveries and knowledge generated at BGSU to the private marketplace by providing an incentive for faculty who develop inventions with commercial applications. The opportunity to participate in these transactions is also essential to BGSU's efforts to attract and retain highly qualified faculty, staff or student. The procedures and guidelines set forth in this policy are intended to enable the university to realize the benefits of these entrepreneurial activities while protecting the integrity of its research and educational mission and to comply with BGSU policies and applicable federal and state laws. These rules serve as an exception to the Ohio Ethics Law and related statutes [ Chapter 102, and section 2921.42, 2921.43 of the revise code], which might otherwise apply. Matters outside the scope of these rules will be subject to such laws to the extent applicable.

(2) Procedure:

(a) Definitions

(i) A commercialization company is a private, commercial entity that is owned in whole or in part by a university employee and that has as its purpose, the development and commercialization of university owned intellectual property created by that employee.

(ii) BGSU's ownership of intellectual property rights in technology created by its faculty, staff or students is determined in accordance with Section 3345.14 of the Revised Code and the BGSU policy on patents and copyrights. As more fully explained in the policy on patents and copyrights, university owned technology generally does not include textbooks and other scholarly or artistic works created with minimal use of BGSU resources.

(iii) A BGSU employee is any member of the faculty or staff, including, but not limited to full-time and part-time faculty, adjunct faculty, non-tenure track research faculty, postdoctoral fellows, classified and administrative employees, graduate assistants/students, work-study students, employed undergraduate assistants, and technicians.

(iv) The patent advisory and technology commercialization oversight committee is a university body responsible for making recommendations to the vice president for research & economic development regarding commercialization companies.

(v) The vice president for research and economic development is the university official who is responsible for assisting employees of BGSU in identifying, managing and eliminating conflicts of interest, and in developing conflict of interest management plans for employees of BGSU involved in the development of commercialization companies.

(vi) The sponsored programs and research office is the unit of the institution charged with providing leadership in setting the research agenda of the university and facilitating and overseeing research and sponsored programs and technology transfer.

(b) Applicability

(i) This policy shall apply to all BGSU employees.

(ii) This policy shall apply to students who

(a) engage in research and development activities

(b) create intellectual property owned by BGSU: and

(c) desire to hold an ownership interest in a commercialization company.

(c) Responsibilities of department chairs, school directors, center directors, and staff supervisors

(i) Department chairs and school directors are responsible for ensuring that faculty who participate in commercialization companies comply with applicable university policies governing the terms and conditions of employment, academic and research activities. Department chairs and school directors are also responsible for ensuring compliance with the policies on consulting and conflict of interest, and for reviewing and making recommendations as to the propriety of private business activities as reported by their faculty in disclosure forms required by those policies.

(ii) Center directors are responsible for ensuring that members of their centers who participate in commercialization companies comply with applicable university policies governing the terms and conditions of employment and academic and research activities. Center directors are also responsible for ensuring compliance with the university policies on consulting, conflict of commitment, and conflict of interest. Further, they are responsible for reviewing and making recommendations addressing the propriety of private business activities as reported by their faculty in any required disclosure forms.

(iii) Staff supervisors are responsible for ensuring that staff members who participate in technology commercialization companies comply with this policy. They are also responsible for ensuring compliance with the university policies on conflict of interest and working outside the university applicable to staff employees and for reviewing and making a recommendation as to the propriety of private business activities reported by staff in disclosure forms required by those policies.

(d) Approval process

(i) Faculty and staff members or students who wish to participate in a commercialization company must first obtain approval from their department chairs, school or center directors, and deans or other appropriate supervisors. The vice president for research & economic development will be responsible for negotiating the business terms of the transaction between the company and BGSU, and will facilitate the development of a conflict-of-interest management plan, in consultation with the patent advisory and technology commercialization oversight committee.

(ii) The patent advisory and technology commercialization oversight committee will review the sufficiency of business terms and conflict of interest management plans relating to technology commercialization companies. Written approval from this committee must be obtained before any business agreements relating to a technology commercialization company are finalized.

(iii) Faculty, staff or students who wish to participate in a commercialization company may discuss initial company formation with the sponsored programs and research office; however, they should not, as a general rule, participate in the ongoing negotiation of option and licensing terms between the company and BGSU. As soon as possible, third parties, such as company management and/or legal counsel should perform this function.

