Research

400.010 Occupational Health and Safety Program for Laboratory Animal Care and Use Personnel

kuscheld — Thu, 27 May 2010 16:43:00 +0000

400.010 Occupational Health and Safety Program for Laboratory Animal Care and Use Personnel kuscheld Thu, 05/27/2010 - 16:43

Executive Guideline No. 21, 11-11-83; Revised 7-6-16.

Purpose - This Executive Guideline is intended to provide general direction for the development and maintenance of an Occupational Health and Safety Program (OHSP) tailored to the needs of persons whose employment involves contact with laboratory animals and/or animal tissue. Because of this contact, these individuals are considered to experience a greater risk of encountering certain health hazards than is the case with the general population. Health hazards of concern include development of allergies, physical injury, exposure to cleaning and disinfecting chemicals, and rarely, zoonotic diseases. The goal of the OHSP is to maintain a safe and healthy workplace.
Scope
1. The OHSP is applicable to all University employees whose work involves contact with laboratory animals and/or animal tissues, defined as follows:
  1. "Contact" is any contact with animals, animal waste and unfixed animal tissues and fluids.
  2. "Laboratory animal" means any University owned animal that is produced for or used in research, testing or teaching.
2. The OHSP described herein is basic in that it applies to a baseline level of risk experienced by personnel using or caring for laboratory animals and/or animal tissue as part of their assigned job duties. This program is not sufficiently broad in scope or sufficiently detailed to address situations in which specific hazardous agents are used that are known to present specific risks above the routine. In these cases, specific procedures are indicated to protect personnel, monitor exposure and/or facilitate diagnosis and treatment in the event of exposure.
Responsibilities
1. It is the responsibility of each campus Institutional Animal Care and Use Committee (IACUC) to review the adequacy of their OHSP semiannually.
2. Funding of the OHSP shall continue to be the responsibility of the individual campus. Direct animal care funds such as “per diem” charges are not appropriate for funding of this program.
3. Individuals (Principal Investigators, facility directors/managers or supervisors) responsible for hiring or supervising full-time, part-time, or student personnel who have contact with laboratory animals, animal waste or unfixed animal tissues or fluids are responsible for seeing that such persons hired or supervised are included in the appropriate OHSP.
4. Each OHSP shall include the following:
  1. Mandatory training of personnel–regarding occupational hazards associated with the care and use of laboratory animals, including information related to animal-related hazards such as allergies, bites and scratches, zoonotic disease, physical hazards such as sharps handling and the use of hazardous agents.
  2. Risk Assessment–for each individual, to mitigate risks associated with each individual's personal medical status; this will include an assessment of the specific hazards to the individual of the animals and materials used; the exposure intensity, duration and frequency, the susceptibility of the individual to harm, and the individual's history of occupational illness and injury in the specific workplace. The Risk Assessment will also include identification of the necessary immunizations and personal protective equipment for each individual.
  3. Monitoring–on-going monitoring of hazards should occur, including periodic inspections and on-going assessments of risks to determine appropriate strategies to minimize or manage the risks.
  4. Reporting–all incidents/accidents, including "near misses," must be reported to the employee's supervisor.
  5. Operational and day-to-day responsibility for safety in the work place resides with the laboratory or facility supervisor (e.g., principal investigator, facility director or a staff veterinarian) and depends on safe work practices by all employees.
Control and Prevention Strategies
1. Each OHSP should identify potential hazards in the work environment and conduct an assessment of the associated risks, so as to reduce and manage such risks at minimal acceptable levels.
2. Personal protective measures should be made available to individuals including but not limited to:
  1. Protective Clothing:
    1. Depending on the level of risks, suitable attire and personal protective equipment should be provided by the University for use in animal facilities and laboratories in which animals are used. Soiled attire should be disposed of, laundered or decontaminated by each facility. Outer garments worn in animal areas should not be worn outside of the animal facilities unless covered. Work clothing must be changed with sufficient frequency to avoid prolonged exposure of personnel to contaminants that have soiled the clothing and to ensure that clothing does not spread contamination within the work place.
    2. Exam gloves should be worn while handling animals.
    3. Eye protection is mandatory when handling concentrated acids, caustics, detergents, disinfectants, and other irritant chemicals.
    4. When known hazards exist which are beyond those routinely found in the laboratory animal quarters or laboratories, special personal protective equipment appropriate to the nature of the hazard should be used. Examples of such equipment include but are not limited to hearing protection, arm protectors, face masks, goggles and respiratory protection.
  2. Personnel Hygiene:
    1. Standards of personnel hygiene must be high to protect both personnel and laboratory animals.
    2. Hand washing and/or Disinfection - frequent hand washing/ disinfection is necessary. In particular, hand washing/ disinfection should occur at the start of the workday, when changing gloves, upon leaving work for breaks, meals or rest rooms, and when returning to work.
    3. Eating, drinking, use of tobacco products, application of cosmetics, and handling or applying contact lenses are prohibited in laboratory animal quarters and other areas where laboratory animals or hazardous agents are used.
  3. Medical Surveillance:
    1. The purposes of medical surveillance are to identify persons who may be at higher than normal risk for exposure related illness or injury, and to monitor for changes in the health of the worker which may be due to exposure to animals or hazardous agents.
    2. The animal facility director/manager/supervisor or principal investigator will provide the occupational health medical professional with a description of the employee's duties which includes the animal species contacted and the toxic, biologic, and radiologic agents to which the employee may be exposed.
    3. The employee should provide the occupational health medical professional with a confidential health history so that an accurate risk assessment can be made and further action can be recommended.
    4. Following the risk assessment, the employee and his/her supervisor must be provided a written report from the occupational health medical professional stating what actions are required to maintain a safe work environment for the employee.
  4. Immunizations
    1. An appropriate immunization schedule should be adopted by each OHSP. Pre-exposure immunization should be offered to employees at risk of infection or exposure to specific agents, such as rabies, tetanus or hepatitis B. Current, applicable vaccine information statements must be provided whenever a vaccine is administered. Each employee's immunization history should be evaluated for completeness and currency at the time of employment and re-evaluated when the employee is assigned job responsibilities with a new hazard. Employees may decline a recommended vaccine but must sign a waiver; employees will not be permitted to decline a recommended vaccine if the employee's failure to get such vaccine places other personnel or laboratory animals at a material risk of harm.
  5. Report of Injuries:
    1. The University requires that all accidents or incidents (including near misses), including but not limited to bites, scratches, allergic reactions or other injuries, shall be reported to the employee's supervisor immediately (even if the employee does not feel medical treatment will be required at the time).
    2. Each campus shall develop its own procedure for handling accidents or incidents; however, at a minimum, each procedure must include a written record documenting the nature of the accident/ incident including date and location, the identification of all persons involved or who witnessed the accident/ incident, including contact information, and the nature of any injuries sustained as a result of the accident/ incident.
    3. The procedure for the handling of accidents shall include an assessment of the need for medical attention.

400.020 Care and Use of Vertebrate Animals as Subjects in Research and Teaching

kuscheld — Thu, 27 May 2010 16:45:02 +0000

400.020 Care and Use of Vertebrate Animals as Subjects in Research and Teaching kuscheld Thu, 05/27/2010 - 16:45

Executive Guideline No. 22, 2-15-84; Revised 5-20-87.

Purpose -- The policy of the University of ��ӰԺ is to foster the humane care and use of vertebrate animals in research and teaching and to adhere to applicable laws, principles, standards, guidelines and policies affecting such care and use.
This policy and the principles below apply in all situations and activities of the University where vertebrate animals are used in research, instruction or other activities regardless of the source(s) of support. It shall apply equally whether the supporting funds are from outside or from within the University, whether separately budgeted or unbudgeted.

Responsibility for implementing and administering this policy shall rest wit the Chancellor of each campus (the Vice President for Academic Affairs in the case of UM research programs). In accordance with federal policy and regulations, the Chancellor has responsibility for appointing the Institutional Animal Care and Use Committee. The composition of this committee shall conform to Federal Guidelines.

The committee will:
1. Review, at least once every six months, the institution's program for humane care and use of animals, using the Guide for the Care and Use of Laboratory Animals and the Animal Welfare Act Regulations and Standards as a basis for evaluation.
2. Inspect, at least once every six months, the institution's animal facilities (including satellite facilities).
3. Prepare reports of the IACUC evaluation set forth in the PHS policy and submit the reports to the Chancellor. A more complete list of IACUC regulations and responsibilities is in the PHS policy and 9CRF Parts 1 and 2, Animal Welfare Proposed Rules.
  As part of the campus's program for animal care and use, the Chancellor will provide training or instruction to scientists, animal technicians, and other personnel involved in animal care, treatment, or use in both the practice of animal care and in research and testing methods that minimize the number of animals required to obtain valid results and minimize animal distress.
  
  The Chancellor will ensure that records of the semiannual reports and recommendations are maintained for at least three years and that, at least once every twelve months, the Institutional Animal Care and Use Committee (IACUC) will report through the Chancellor to Office for Protection from Research Risks (OPRR) on its activities, especially with regard to any changes in the status of the institution's Assurance and other information as required by OPRR.
Principles for the Care and Use of Animals
1. The Personnel
  1. Experiments involving live, vertebrate animals and the procurement of tissues from living animals for research must be performed by , or under the immediate supervision of, a qualified biological, behavioral or medical scientist.
  2. The housing care and feeding of all experimental animals must be supervised by a properly qualified veterinarian or other scientists competent in such matters.
2. The Research
  1. The research should be expected to yield results beneficial to society and not be random or unnecessary in nature.
  2. The experiment should be based on knowledge of the disease or problem under study and so designed that the anticipated results will justify its performance.
  3. Statistical analysis, mathematical models or in vitro biological systems should be used when appropriate to complement animal experiments and reduce numbers of animals used.
  4. The experiment should be conducted so as to avoid all unnecessary suffering and injury to animals.
  5. The scientist in charge of the experiment must be prepared to terminate it whenever he or she believes that its continuation may result in unnecessary injury or suffering to animals.
  6. If the experiment or procedure is likely to cause greater discomfort than that attending anesthetization, the animals must first be rendered incapable of perceiving pain and be maintained in that condition until the experiment or procedure is ended. The only exception to these guidelines should be in those cases where anesthetization would defeat the purpose of the procedures. Such procedures must be carefully supervised by the principal investigator or other qualified senior scientists.
  7. Post-experiment care of animals must be such as to minimize discomfort and the consequences of any disability resulting from the experiment in accordance with acceptable practices in veterinary medicine.
  8. If it is necessary to kill an experimental animal, the animal must be killed in a humane manner; i.e., in such a way as to ensure immediate death in accordance with procedures approved by an institutional committee. No animal shall be discarded until after it is dead.
  9. Occupational health procedures outlined in the Personnel Health and Medical Surveillance Program for Animal Care Personnel (See Executive Guideline No. 21) must be followed to minimize the risk of disease transmission between animals and humans.
  10. Safety procedures shall be such as to minimize the risk of exposure of personnel or the unintended risk of animals to hazardous agents.
3. The Facilities -- Standards for the construction and use of housing, service and surgical facilities should meet those described in the current edition of the publication, Guide for the Care and Use of Laboratory Animals, DHHS, (NIH_ 85-23, or as otherwise required by the U.S. Department of Agriculture regulations established under the terms of the Laboratory Animal Welfare Act (P.L. 89-544) 1966; P.L. 91-579, as amended, 1970; P.L. 94-270; as amended, 1976; P.L. 99-198, as amended 1985), and other laws and regulations as duly promulgated.
4. Transportation -- Transportation of animals must be in accord with applicable standards and regulations, especially those intended to reduce discomfort, stress to the animals, or spread of disease.
5. References
  1. Committee on Care and Use of Laboratory Animals: Guide for the Care and Use of Laboratory Animals. DHHS (NIH) 85-23, Institute of Laboratory Animal Resources, NRC, revised, 1985.
  2. Code of Federal Regulations, Title 9-Animals and Animal Products, Subchapter A-Animal Welfare, January 1985.
  3. Recommendations for Governance and Management of Institutional Animal Resources. Association of American Medical Colleges; Association of American Universities, October 1985.
  4. Rules for Animal Welfare. Federal Register, Vol. 52, No. 61, p. 10292 et seq.
  5. Public Health Service Policy on Humane Care and Use of Laboratory Animals, OPRR, Revised September 1986.

410.010 Research Involving Humans in Experiments

kuscheld — Thu, 27 May 2010 16:47:06 +0000

410.010 Research Involving Humans in Experiments kuscheld Thu, 05/27/2010 - 16:47

Executive Order No. 10, 8-10-72, Amended 8-28-07.

Human Subject Research, Defined --
1. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information
2. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human Subject Research Subject to Review and Approval -- It shall be the policy of the University of ��ӰԺ that all research projects which involve human subjects shall be subject to review and approval by an appropriate, officially appointed, Institutional Review Board registered with the Office of Human Research Protections (or other office designated by the United States Department of Health and Human Services) prior to project initiation, and without respect to the source of funding or sponsorship. This policy shall include all faculty, staff, and student research regardless of source of support.

410.020 Institutional Conflicts of Interest in Human Subjects Research

kuscheld — Thu, 27 May 2010 16:48:51 +0000

410.020 Institutional Conflicts of Interest in Human Subjects Research kuscheld Thu, 05/27/2010 - 16:48

Executive Order No. 37, 03-24-10.

This policy is established to meet the institutional conflict of interest requirements of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), specifically Standard I-6, under which the University must have and follow written policies and procedures to ensure that research is conducted so that financial conflicts of interest are identified, managed, and minimized or eliminated. It is intended to provide appropriate institutional safeguards to sustain a climate in which human subjects research at the University can be carried out responsibly without undue influence from its entrepreneurial and its financial aspirations. Each institutional financial interest that presents a potential for financial conflicts of interest, whether real or perceived, must be fully disclosed to the President or designee, must be managed, reduced, or eliminated, and the potential conflict of interest and management plan, if any, must be disclosed to the various Institutional Review Boards (IRBs) so that the appropriate IRB can decide whether the interest and its management, if any, allows the human subjects research to be approved.

Conflicts of interest of University officials and employees are addressed separately in Sections 10.090 (Curators), 330.015 (all employees), and 420.030 (“investigators” on funded or proposed NSF or PHS research or educational activities).

Institutional Conflict of Interest in Human Subjects Research, Defined --
1. The University may have a conflict of interest (“institutional COI”) in human subjects research whenever the interests of the institution might affect – or reasonably appear to affect – institutional processes for the design, conduct, reporting, review, or oversight of human subjects research.
Human Subjects Research, Defined –
1. Human subjects research for the purposes of this policy is the same as that in Section 410.010A., namely:
  1. Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains
    (1) Data through intervention or interaction with the individual, or
    (2) Identifiable private information.
  2. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
2. Human subjects research requires review and approval by an appropriate, officially appointed, Institutional Review Board registered with the Office of Human Research Protections prior to project initiation, and without respect to the source of funding or sponsorship, as provided by Section 410.010B.
Identification of Potential Institutional Conflicts of Interest. As a general guide, the following significant financial and fiduciary interests of the University warrant formal review of potential institutional COI with respect to human subjects research, as provided in this policy:
1. Royalties: The University has the potential to receive significant milestone payments and/or royalties from the commercialization of a product based at least in part on technology that is the subject of University research.
2. Non-publicly traded equity: Through its technology licensing activities or investments related to such activities, the University has obtained an equity interest or an entitlement to equity of any value (including options or warrants) in a non-publicly traded company that is (i)the sponsor of human subjects research at the University, or (ii) the manufacturer or distributor of a product to be studied or tested in human subjects research at or under the auspices of the institution or based at least in part on technology developed at the University.
3. Publicly traded equity: Through technology licensing activities or investments related to such activities, the University has obtained a significant equity interest or an entitlement to significant equity (including options or warrants), in a publicly traded company that is (i) the sponsor of human subjects research at the institution, or (ii) the manufacturer or distributor of a product to be studied or tested in human subjects research at or under the auspices of the institution, or based at least in part on technology developed at the University.
4. Governance/Fiduciary roles: Through technology licensing activities or investments related to such activities, the University has obtained the right to appoint one or more members to the governing board of any company that is (i) the sponsor of research at the University, or (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University.
5. Gifts from companies/sponsors. The University is offered or has received significant gifts (including, but not limited to, gifts in kind, discounts, fellowships, and unrestricted educational grants) from a person, company or a foundation established by or closely affiliated with a company that is (i) sponsoring or offering to sponsor research at the University, (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University; or (iii) a company known to be a business competitor of companies described in (i) or (ii) above.
  The following circumstances, among others, should be evaluated in the gifting context:
  1. Whether a gift is of sufficient magnitude that even when held in the general endowment, it might affect, or reasonably appear to affect, oversight of research at the University;
  2. Whether a gift is held for the express or limited benefit of a school, department, institute or other unit where some or all of the research is conducted; or
  3. Whether any institutional official who has the authority to affect or reasonably appear to affect the design, conduct, reporting, review, or oversight of the research has also been actively involved in solicitation of the gift, or in the management of the gift once received by the University.
The goal of this policy is not to preclude or discourage the University from accepting philanthropy from individuals or entities that support research, or that own or control products whose underlying technologies are developed, studied or tested in research at the University, provided that such gifts do not limit or reasonably appear to limit the professional independence of faculty and staff engaged in the research or research related activities. This policy is intended to help the University develop means of identifying and examining such circumstances, and of managing, through disclosure, separation of responsibilities, and as otherwise appropriate, any actual or reasonably apparent conflicts of interest that may result.
Procedures
1. As part of the IRB application process, each Principal Investigator applying for IRB approval of proposed human subjects research shall identify parties with a potential financial interest in the outcome, if known.
2. Annually by January 31 and immediately whenever there is a significant change, the Vice President for Finance and Administration and the Vice President for Research and Economic Development shall report to the President any significant financial or fiduciary interests of the University relating to human subjects research, and the campus offices of research shall report information regarding sources of research funding to the University.
3. Annually by January 31 and immediately whenever there is a significant change, each General Officer of the University shall report to the President or designee any significant gift to the University or any of its parts (including, but not limited to, gifts in kind, discounts, fellowships, and unrestricted educational grants) from an individual or entity or a foundation established by or closely affiliated with an individual or entity that is (i) sponsoring or offering to sponsor research at the University, (ii) the manufacturer or distributor of a product that is either studied or tested in research at or under the auspices of the University, or based at least in part on technology developed at the University; or (iii) a company known to be a business competitor of companies described in (i) or (ii) above.
4. The President or his designee shall:
  1. Identify potential institutional conflicts of interest from the information provided by the Principal Investigators, Vice Presidents of Finance and Administration and for Research and Economic Development, General Officers, campus research offices and other sources of information.
  2. Implement an oversight process and administrative policies and procedures to address institutional conflicts of interest relating to human subjects research and to identify situations in which such conflicts may arise;
  3. Devise and implement plans to manage, reduce, or eliminate institutional conflict of interest relating to human subjects research;
  4. Inform the various IRBs on each of the campuses of the potential institutional conflict of interest relating to human subject research and any plan to manage, reduce or eliminate it for the IRB’s review of human subjects research under Section 410.020, with the IRB having the final authority to decide whether the interest and its management, if any, allows the research to be approved.

420.010 Research Misconduct

kuscheld — Thu, 27 May 2010 16:49:53 +0000

420.010 Research Misconduct kuscheld Thu, 05/27/2010 - 16:49

Bd. Min. 3-24-06; Amended 11-29-07; Amended 11-20-24.

Policy for Reviewing Alleged Research Misconduct
1. Statement of Principles
  1. Integrity in scholarship and research is a fundamental value upon which the University is founded.
  2. It is the shared responsibility of all members of our academic community to ensure that misconduct in scholarship and research is dealt with in a timely and effective manner, and that the reputation of the University for high standards of scholarly and research integrity is preserved.
  3. The purpose of this policy is to reaffirm the University's commitment to integrity of research and scholarship and establish the principles and procedures that will be followed in the University's review of allegations of research misconduct. The National Science Foundation, the Public Health Service, and other federal agencies have published regulations regarding the investigation of allegations of research misconduct in the context of activities supported by those agencies. The University will comply with those statutory and regulatory requirements if applicable and this policy shall be interpreted so as to conform with those requirements.
2. Applicability
  1. This policy addresses research misconduct as defined in section A.3 of this policy in connection with any research conducted at the University of ��ӰԺ, regardless of the presence or absence of external funding or sponsorship of the specific research project. Other forms of misconduct that may relate to activities in scholarship and research are not addressed through this policy but may be addressed through other applicable University rules and policies, including but not limited to the Standards of Faculty Conduct, Section 330.110.
  2. The provisions of this policy apply to:
    
    1) All individuals who hold University appointments who are engaged in the design or conduct of research or the reporting of research results, regardless of the presence or absence of external funding or sponsorship of the specific research project; and
    2) Anyone engaged in the design or conduct of research or the reporting of research results through a Sponsored Program at the University of ��ӰԺ, to the extent of that research.
  3. Misconduct by undergraduate students shall be addressed through Sections 200.010, Standard of Conduct; and 200.020, Rules of Procedures in Student or Student Organization Conduct Matters.
  4. Research misconduct by graduate students generally will be dealt with under this policy, provided that, after consultation with a university’s chief academic administrator for graduate studies (such as Dean of the Graduate School or similar official), the Deciding Official as defined in this rule may, determine that an allegation of research misconduct on the part of a graduate student is more appropriately addressed under Section 200.010 and Section 200.020 or duly authorized student honor systems established pursuant to CRR 200.020.E.9 and refer the allegation to appropriate officials for action in accordance with such rules or student honor systems.
3. Definitions
  1. Definitions of Research Misconduct
    
    1) Fabrication: making up data or results and recording them in the research record.
    2) Falsification: manipulating research materials, equipment, or processes, and/or changing or omitting data or results such that the research is not accurately represented in the research record.
    3) Plagiarism: the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
    4) Research misconduct does not include honest error, author disputes, or differences of interpretation inherent in the scientific and creative processes that are normally corrected through further research and scholarship.
  2. Definitions of Key Roles and Federal Agencies
    
    1) Complainant: refers to an individual(s) who makes an allegation of research misconduct.
    2) Respondent: refers to the person against whom an allegation of research misconduct is directed or the person whose actions are the subject of the inquiry or investigation. There can be more than one Respondent in any inquiry or investigation.
    3) Research Integrity Officer (RIO): refers to the University official responsible for assessing allegations of research misconduct and determining whether such allegations warrant inquiries and for overseeing inquiries and investigations. This position is appointed by the Chancellor.
    4) Deciding Official (DO): refers to the University official, who makes final determinations on allegations of research misconduct and any responsive institutional actions. The Chancellor may serve as the DO or may designate the Provost or other individual to serve as the DO, provided that the DO will not be the same individual as the RIO and should have no direct prior involvement in the institution's inquiry, investigation, or allegation assessment.
    5) U.S. Public Health Service (PHS): an operating component of the U.S. Department of Health and Human Services (DHHS).
    6) Office of Research Integrity (ORI): an operating component of the United States Department of Health and Human Services (DHSS) that is responsible for research misconduct proceedings and research integrity activities of the U.S. Public Health Service (PHS).
  3. Definitions of Other Key Terms
    
    1) Allegation refers to any written or oral statement or other indication of possible research misconduct made to an institutional official, including but not limited to department chairs, deans, Research Integrity Officers (RIOs), the Vice Chancellor for Research (VCR) or equivalent, the Associate Vice Chancellor for Research (ACVR) or equivalent, and the Provost.
    2) Conflict of interest and commitment refers to a divergence between an individual’s interests and the individual’s professional obligations, such that an independent observer might reasonably question whether the individual’s professional actions or decisions are determined by considerations other than the best interests of the University.
    3) Good faith as applied to a Complainant, Respondent, or witness, means having a belief in the truth of one's allegation or statement that a reasonable person in the individual’s position could have based on the information known to the individual at the time. An allegation or statement in a research misconduct proceeding is not in good faith if made with knowing or reckless disregard for information that would negate the allegation or statement. Good faith as applied to a committee member means cooperating with the research misconduct proceeding by carrying out the duties assigned impartially. A committee member does not act in good faith if the member’s acts or omissions on the committee are dishonest or influenced by personal, professional, or financial conflicts of interest with those involved in the research misconduct proceeding.
    4) Inquiry refers to the initial process for determining whether an allegation or apparent instance of research misconduct has substance and warrants an investigation.
    5) Investigation refers to the formal development of a factual record and the examination of that record to determine, based on a preponderance of evidence, whether research misconduct has occurred and, if so, to determine the responsible person and the nature and seriousness of the research misconduct.
    6) Research refers to any systematic investigation, including research development, testing, and reporting, designed to develop or contribute to generalizable knowledge or specific knowledge. The term encompasses basic research, applied research, and research training activities in areas such as biomedical and life sciences, natural sciences, engineering, humanities and arts, and social and behavioral sciences.
    
    a) Research record means any physical or electronic record of data or results that embody the facts resulting from scientific inquiry. It includes, but is not limited to data, document, computer file, computer storage device, or any other written or non-written account or object that reasonably may be expected to provide evidence or information regarding the proposed, conducted, or reported research that constitutes the subject of an allegation of research misconduct. Examples of research records include, but are not limited to, research proposals, grant or contract applications, whether funded or unfunded; grant or contract progress and other reports; abstracts; theses; oral presentations; internal reports; journal articles; laboratory notebooks; notes; correspondence; videos; photographs; X-ray film; slides; biological materials; computer files and printouts; manuscripts and publications; equipment use logs; laboratory procurement records; animal facility records; human and animal subject protocols; consent forms; medical charts; and patient research files.
    
    7) Retaliation means any adverse action taken against an individual because the individual a) has made a good faith allegation of research misconduct or of inadequate institutional response thereto; or b) cooperated in good faith with any action or proceeding under this rule. This includes adverse action taken by any individual, the University, or any unit of the University.
    8) Student refers to a person having once been admitted to the University who has not completed a course of study and who intends to or does continue a course of study in or through one of the Universities of the University System. For the purpose of these rules, student status continues whether or not the University's academic programs are in session.
4. General Principles
  1. Prohibition: Research misconduct is prohibited and subject to sanctions pursuant to this rule.
  2. Requirements for findings of research misconduct: A finding of research misconduct requires a determination that there has been a significant departure from accepted practices of the relevant academic community; that the research misconduct was committed intentionally, knowingly, or recklessly; and that the allegation has been proved by a preponderance of evidence.
  3. Handling of questionable research practices: Concerns in the context of research and scholarship that do not constitute research misconduct as defined in this rule, such as carelessness or questionable research practices, as well as authorship disputes, will generally be handled through the appropriate administrative channels or other applicable processes, including but not limited to Standards of Faculty Conduct CRR 330.110.
  4. Retaliation is prohibited and is subject to disciplinary action in accordance with applicable University policies. The University will take reasonable and practical steps to counter potential or actual retaliation against individuals participating in proceedings under this rule.
  5. Good faith participation: Complainants, respondents, and other participants in the research misconduct review process are expected to act in good faith throughout. Failure to act in good faith may lead to disciplinary action in accordance with applicable University rules and policies.
  6. Conflicts of Interest Prohibited: No individual responsible for carrying out proceedings under this rule shall have any unresolved personal, professional, or financial conflict of interest with the Complainant, Respondent, or witnesses. An individual having such a conflict of interest must promptly recuse from participation in any proceedings.
  7. Responsibility to Report Research Misconduct: All employees or individuals associated with the University of ��ӰԺ must report observed, suspected, or apparent research misconduct to the RIO. If an individual is unsure whether a suspected incident falls within the definition of research misconduct, the individual may contact the RIO to discuss the suspected misconduct informally. If the circumstances described by the individual do not meet the definition of research misconduct, the RIO may refer the individual or allegation to other offices or officials. At any time, an employee may have discussions and consultations about concerns of possible research misconduct with the RIO and will be counseled about appropriate procedures for reporting allegations.
  8. Protecting the Complainant and Cooperating Individuals: The RIO will monitor the treatment of individuals who bring allegations of research misconduct or of inadequate institutional response thereto, and those who cooperate in inquiries or investigations. The RIO will attempt to ensure that these persons will not be retaliated against and will review instances of alleged or apparent retaliation for appropriate action. Employees or those affiliated with the University or a PHS grant should immediately report any alleged or apparent retaliation to the RIO. Also, the University will maintain confidentiality as required by the terms of this rule. If the Complainant requests anonymity, the University will make a reasonable effort to honor the request during the allegation assessment or inquiry within applicable policies, regulations, and laws, if any, but the Complainant will be advised that if the matter is referred to an investigation committee, anonymity will no longer be guaranteed. The University will take all reasonable and practical steps to protect the positions and reputations of good faith Complainants, witnesses and committee members.
  9. Protecting the Respondent: Inquiries and investigations will be conducted in a manner that will ensure fair treatment to the Respondent and confidentiality as required by the terms of this rule. The Respondent may have an advisor (who is not a witness and does not otherwise have a role in the case and who may be, but is not required to be, an attorney). The Respondent’s advisor may accompany the Respondent to all interviews, meetings, and proceedings involved in the case. The advisor may actively participate and assist the Respondent. The advisor may make presentations and speak on behalf of the Respondent, request clarification of a procedural matter or object on the basis of procedure, ask any witnesses all relevant questions and follow-up questions, including cross-examination.
  10. Cooperation with Inquiries and Investigations: University employees and those working on PHS grants will cooperate with the RIO and other institutional officials involved in the review of allegations and the conduct of inquiries and investigations. Employees have an obligation to provide relevant evidence to the RIO and other University officials involved in review of research misconduct allegations.
  11. Responsibility of Institution to Respond to Credible Reports of Allegations of Research Misconduct: Because the University of ��ӰԺ values the credibility of its research activities and the integrity of its community, allegations of research misconduct are evaluated to determine whether there is specific and credible information on which to act. Just as the University protects Complainants against retaliation, the University is equally concerned about malicious or frivolous allegations made against its research community. The university performs a careful assessment of all allegations brought to the attention of institutional officials. The RIO, AVCR, VCR, and the DO shall consider and act upon any specific and credible information that comes to their attention indicating that research misconduct may have occurred. The RIO and other institutional officials assigned responsibility for handling allegations of research misconduct ensure that:
    
    1) The allegation assessment, inquiry, and investigation are completed in a timely, fair, objective, thorough, and competent manner; and
    2) Reasonable precautions are taken to avoid bias and conflict of interest on the part of those involved in conducting the inquiry and investigation.
  12. At any time during the assessment period or research misconduct proceedings, the University of ��ӰԺ will notify the appropriate funding and oversight agencies if:
    
    1) Public health or safety is at risk;
    2) Agency resources or interests are threatened;
    3) Research activities should be suspended;
    4) There is reasonable indication of possible violations of civil or criminal law;
    5) Federal action is required to protect the interests of those involved in the investigation;
    6) The University believes the research misconduct proceeding may be made public prematurely, so the agency may take appropriate steps to safeguard evidence and protect the rights of those involved or
    7)The research community or public should be informed.
  13. Confidentiality:
    
    1) Disclosure of the identity of Respondents and Complainants in research misconduct proceedings is limited, to the extent possible, to those who need to know, consistent with a thorough, competent, objective, and fair research misconduct proceeding, and as allowed by law. The applicable laws and regulations may require the institution to disclose the identity of Respondents and Complainants to federal oversight agencies pursuant to the agency’s review of institutional research misconduct proceedings.
    2) Except as may otherwise be prescribed by applicable law, confidentiality must be maintained for any records or evidence from which research subjects might be identified. Disclosure is limited to those who have a need to know to carry out a research misconduct proceeding.
  14. Restoration of Reputations: The University of ��ӰԺ takes all reasonable and practical efforts, if requested and as appropriate, to restore the reputations of individuals alleged to have engaged in research misconduct but against whom no finding of research misconduct is made.
  15. Referrals: If the University’s review of the allegations identifies misconduct other than research misconduct, the RIO refers these matters to the proper institutional or federal office for action.
5. Sanctions
  The University may take disciplinary action, up to and including termination of employment, upon a finding of research misconduct. Applicable sanctions may include, but are not limited to:
  1. Warning. A notice in writing to the Respondent and included in the Respondent’s personnel file indicating that there is a finding of research misconduct.
  2. Loss of Privileges. Denial of specified privileges of Respondent for a designated period of time. This may include but is not limited to suspending travel privileges and/or payment of travel or conference expenses, restricting use of laboratories or offices, limiting contact with students, or suspending access to teaching or research assistance or grant accounts, service on University committees or representation of the University on official business. The loss of privileges sanction may not be applied in a manner to create a constructive suspension.
  3. Education or Training. Respondent may be required to complete education or training.
  4. Restitution. Compensation by Respondent for loss, damage or injury to the University or University property. This may take the form of appropriate service and/or monetary or material replacement.
  5. Suspension. Separation of the Respondent from the University for a definite period of time, after which the Respondent is eligible to return. Conditions for return should be specified. Suspension may be with or without salary (full or partial) for a period not to exceed one-half of the individual’s normal appointment period. During the suspension period, health and retirement benefits shall be maintained.
  6. Termination. Termination of an appointment with tenure will be pursuant to Section 310.060.
Procedure for Reviewing Alleged Research Misconduct
1. Statement of Purpose: It is the policy of the University of ��ӰԺ to inquire into and, if necessary, investigate and resolve promptly and fairly all instances of alleged research misconduct. As a recipient of federal research funds, the University of ��ӰԺ must have institutional policies and procedures in place to handle allegations of research misconduct.
2. Procedures for Conduct of Research Misconduct Proceedings
  1. In conducting a research misconduct proceeding:
    
    1) the procedures shall be those best suited to achieve a fair and equitable review of the Allegation;
    2) the procedures shall reflect a spirit of mutual respect and collegiality, and may, therefore, be as informal as agreed by the Respondent under the circumstances;
    3) the Respondent shall have the right to have an advisor as stated in this rule;
    4) in all preliminary assessments, inquiries, and investigations, the Respondent shall have the right to present evidence and to identify persons who might have evidence about the allegation;
    5) formal rules of evidence shall not apply;
    6) to the extent that a published regulation of a federal funding source requires a specific procedural element in the review and adjudication of an Allegation concerning a proposal to or an award from that federal funding source, that procedural element shall be included in the procedures adopted.
  2. General Counsel Advice: The Office of the General Counsel shall, when so requested, provide legal advice regarding the implementation of these procedures and other aspects of the University's review of an allegation under these procedures to the RIO, the Inquiry Committee, the Investigative Committee, the VCR, the DO, the Chancellor, and the Appellate Officer.
  3. Admission of Misconduct: When the case involves PHS funds, the University cannot accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI. For non-PHS funding, the DO shall have authority to terminate the University's review of any allegation upon the admission by the Respondent that research misconduct occurred and that the Respondent was responsible for it, if the termination of the review of that allegation would not prejudice the University's review of another allegation against that Respondent or a different Respondent or the University's ability to assess the extent and consequences of the research misconduct and what action should be taken in response to it.
  4. Additional Respondents. If, during the course of any research misconduct proceeding, additional Respondents are identified, they shall be notified immediately, and the RIO shall, to the degree feasible, attempt to coordinate the research misconduct proceedings against all the Respondents with respect to the same or related research misconduct.
3. Allegations of Misconduct and Preliminary Assessments
  1. Allegation of Research Misconduct
    
    1) Any member of the University community or other person who wishes to make an allegation shall contact the RIO or other institutional official who will promptly notify the RIO.
    2) The RIO shall notify the Respondent promptly of an allegation.
    3) The RIO shall advise the VCR of all allegations.
  2. Preliminary Assessment of Allegations
    
    1) Promptly after receiving an allegation, the RIO shall assess the allegation to determine if:
    
    a) it meets the definition of research misconduct;
    b) it involves either the PHS funded research, applications for PHS research funding, or research records specified in U.S. Code of Federal Regulations or other non-PHS funding; and,
    c) the allegation is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
  3. Inquiry Not Warranted
    
    1) Preliminary Assessment Report: If the RIO determines that an inquiry is not warranted because the allegation is not sufficiently credible and specific so that potential evidence of research misconduct may be identified, the RIO shall prepare a written preliminary assessment report that states the basis and rationale for the RIO’s determination. The RIO shall provide a copy of the preliminary assessment report to the VCR.
    2) End of Review: If the VCR concurs with the RIO's determination that an inquiry is not warranted, the University's review of that allegation shall be concluded. The Complainant and Respondent shall be notified in writing that the matter has been closed after preliminary assessment.
4. Conducting the Inquiry
  1. Initiation and Purpose of the Inquiry: Following the preliminary assessment, if the RIO determines that the allegation provides sufficient information to allow specific follow-up and falls under the definition of research misconduct, the RIO will initiate the inquiry process whether it involves PHS funding or not. In initiating the inquiry, the RIO should clearly identify the original allegation and any related issues that should be evaluated. The purpose of the inquiry is to make a preliminary evaluation of the available evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation. The purpose of the inquiry is not to reach a final conclusion about whether misconduct definitely occurred and therefore does not require a full review of all the evidence related to the allegation.
  2. Timeframe: The inquiry committee is generally convened within 30 days of the determination to convene an inquiry. The inquiry, including the final report of the inquiry committee and decision of whether an investigation is warranted, should generally be completed within 60 days of the convening of the inquiry.
  3. Notice to Respondent:
    
    1) Within 15 days of the determination to convene an inquiry, the RIO will notify the Respondent in writing of the allegation(s). Respondent notification includes:
    
    a) The specific allegation(s);
    b) The rights and responsibilities of the Respondent;
    c) The role of the inquiry committee;
    d) A description of the inquiry process; and
    e) A copy of this rule.
    
    2) The RIO also will notify the dean and department chair, or equivalent in the Respondent’s department, in writing of the determination to convene an inquiry.
  4. Sequestration of the Research Records:
    
    1) After determining that an allegation falls within the definition of research misconduct, the RIO must ensure that all original research records and materials relevant to the allegation are secured. The RIO may consult with ORI for advice and assistance in this regard. 2) The RIO shall take the following specific steps to obtain, secure, and maintain the research records and evidence pertinent to the research misconduct proceeding:
    
    a) Either before or when the RIO notifies the Respondent of the allegation, the RIO shall promptly take all reasonable and practical steps to obtain custody of all research records and evidence needed to conduct the research misconduct proceeding, inventory those materials, and sequester them in a secure manner. Provided that in those cases where the research records or evidence encompass scientific instruments shared by a number of users, custody may be limited to copies of the data or evidence on such instruments, so long as those copies are substantially equivalent to the evidentiary value of the instruments. b) Where appropriate, give the Respondent copies of, or as reasonable, supervised access to the research records.
  5. Appointment of the Inquiry Committee:
    
    1) The RIO, in consultation with other University officials (Deans, Chairs, VCR) as appropriate, will appoint an inquiry committee and committee chair. The inquiry committee should consist of at least 3 individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegation, interview the principals and key witnesses, and conduct the inquiry. These individuals may be scientists, subject matter experts, administrators, lawyers, or other qualified persons, and they may be from inside or outside the University. The majority of the committee will consist of tenured faculty.
    2) The RIO will notify the Respondent of the proposed committee membership in writing. If the Respondent submits a written objection to any appointed member of the inquiry committee or expert based on bias or conflict of interest within 5 days, the RIO will determine whether to replace the challenged member or expert with a qualified substitute.
  6. Charge to the Committee and the First Meeting:
    
    1) Charge to the Committee: The RIO will prepare a charge for the inquiry committee that describes the allegations and any related issues identified during the allegation assessment and states that the purpose of the inquiry is to make a preliminary evaluation of the evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether there is sufficient evidence of possible research misconduct to warrant an investigation.
    2) The First Meeting: At the committee's first meeting, the RIO will review the charge with the committee, discuss the allegations, any related issues, and the appropriate procedures for conducting the inquiry, assist the committee with organizing plans for the inquiry, and answer any questions raised by the committee. The RIO and the Office of the General Counsel will be available throughout the inquiry to advise the committee as needed.
  7. Inquiry Process: The inquiry committee will normally interview the Complainant, the Respondent and key witnesses as well as review relevant research records and materials. Then the inquiry committee will evaluate the evidence and testimony obtained during the inquiry. After consultation with the RIO and the Office of the General Counsel as needed, the committee members will decide whether there is sufficient evidence of possible research misconduct to recommend further investigation. The inquiry committee then prepares a report and submits it to the RIO.
5. The Inquiry Report
  1. Elements of the Inquiry Report: The written inquiry report shall contain the following information:
    
    1) The name and position of the Respondent(s);
    2) A description of the allegations of research misconduct;
    3) Research sponsorship, including, for example, grant numbers, grant applications, contracts, and publications listing PHS funding or other non-PHS funding;
    4) The basis for recommending that the alleged conduct does or does not warrant an investigation; and
    5) Any comments on the report by the Respondent or the Complainant. The report also should include recommendations on whether any other actions should be taken if an investigation is not recommended. The Office of the General Counsel will review the report for legal sufficiency.
  2. Comments on the Report by the Respondent and Complainant: The RIO will provide the Respondent with a copy of the inquiry report for comment and rebuttal. At the RIO’s discretion, the RIO also may provide the Complainant with a copy of the inquiry report for comment and rebuttal.
    
    1) Confidentiality: The RIO may establish reasonable conditions for review to protect the confidentiality of the report.
    2) Receipt of Comments: Within 10 days of receipt of the report or summary, the Respondent and Complainant will provide their respective comments, if any, to the inquiry committee. For good cause, the Respondent or Complainant may request an extension of time from the RIO, which shall be granted whenever reasonable.
    3) Any comments that the Complainant or Respondent submits on the report will be shared with the inquiry committee and will become part of the final inquiry report and record. Based on the comments, the inquiry committee may revise the report as appropriate.
  3. Inquiry Decision and Notification:
    
    1) Decision by VCR: The RIO will transmit the final report of the inquiry committee and any comments to the VCR, who will make the determination of whether findings from the inquiry provide sufficient evidence of possible research misconduct to warrant conducting an investigation. The inquiry is completed when the VCR makes this determination.
    2) Notification: The RIO will notify the Respondent and may notify the Complainant in writing of the VCR’s decision of whether to proceed to an investigation. If an investigation is opened, the notice will include a reminder of the obligation to cooperate. The RIO also will notify all appropriate University officials and ORI (as applicable) of the VCR’s decision.
  4. Time for Completing the Inquiry Report:
    
    1) The inquiry committee will normally complete the inquiry and submit its report in writing to the RIO no more than 60 days following its first meeting, unless the RIO approves an extension because circumstances warrant a longer period. If the RIO approves an extension, the reason for the extension will be entered into the record of the proceeding. The Respondent also will be notified of the extension.
    2) For allegations that involve PHS funding, within 30 days of the VCR’s decision that an investigation is warranted the RIO shall provide ORI with the written finding and a copy of the inquiry report containing the information required by the U.S. Code of Federal Regulations. Upon a request from ORI, the RIO shall promptly send to ORI:
    
    a) a copy of institutional policies and procedures under which the inquiry was conducted;
    b) the research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
    c) the charges for the investigation to consider.
    
    3) Inquiry reports of allegations that do not involve PHS funding in accordance with the definition of research misconduct will not be forwarded to ORI, but will otherwise be in accordance with this rule.
  5. Documentation of Decision Not to Investigate: If the VCR decides that an investigation is not warranted, the RIO shall secure and maintain for 7 years after the termination of the inquiry sufficiently detailed documentation of the inquiry to permit a later assessment by ORI of the reasons why an investigation was not conducted. These documents must be provided to ORI or other authorized HHS personnel upon request.
6. Initiation and Purpose of the Investigation
  1. Purpose of the Investigation: The investigation must begin within 30 days after the determination by the VCR that an investigation is warranted. The purpose of the investigation is to explore in detail the allegations; to examine the evidence in depth; to determine specifically whether research misconduct has been committed, by whom, and to what extent; and, if research misconduct has been committed, to recommend appropriate sanctions. The investigation also will determine whether there are additional instances of possible research misconduct that would justify broadening the scope beyond the initial allegations. This is particularly important where the alleged research misconduct involves clinical trials or potential harm to human subjects, animals, or the general public or if it affects research that forms the basis for public policy, clinical practice, or public health practice. The findings of the investigation will be set forth in an investigation report.
  2. Sequestration of the Research Records: The RIO will promptly sequester any additional pertinent research records and evidence that were not previously sequestered during the inquiry. This sequestration should occur before or at the time the Respondent is notified that an investigation has begun and whenever additional items become known or relevant to the investigation. The need for additional sequestration of records may occur for any number of reasons, including the University's decision to investigate additional allegations not considered during the inquiry stage or the identification of records during the inquiry process that had not been previously secured. Sequestration during the investigation will proceed in the same manner as during the inquiry outlined in Section 4.d of this rule.
  3. Appointment of the Investigation Committee: The committee will consist of at least three tenured professors appointed by the Faculty Council/Senate and optionally two members appointed by the RIO. This appointment will occur as soon as practicable after the Respondent has been notified that an investigation is planned. The investigation committee should consist of individuals who do not have real or apparent conflicts of interest in the case, are unbiased, and have the necessary expertise to evaluate the evidence and issues related to the allegations, interview the principals and key witnesses, and conduct the investigation. Individuals appointed by the RIO, as well as additional consultants to the committee, may be scientists, administrators, subject matter experts, lawyers, or other qualified persons, and they may be from inside or outside the University. Individuals appointed to the investigation committee may also have served on the inquiry committee. The RIO will notify the Respondent of the proposed committee membership. If the Respondent submits a written objection to any appointed member of the investigation committee, the RIO will determine whether to replace the challenged member with a qualified substitute.
  4. Charge to the Committee and the First Meeting:
    
    1) Charge to the Committee: The RIO will define the subject matter of the investigation in a written charge to the committee that describes the allegations and related issues identified during the inquiry, defines research misconduct, and identifies the name of the Respondent. The charge will state that the committee is to evaluate the evidence and testimony of the Respondent, Complainant, and key witnesses to determine whether, based on a preponderance of the evidence, research misconduct occurred and, if so, to what extent, who was responsible, and its seriousness. During the investigation, if additional information becomes available that substantially changes the subject matter of the investigation or would suggest additional Respondents, the committee will notify the RIO, who will determine whether it is necessary to notify the Respondent of the new subject matter or to provide notice to additional Respondents.
    2) The First Meeting: The RIO, with the Office of the General Counsel, will convene the first meeting of the investigation committee to review the charge, the inquiry report, and the prescribed procedures and standards for the conduct of the investigation, including the necessity for confidentiality and for developing a specific investigation plan. The investigation committee will be provided with a copy of this rule and, where PHS funding is involved, the PHS regulation.
  5. Investigation Process: In conducting all investigations, the University shall:
    
    1) Use diligent efforts to ensure that the investigation is thorough and sufficiently documented and includes examination of all research records and evidence relevant to reaching a decision on the merits of the allegations;
    2) Interview each Respondent, Complainant, and any other available person who has been reasonably identified as having information regarding any relevant aspects of the investigation, including witnesses identified by the Respondent, and record or transcribe each interview, provide the recording or transcript to the interviewee for correction, and include the recording or transcript in the record of investigation;
    3) Pursue diligently all significant issues and leads discovered that are determined relevant to the investigation, including any evidence of additional instances of possible research misconduct, and continue the investigation to completion; and
    4) Otherwise comply with the requirements for conducting a research misconduct investigation in the U.S. Code of Federal Regulations.
    5) The Respondent will be notified sufficiently in advance of the scheduling his or her interview so that the Respondent may prepare for the interview and arrange for the attendance of an advisor, if the Respondent wishes.
7. The Investigation Report
  1. Elements of the Investigation Report: The RIO, in conjunction with the investigation committee, shall prepare the draft and final institutional investigation reports in writing and provide the draft report for comment as provided elsewhere in this rule and the U.S. Code of Federal Regulations. The final investigation report shall:
    
    1) Describe the nature of the allegations of research misconduct; 2) Describe and document the PHS funding (if applicable), including, for example any grant numbers, grant applications, contracts, and publications listing PHS funding; 3) Describe the specific allegations of research misconduct considered in the investigation and the charge to the Investigation Committee; 4) If reporting to ORI is required and not already provided to ORI, include the institutional policies and procedures under which the investigation was conducted; 5) Identify and summarize the research records and evidence reviewed, and identify any evidence taken into custody, but not reviewed. The report should also describe any relevant records and evidence not taken into custody and explain why. 6) Provide a finding as to whether research misconduct did or did not occur for each separate allegation of research misconduct identified during the investigation. For each instance where research misconduct was found, the Investigation Committee’s report shall do the following:
    
    a) identify it as falsification, fabrication, or plagiarism;
    b) identify the basis for determining that it was a significant departure from accepted practices, that it was committed intentionally, knowingly, or recklessly, and that it was proved b a preponderance of the evidence;
    c) summarize the facts and the analysis supporting the conclusion and consider the merits of any reasonable explanation by the Respondent and any evidence that rebuts the Respondent's explanations;
    d) identify the specific PHS funding or other support (if applicable);
    e) identify any publications that need correction or retraction;
    f) identify the person(s) responsible for the research misconduct; and
    g) list any current support or known applications or proposals for support that the Respondent(s) has pending with non-PHS Federal agencies or other funding entities; and
    h) Include and consider any comments made by the Respondent and Complainant on the draft investigation report.
    
    7) Recommend one or more sanctions to be imposed on each Respondent found responsible for research misconduct.
  2. Comments on the Draft Report
    
    1) Respondent: The RIO will provide the Respondent with a copy of the draft investigation report, and concurrently, a copy of, or supervised access to, the evidence on which the report is based and notify the Respondent that any comments must be submitted within 14 days of the date on which the Respondent received the draft report. For good cause, the Respondent may request an extension of time from the RIO, which shall be granted whenever reasonable. The Respondent's comments will be attached to the final report and are considered in the final investigation report.
    2) Complainant: At the RIO’s discretion, the RIO may provide the Complainant a copy of the draft investigation report or relevant portions of that report and notify the Complainant that any comments must be submitted within 14 days of the date on which the Complainant received the draft report or relevant portions of it. For good cause, the Complainant may request an extension of time from the RIO, which shall be granted whenever reasonable. The Complainant’s comments will be attached to the final report and are considered in the final investigation report.
    3) Review by Office of the General Counsel: The draft investigation report will be transmitted to the Office of the General Counsel for a review of its legal sufficiency. Comments should be incorporated into the report as appropriate.
    4) Confidentiality: In distributing the draft report, or portions thereof, to the Respondent and Complainant, the RIO will inform the recipient of the confidentiality under which the draft report is made available and may establish reasonable conditions to ensure such confidentiality. For example, the RIO may request the recipient to sign a confidentiality statement or to come to RIO’s office to review the report.
    5) Transmittal of the Final Investigation Report: After comments have been received and the necessary changes have been made to the draft report, the investigation committee will transmit the final report with attachments, including the Respondent's comments, to the DO, through the VCR.
  3. University Review and Decision
    
    1) Based on a preponderance of the evidence, the DO will make the final determination whether to accept the investigation report, its findings, and the recommended University actions, including sanctions to be imposed on each Respondent determined to be responsible for research misconduct. A preponderance of the evidence means proof by information that, compared with that opposing it, leads to the conclusion that the fact at issue is more probably true than not. If this determination varies from that of the investigation committee, the DO will explain in detail the basis for rendering a decision different from that of the investigation committee, and will include such explanation in the institution's letter transmitting the report to ORI (if applicable). The DO's explanation should be consistent with the PHS definition of research misconduct, this rule, and the evidence reviewed and analyzed by the investigation committee. The DO may also return the report to the investigation committee with a request for further fact-finding or analysis. The DO's determination, together with the investigation committee's report, constitutes the final investigation report for purposes of ORI review.
    2) When a final decision on the case has been reached, the RIO will notify the Respondent in writing of the decision. In addition, the DO will determine whether law enforcement agencies, professional societies, professional licensing boards, editors of journals in which falsified reports may have been published, collaborators of the Respondent in the work, or other relevant parties should be notified of the outcome of the case. The RIO is responsible for ensuring compliance with all notification requirements of funding or sponsoring agencies.
  4. Time Limit for Completing the Investigation Report: An investigation should ordinarily be completed within 120 days of its initiation, with the initiation ordinarily beginning with the first meeting of the investigation committee. This includes conducting the investigation, preparing the report of findings, making the draft report available to the subject of the investigation for comment, submitting the report to the DO for approval, and submitting the report to the ORI (if applicable). If the University will not be able to complete the investigation in 120 days and the matter involve PHS funding, it will submit to ORI a written request for an extension and an explanation for the need for an extension.
8. Appeals
  1. The Respondent may appeal the decision by the DO to the appropriate Appellate Officer. If the Provost or other official served as the DO, the Appellate Officer will be the Chancellor or designee; if the Chancellor served as the DO, the Appellate Officer will be the President or designee. An appeal must state the reasons for appeal in detail and must be submitted to the Appellate Officer within seven days after receipt of notification of the decision. The appeal shall be limited to the following grounds:
    
    1) A procedural error occurred that significantly impacted the outcome of the finding or sanctions, e.g., substantiated bias or material deviation from established procedures.
    2) To consider new evidence, unavailable during the investigation, that could substantially impact the original findings or sanction.
    3) The sanction falls outside the range typically imposed for this offense, or for the cumulative disciplinary record of Respondent.
  2. Within seven days of receipt of the appeal from Respondent, the Appellate Officer shall provide a copy of the appeal to the DO.
  3. Within seven days of receiving a copy of the appeal, the DO may file a response to the appeal.
  4. Within 14 days of receiving the DO’s response to the appeal, the Appellate Officer shall provide a determination in writing to the DO and Respondent. The Appellate Officer can affirm, modify or reverse the decision of the DO.
  5. The determination of the Appellate Officer is final and not subject to further review, including under the Academic Grievance Procedure in Section 370.010 of the Collected Rules and Regulations.
  6. Status during appeal – The Respondent may petition the Appellate Officer in writing for permission to stay the imposed sanction pending final determination of the appeal. The Appellate Officer may permit the stay of sanctions under such conditions as may be designated pending completion of the appeal, provided such continuance will not seriously disrupt the University or constitute a danger to the health, safety or welfare of members of the University community. If a stay is granted, any final sanctions imposed shall be effective from the date of the final decision.
  7. An appeal must be completed within 120 days of its filing. If additional time is needed, the Appellate Officer may extend this deadline for good cause. If the matter involves PHS support, the deadline may be extended only if an extension is requested from and granted by ORI.
9. Requirements for Reporting to ORI:
  1. In cases involving Respondents who receive funding from the PHS, the University shall promptly provide the following information to ORI after the investigation has concluded:
    
    1) A copy of the investigation report and all attachments;
    2) A statement of whether the institution found research misconduct and, if so, who committed it;
    3) A statement of whether the institution accepts the findings in the investigation report; and
    4) A description of any pending or completed administrative actions against the Respondent.
  2. The University shall maintain and provide to ORI upon request all relevant research records and records of its research misconduct proceeding, including results of all interviews and the transcripts or recordings of such interviews.
  3. If the University plans to terminate an inquiry or investigation for any reason without completing all relevant requirements of the PHS regulation, the RIO will submit a report of the planned termination to ORI, including a description of the reasons for the proposed termination.
  4. If the University determines that it will not be able to complete the investigation in 120 days, the RIO will submit to ORI a written request for an extension that explains the delay, reports on the progress to date, estimates the date of completion of the report, and describes other necessary steps to be taken. If the request is granted, the RIO will file periodic progress reports as requested by the ORI.
  5. When the case involves PHS funds, the University cannot accept an admission of research misconduct as a basis for closing a case or not undertaking an investigation without prior approval from ORI.
  6. At any time during a research misconduct proceeding, the University shall notify ORI immediately if it has reason to believe that any of the following conditions exist:
    
    1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects.
    2) HHS resources or interests are threatened.
    3) Research activities should be suspended.
    4) There is a reasonable indication of violations of civil or criminal law.
    5) Federal action is required to protect the interests of those involved in the research misconduct proceeding.
    6) The University believes the research misconduct proceeding may be made public prematurely, so that HHS may take appropriate steps to safeguard evidence and protect the rights of those involved.
    7) The University believes the research community or public should be informed.
10. Other Considerations
  1. Termination of University Employment or Resignation Prior to Completing Inquiry or Investigation
    
    1) The termination of the Respondent's employment with the University, by resignation or otherwise, before or after an allegation of possible research misconduct has been reported, ordinarily will not preclude or terminate the misconduct proceedings. If the Respondent, without admitting to the misconduct, elects to resign the Respondent’s position prior to the initiation of an inquiry, but after an allegation has been reported, or during an inquiry or investigation, the inquiry or investigation ordinarily will proceed. If the Respondent refuses to participate in the process after resignation, the committee will use its best efforts to reach a conclusion concerning the allegations, noting in its report the Respondent's failure to cooperate and its effect on the committee's review of all the evidence.
11. Notice: All communication, including notices, decisions, and appeals may be sent via University e-mail. Notice sent to a University email account shall be deemed to have been received on the day following the day it was sent.

420.020 Procedures Governing the Disposition of Charges of Research Dishonesty by Academic Faculty

kuscheld — Thu, 27 May 2010 16:50:26 +0000

420.020 Procedures Governing the Disposition of Charges of Research Dishonesty by Academic Faculty kuscheld Thu, 05/27/2010 - 16:50

Bd. Min. 5-1-87; Revised 5-4-90, Revised 10-24-96.

This regulation was rescinded on 3-23-06.

420.030 Conflict with the Interests of Federal Grant Agencies

kuscheld — Thu, 27 May 2010 16:52:48 +0000

420.030 Conflict with the Interests of Federal Grant Agencies kuscheld Thu, 05/27/2010 - 16:52

Executive Order 39, previously issued as Executive Guideline 32, 9-18-95, Amended 8-24-12.

Purpose – This Executive Order is intended to comply with the requirement of the National Science Foundation (NSF) and the Public Health Service of the Department of Health and Human Services (PHS), that grantee institutions maintain an appropriate written and enforced policy on conflict of interest consistent with provisions in the NSF Grant Policy Manual and 42 CFR Part 50 and 45 CFR Part 94. This policy pertaining to conflicts with the interests of federal grant agencies is applicable to investigators, as defined below, involved in proposed or funded research by NSF or PHS (including NIH). All University employees are also subject to CRR 330.015, pertaining to conflicts with the interests of the University. Researchers on Human Subjects and certain University officials are also subject to CRR 410.020 pertaining to Institutional Conflicts in Human Subjects Research.
Definitions – For the purposes of this Executive Order, the following terms have the meanings stated:
1. The term “investigator” means the project director, principal investigator, co-principal investigators, collaborators or consultants and any other person who is responsible for the design, conduct, or reporting of research or educational activities funded or proposed for funding by NSF or PHS.
2. The term ‘significant financial interest’ means
  1. A financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator’s spouse and dependent children) that reasonably appears to be related to the Investigator’s institutional responsibilities:
    
    (1) With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration (salary, consulting fees, honoraria, paid authorship or other payment for services) received from the entity in the twelve months preceding the disclosure and the value of any equity interests (stock, stock option, or other ownership interest and determined through reference to public prices or other reasonable measures of fair market value) in the entity as of the date of disclosure, when aggregated, exceeds $5,000 for PHS-funded purposes and $10,000 for NSF-funded purposes.
    (2) With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator’s spouse or dependent children) holds any equity interest (e.g. stock, stock option, or other ownership interest); or
    (3) Intellectual property rights and interests (e.g. patents, copyrights) upon receipt of income related to such rights and interests.
  2. PHS-funded Investigators must also disclose the occurrence of any reimbursed or sponsored travel (i.e. that which is paid on behalf of the investigator and not reimbursed to the Investigator so that the exact monetary value may not be readily available), related to their institutional responsibilities; provided, however, that this disclosure requirement does not apply to travel that is reimbursed or sponsored by a Federal, state or local government agency, an institution of higher education as defined by 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an institution of higher education. The University will determine if a determination or disclosure of monetary value is required in order to determine whether the travel constitutes a conflict of interest with PHS-funded research.
  3. The term does not include:
    
    (1) salary, royalties or other remuneration from the University, including intellectual property rights assigned to the institution and agreements to share in royalties related to such rights;
    (2) income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles;
    (3) income from seminars, lectures, or teaching engagements sponsored by a Federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
    (4) income from service on advisory committees or review panels for a Federal, state or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
    (5) public or nonprofit entities.
3. For the purpose of this Executive Order, a “Financial Conflict of Interest” means a significant financial interest that could directly and significantly affect the design, conduct or reporting of NSF- or PHS-funded research.
Investigator’s Duty – Training. Each investigator involved in any PHS- or NSF- funded grant or contract shall complete training prior to engaging in research related to such grant or contract; shall complete training at least every four years; and shall complete training immediately if (a) there is a change in this policy that affects investigator requirements, (b) the investigator is new to the University, or (c) the University finds the investigator noncompliant with this policy or management plan created pursuant to this policy.
Investigator’s Duty – Disclosure. Each investigator shall disclose to the designated Institutional Official(s) all significant financial interests of the investigator (including those of the investigator’s spouse and dependent children) that reasonably appear to be related to the Investigator’s institutional responsibilities.
This information must be disclosed:
1. at the time the application is submitted;
2. on an annual basis during the period of the award; and
3. within 30 days of discovering or acquiring a new significant financial interest.
For PHS proposals and awards, subgrantees, contractors and collaborators shall have the same duty to disclose as investigators.
Institutional Duties
1. Institutional Duties – The Chancellor of each campus shall designate one or more persons (Reviewer) to
  1. provide training for investigators;
  2. solicit and review financial disclosures;
  3. determine whether a financial conflict of interest with the interests of NSF or PHS exists;
  4. determine what conditions or restrictions, if any, should be imposed by the University to manage, reduce or eliminate such conflict of interest and resolve actual or potential problems revealed;
  5. conduct a retrospective review in cases of noncompliance and make any reports required by the appropriate regulations to the granting agency or the public;
  6. incorporate in a written agreement with any subrecipient terms that establish whether the conflict of interest policy of the University or that of the subrecipient will apply to the subrecipient’s Investigators, and otherwise comply with the requirements of 42 U.S.C. Section 50.604; and
  7. develop and publish campus guidelines and procedures to comply with NSF and PHS requirements for the identification, management and reporting of financial conflicts of interest with respect to all research projects for which funding is sought or received from NSF or PHS, and for any reporting or records maintenance requirements of those agencies.
2. Examples of conditions or restrictions that might be imposed to manage, reduce or eliminate actual or potential conflicts of interest include, but are not limited to:
  1. public disclosure of significant financial conflicts of interest (e.g. when presenting or publishing the research);
  2. For research projects involving human subjects research, disclosure of financial conflicts of interest directly to participants;
  3. monitoring of research by independent reviewers capable of taking measures to protect the design, conduct and reporting of the research against bias resulting from the financial conflict of interest;
  4. modification of the research plan;
  5. Change of personnel or personnel responsibilities, or disqualification from participation in the portion of the NSF-funded research that would be affected by the significant financial interests;
  6. reduction or elimination of the financial interest (e.g. sale of an equity interest); or
  7. severance of relationships that create financial conflicts.
If the University is unable to satisfactorily manage an actual or potential conflict of interest, the Reviewer shall keep the NSF or PHS appropriately informed.

PHS shall be informed of all conflicts with its interests and mechanisms for managing them.
Enforcement
1. Allegations of undisclosed conflicts with the interests of NSF or PHS or of failures to comply with conditions or restrictions imposed to manage, reduce or eliminate such conflicts shall be investigated by the University, and appropriate notifications to NSF, PHS and the public shall be made.
2. Conduct by an employee that violates this policy shall constitute a breach of the employment contract and may lead to disciplinary action up to and including termination.
3. Conduct by subgrantees, contractors or collaborators that violates this policy shall constitute a breach of contract and may lead to appropriate action, up to and including termination of the contractual agreement.
Records – The University will retain records of investigator financial disclosures and of actions taken to manage conflicts of interest for (for NSF) three years after the later of the termination or completion of the award to which they relate or the resolution of any government action involving those records; or (for PHS) for three years after final payment or, where applicable, for the other time periods specified in 45 CFR 74.53(b), 45 CFR 92.42(b), and 48 CFR Part 4, subpart 4.7.

430.010 Industrial Security Program

kuscheld — Fri, 19 Jul 2024 19:55:01 +0000

430.010 Industrial Security Program kuscheld Fri, 07/19/2024 - 19:55

Bd. Min. 06-27-24; Amended Bd. Min. 11-20-24.

Statement of Purpose
1. This rule addresses ��ӰԺ (a.k.a., the University of ��ӰԺ System (UM System)) compliance with U.S. industrial security policy, including applicable federal statutes, Executive Orders (E.O.), Code of Federal Regulations (CFR), Department of Defense Instructions (DoDI), and other applicable authorities. UM System is committed to compliance for the protection of classified information disclosed to or developed by contractors of the U.S. Government (USG), employed or the responsibility of UM System (contractors).
2. This rule will be applied to achieve compliance with applicable federal authorities, including:
  1. E.O. 12829, National Industrial Security Program
  2. E.O. 10865, Safeguarding Classified Information within Industry
  3. 32 CFR Part 2004, National Industrial Security Program
  4. DoDI 5220.22, National Industrial Security Program
  5. 32 CFR Part 117, National Industrial Security Program Operating Manual (NISPOM)
3. This rule implements policy, assigns responsibilities, and establishes requirements for the protection of classified information disclosed to, or developed by contractors across the UM System.
Scope and Compliance Policy
1. This rule applies to all cleared facilities (i.e., Facility Clearances or FCLs) within the UM System holding a FCL, to all personnel whose personnel security clearances are held by a UM System or subsidiary FCL, and to all personnel who hold roles related to ensuring compliance with the authorities outlined in subsection A.2 (e.g., Key Management Personnel or KMPs).
2. The UM System is the “corporate family” for all classified work taking place at any FCL within the System. Individual universities may have subsidiary Facility Clearances under the UM System Facility Clearance if they have federal authorization to hold classified materials on-site, a secondary place-of- performance, or flow down to a sub-tier contractor.
3. The UM System shall implement a corporate-wide Insider Threat Program to address insider threats throughout the UM System.
4. The President will appoint the following personnel to oversee and implement the UM System industrial security program (ISP) (System ISP):
  1. Senior Management Official (SMO)
  2. Insider Threat Program Senior Management Official (ITPSO)
  3. Facility Security Officer (FSO)
5. The personnel identified in subsection B.4 must:
  1. Oversee the implementation of the requirements of the NISPOM;
  2. Undergo the same security training that is required of all contractors, in addition to any position specific training;
  3. Be designated in writing; and
  4. Undergo a personnel security investigation and national security eligibility determination for access to classified information at the level of the entity’s eligibility determination for access to classified information.
6. SMO: The President of the UM System is the SMO for the UM System FCL and for all subsidiary FCLs held by an individual university within the UM System. The SMO will:
  1. Ensure a system of security controls in accordance with the NISPOM;
  2. Appoint an UM System ITPSO and FSO in writing;
  3. Remain fully informed of the UM System ISP classified operations;
  4. Make decisions based on the threat reporting and information and the potential impacts to the UM System ISP; and
  5. Retain accountability for the management and operations of the System’s ISP without delegating that accountability.
7. ITPSO: The Director, Research Security and Compliance is the ITPSO and will be designated in writing by the SMO. The ITPSO will:
  1. Ensure the FSO(s) is part of the insider threat program;
  2. Complete training in accordance with the NISPOM; and
  3. Develop an insider threat program that meets the requirements of the NISPOM.
8. FSO: An FSO will be appointed in writing by the SMO for any University with an active FCL. Each FSO will:
  1. Supervise and direct security measures necessary for implementing the NISPOM to ensure the protection of classified information.
  2. Complete security training as deemed appropriate by the Cognizant Security Agency (CSA) who accredits the FCL. Both direct and reciprocity CSAs training must be met.
  3. Appoint an Information System Security Manager (ISSM) if classified information will be processed on an information system at a University with an FCL.
9. ISSM: If classified information will be processed on an information system at a University with an FCL, the FSO will appoint an ISSM. Each ISSM will:
  1. Be adequately trained and possess the technical competence required to operate, maintain, and secure the contractor’s classified information system; and
  2. Oversee development, implementation, and evaluation of the University's classified information system program.
University of ��ӰԺ Research Security and Compliance Team
1. UM Research Security and Compliance Team
  Each FCL within the UM System will have an appointed FSO who reports to the UM System Director of Research Security and Compliance. Each FSO shall be a member of the University of ��ӰԺ Research Security and Compliance Team (“UM RSC Team”).
2. Collaboration
  Recognizing both the necessity and administrative efficiencies gained, the UM RSC Team shall work in collaboration with each other and with those also holding responsibilities for compliance with the authorities outlined in subsection A.2. to ensure that no single point of failure exists within the System.
3. Accountability and Alignment
  To ensure the accountability and alignment of the UM RSC Team, each Chancellor shall designate one of that University's Vice Chancellors to work with the UM System Director for Research Security and Compliance, who will jointly approve the following as it relates to the FSO at each institution:
  1. Recruitment and hiring decisions;
  2. Disciplinary and termination decisions; and,
  3. Annual performance evaluations and compensation decisions.
  For situations in which concurrence is not reached, the collective decision will be made with the President.
Strategies
1. The FSO(s) will develop the industrial security strategies for the UM System to establish, document, and implement processes and procedures to ensure the System remains in compliance with the authorities outlined in subsection A.2. These strategies will be brought before the UM RSC Team for approval before implementation.
2. A Standard Practice Procedures (SPP) is developed and maintained by the UM RSC Team and maintained. This SPP documents the current processes and procedures used across the System. The SPP will contain information describing acceptable structures for the Security Executive Committee (SEC).
3. University-specific appendices will be maintained within the SPP as needed.
4. At least once annually, the Board of Curators will review and ratify a Security Resolution outlining the members of the SEC and those who are excluded from the SEC in alignment with the structure outlined in the SPP.
Implementation
The FSOs and Insider Threat Program Senior Official on the UM RSC Team are responsible for the implementation of the industrial security programs and the Insider Threat Program for the UM System.

430.020 Export Control and Sanctions Compliance

kuscheld — Mon, 30 Jan 2023 14:59:50 +0000

430.020 Export Control and Sanctions Compliance kuscheld Mon, 01/30/2023 - 14:59

Executive Order No. 49, issued 1-24-23; Amended 11-21-24.

Statement of Purpose
1. This rule addresses the University’s compliance with U.S. export control and sanctions laws and regulations (“export controls”). The University is committed to export control compliance in all activities that may result in an export or sanctioned transaction with a foreign person, entity, or country.
2. