1. Financial Conflict of Interest in Research
2. Scientific Misconduct
3. Intellectual Property
4. Human Subjects
5. Animal Welfare
6. Subcontractor Regulations

A.  Policy on Financial Conflict of Interest in Research

Statement of Need and Purpose: Externally sponsored research is a vital part of the Keene State College mission. As this activity grows in sophistication and complexity it may intersect increasingly with industrial explorations and entrepreneurial ventures, creating for investigators the potential for conflicting interests.

A conflict of interest exists when it can be reasonably determined that an investigator's personal financial concerns could directly and significantly influence the design, conduct, or reporting of sponsored research activities. Faculty and staff of the College have an obligation to scrupulously maintain the objectivity of their research, avoiding any conflict of interest.

Keene State College has developed this policy to protect the integrity of sponsored research and to comply with federal regulations. It is the intent and policy of KSC, as an institution of higher education in receipt of federal research support, to comply with present and future regulations. To that end, this policy is subject to further refinements as other rules are published.

Specifically, the intent of this policy is to identify and eliminate or manage any possible threat to research objectivity at KSC. The main components are disclosure of investigators' financial interests that might be affected by the research, and application of methods to minimize or eliminate the risks associated with such connections. It is not meant to discourage, but rather to safeguard the pursuit and dissemination of knowledge.

Applicability: This policy became effective October 1, 1995 and applies to any employee of KSC who is responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources. The policy also includes the investigator's immediate family, which is defined as his/her spouse or domestic partner and dependent children.

Principal Investigators and/or Project Directors are responsible for ensuring that all participants in a project who are responsible for the design, conduct, or reporting of the research disclose any significant financial interests that would reasonably appear to be affected by the research. Individuals who come to work on an established project through reallocation of effort, hiring, transfer, promotion, etc., and thereby take on a responsible position in a project, must also disclose any such significant financial interests.

Collaborators, subcontractors, subrecipients, and visiting scientists must either comply with this policy or provide a certification to the KSC Director of Research and Sponsored Projects that their institutions are in compliance with pertinent federal policies and that they in turn are in compliance with their own institutional policies. Subcontractors from commercial firms need make a certification only when the prime award is from the Public Health Service.

Significant Financial Interests: Any KSC employee responsible for the design, conduct, or reporting of research activities funded or proposed for funding by external sources must reveal all current significant financial interests that would reasonably appear to be affected by the research.

Significant financial interest is defined as any current financial interest of the investigator and his/her immediate family that could reasonably appear to be affected by the activities proposed for funding; or any interest held by the investigator and his/her immediate family in a business entity (company, corporation, or other enterprise) whose financial interests might reasonably appear to be affected by such activities.

Specifically, significant financial interests might include, but are not limited to, any of the following:

• Anything of significant monetary value, including salary or other payments for services, such as consulting fees or honoraria;
• Direct equity interests, such as stock, stock options, or ownership interests;
• Intellectual property rights owned by the investigator, such as patents, copyrights, and royalties from such rights.

The term does not include:

• Financial interests in business enterprises or entities that when aggregated for the investigator and his/her immediate family meet both of the following tests:
  1. the financial interest does not exceed $10,000 in value as determined through reference to public prices or other reasonable measures of fair market value, and
  2. the financial interest does not represent more than a five percent ownership interest in any single entity;
• Salary, royalties, or other remuneration from KSC;
• Salary, royalties, or other payments that when aggregated for the investigator and his/her immediate family, are not expected to exceed $10,000 during the next twelve month period;
• Income from seminars, lectures, or teaching engagements sponsored by public or nonprofit entities;
• Income from service on advisory committees or review panels for public or non-profit entities.

An investigator may choose to disclose any other financial or related interest that might present an actual, potential, or perceived conflict of interest. Disclosure can be a key factor in protecting an individual's reputation and career from potentially harmful allegations of misconduct.

