Chapter 3: Part II
ARTICLE I. University Policies on Research and Scholarship
This section contains four university policies governing aspects of university activity in research and scholarship. They are:
- Case Western Reserve University Intellectual Property Policy;
- University Policy on Involvement of Human Participants in Research, Training, Demonstration, and Related Activities;
- University Policy on Authorship and Copyright;
- University Policy on Equipment Transfer; and
- Guidelines on Technology Transfer Operations Involving Non-University Personnel on University Premises.
As notes in the texts of the policies themselves, further information about research related matters can be obtained from the Office of Research Administration. Formulating and recommending policy on research and scholarship is a responsibility of the Committee on Research of the Faculty Senate. Its membership includes the dean of graduate studies and research, nine elected faculty members, and three elected student members.
Case Western Reserve University is a privately financed institution devoted to teaching, research, and other scholarly activities benefiting the public. The university faculty, staff, and students, as part of their normal professional activities, conduct research that may be of significant benefit to the public and that merits development of its commercial potential. The University supports such research from its own resources; corporations, foundations, and governmental entities also provide funding for such research ("external funding"). The sponsors of external funding impose a variety of contractual terms on the University in connection with their financial support, including requirements regarding disclosure of matters pertaining to the research supported by external funding and allocation of the rights to inventions and discoveries produced by such research (collectively such inventions and discoveries are referred to herein as "applications"). These contractual terms are especially important in connection with those applications with commercial potential. This policy is therefore intended to provide an equitable and orderly procedure to promote the commercial development of applications while also maintaining compliance with the rights and duties associated with the external funding supporting it. The further purpose of this policy is to contribute to the promotion of a culture and spirit of innovation, creativity, imagination, dynamism, and scholarship that characterizes a research university.
- Intellectual Property
For purposes of this policy, except as provided below, "intellectual property" includes any research results having potential commercial value produced by university faculty, staff, and students in connection with activities funded by the University and/or by external funding or using university employees, facilities, or equipment, including but not limited to any inventions, computer programs or other software, data bases, any information or material subject to copyright under the laws of the United States or any other government, trade secrets (as defined in the Ohio Uniform Trade Secrets Act) and know-how related to inventions.
Notwithstanding the foregoing, intellectual property does not include books (or textbooks), articles, novels, poems, psychological and educational tests and measures and educational software, musical works, dramatic works including any accompanying music, pantomimes and choreographic works, pictorial, graphic and sculptural works, motion pictures, audio-visual works, and sound recordings, regardless of whether such exempt materials were produced in connection with the use of university facilities, staff, or equipment. This policy does not apply to educational software.
- Objectives of the Policy
- To promote creative intellectual effort by university faculty, staff, and students for the purposes of developing the commercial value of intellectual property.
- To establish principles for recognizing the rights of the creators of intellectual property, the sponsors of external funding, and the University.
- To provide means to determine the commercial potential of intellectual property and to promote the commercialization of such intellectual property for the benefit of its creators and of the University.
- General Provisions
The University owns title to intellectual property except as otherwise contractually provided, whether such contractual provisions are associated with external funding or otherwise. This ownership helps further the University's academic mission in that it promotes research, the dissemination of knowledge, and the well being of society in general. University ownership of intellectual property expedites commercialization, and ownership is often a condition of external funding; indeed the Bayh-Dole Act requires it for research funded by federal agencies. The benefits accruing to the University as a result of its ownership of intellectual property benefits its faculty by increasing the resources available to (1) promote the commercialization of intellectual property, thus providing royalties and other benefits to faculty and staff, and (2) advance the long-range development of departmental capabilities and of the University.
The University recognizes that if creative intellectual effort is to be fostered and stimulated, there must be a fair appraisal of rights to intellectual property and a funded mechanism for commercializing intellectual property. In order to recognize the interests of the appropriate parties, it is necessary that faculty, staff, and students who develop intellectual property during their association with the University cooperate with the University in defining and securing the rights to such intellectual property and assist in the University's commercialization efforts as requested by the University. In order to achieve protection and commercialization of intellectual property, the creator shall provide the vice president for research and technology management or his or her representative with a statement disclosing the intellectual property and the circumstances under which the intellectual property was conceived with particular reference to (a) whether the project or program from which the intellectual property derived was financed in whole or in part by a grant or contract, and if so, the name of the funding entity; (b) whether the intellectual property falls within the creator's activities and responsibilities for the University; and (c) whether university funding, equipment, staff, or physical facilities were employed in the process of developing the intellectual property. This should be done as soon as the creator is aware of the novelty and potential value of the intellectual property.
The vice president for research and technology management, or his or her designee, shall make a decision whether or not the University elects to pursue the commercialization of the intellectual property and shall inform the creator or creators of the disposition of said intellectual property within 120 days of receiving all information necessary for a complete disclosure. In cases where the university elects to pursue commercialization of the intellectual property, the Office of Technology Transfer shall incur the costs of protecting (through patenting, trademark, or copyright as necessary) and marketing the intellectual property to interested potential licensees. The Office of Technology Transfer is obligated to pursue commercialization expeditiously and in consultation with the creator(s). In cases where the University elects not to pursue commercialization of the intellectual property, subject to funding and governmental restrictions and in accordance with Sections 6 and 9 of this policy, said intellectual property shall be released to the creators at their request.