(iv) As a prerequisite to the granting of an exclusive license to BGSU technology, a commercialization company must provide the vice president for research and economic development with a due diligence review as evidenced by the following:

(a) A capitalization plan demonstrating access to funds necessary for company growth;

(b) A proposed management team;

(c) Milestones for product development and commercial sale

(d) A periodic review of progress within a timeframe identified at the time of negotiation; and

(e) Reversionary rights for the institution when company fails due-diligence after a mutually agreed-upon period of time.

(v) In recognition of the university's ownership of the technology or invention, a commercialization company in early stage may grant the university an equity interest in the company as negotiated by the office of sponsored programs and research and approved by the vice president for research &economic development, to be held by the BGSU foundation.

(vi) The faculty member's department chair, school director, center director, dean or staff supervisor shall be active participants in discussions with the office of sponsored programs and research and in the development of conflict of interest management plans relating to a commercialization company.

(vii) A chair, school director, center director or staff supervisor who has a financial interest or is a co-participant with a faculty, staff member or student in a commercialization company is not in a position to provide effective oversight of that activity. In these situations, another disinterested administrator must be appointed to perform the responsibilities of the chair, center director or staff supervisor.

(viii) If the patent advisory and technology commercialization oversight committee members determine that, for any reason, it is not possible for the chair, school director, center director, the staff supervisor or another disinterested administrator to provide effective oversight of a transaction involving a commercialization company, the transaction should not be approved.

(e) Responsibility for university duties

(i) Faculty members are encouraged to develop discoveries and inventions with commercial potential within the broader teaching and research mission of BGSU. Care must be taken that faculty not allow their interest in a financial opportunity arising out of their research efforts to result in a potential for either a conflict of interest or a conflict of commitment to the institution, or the misuse of students, employees or resources of the university for benefit of the company.

(ii) While faculty members are permitted to serve as consultants to commercialization companies and other private enterprises, they continue to be responsible for all of their university teaching, research, and service obligations. Authorized private business activities must be undertaken in accordance with the BGSU policy on consulting and pursuant to formal consulting and conflict of interest management plans signed by the faculty, the commercialization company and the university, and approved by the department chair, the center director, the vice president for research & economic development, the office of sponsored programs and research and the general counsel.

(iii) Staff members may take approved leave in order to engage in activities relating to a commercialization company during regularly assigned working hours. When performed outside regularly assigned working hours, these activities must be undertaken in accordance with university policies and pursuant to a formal conflict of interest and conflict of commitment agreement between the staff member, the commercialization company, and the university. The department chair, the school or center director, the dean and/or supervisor, and the office of sponsored programs and research must approve such an agreement.

(iv) Staff members may pursue research projects as authorized by their supervisors. Supervisors shall authorize only those staff research projects that will advance the mission of the university without regard to the financial interests of the individual employees.

(f) Conflict-of-interest management standards

(i) BGSU facilities, equipment and other resources may not be used for research benefiting a commercialization company except when such use is pursuant to a sponsored research agreement, facilities use agreement or other appropriate contractual arrangement.

(ii) As a general rule, faculty, staff or students shall not hold management positions in commercialization companies. 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. In order to ensure the application of this principle, agreements between BGSU and a commercialization company should contain enforceable milestones for the reduction of these management responsibilities. Failure to comply with these agreed-upon milestones will result in the company's inability to engage in sponsored research with BGSU. utilize BGSU faculty, staff or student employees and the other commercialization agreements and/or activities permitted under these guidelines.

(iii) Faculty members engaged in approved private business activities who find they are unable to perform all of their regular university responsibilities shall request a reduction of appointment or other approved leave subject to the restrictions found in section 3345.28 Revised Code.

(iv) Staff members who are unable to perform all of their university duties because of activities in connection with commercialization companies must reduce those activities or request a reduction of appointment or other approved leave.

(v) Graduate and undergraduate students may use university facilities, equipment, and other resources to perform research benefiting a commercialization company only pursuant to a sponsored research agreement or other formal agreement made with BGSU. Research leading to thesis or dissertation may not be unreasonably restricted from publication or public disclosure, as determined by the patent advisory and technology commercialization oversight committee. Students should be informed in writing of any restrictions that their involvement in research related to the company may impose upon them (e.g. confidentiality requirements that may negatively impact public disclosure of their research results) prior to the start of their research. Faculty investigators should exercise care in involving students in research that may impede completion of their academic program.

(vi) Students may be employed by a commercialization company subject to limitations set forth in paragraph (G)(7) of this policy. Prior to such employment, the student, the faculty or staff member, the chair of the student's department and/or school or center director, the chair of the graduate studies committee and a company representative must sign an agreement disclosing the student's rights and obligations.

(vii) A student may not be employed by a commercialization company in which a faculty member has an ownership 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 commercialization company only pursuant to a sponsored research agreement or other formal internship agreement through the university.

(viii) Commercialization companies may not enter into any agreements with the university for the purchase, sale or rental of equipment, supplies or services other than those explicitly authorized by the vice president for research & economic development on the advice of the patent.

(g) Advisory and technology commercialization oversight committee.

As a general rule, faculty and staff members who are not directly involved with research and development of technology licensed to a commercialization company may hold equity interests in that company.

Equity ownership in these situations is permissible only to the extent allowed by by 2921.42 and 2921.43 of the Revised Code.

(h) Revised Code requirements.

(i) BGSU regulatory review boards including, for example, the human subjects review board (HSRB) and the institutional animal care and use committee (IACUC), may be utilized for research benefiting a technology commercialization company only pursuant to a sponsored research agreement between BGSU and the company, and then only for work performed in BGSU facilities by BGSU faculty, staff and students.

(ii) As a general rule, an individual faculty or staff member or their immediate family should not hold more than twenty-five per cent of the outstanding equity in a commercialization company on an ongoing basis. Under circumstances where family ownership exceeds twenty-five per cent but does not interfere with the employee's obligation to BGSU and does not create an additional conflict-of-interest, this ownership provision limit may be considered and amended by the vice president for research and economic development. While significant faculty or staff equity ownership may be inherent in a newly formed company, it is expected that their ownership interests, as a per centage of the total outstanding shares or membership interests of the company, will decrease as the company develops and attracts additional equity. In order to ensure the observance of this principle, agreements between the university and commercialization companies should contain enforceable milestones for the dilution of these equity interests. Failure to comply with these agreed-upon milestones will result in the company's inability to engage in sponsored research with BGSU, utilize BGSU faculty, staff or students, and the other commercialization agreements and/or activities allowed for under this policy.

(iii) Faculty or staff members may not assume the role of principal investigator/project director in sponsored research projects awarded to BGSU and funded by commercialization companies in which they have an interest if the projects involved the use of human subjects. Faculty or staff members may assume the role of principal investigator/project director for sponsored research projects funded by commercialization companies in which they have an interest if a formal research integrity, conflict of interest management plan approved by the patent advisory and technology commercialization oversight committee and the vice president for research and economic development is in place.

(iv) Agreements for sponsored research projects funded by companies must include, at a minimum, a requirement for full BGSU publication rights, BGSU rights to own or use data, and payment of fully negotiated facilities and administrative fees at the on-campus research rate assigned by the U.S. Department of health and human services. The office of sponsored programs and research must approve any exceptions to these conditions.

(v) Faculty, staff and students participating in commercialization companies approved pursuant to - and this chapter continue to be bound by all BGSU policies regarding the development and ownership of intellectual property. New inventions and/or discoveries made as a result of research efforts of BGSU faculty, staff and students for the company, including those made under formal consulting agreements through the institution, will be owned by BGSU. The company will be offered an exclusive option to license the technology. If it is in the best interests of the institution, the president has the authority under Section 3345.14 of the Revise Code and Article 10 of the institution's patent policy, to sell, assign, convey or grant ownership of intellectual property rights to companies. New inventions and/or discoveries developed by the faculty, staff or student for the company must be disclosed to the office of sponsored programs and research as required by the university patent policy.

Date: May 25, 2003

Effective: 3/20/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-07 Protection of human subjects.

(A) Policy statement and purpose

(1) Statement of institutional authority

Bowling Green state university (BGSU) has given assurance via a federalwide assurance (FWA00003853) that it will comply with the department of health and human services regulations for the protection of human research participants (45 CFR part 46). BGSU requires that all research projects involving human subjects, as defined by the federal regulations ( 45 CFR 46.102(d)(f) ), regardless of the source of support or location of the performance site, be reviewed and approved by the human subjects review board (HSRB) prior to the initiation of the research project. The HSRB is under the authority of the vice president for research and economic development.

(2) Purpose of the HSRB

The purpose of the HSRB is to protect the rights and welfare of human subjects participating in research. The HSRB reviews and oversees research with human subjects to assure that the ethical principles described in the "Belmont Report", a publication of the "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" are being followed, and that the research complies with federal regulations that pertain to human subject protections ( 45 CFR 46 ) and other pertinent regulations, guidance, state, and local laws.

(3) Governing principles

The HSRB is guided by the ethical principles in the belmont report. The following principles are defined in the belmont report:

(a) Respect for persons - Individuals should be treated as autonomous agents,and persons with diminished autonomy are entitled to protection.

(b) Beneficence - The benefits to participants and to the importance of knowledge must outweigh the risks to participants.

(c) Justice - Selection of subjects is equitable and is representative of the group that will benefit from the research.

(B) Policy

(1) HSRB jurisdiction and authority

The HSRB has the authority to review research with human subjects when, but not limited to:

(a) The research will be conducted by BGSU faculty, staff, or students.

(b) The research is under the direction of a BGSU faculty or staff member.

(c) The research is conducted by investigators at institutions in which there is

an IRB authorization agreement in place with BGSU.

(d) BGSU is the awardee institution (i.e., received an award through a grant, contract, or cooperative agreement), but all activities with human subjects will be carried out by employees or agents of another institution.

(e) The research involves the use of BGSU's non-public information to identify or contact human research participants.

The HSRB has the authority to approve, require modifications, or disapprove research activities with human subjects. The HSRB has the authority to suspend or terminate approval of research with human subjects that is not being conducted in accordance with the HSRB approved protocol or when research has been associated with unexpected serious harm to participants.

(2) Review by institution

Research covered by this policy may be subject to additional review and approval or disapproval by officials of BGSU. However, those officials may not approve research with human subjects if it has not been approved by the HSRB.

Inappropriate attempts to influence the HSRB process, individual HSRB members, or office of research compliance staff will be reported to the vice president for research and economic development. The vice president for research and economic development will investigate and appropriately respond to these concerns, and has the authority to limit or remove an investigator's privilege to conduct research after due process.

(3) Funded research

If research with human subjects is being internally or externally funded, the protocol must be reviewed and approved by the HSRB prior to expenditure of any grant funds. The funded grant proposal must substantially correspond to the HSRB approved protocol.

(4) Use of procedures

The HSRB must maintain and follow written procedures consistent with applicable laws and regulations such as the "Belmont Report'. J 45 CFR 46. and the university's federal-wide assurance. These procecmres will be available to all researchers through a link at the office of research compliance website.

(5) IRB authorization agreements

The HSRB can serve as the IRB of record for other institutions and can rely on another IRB for review and continuing oversight when there is an IRB authorization agreement in place as an effort to avoid duplication of effort. This is at the discretion of the BGSU HSRB and will only be done in cases where the other institution has a valid federal-wide assurance.

(6) Compliance

All university personnel and students shall cooperate fully with the procedures implemented by the university HSRB to provide protections to human subjects.

Violations of law, regulation, or university policies respecting human subject protections will be considered serious matters, which may warrant sanctions or more serious action, such as suspension of research protocols, termination of research protocols, and loss of research privileges, as the situation may warrant, including investigation for scientific misconduct in accord with established policies.

(7) Policy definitions

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge ( 45 CFR 46A02(d) ).

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (a) /Data through intervention or interaction with the individual, or (b) identifiable private information ( 45 CFR 46.102 ('f))

(8) Responsible officer

The office of research compliance is responsible for the oversight and implementation of this policy.

(9) Implementation of policy

WHO

TASK

HSRB chairperson, research compliance officer

Ensure compliance with federal regulations, policy and procedures to protect human subjects participating in research. Report to the vice president for research and economic development any inappropriate attempts to influence the HSRB process.

Vice president for research and economic development

Investigate and act on reports of inappropriate attempts to influence the HSRB process. Evaluate on an on-going basis the human research protections program for adherence and compliance with federal, state, and local policy and regulation. Evaluate (at least yearly) the HSRB workload in regard to timely and thorough review.

(10) Related university policies

(a) Policy on misconduct in research

(b) " Federalwide Assurance (FWA) for the Protection of Human Subjects for Institutions within the United States: Update or Renewal for FWA Number: FWA00003853"

(11) Related government policies and guidance

(a) "Protection of Human Subjects," Title 45 C.F.R., Pt. 46. 2009 ed. (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html)

(b) "Belmont Report: Ethical Principles and Guidelines for the Protection ofHuman Subjects of Research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research(http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

(c) "Guidance on Engagement of Institutions in Human Subjects Research"(http://www.hhs.gov/ohrp/policy/engage08.html)

Date: March 23, 2015

Effective: 5/6/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-08 Protection of vertebrate animals.

(A) Policy statement and purpose

(1) Statement of institutional authority

Bowling Green state university (BGSU) requires that all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as research activities, involving live vertebrate animals conducted at BGSU, or at another institution as a consequence of a subgrant or subcontract or supported activity by BGSU, be reviewed and approved by the institutional animal care and use committee (IACUC) prior to the initiation of the research project. The IACUC is under the authority of the vice president for research and economic development.

(2) Purpose of the IACUC

The purpose of the IACUC is to assure that researchers care for and use animals in ways judged to be scientifically and humanely appropriate. To this end, the IACUC reviews and oversees research with live vertebrate animals to ensure that the research complies with the BGSU PHS assurance, applicable provisions of the Animal Welfare Act, as well as other applicable statutes, laws and regulations pertaining to animal care and use.

(3) Governing principles

The IACUC is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" and will maintain a program for activities involving animals in accordance with the "Guide for the Care and Use of Laboratory Animals"

(B) Policy

(1) IACUC jursidiction and authority

The IACUC has the authority to review research activities with vertebrate animals when:

(a) The research activities will be conducted by BGSU faculty, staff, or students.

(b) The research activities are under the direction of a BGSU faculty or staff member.

(c) BGSU is the awardee institution (i.e., received an award through a grant, contract, or cooperative agreement), but all activities with live vertebrate animals will be carried out by employees or agents of another institution.

The IACUC has the authority to approve, require modifications, or withhold approval of activities related to the care and use of animals. The IACUC has the authority to suspend an activity involving animals that is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the "Guide", the PHS assurance, or the IACUC approved protocol.

(2) Review by institution

Research covered by this policy may be subject to additional review and approval or disapproval by officials of BGSU. However, those officials may not approve research with animals if it has not been approved by the IACUC.

Inappropriate attempts to influence the IACUC process, individual IACUC members, the office of research compliance staff, or the university animal facility staff will be reported to the vice president for research and economic development. The vice president for research and economic development will investigate and appropriately respond to these concerns, and has the authority to limit or remove an Investigator's privilege to conduct research.

(3) Funded research

If research with animals is being internally or externally funded, the protocol must be reviewed and approved by the IACUC prior to expenditure of any grant funds. The funded grant proposal must substantially correspond to the IACUC approved protocol.

(4) Use of procedures

The IACUC must maintain and follow written procedures consistent with federal regulations.

(5) Inter-institutional collaboration

In instances where BGSU is collaborating with another institution, and both the awardee institution and the performance site have full PHS assurances, duplicate IACUC review is not required. Based on NIH notice NOT-OD-01-017, documentation of review and any significant issues related to the research activity raised during a semiannual program inspection will be maintained by both committees.

(6) Responsible office

The office of research compliance is responsible for the oversight and implementation of this policy.

(7) Implementation of policy

WHO

TASK

IACUC chairperson, research compliance officer

Ensure compliance with BGSU PHS assurance, applicable provisions of the Animal Welfare Act, as well as other applicable statutes, laws and regulations pertaining to animal care and use. Report to the vice president for research and economic development any inappropriate attempts to influence the IACUC process.

Vice president for research and economic development

Investigate and act on reports of inappropriate attempts to influence the IACUC process. Evaluate on an on-going basis the animal care and use program for adherence and compliance with federal, state, and local policy and regulation. Evaluate (at least yearly) the IACUC workload in regard to timely and thorough review.

(8) Related university policies

(a) Policy on misconduct in research

(b) "Bowling Green State University Animal Welfare Assurance: Assurance Number: A3536-01''

(9) Related government policies and guidance

(a) USDA. Animal Welfare Act as amended. 7 USC, 2131-2156.

(b) "Animal and Animal Products." Title 9. C.F.R.

(c) "Public Health Service Policy on Human Care and Use of Laboratory Animals." Washington, DC: US department of health and human services.

(d) Guide for the care and use of laboratory animals, eighth edition. National research council. Washington (DC): locational academies Press; 2011.

(e) "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training". Published in the Fed. Reg., May 20, 1985, vol. 50, no. 97, by the office of/science and /technology policy.

Date: March 23, 2015

Effective: 5/6/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345

3341-7-09 Use of controlled substances in research.

(A) Policy statement and purpose

Controlled substances are drugs which are regulated by the DEA and the Ohio state board of pharmacy because of potential for abuse. This policy describes the responsibilities of the investigators who use controlled substances in research and the investigators' responsibilities to comply with state of Ohio and DEA requirements concerning the administration, handling, storage, destruction and/or transfer of controlled substances.

(B) Policy

(1) Policy scope

While controlled substances are infrequently purchased by BGSU for research purposes, there are several units on the BGSU campus that hold DEA licenses. This policy has been created to ensure that BGSU and its investigators are in compliance with the federal and state laws governing controlled substances, thus minimizing risk to the university.

Controlled substances are designated by the DEA as schedule I - V according to their medical use, potential for abuse, and safety or dependence liability. Each controlled substance, or basic class thereof, has been assigned an "Administration Controlled Substances Code Number" for purposes of identification of the substances or class on certain certificates of registration issued by the administration pursuant to 21 CFR 1301.35 and on certain order forms issued by the administration pursuant to 21 CFR 1305.05.

(a) Schedule of controlled substances ( 21 CFR 1308 )

Schedule I substances have a high potential for abuse and no accepted medical use in treatment in the United States. Examples of schedule I substances include heroin, lysergic acid diethylamide (LSD), and methaqualone.

Schedule II substances have currently accepted medical use in treatment in the United States; however, they have severe restrictions, due to their high potential for abuse, which may lead to severe psychological or physical dependence. Examples of schedule II substances include pentobarbital, morphine, cocaine, and methadone.

Schedule III substances have currently accepted medical use in treatment in the United States and less potential for abuse the substances listed in schedule I and II. Abuse may lead to moderate or low physical dependence or high psychological dependence. Ketamine, codeine and hydrocodone are examples of schedule III substances.

Schedule IV substances have accepted medical use in clinical treatment and a lower potential for abuse relative to substances in schedule III. Abuse of Schedule IV substance, however, may lead to limited physical dependence or psychological dependence. Examples of drugs included in schedule IV are midazolam, lorazempam, and phenobarbital.

Schedule V substances have currently accepted medical uses with low potential for abuse. Cough medicines with codeine are examples of schedule V drugs.

(b) Corrective measures

Failure of investigators and authorized individuals to follow the requirements of this policy may result in personal civil and criminal liability under state and federal law and termination of university employment. In addition, failure may result in university disciplinary action under applicable faculty and staff policies.

(2) Policy procedures

(a) University registration requirements

Investigators wishing to apply for DEA licenses for research purposes must obtain approval from their department chair, dean, and the vice president for research and economic development using the "request to apply for DEA controlled substance license" form found on the office of research compliance webpage.

The office of research compliance shall serve as the primary point of contact for Investigators under this policy and will notify Investigators when their request has been approved or denied.

(b) Recordkeeping requirements

Every BGSU investigator holding a DEA license is responsible for maintaining appropriate records and inventories of all controlled substances used in their research at the university.

Federal law requires that all controlled substance records shall be maintained for a minimum of two years from the date of such inventory or records, for inspection and copying by authorized employees of the DEA. If the investigator is required to follow a BGSU archival plan which requires a longer retention period, that policy will also be followed.

BGSU controlled substance records must conform to the record keeping and inventory requirements of federal law and the procedures described below. Controlled substance records include all purchasing records, all administration, use and destruction records, all controlled substance ordering forms (DEA form 222), and all inventory records. Investigators who purchase controlled substances are responsible for maintaining the DEA Form 222s and individual purchase invoices associated with such purchases. All investigators are responsible for maintaining the use, administration, transfer and waste/destruction records required by the processes described in this policy below.

Records pertaining to controlled substances in schedules I and II must be maintained separately from all other records of the investigator registrant/licensee. Records for schedule III, IV, and V controlled substances must be maintained separately from all other records of the registrant/licensee.

Federal and state law and this policy require that controlled substance records must be made available immediately upon request by the U.S. department of justice drug enforcement administration, the state medical board of Ohio, and the office of research compliance.

(c) Investigator procedures

Investigators are responsible for managing the use of controlled substances in their laboratories. In the event that investigators are on leave or are absent, they may designate an authorized individual to carry out the duties on their behalf.

(i) Purchasing records

Investigators are responsible for obtaining and maintaining the following information for all controlled substance purchased:

(a) A copy of the invoice

(b) A copy of the purchase order

(c) A copy of the shipping document

(d) A copy of the packing slip

(e) The name, adressm and DEA number of the company from which the controlled substance was purchased

(f) The name of the controlled substance purchased

(g) The size and strength of the controlled substance purchased

(h) The amount purchased (which should match the amount received)

All purchases must be made through FMS. The purchasing record (invoice, purchase order, shipping document, or packing slip) must be annotated with the handwritten date of receipt. Investigators purchasing schedule I or II controlled substances are required to maintain a copy of the invoice and individual DEA Form 222 for each purchase. Investigators purchasing schedule I or II controlled substances must also complete a Record of DEA Form 222 Use to maintain accountability for all DEA Form 222's used.

(ii) Inventory records

Maintaining an accurate inventory for controlled substances is essential and mandatory, as this is a key to detecting loss and theft. In following best research practice, Investigator controlled substance inventories should only include the minimum amount necessary for research use.

Complete DEA inventory requirements can be found at the following site:http://www.deadiversion.usdoj.gov/21cfir/cfr/1304/130411_.htm .

(iii) Administration/use/waste records

Investigators must maintain administration/use records containing the following information:

(a) How the investigator administered/used the controlled substance

(b) The date administered/dispensed

(c) If not administered/used personally by the registered investigator, the initials of person who administered/used under the direction of the investigator

(d) The name of the controlled substance

(e) The strength and size of the controlled substance

(f) The amount administered/used/wasted (number of units or volume)

(iv) Storage and security processes

Security depends greatly on the type, quantity, and form of controlled substances being used in a research project. Schedule I, II, III, IV, and V controlled substances must be stored in a locked steel cabinet or a locked substantially constructed cabinet. Controlled substances should not be located near a glass panel where they can be visible from the outside.

Researchers must provide effective controls to guard against theft of controlled substances, such as limiting the number of keys and the number of employees who will have access to these keys, securing keys when not in use, and developing a key accountability standard operating procedure.

(v) Disposal

To minimize waste, investigators with research registrations/licenses should only purchase and store those quantities of controlled substances that they reasonably intend to use. Damaged, expired, unwanted, unusable, or non-returnable controlled substances must be accounted for, retained, and disposed of in accordance with applicable state and federal regulations.

A registrant's inventory of drugs surrendered (DEA Form 41) must be completed prior to disposing of any DEA controlled substance. Two copies of the form must be sent to the local Ohio DEA branch and one copy must be retained by the investigator for at least five years.

Investigators must maintain disposal records with the following information:

(a) The investigator's DEA number, name, and address

(b) If a reverse distribution (see below) is done, the reverse distributor's DEA number, name, and address

(c) The number of units (in finished forms and/or commerical containers) disposed of in any manner, including the manner of disposal The disposal record must be dated to reflect when the products were sent for destruction and left the investigator's inventory.

(vi) Disposal options

There are two disposal options for expired or unwanted controlled substances:

(a) Contact the supplier:

Some suppliers will take back pharmaceuticals for credit. If possible, this is the best means of controlled substance disposal.

(b) Reverse distribution:

For large quantities (greater than one pound), contact a reverse distributor. This option transfers ownership of the controlled substance to a DEA-approved pharmaceutical returns processor for re-use, re-sale or destruction at a hazardous waste incinerator. This process may involve the completion of DEA form 222 or DEA form 41.

(c) Surrender to DEA:

This is a service that the DEA provides to registrants enabling them to clear their stocks of unwanted items. Follow the instructions for completing DEA Form 41.

(vii) Transfer of investigators from the institution

Controlled substances purchased by Investigators conducting research are the property of Bowling Green state university. Investigators who plan to leave the university (e.g. accept a position at another university, retire, etc.) must contact the office of research prior to their departure to arrange appropriate transfer or disposal of the controlled substances.

(viii) Spills

Breakage, spills, or other witnessed controlled substance losses do not need to be reported. This type of loss, however, must be documented by the registrant and witness on the inventory record. Controlled substances that can be recovered after a spill, but cannot be used because of contamination (e.g., tablets), must be placed in the disposal/destruction waste stream as described in paragraph (B)(2)(c)(v) of this rule , . If the spilled controlled substance is not recoverable (e.g. liquids), the registrant must document the circumstances in their inventory records and the witnesses must sign.

(ix) Theft of or missing controlled substances reporting

Investigators must maintain complete accountability of all controlled substances stored or used in their laboratory. This makes keeping good records essential so that any shortages or missing controlled substances will not go unnoticed. Theft or misuse of a controlled substance is a criminal act that must be reported to the following agencies and offices:

Ohio state board of pharmacy

(614) 446-4143 (phone)

DEA Columbus resident office

(614) 255-4200 (phone)

Bowling Green state univeristy police

(419) 372-2346 (phone)

Office of research compliance

(419) 372-7716 (phone)

In addition to the immediate phone reporting, a report of theft or loss of controlled substances form (DEA form 106) must be completed and submitted to the Ohio DEA office. Investigators must keep one copy of any DEA form 106 submitted to the DEA for at least five years.

Online reporting to the DEA is also necessary if small quantities of controlled substances become unaccounted for on a re-occurring basis. The online reporting process can be accessed at http://www.deadiversion.usdoj.gov/21cfrreports/theft/index.html.Investigators should print and keep one copy of any online DEA form 106 submitted in their controlled substance inventory records.

(x) Other pertinent record information

(a) Maintain current, complete and accurate records to reflect controlled substances

(i) received (purchased),

(ii) sold (administered and dispensed),

(iii) otherwise disposed of,

(iv) theft or loss

(b) Separate records are required for each research location

(c) Separate records are required for each independent activity for which an investigator is registered.

When recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution on any documents of transfer (e.g. invoices or packing slips).

(d) Resources for investigators

(i) BGSU forms

This form is used to request institutional permission to apply for a DEA controlled substance license:

(a) Request to apply for DEA controlled substance license

(ii) DEA forms

These forms will be used to log the purchasing, administering, dispensing, and inventory of controlled substances possessed by BGSU investigators holding DEA research registrations:

(a) Registrants inventory of drugs surrendered (DEA form 41)

(b) Report of theft or loss of controlled substances (DEA form 106)

(c) DEA order forms request (for DEA form 222)

(iii) Manuals

DEA practictioner's manual

(iv) Controlled substances links

(a) Code of federal regulations schedule of controlled substances

(b) U.S. department of justice drug enforcement administration office of diversion control

(c) DEA security regulation ( 21 CFR 1301.71 thru 21 CFR 1301.76 )

(e) Policy definitions

Controlled substances: Drugs that are regulated by the federal drug enforcement administration and the Ohio state board of pharmacy because of potential for abuse.

DEA: The federal drug enforcement administration.

Investigator: A Bowling Green state university faculty or staff member using controlled substances for research purposes. This person is the lead scientist for a particular project.

Authorized individuals: Bowling Green state university lab personnel who handle or manage controlled substances on behalf an investigator. Authorized individuals are trained in shipping, receiving, security, inventory, and record keeping by the investigator.

(f) Implementation of policy

WHO

TASK

Vice president for research and economic development

* Oversight and enforcement of this policy.

Research compliance officer

* Maintaining records (e.g., copies of controlled substance licenses, the purpose of the license, and individuals working under the license). " Monitoring by conducting annual reviews to assure compliance with this policy. " Makes all records available to the vice president for research and economic development. "Annually providing a report to the vice president for research and economic development which contains the information found during annual inspection.

* Serves as "Approver" for all controlled substances in FMS.

Investigators

* Ensuring the appropriate purchase, use/administration, storage, destruction, and transfer for controlled substances. " Maintaining all required controlled substance recordkeeping. " Providing controlled substance documentation to the state, federal and university oversight entities listed in this policy. " Notifying the department chair/school director and office of research compliance of all controlled substance licenses, the purpose for holding the license, and the individuals working under the license. " Ensure that all requests to purchase controlled substances are made through FMS.

Date: March 23, 2015

Effective: 5/6/2015
Promulgated Under: 111.15
Statutory Authority: 3345
Rule Amplifies: 3345