Disclosure Process: All Disclosure Statements and related documents are considered sensitive information and only those persons involved in the implementation of this policy will have access to such records.

Each investigator who has significant financial interests possibly affected by the research must complete a Keene State College Financial Disclosure Statement and attach all required supporting documentation. In addition, the investigator must submit a proposed conflict of interest management plan that details steps that could be taken to manage, reduce, or eliminate any conflict of interest. The form, documentation, and plan should be submitted in a sealed envelope marked confidential to the Director of Research and Sponsored Projects.

All significant financial interests must be disclosed prior to the time a proposal is submitted. All financial disclosures must be updated by investigators during the period of the award as new reportable significant financial interests are obtained.

Review of Disclosures: A Disclosure Review Committee (DRC) will review all disclosure statements. The committee will be chaired by the Vice President for Academic Affairs. The President will appoint three additional faculty members representing the diverse colleges, schools, and programs of KSC. Members will serve three year staggered terms.

The Committee will be responsible for determining whether the significant financial interests of the investigator could reasonably be expected to affect the design, schedule, conduct, or reporting of the activities funded or proposed for funding. The Committee may request additional clarifying information from the individual which will be treated as non-public information to the extent allowed by law.

Management Plans for Conflict: The Committee will review the proposed conflict management plan and approve it or add conditions or restrictions to ensure that any conflict is managed, reduced, or eliminated. Such conditions or restrictions may include, but are not limited to, the following:

• Public disclosure of significant financial interests;
• Monitoring of the research by independent reviewers;
• Modification of the planned activities (possibly subject to sponsor approval);
• Disqualification from participation in all or part of the project;
• Divestiture of significant financial interests;
• Severance of relationships creating conflict.

In all cases, resolution of the conflict or establishment of an acceptable conflict management plan must be achieved before expenditure of any funds under an award.

Appeals: Appeal of the Disclosure Review Committee's decision may be made to the College President, who will consult with the investigator and the Committee and make a final determination.

Compliance: As part of the Financial Disclosure Statement each investigator must certify that if the Disclosure Review Committee determines a conflict exists, the investigator will adhere to all conditions or restrictions imposed upon the project and will cooperate fully with the individual(s) assigned to monitor compliance.

Enforcement: Failure to properly disclose relevant financial interests or to adhere to conditions or restriction imposed by the Disclosure Review Committee will be considered a deviation from accepted standards of conducting research at KSC.

Alleged violations of this policy will be investigated by the Disclosure Review Committee which will make recommendations for action to the President. Breaches of policy include failure to file the necessary disclosure statements; knowingly filing incomplete, erroneous, or misleading disclosure forms; or failure to comply with procedures prescribed by the Committee. If the President determines that the policy has been violated, he/she may impose sanctions including notification of sponsor and termination of award; formal admonition; a letter to the investigator's personnel file; and suspension of the privilege to apply for external funding and/or to seek IRB approval.

Records: The Business Office will maintain records of all disclosures and associated activities securely and confidentially.

All records will be maintained for three years following the letter of termination or completion of the project or resolution of any government action involving the records.

Records will not be routinely provided to sponsors unless such is an agency requirement, the agency submits a written request, or KSC is unable to satisfactorily manage an actual or potential conflict of interest. The Director of Research and Sponsored Projects will be responsible for communications with sponsors. Disclosure statements and associated information will not be released without notifying the investigator.

Federal Regulations References

Department of Health and Human Services. Responsibility of Applicants for Promoting Objectivity in Research for Which PHS Funding is Sought. July 11,1995. 60 Fr 35810, Part III.

National Science Foundation. Investigator Financial Disclosure Policy. July 11, 1995. 60 FR 35810, Part III.

B.  Policy on Scientific Misconduct

In recent years, a few well-publicized cases of misconduct in research, including fabrication of results, plagiarism, and misrepresentation of findings, have aroused concern among institutions of higher education, individual investigators, sponsors of research, professional societies, and the general public. Although verified instances of such dishonest behavior are relatively rare, they do indicate the need to be diligent in protecting the integrity of academic work and the stewardship of public and private funds. Allegations of dishonesty by members of the college and university community must be dealt with carefully and thoroughly and with appropriately defined procedures if a college or university is to merit continued public confidence and trust.

In the event of allegations of scientific misconduct, Keene State College identifies the Procedures for Grievance and Arbitration (Article VI) outlined in the Collective Bargaining Agreement between the USNH Board of Trustees, Keene State College, and the Keene State College Education Association (July 1, 1996 - June 30, 1999) as that which will be followed by the Institution and which will be available to any faculty member named in an allegation of misconduct in science.

In the National Science Foundation notice, "Responsibilities of Institutions and Investigators in the Conduct of Science," dated October 7, 1996, the NSF indicates that the "primary responsibility for investigation, enforcement, and reporting when fraud or misconduct is alleged rests with the grantee institution." In the event that the results of the proceedings indicate it is appropriate, Keene State College will report to the funding agency and will notify any professional organization or publication which has disseminated research or service results which are determined to be tainted as a result of serious scientific misconduct.

C.  Intellectual Property Policy

Section 1: Definition

For the purpose of this policy, "Intellectual Property" includes materials which may be copyrighted, patented and/or trademarked.

Section 2: Applicability

This policy applies to all Keene State College faculty (including adjunct faculty) or staff (including ancillary staff), to students employed by the College, and to non-employees of the College hired on a contracted basis

Section 3: Materials which may be Copyrighted

Materials which may be copyrighted include, but are not limited to, the following examples:

• Books, journal articles, reports, texts, glossaries, bibliographies, study-guides, laboratory manuals, syllabi, tests and proposals;
• Lectures, musical or dramatic compositions, and unpublished scripts;
• Photographs, films, film strips, charts, transparencies, and other visual aids;
• Video and audio tapes and cassettes;
• Live video and audio broadcasts;
• Programmed instructional materials, (including Web-based courses or materials);
• Computer programs (software);
• Graphic and sculpture works; works of art;
• Drawings and plastic works of a scientific or technical character;
• Architectural plans and structures;
• Dress and fabric designs;
• Computer generated and transmitted materials;
• World Wide Web pages, and or sections of those pages;
• Databases (in some cases); and
• Digital representation of the above items.

Examples of Intellectual Property eligible for trademark or patent are not provided in this document at this time. Nonetheless, inventions eligible for Patents and items eligible for Trademark registration and protection are also included in this policy.

Section 4: Categories of Intellectual Property

For purpose of this policy, intellectual property (eligible for patent, trademark and/or copyright) falls into the following four categories depending upon the status of the inventor. The status of interest to this policy are:

1. Works made for hire by non-faculty employees (including ancillary staff), by students employed by the College, or by non-employees hired on a contractual basis.
2. Individual efforts by faculty (including adjunct faculty).
3. College-sponsored efforts by faculty (including adjunct faculty).
4. Externally sponsored efforts.

Statutory Definition

1. "Works made for hire" (Under Section 101 of the 1976 Copyright Act) are defined as: a) a work prepared by an employee within the scope of his or her employment; or b) a work specially ordered or commissioned for use as a contribution to a collective work, as a part of a motion picture or other audiovisual work, as a translation, as a supplementary work, as a compilation, as an instructional text, as a test, as answer materials for a test, or as an atlas, if the parties expressly agree in a written instrument signed by them that the work shall be considered a work made for hire.
2. In the event the definition of "Works made for hire" change in future Copyright laws, the then current law will govern.
3. Patents and Trademarks are more complicated than Copyrights, and are each subject to separate laws than item 1 above. While generally the same, the appropriate and current US statutes for each class of property shall govern with respect to this policy.

Section 5: Ownership of Intellectual Property

The ownership of intellectual property depends upon the category of the inventor as described in Section 4. The following numbered sections correspond to those categories.

1. Works made for hire: Intellectual property produced as a work made for hire by non-faculty employees (including ancillary staff), by students employed by the College, or by non-employees hired on a contractual basis is the exclusive property, including copyright, of the College.
2. Individual efforts by faculty:

   Definitions

   Individual faculty includes all full time faculty (tenure-track and other), adjunct faculty, part time faculty, Faculty in Residence (FIR), exchange faculty, faculty fellows, faculty emeritus, retired faculty and administrative employees while they are serving in a faculty role.

   Significant College Sponsorship is defined to mean to mean use of College resources beyond:

   1. Payment of contractual salary or stipends.
   2. Payment of authorized Supplemental Pay or College of Continuing Education pay if such pay is not expressly for the development of the intellectual property in question.
   3. Provision of office and/or laboratory space, including general media laboratory space and general administrative support.
   4. Use of library and interlibrary resources.
   5. The support of internal grant or seed money programs including but not limited to TALENT grants, Alumni grants or matching research grant funds.
   6. Works performed while on sabbatical or other KSCEA contract benefits such as co-ordinator release time (such as family release time, sick leave etc.).
   7. Works performed as professional activity while on "teaching release time" specifically granted for that purpose (unless other mutually acceptable arrangements are made in advance and in writing).
   8. The use of computer and network hardware facility (including mail addresses, ISPs and domains) and/or software shall not constitute college sponsorship.
   9. Works performed in unrelated college activities, other contracts or employment, off campus and on non-college time.
   10. The use of college facilities or equipment normally available to faculty members at large, in their specific division or discipline, not included in b), c) and g) above, including, but not limited to workshops, tools, video camera's, recording devices, instruments, measuring devices, copiers, telephones, fax machines forth.
   11. Use of college name, job title, stationary and letter head assuming such use is otherwise authorized (e.g. When making a survey for inclusion in publication).

   Ownership

   All rights and ownership of inventions and/or Intellectual Property developed by Individual Faculty without Significant College Sponsorship, will remain the sole property of the Individual Faculty Member. Where intellectual property is invented, developed and/or conceived jointly by two or more creators or inventors, then each of the co-creators/inventors shall share ownership rights in such proportions as the joint creators/inventors and the Vice President for Academic Affairs agree reflect their respective contributions. If agreement cannot be reached by all parties, and absent other written agreement, ownership will be shared equally and jointly. Such a collaboration or team effort will considered as an individual effort for purposes of this policy with respect to the College. If other sharing rules are contained in US or State law, those rules shall govern for distribution of ownership rights outside this policy. The individual faculty member shall bear the costs of copyright, trademark and/or patents if he/she chooses to pursue such protections.

3. College-Sponsored Efforts of Faculty: Inventions and rights to Intellectual Property (including software and World Wide Web-based courses or materials) produced through significant College sponsorship (as defined above) shall be owned by the College. For this case the College shall bear the costs (if any) of the copyright or patent if it so chooses.
4. Externally-Sponsored Efforts: Rights to intellectual property developed by faculty as a result of work supported partly or wholly by an external agency under a grant or contract shall be determined in accordance with the terms of the contract or agreement.

   In the absence of such agreement ownership shall:

   1. In the case of non-faculty, become the property of the College.
   2. In the case of faculty without significant College sponsorship, become the property of the faculty member(s).
   3. In the case of faculty with significant College sponsorship (as defined in paragraph 2 above), become the property of the College.

Section 6: Income from Intellectual Property

Intellectual Property royalties related to individual efforts by faculty are the sole responsibility and property of the creator(s)/inventor(s).

Net income received by the College through the sale, licensing, leasing or use of intellectual property produced through significant College sponsorship will be shared with the faculty creator(s)/inventor(s) as described in this section. Net income is to be interpreted as that amount of money cumulatively received after deduction of expenses connected with developing the product, and securing and maintaining the copyright, patent, or license. Expenses connected with developing the product could include additional faculty salary for the project-related work (other than that defined in Section 2, paragraph 2), grant match funds, student salaries and facility improvements necessary for the project.

The College will distribute net income (described above) according to the following schedule:

• 50% of net income to the creator(s)/inventor(s),
• 20% of the net income to the creator's/inventor's discipline to be administered by the appropriate Dean,
• 30% of the net income to a College-wide Research and Development Fund to be administered by the Vice President for Academic Affairs.

Where copyright materials are conceived jointly by two or more creators or inventors, then each of the co-creators/inventors shall share in the gross sums of money referred to above in such proportions as the joint creators/inventors and the Vice President for Academic Affairs agree reflect their respective contributions. If no agreement can be reached, the Vice President for Academic Affairs shall decide the distributions.

Section 7: Administrative Procedures/Right of Appeal

The administration of the principles and policies set forth herein shall be the responsibility of the Vice President for Academic Affairs. In cases where rights and/or equities are in dispute regarding intellectual property rights of a member of the KSCEA bargaining unit, the dispute shall be resolved according to the Collective Bargaining Agreement Grievance and Arbitration Article. In cases where and/or equities are in dispute regarding an individual not covered by the KSCEA Collective Bargaining Agreement, the Vice President for Academic Affairs shall appoint an ad hoc review committee consisting of three persons. One person shall be selected by the individual(s) to be represented, one by the Vice President for Academic Affairs, and one by the College Senate. This committee shall recommend an agreement that shall take effect unless a further appeal is made by the individual(s) involved or by the Vice President for Academic Affairs. In this event the Review Committee will present the case to the President whose decision shall be final and binding upon all parties.

D.   KSC Human Subjects Policy

Keene State recognizes the need for investigations in which human beings may serve as research subjects. The College is also cognizant of its responsibility for ensuring that the privacy, safety, health and welfare of such subjects are adequately protected. Thus the College has established an Institutional Review Board (IRB) to review and approve the adequacy of human subject protection. The policies of the College with respect to research, development, and related activities involving human subjects are based on the following principles:

1. Participation of a human subject in any experiment must be voluntary, and the information provided to gain subject consent must be adequate and appropriate. In those cases where participation in an experiment is intended to provide an educational experience such as might be encountered in a course of study, potential participants must be informed that they are not obliged to participate and that appropriate alternatives to participation will be provided.
2. The risks to the subject must be acceptable when measured against possible benefit to him/her or by the importance of the knowledge to be gained as a result of participation.
3. Research and training activities involving human subjects must be supervised by qualified persons.
4. Except for activities presented below, all research programs which involve human subjects must be reviewed by, and receive the approval of, the IRB prior to initiation of the protocol. Continuing research programs are subject to review. This review must be carried out on at least an annual basis.

Activities Exempt from Review by the IRB: Research activties in which the only involvement of human subjects will be in one or more of the following categories are exempt from review by the full KSC IRB. However, it is KSC policy that only the IRB Chairman can determine exemption. A project which has not been reviewed by the IRB Chairman but which would otherwise be "exempt" is NOT in compliance with KSC policy or with federal regulations.

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
   1. research on regular and special education instructional strategies
   2. research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
3. Research involving survey or interview procedures, except where responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, and either:
   1. the subject's responses, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, or
   2. the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
   All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.
4. Research involving the observation (including the observation by participants) of public behavior, except where observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, and either:
   1. the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, or
   2. the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
5. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Exempting an activity from review does not absolve the investigator(s) of the activity from ensuring that the welfare of subjects in the activity is protected and that methods used, and information provided, to gain subject consent are appropriate to the activity.

The exemptions do not apply when deception of subjects may be an element of the research, when the activity might expose the subject to discomfort or harassment beyond levels encountered in daily life, or when individuals involuntarily confined or detained in penal institutions are subjects of the activity.

A judgment that a particular activity falls within one of the categories exempted from review should be made with care, especially when children are involved. The exemptions of categories 3 and 4 do not apply when individuals under the age of 18 are subjects of the activity. Questions of interpretation may be directed to 358-2427, from which callers will be referred to the chairperson of the review committee.

Basic Elements of Informed Consent (from Code of Federal Regulations 46.116)

Informed consent document should contain the following elements:

• A statement that the study involves research, an explanation of the purposes of research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the subject or to others which may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• A statement describing the extent, if any, to which the confidentiality of records identifying the subject will be maintained;
• For research involving more than minimal risk, an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• An explanation of whom to contact for answers to pertinent questions about the research and research subject's rights, and whom to contact in the event of research-related injury to the subject; and
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

PLEASE NOTE: If minors or legally incompetent persons are to be involved as human subjects, written consent must be obtained from the parent(s) or legal guardian(s).

Obligations and Responsibilities of the Researchers: All full time faculty, research faculty, and faculty in residence may serve as research investigators. Undergraduate and graduate students, instructors, adjunct faculty/other instructional personnel and staff must be sponsored by full time faculty. Research investigators acknowledge and accept their responsibility for protecting the rights and welfare of human research subjects and for complying with all applicable IRB rulings.

Research investigators who intend to involve human research subjects will not make the final determination of exemption from applicable Federal regulation. Research investigators are responsible for providing a copy of the IRB-approved and signed informed consent document to each subject at the time of consent, unless the IRB has specifically waived this requirement. All signed consent documents are to retained in a manner approved by the Office of Research and Sponsored Projects.

Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to subjects.

Research investigators are responsible for reporting progress of approved research to the Office of Research and Sponsored Projects, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but no less than once per year.

Research investigators will promptly report to the IRB any injuries or other unanticipated problems involving risks to subjects and others.

For More Information

E.   KSC Animal Welfare Policy

Keene State college complies with the principles set forth in the National Research Council's Guide for the Care and Use of Laboratory Animals, 1996 (Guide). Keene State College's Institutional Animal Care and Use Committee (IACUC) / Institutional Review Board (IRB) is responsible to oversee and evaluate the institution's animal program, procedures, and facilities to ensure that they are consistent with the recommendation on the Guide, the Animal Welfare Regulations (AWRs, CFR 1985), and the Public Health Services Policy (PHS 1996).

The following topics will be considered in the preparation and review of animal care and use protocols:

• Rationale and purpose of the proposed use of animals.
• Justification of the species and number of animals requested. Whenever possible, the number of animals requested should be justified statistically.
• Availability or appropriateness of the use of less-invasive procedures, other species, isolated organ preparation, cell or tissue culture, or computer simulation (see Guide, Appendix A, "Alternatives").
• Adequacy of training and experience of personnel in the procedures used.
• Unusual housing and husbandry requirements.
• Appropriate sedation, analgesia, and anesthesia. (Scales of pain or invasiveness might aid in the preparation and review of protocols; see Appendix A, "Anesthesia, Pain and Surgery.")
• Unnecessary duplication of experiments.
• Conduct of multiple major operative procedures.
• Criteria and process for timely intervention, removal of animals from a study, or euthanasia if painful or stressful outcomes are anticipated.
• Postprocedure care.
• Method of euthanasia or disposition of animal.
• Safety of working environment for personnel.

F.  Sub-Contractor Regulations

KSC Federal Grant/Award Applicants - Sub-Contractor Regulations

If KSC contracts with a for-profit business to provide some or all of the sponsored services under a Federal grant/award, there are specific regulations that cover this situation. Any grant seekers intending to engage a for-profit subcontractor to perform work under a Federal grant/award must use a standard form of contract that is available through Jim Draper in the Purchasing Office. This standard form of contract includes a clause that assists the College in meeting its obligations under Federal regulations (OMB Circular A-133 http://www.whitehouse.gov/OMB/circulars/a133/a133.html) and which are required by our auditors.

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