- Distribution of Rights
- Intellectual property may result from research falling generally into one or more of the following categories: (i) supported wholly or in part by university funding or use of university facilities, staff, or equipment; (ii) financed wholly or in part by a government grant or contract; (iii) financed wholly or in part by an industrial corporation or other private source under contract or written agreement; or (iv) conducted wholly on the creator's own time, at the creator's expense, and without use of university facilities, staff, or equipment. Intellectual property arising from research conducted wholly on the inventor's time and at the inventor's expense is not a product of university funding. In all categories other than category (iv), all rights to the intellectual property have automatically been assigned to the University by reason of this policy and the creators, whether staff, students, or faculty, shall be obligated to execute any documents necessary to reflect such assignment of all rights to intellectual property to the University and to participate as necessary and appropriate in the acquisition and protection of proprietary rights to the intellectual property.
- The University is obligated to report to the appropriate government agency all intellectual property that has been derived from government funding in whole or in part for definition of the government's rights and interests. This definition can result in: (i) a release of the intellectual property to the University (also see Section 6), with the government retaining a non-exclusive, non-transferable, royalty-free license (i.e. the normal course); or (ii) the government acquiring and reserving to itself specific rights.
- Rights with respect to intellectual property that is financed by industrial corporations or other private sources or that results from joint work with persons or agencies outside the University are governed by the terms of contracts or agreements with the corporation or agency (also see Section 6). The responsible investigator is responsible for informing all persons working on the project of their rights and obligations under such contracts or agreements before initiation of the research.
- The University assumes no right or responsibility with respect to intellectual property coming within clause A(iv) above. However, to be sure that there is no disagreement over whether intellectual property falls within that clause and for a creator to secure ownership rights with respect to such intellectual property, the creator must notify the vice president for research and technology management, or his or her designee, of the intended disposition of said intellectual property and request and obtain a waiver of university ownership prior to engaging in any commercialization activities of such intellectual property, including application to obtain property rights through patenting, etc. If the creator and the University mutually agree, the creator may assign the intellectual property to the University and thus avail himself or herself of the commercialization services of the University. (Complete information on these services is available from the vice president for research and technology management.)
- This policy applies to post-doctoral scholars, research associates, senior research associates, research and clinical faculty, and visiting faculty and scholars in the same way that it applies to faculty.
- General Provisions
Disclosures of intellectual property must be made by creators to the vice president for research and technology management or his or her designee. In all cases where rights to intellectual property reside with the University, the vice president for research and technology management or his or her designee shall decide, in consultation with the creator(s), whether the intellectual property shall be commercialized by or through the university (or through an external source acting as agent for the University) or offered for release to the creator(s).
When the intellectual property is offered for release to the creator(s), they must inform the vice president for research and technology management, or his or her designee, in writing if they wish to pursue commercialization of the intellectual property on their own. The University shall release the intellectual property to the creator(s), except in cases where one or more of the following conditions prohibits such release: 1) federal regulations governing the intellectual property prohibit such release; 2) release of the intellectual property in question would create an undue liability or risk for the University, due to the potentially dangerous or inappropriate way(s) in which the intellectual property could be used; 3) the intellectual property in question is not yet developed to a point where its commercialization potential can be determined or maximized.
Irrespective of which alternative may be selected, wherever federal funding is involved in the development of the intellectual property, the U.S. government shall generally retain as a minimum the right to a royalty-free, non-exclusive, irrevocable license throughout the world under any patent which may eventually be issued, as well as the right to take back the intellectual property absent adequate commercial development.
- Maximizing Commercial Potential of Intellectual Property
A viable technology transfer operation generates significant benefit to faculty, staff, and students of a university. In addition to providing a mechanism for transfer of knowledge and discoveries from research to commerce, a technology transfer operation also increases researchers' exposure to commercial entities, thus increasing the potential for sponsored research. A world-class technology transfer operation helps the University to recruit and retain the best research talent. There is direct benefit derived from the license income and start-up companies created by technology transfer activities, in terms of income for creators and their departments, and job creation for the local community.
Start-ups of new technology-based business ventures are among the pathways for transferring university ideas to practical application and public benefit. Faculty participation in such business ventures is premised on the strong affirmation that a faculty member's primary loyalty and attention must be given to the role of teacher and scholar. Properly managed, however, appropriate participation in such ventures can provide a special channel of intellectual satisfaction for faculty members wishing to play a role in seeing their research results converted to practical products. Such ventures also provide the opportunity for financial rewards to participating faculty, their department or school, and the University, through equity and/or royalty participation in the start-up granted in return for license of intellectual property rights.
The vice president for research and technology management, or his or her designee, shall monitor all such start-up arrangements in consultation with the appropriate department chair or division head having administrative oversight over the faculty member involved in a startup; and the management center dean and shall submit a written report annually of his or her findings to the provost. In the event that the interested party (faculty member) involved is a chair or division head, the vice president for research and technology management, or his or her designee, and the management center dean shall select another administrator to consult with the vice president for research and technology management.
To expedite the flow of intellectual property into the stream of commerce and hence ensure maximum benefit to the public, the creators, and the University, the University shall invest in the establishment of its own commercialization capabilities and may also develop relationships with several licensing institutions, economic development centers, and other organizations to realize the commercial benefit of this intellectual property. The establishment of such an organization will be partially funded by proceeds derived from technology transfer activities, as outlined in Section 8.
- Division of Income
Unless contractually agreed otherwise in advance, the net income received by the University in the form of royalty payments or other earnings on the intellectual property shall be allocated as specified below. "Net income," as used here, means the income which remains after deducting from gross income the expenses for external marketing, legal, intellectual property protection, travel, litigation, consulting payments, and/or fees due to third parties as a result of their support of research or commercialization of the intellectual property and other services and expenses directly related to the intellectual property in question or commercialization thereof. The deductions shall be reasonable and fair and shall be properly disclosed on a periodic basis to the creator(s) and the relevant department chair and dean. In no event shall payments for research activities be deemed to be part of 'net income' for purposes of distribution to creator(s).
Net income up to $100,000 shall be divided equally between the University and the creator(s). When net income exceeds $100,000, a fifteen percent (15%) administrative charge to defray the expenses of general operation and services of the Office of Technology Transfer shall be deducted; and the remainder shall be divided equally between the University and the creator(s). Unless otherwise agreed in writing, the University's share of net income shall be divided equally between the University and the school of the creator(s). The allocation of net income between units with the school shall be specified in an agreement signed by the creator(s) and the dean. This allocation remains the same if the creator(s) should leave the University.
If there should be a plurality of creators, that part of the income accruing to the creators shall be distributed as specifically requested in writing by all the creators involved in that disclosure, typically as specified in the original invention disclosure forms used by the inventors in their disclosure to the Office of Technology Transfer. In case of dispute among the creators, the allocation shall be determined by the vice president for research and technology management, who shall make the final decision.
Where intellectual property has been developed with federal grant support, the University and its researchers are bound by the terms of the grant agreement. Those terms supersede this policy to the extent this policy is inconsistent with them. If a grant agreement reduces the amount of earnings that can be shared with a creator, the percentage of gross proceeds contributed to the operation of the technology transfer office shall also be adjusted on a pro rata basis.
The principle of sharing financial rewards of commercialization with the creators of intellectual property also applies when those rewards are in the form of equity participation in a company. However, it should be noted, because of the complexity of business start-up arrangements, the precise division of benefits will have to be negotiated on a case-by-case basis, particularly when faculty may have a continuing role in the company.
- Intellectual Property Created by Staff Within Scope of Employment
Intellectual property created by staff within the normal scope of their employment shall be owned by the University by virtue of the employment relationship and therefore shall not be subject to the division of income provisions of this policy. Other intellectual property created by staff is subject to this policy.
- Release to Creator of University-Owned Intellectual Property
In the event that the University releases intellectual property owned by the University to the creator(s), the University shall retain a perpetual, non-exclusive, non-transferable, world-wide, royalty free license to use said intellectual property for educational and research purposes of the University and to sublicense it for current or future research in conjunction with the results of such research. The University may set requirements concerning such release as are appropriate, in the judgment of the vice president of research and technology management, to (i) provide for protection of the University's interests should creator seek to utilize university facilities thereafter in relation to the released intellectual property, (ii) preserve any rights of the sponsor, and (iii) protect the University from claims or costs arising from the use of the intellectual property after its release. In the case of software, this policy requires access by specified university personnel to the source code, and the University shall require each person to whom a disclosure is made to execute in advance a binding confidentiality agreement in favor of and enforceable by the creator.
- Individual Agreements
Intellectual property that is the subject of a specific agreement between the University and the creator(s) thereof shall be owned as provided in said agreement. Such agreements by the University and the creators are encouraged. Except where limited by external sponsorship agreements, creators and the University may negotiate individual agreements to govern ownership of intellectual property and any other matters, regardless of the applicability of any other provision hereof. The faculty and the University are encouraged to participate in unique agreements that promote reinvestment of royalties and receivables to further the research and educational activities of the University. In such cases, the University shall match such commitments of the faculty from their portion of the benefits.
- Student Materials
Regardless of use of university facilities, student coursework or other intellectual property shall belong to the student unless created (a) while student is acting as an employee of the University, (b) while student is engaged in research funded by the University or external funding, or (c) as part of a class or other academic project involving a commercial entity's intellectual property, provided that it is announced at the commencement of the project that students will not have ownership of intellectual property created in conjunction with that project.
If faculty or teaching assistants, acting as advisors, assist in the creation of intellectual property and are therefore co-creators (with the student as creator), they may choose to disclose the invention to the vice president for research and technology management, or his or her designee, and avail themselves of the services of the Office of Technology Transfer in commercializing such inventions.
- Role of Faculty Committee
In the event there is a disagreement between the creator and the University regarding the interpretation of this policy or its application, the Faculty Committee on Research or its designated resource group shall be consulted for its advice. This group shall consider all of the relevant facts concerning the development and reduction to practice of the intellectual property and meet with the creator and/or avail itself of appropriate legal assistance if either or both are deemed necessary. The committee shall make its recommendations on the disposition of the case to the president of the University who shall make the final decision.
*Adopted by the Faculty Senate 12/2/02; approved by the Board of Trustees 7/23/03
The promotion of scholarship and the discovery of new knowledge through research are among the major functions of Case Western Reserve University as an institution of higher learning. If this research is to be meaningful and beneficial to humanity, involvement of human subjects as experimental participants is necessary. It is imperative that investigators in all disciplines strive to protect human subjects. University policy and federal regulations demand compliance. Moreover, faculty investigators also have a moral obligation to humankind. The rights of society and the rights of individual subjects must be protected at the same time that investigators are privileged to carry out the mandate to advance knowledge. Research may entail risks to human subjects. Therefore, investigators are obligated to weigh those risks in light of potential benefits to the subject and/or to society.
The Case Western Reserve University Human Research Protection Program (HRPP) covers all human research conducted by any student, employee, faculty member of Case Western Reserve University (CWRU), University Hospitals of Cleveland (UHC) and The MetroHealth System (MHS) as part of his or her job responsibilities with that organization, or any human research conducted by an independent contractor of these organizations as part of the organization's contract. In addition, for any human research in which Case Western Reserve University acts as the grantee, employees of the Louis Stokes Cleveland Department of Veterans Affairs Medical Center (LSCDVAMC) and the Cleveland Clinic Foundation (CCF) are also responsible for complying with the HRPP. Hereafter, these institutions shall be referred to as 'member Institutions' under the Case Western Reserve University HRPP. The following policy statements enunciate the guidelines under which investigations involving human subjects may be pursued through the Case Western Reserve University HRPP:
- Ethical Principles and Regulatory Mandates
Human subject research associated with the Case Western Reserve University HRPP must be carried out in an ethical manner and in accordance with The Belmont Report. In addition, investigators must comply with all applicable federal, state and local regulations that related to the protection of human subjects, including any and all Food and Drug Administration regulations (i.e., 21 CFR 50 and 56) and any and all Department of Health and Human and Services (DHHS) regulations (i.e., 45 CFR 46). Case Western Reserve University maintains a Federalwide Assurance (FWA) with DHHS and applies the requirements of this assurance to all research regardless of funding. Research must not begin until investigators have received review and approval to conduct such research by one of the Institutional Review Boards (IRBs) listed on the Case Western Reserve University FWA. The IRB Advisory Committee (IAC) was created to ensure that oversight of human subject research is appropriate and in accordance with institutional, federal and state regulations and local mandates. It is empowered by this policy to create procedures and programs for the Case Western Reserve University HRPP to accomplish this mission. The provost will act as the institutional official for the Case Western Reserve University HRPP.
"Research" is defined in 45 CFR 46 as "systematic investigation designed to develop or contribute to generalizable knowledge." Therefore, any investigation designed to generate results that could be published (e.g. journal, book, or technical report) or presented at a conference is considered to be research. Research conducted with human subjects for masters or doctoral theses also must receive IRB approval prior to initiation.
"Human subject" is defined in 45 CFR 46 as a "living individual about whom an investigator (whether professional or student) conducting research obtains: data through intervention or interaction with the individual or identifiable private information." See 45 CFR 46 for definitions of "intervention," "interaction," and "private information." Subjects may include, for example, persons involved in behavioral science studies; normal volunteers; donors of services; in-patients and out-patients; living donors of body fluids, organs, and tissues; and members of the general population who may be involved in environmental or epidemiological studies or similar activities.
"Minimal Risk" is defined in federal regulations at 45 CFR 46.102(f) and 21 CFR 56.102(i) as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
- Informed Consent
An investigator may involve a human subject in research only if the investigator has obtained the informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The investigator must provide the information in written documentation, which uses language that is understandable to the subject or representative. The investigator cannot include in the consent process, either orally or in writing, any language through which the subject or representative is made to waive or appear to waive any of the subject's legal rights or which releases the investigator, the sponsor, the institution, or its agents from liability for negligence. Informed consent is a process.
The basic elements of informed consent are as follows:
- statement that study involves research, explanation of purposes of research and expected duration of subject's participation, description of procedures to be followed, and identification of any procedures which are experimental;
- description of risks or discomfort to subject;
- description of benefits to subject or to others;
- disclosure of alternative procedures, if appropriate;
- description of the extent to which confidentiality will be maintained;
- for research involving more than minimal risk, explanation as to whether compensation and medical treatments are available if injury occurs;
- explanation of whom to contact if questions arise about the research, the subject's rights or whom to contact if research related injury occurs; and
- statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefits, and that subject may discontinue at any time.
- Privacy and Confidentiality of Data
University investigators are responsible for protecting the right to privacy of research subjects by safeguarding the confidentiality of all individual data and all data that could in any way be attributed to or used to identify the individuals. Should any investigator be called upon by any individuals or groups, private or public, to reveal research data which would in any way endanger confidentiality, it is his or her obligation to refuse to divulge such information as privileged communication between researcher and subject.
However, the University itself has the right to audit data in order to ensure that human subjects are being adequately protected and that the University is in compliance with the MPA. Those individuals performing the audit are bound by the same rules of confidentiality as the investigator.
- Investigator Non-compliance
All investigators working with human subjects have a responsibility to comply with federal regulations and university policy. Human subject non-compliance is defined as conducting research involving human subjects in a manner that disregards or violates federal regulations governing such research or policies established by the applicable IRB. This can include, but is not limited to, failure to obtain IRB approval for research involving human subjects; inadequate or non-existent procedures for informed consent; inadequate supervision in research involving experimental drugs, devices or procedures; failure to follow the approved version of the protocol; failure to follow recommendations made by the IRB to insure the safety of subjects; failure to report adverse events or proposed protocol changes to the IRB; and continued failure to provide ongoing progress reports.
Per the applicable regulations, IRBs have the authority to review allegations of human subject non-compliance for their particular institution. An IRB may receive allegations in several different ways including, quality assurance auditing reports, subject complaints, internal allegations, or investigator self-reporting. The process by which an IRB reviews allegations should be determined by the seriousness of the allegations and the probability or occurrence of subject harm. It is important to note that harm to subjects is not limited to physical harm, but also includes social/psychological harms such as breach of confidentiality.
- Submitting Research to an Institutional IRB under the FWA
IRBs are charged with reviewing and approving protocols to assure the adequate protection of human subjects.
- Types of Review
Exempt Review. All research involving human subjects must be submitted to the appropriate IRB. Determination of exemption must be made by an appropriate IRB. Research may be exempt from IRB review if it meets the criteria described in 45 CFR 46. FDA regulations do not allow for exemptions for research (except in the case of emergency use of test article), therefore research subject to such regulation cannot be exempt. If a determination of exemption is made, investigators are still responsible for ethical conduct of research with human subjects in accordance with The Belmont Report.
Expedited Review. Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the full IRB. DHHS and FDA regulations specifically define when minimal-risk research can receive expedited review by an IRB.
Full Review. All research that has not received an exemption or expedited review by the IRB must be reviewed by a convened meeting of the IRB where a quorum of voting members is present. Amendments. Investigators wanting to change a procedure in a study that has already been approved must prepare a written description of the change and the reason for the change. Such changes include the entry or enrollment criteria of subjects, procedures for data collection, or some activity or procedure that must be changed due to an adverse event. The IRB will then reassess the balance of risks to benefits. In light of the reassessment, the IRB may require the research to be modified or terminated. Any amendment to a study must be reviewed and approved in accordance with IRB policies prior to initiation of the change.
Adverse Events. An adverse event is defined as any undesirable and unintended (although not necessarily unexpected) impact on the subject, as a result of therapy or other intervention. Investigators must report in writing to the IRB all adverse events in accordance with the IRB's policies and procedures for reporting such events. If during the course of an investigator's approved research subjects experience adverse effects or new knowledge impacts research design, investigators must inform subjects of any information deemed important by the IRB, which may affect a subject's willingness to continue participation.
- Faculty Advisors are Responsible for Student Research
A faculty member assigning research projects involving human subjects must take an active role in assuring that the subjects of student research are adequately protected. The University expects that advisors will take an active part in preparing students for the role of researcher, instructing them in the ethical conduct of research and assisting in the preparation of IRB applications. After protocol approval, the advisor should meet regularly with the student in order to review their work and progress. While a student serves as the primary researcher for the protocol, the faculty advisor is ultimately responsible for the protection of human subjects. A faculty member's signature on the application indicates their willingness to comply with all administrative and federal regulations.
- International Research
All human subject research, regardless of funding, performed outside the United States must obtain appropriate institutional IRB approval according to federal regulations and the FWA. The University recognizes that 'the procedures normally followed in the foreign countries may differ from those set forth in this policy.' The research, however, may be approved if 'the procedures prescribed by the (foreign) institution afford protections that are at least equivalent to those provided in the FWA.'
*approved by the Board of Trustees 3/6/99.
**approved by the Faculty Senate 12/19/05 and the Board of Trustees 2/25/06.
The University should concern itself with matters of authorship, author-university relations, and copyright in order to stimulate faculty interest in creating learning materials and ensure that the learner, the author, and the University appropriately share the benefits of the creativity, money, and energy expended.
To fulfill these purposes, the university policy must be highly flexible and must be incorporated in an administrative process responsive to the needs of the learner, the author, and the unit of the University which sponsors and/or produces the learning material.
Within the context of this policy, the "university unit" is defined as a school, department, center, or other academic organization having an assigned budget or supporting grant. "Learning Materials" may be defined as any copyrightable item which contributes to an educational objective, except that in the process of commercialization computer software other than computer aided instructional material, will ordinarily be treated as an invention or discovery and governed by the "University Policy on the Disposition of Inventions and Discoveries" in this section, notwithstanding the possibility that the software may be protected by copyright.
- University Guidelines on Authorship of Research and Scholarly Publications**
Contributing to knowledge is a core activity of faculty, staff, and students in a research university. Contributions to knowledge are evaluated by the publications produced, regardless of the medium or format. Recognizing that authorship can sometimes be a complex process, Case Western Reserve offers these guidelines for helping faculty, staff, and students navigate authorship issues. For the purposes of these guidelines, publications include any and all articles, abstracts, and/or manuscripts based on original work (research and scholarship) conducted at Case Western Reserve University. These guidelines describe what is expected of faculty, staff, and students in authorship matters and are intended to encourage open communication about authorship issues.
- Purpose of the Guidelines
- Granting agency and public concerns are requiring explicit standards of accountability for all authors of research and scholarly publications.
- In multiple investigator research and scholarly projects, standards are needed so that contributors can anticipate and understand their rights and responsibilities related to authorship or acknowledgment. However, in very large, multidisciplinary, or multi-institutional projects, following these precise guidelines may not be feasible. Nevertheless, scholars are expected to adhere to the spirit of the guidelines.
- Not all contributors in any research or scholarship endeavors have the same role, power, or seniority in relationships. It is necessary to clarify the roles of all those involved and to understand each person's rights and obligations in authorship. The potential scholarly contributions of all collaborators, including students, need to be considered in the decisions of authorship.
- Responsibilities and Criteria for Authorship
- Authorship is attributed to persons responsible for the intellectual content of the publication. Only those who have contributed substantially to the conception, execution, or interpretation of the work, such that they are willing and able to take public responsibility for the publication, should be included as authors. Honorary authorship that is listing someone as a co-author in the absence of substantial intellectual contribution is discouraged.
- All authors must have contributed to developing the manuscript and have read and understood the entire contents of the publication.
- All authors must be sufficiently familiar with the conduct and at least the general interpretation of the research to accept responsibility for its integrity and credibility.
- It is the responsibility of the author corresponding with the journal or conference, or his or her proxy, to ensure that authorship decisions conform to Case Western Reserve University guidelines and ensure that all authors approve the final submission before publication.
- All investigators accepting authorship should also accept the responsibility of avoiding unnecessary duplicate journal publication of similar material. Previous publication should be cited in any repeated use of data or theory, and a new publication should meet the criterion of making a new intellectual contribution to the field.
- In the absence of meeting the above criteria, limited contributions such as provision of standard materials (for example, plasmids, cell lines, tissue, and antibodies), performance of incidental assays or measurements, use of facilities, routine patient care, critical review of the manuscript, providing access to subjects or providing an environment and/or financial support for the research, collecting or analyzing data in a routine format, chairing or advising a dissertation or thesis committee, having an administrative relationship to the research, or contributing to the general intellectual development of one or more authors are insufficient to justify authorship unless the above criteria have also been met but may be recognized by acknowledgment.
For large group projects, it is important at the outset that all members of the research team understand and agree to these principles of authorship. It is also important that procedures for resolving more detailed concerns, such as the timing of presentations or publications, order of authorship, and privilege of presenting results at meetings, be discussed to the extent feasible at the beginning and throughout the work as needed.
- If disputes or questions concerning authorship have not been successfully resolved among members of a collaboration, these disputes or concerns should be brought, by the individual having a concern, for assistance in resolution to the following administrative officials in this order: a) the department chair, division head, or similar first line of academic management; b) the dean; and c) the provost.
However, if these matters involve allegations or evidence of scholarly misconduct or threats of retribution, they must immediately be brought to the attention of the appropriate university official, as per Chapter 3, Part 2, II. Policy for Responding to Allegations of Research misconduct, in the Faculty Handbook. Journals, societies, and conferences may have different authorship policies that are more stringent or more lenient than these guidelines. In such cases, the guidelines expressed in the present document are to be considered as the minimum standards to which all faculty, staff, and students should adhere.
For the purpose of these guidelines, research publications include articles based on original research submitted to journals, abstracts or manuscripts submitted for conference proceedings, or review articles submitted to journals or book publishers.
- Relationship of the Author and the University
- Independently-Authored Learning Material
In the absence of a prior agreement between the author and the University, it is assumed that materials developed through the normal activities of faculty (including sabbatical leave) are the property of the faculty member. He or she shall have full ownership of the copyright in the materials which he or she has prepared, and the University shall have no claim or rights to the material.
If, however, material is developed as a consequence of initiatives taken by others (e.g., department head, curriculum committee, etc.), then the university unit shall be entitled to the royalty free right to its internal use for an indefinite period, even though the faculty member may leave the University.
- University Sponsored Learning Material
Where a university unit sponsors the preparation of copyrightable materials, there is to be a prior written agreement or contract specifying the rights of the author and the rights of the University.
- Where in the preparation of instructional material the author makes extensive use of university personnel and/or facilities without personal charge to him or her, the material shall be considered "university sponsored;" and, depending on the extent and cost of the university facilities and personnel, one of the following conditions will apply:
- The author shall own the copyright, and the University shall have royalty free rights to internal use of the material for an indefinite period, even though the faculty member may leave the University.
- The author shall own the copyright, and the University shall have a royalty free right to internal use of the material and shall be entitled to a percentage of income derived from such material.
- The University shall own the copyright, shall have a royalty free right to internal use of the material, and shall pay the author a percentage of income from the material.
- In all the above cases the author and/or the university unit shall have the right to limit or restrict the use of university sponsored material, and any such restrictions shall be stated in the contract between the author and the university unit.
- When conditions and demand require a revised or subsequent edition, a new contract shall be entered into by the author and the University for revision of the material. If the author declines to revise or fails to complete the revision within the time specified by contract, the university unit may then make arrangements with another person or persons for the revision. In such cases the original author shall retain a partial royalty, as it may be provided for in the original contract or the contract covering the revised edition.
- The author and the university unit may mutually agree to market or license the marketing of university sponsored material for audiences external to the University.
- Any net income which may derive from externally used copyrighted material generally will be divided between the author (or authors) and the University. However, since circumstances will alter the relative equities of the author and the University, the final terms of division in any particular case are to be negotiated at the time a written agreement is developed.
- In the event that the author and the university unit fail to agree on matters of development, production, or marketing of university sponsored learning materials, the author may, upon approval by the University Advisory Committee on Copyright, elect to have the material published or marketed by another organization. In such cases, the University shall receive reasonable compensation, either from the author or from the new agency, for the release of the University's rights to the material.
- University Commissioned Learning Material
Where the author is "commissioned" by a university unit, i.e. given release time from his normal workload to prepare learning material, the University, unless it otherwise agrees in writing, may:
- Copyright the material in its name and may claim absolute and exclusive title to the material or
- Make any other arrangements concerning copyright and concerning the distribution of income derived from that copyright which it deems best.
- Role of the University Advisory Committee on Copyright
- Advise faculty and administrators of the requirements and procedures for establishing, maintaining, and registering copyright.
- Urge faculty to acquire and maintain copyright on all appropriate material which they create independently of the University and, when appropriate, to register the copyright.
- Urge the party (author or university unit) entitled to the copyright of university sponsored material promptly to copyright the material; to maintain copyright; and, as soon as appropriate, to register the copyright.
- Advise faculty and administrators that the "rights-in-data" clause in federal contracts, which can preclude or complicate copyright, can usually be altered at the request of the author and the University and that the University's Office of Research Administration is available for consultation on this matter.
- Hear any disputes which may arise between authors and the University regarding the implementation of this policy. This mechanism shall not preclude use of the grievance provisions of the policies and procedures for faculty members.
- Implementation of the Policy
- Administrative Responsibility
Advice and assistance in obtaining copyright are available to faculty and administrators through the Technology Transfer Office. This office, in taking responsibility for administering the policy, will act as a clearinghouse in referring questions to appropriate internal or external experts so that definitive answers will be obtained. Assistance will also be given in arranging or finalizing contracts or agreements such as specified under 2,b above.
As indicated above (3,e), the University Advisory Committee on Copyright shall review disputes and make recommendations to the Committee on Research as to their settlement.
- University Policy on Custody of Research Data
- Rationale and Purpose of the Guidelines
This policy establishes the assurance that research data are appropriately recorded, archived for a reasonable period of time, and available for review under the appropriate circumstances.
- Research support agencies, journals, clinical care sites, or colleagues in the field may need or be legally entitled to review primary research data well after publication or dissemination of results and will hold the University accountable for the availability of these data.
- Researchers involved in multi-investigator projects have rights to access to data gathered by all members of the group.
- The University may be required to review internally the adequacy and integrity of data if findings of university research are called into question.
- Contact person
Associate Vice President for Research
- Applicability and Definitions
This policy shall apply to all Case Western Reserve University faculty, staff, students, and other persons at Case Western Reserve University involved in the design, conduct, or reporting of research at or under the auspices of Case Western Reserve University or with the use of university resources or facilities. It shall apply to all research projects on which those individuals work, regardless of the source of funding for each project.
Research is defined as "a systematic investigation designed to develop and contribute to generalizable knowledge." Examples of activities that constitute research include any study intended to result in publication or public presentation; any activity resulting in publication or public presentation, even though it involves only review of existing data that were collected with no intent to publish; or any use of an investigational drug or device.
Research data are defined as the material, originally recorded by or for the investigator, commonly accepted in the scientific community as necessary to validate research findings. Research data include but are not limited to laboratory notebooks, as well as any other records that are necessary for the reconstruction and evaluation of reported results of research and the events and processes leading to those results, regardless of the form or the media on which they are recorded.
The principal investigator (PI) is defined as the person responsible for the research or who is the signatory person for sponsored research. Confidential information is specified in the "Case Western Reserve University Intellectual Property Policy" and the "University Policy on the Involvement of Human Participants in Research." For student research involving human subjects, the faculty member who is serving as the responsible investigator with respect to the human subject research is considered the PI.
- Rights and responsibilities
Both the University and principal investigator (PI) have responsibilities and rights concerning access to, use of, and maintenance of research data. The PI is responsible for maintenance and retention of research data in accord with this policy. Case Western Reserve's responsibilities with regard to research data include, but are not limited to:
- Complying with terms of sponsored project agreements;
- Ensuring the appropriate use of animals, human subjects, recombinant DNA, etiological agents, radioactive materials, and the like;
- Protecting the rights of faculty, students, postdoctoral scholars, and staff, including, but not limited to, their rights to access data from research in which they participated;
- Securing intellectual property rights other than copyright;
- Facilitating the investigation of charges, such as research misconduct or conflict of interest;
- Responding to legal actions involving the University related to research carried out under its auspices.
- Collection and retention of research data
Case Western Reserve University must retain research data in sufficient detail and for an adequate period of time to enable appropriate responses to questions about accuracy, authenticity, primacy, and compliance with laws and regulations governing the conduct of the research.
The PI is the custodian of research data, unless agreed on in writing otherwise, and is responsible for the collection, management, and retention of research data. The PI should adopt an orderly system of data organization and should communicate the chosen system to all members of a research group and to the appropriate administrative personnel, where applicable. Particularly for long-term research projects, the PI should establish and maintain procedures for the protection of essential records.
Research data must be archived for not less than three years after the final close-out or publication, whichever occurs last, with original data retained whenever possible. This should include reasonable and prudent practice for off-site back-up of electronic and hard-copy data. Where applicable, appropriate measures to protect confidential information must be taken. In addition, any of the following circumstances may justify longer periods of retention:
- Data must be kept for as long as may be necessary to protect any intellectual property resulting from the work;
- If any charges regarding the research arise, such as allegations of research misconduct or conflict of interest, data must be retained until such charges are fully resolved; and
- If the data involved constitute part of a student's work toward a degree, they must be retained at least until the degree is awarded or it is clear that the student has abandoned the work.
- Transfer in the event a researcher leaves Case Western Reserve University
When individuals involved in research projects who are not PI's at Case Western Reserve University leave the university, they may take copies of research data for projects on which they have worked. The PI must, however, retain original data, at Case Western Reserve University, unless specific permission to do otherwise is granted by the associate vice president for research. In the case of student research where the student is not the PI, the individual who is the PI may allow the student to take the original data (except for original informed consent documents if the study involves human subjects) when the student leaves the university as long as the student signs a written agreement (also signed by the PI and the associate vice president for research or his or her designee) agreeing to accept custodial responsibilities for the data and that Case Western Reserve University will be given access to the data should that become necessary.
If a PI leaves Case Western Reserve University, custody of the data may be transferred as long as there is a written agreement signed by the vice president for research and technology management or his or her designee and either the PI or (in the event the project is moved to another institution) both the PI and the new institution that guarantees:
- acceptance of custodial responsibilities for the data, and
- that Case Western Reserve University be given access to the data should that become necessary.
**approved by Board of Trustees 7/13/05
*approved by the Board of Trustees 8/5/74.
Beyond the period of retention specified here, the destruction of the research record is at the discretion of the PI and his or her department or laboratory.
To enable the University to meet its responsibilities related to custody of research data (as previously described), the PI is obligated, upon appropriate request, to make all data available for review by the University, its officials or bodies, or the external funding agency or journals, or other external regulatory agencies. This obligation continues even after the PI leaves the University.
In group research projects, the PI is obligated to give co-investigators access to the research data or copies thereof for review and/or use in follow-on research, with proper acknowledgment. Data sharing and custody arrangements by co-investigators or group projects should be determined by the investigators when joining the project and preferably defined in a data use agreement.
Research data will normally be retained in the unit where they are produced. Research data must be retained in such a manner that they are accessible for inspection and copying by authorized representatives of Case Western Reserve University at reasonable times and in a reasonable manner.
Approved by the Board of Trustees 5/18/93. Amended by the Faculty Senate 12/14/00 and approved by the Board of Trustees 6/13/01. Amended by the Faculty Senate 2/27/06 and approved by the Board of Trustees 4/26/06; red text approved by the Faculty Senate 4/21/11; pending BOT approval.
As established by the Board of Trustees, current Case policy on equipment transfer includes the following provisions:
- Since grants and contracts are awarded to the University and not to individual faculty members, all equipment purchased under outside sponsorship, unless otherwise specified by the grant or contract, is the property of the University.
- Equipment purchased under grants and contracts is intended for use in the research and educational programs of the University.
- When a faculty member leaves the University for another academic position, it is anticipated that equipment which has been purchased will usually continue to be needed in the ongoing research and/or educational activities of the specific department concerned and will therefore remain at the University.
- Where a faculty member requests that certain specialized items of equipment be made available for transfer to the new institution, exceptions to item 3 above will be considered by the department chair and dean. If in their judgment the equipment in question is of such a nature that it will not be put to good use following the departure of the faculty member, it may be recommended for transfer to the new institution. If the equipment was purchased under a grant or contract, the grant or contract must be reviewed since the grant or contract may prohibit or require transfer of the equipment.
- Since university property cannot be given to another institution by a dean, department chair, or faculty member, the recommendation of the dean is subject to final approval of the university vice president (acting on behalf of the Board of Trustees). He or she will consider these recommendations when the new institution has formally requested transfer of specific items of equipment.
- Transfers of equipment for reasons other than the relocation of a faculty member to another academic institution are also subject to the procedures in items 4 and 5 above. The transfer request should include the proposed disposition of the equipment, the reasons why the equipment should be disposed of, the original funding source, and a statement that the terms of any grant or other source do not prohibit such a disposition.
*adopted by the Board of Trustees 7/5/67; amended 12/8/69
As part of the process of bringing the practical benefits of university research into widespread societal application, it may be necessary that personnel not on the university payroll (outside personnel) from organizations commercializing or otherwise applying these results (sponsoring organizations) be allowed to work temporarily within university facilities to learn and develop needed techniques. However, it is important that such interactions be conducted on a scale, and in a framework of defined guidelines, so that they do not disrupt academic activities and do not allow any use of university or governmental assets to benefit sponsoring organizations without appropriate compensation and only under written agreements.
The following guidelines will govern such interactions at Case Western Reserve University:
- Faculty involvement with outside personnel must be at a scale and character that it does not cause disruptions in the primary role of university teacher and scholar. If time commitments are to exceed levels compatible with full-time commitment to the university faculty role, these must be designated in written agreements with which the faculty dean and department chair concur.
- The time period during which outside personnel will be permitted to work within university academic facilities will be strictly limited to a time defined by a specific work plan for technology transfer steps and training. All such arrangements will be reviewed annually by the dean of graduate studies and research and the cognizant department chair and management center dean.
- In these interactions, there must be no conversion of university facilities, or staff or student effort, to the benefit of the sponsoring organization unless this support is paid for at normal rates and arrangements and expectations are detailed in written agreements with the University. It will be especially important to ensure that student and faculty freedom of choice in determining project and research interests is not limited by the relationship with the sponsoring organization.
- In determining the terms of the agreements, such sponsoring organizations will be treated no more favorably than we have treated and/or are prepared to treat federal or other research agencies or any other organizations wanting to work with the University on research and technology transfer projects which conform to our guidelines. A faculty and/or university equity role in the sponsoring organization will not be used as a rationale to provide terms more favorable to it than we would offer to organizations without such linkages to us.
- There will be no conversion of government, foundation, or any other grant or contract support or results to the benefits of the sponsoring organization unless specified in a written agreement and in compliance with the policies of the agency providing that grant or contract support.
- All university personnel and/or students whose efforts are covered in whole or in part by agreements with the sponsoring organization will be made aware of that fact and of the obligations and limitations of those agreements.
- Any charges related to the activities of outside personnel will be paid for from specific accounts set up for those purposes, and funds received from the sponsoring organization for expenses related to agreements with it will be deposited in these accounts. Charges and funds related to the activities of the outside personnel will not be commingled with other university funds or channeled through unspecified discretionary accounts.
- Outside personnel will carry out activities in university academic laboratory space only for agreed and limited periods in order to facilitate effective technology transfer and scale-up from the academic laboratory to commercial scale activities. While operating in university academic laboratory space they will be treated and regarded as visitors, not university employees. The University will accept no liability related to their presence on university premises. They will comply with such working guidelines as the university, laboratory head, and/or department chair may require to ensure that their presence does not disrupt academic functions and that the principles 1-7 above are not violated. They will also comply with all regulatory requirements governing Case Western Reserve research, including those governing laboratory safety, hazardous material use and disposal, and animal care and use.
- These guidelines will apply equally to all such arrangements with sponsoring organizations, whether or not university faculty or the university itself have equity or other roles in the sponsoring organization or receive any financial rewards from the application of the research results transferred.
*Approved by the Board of Trustees 6/25/94.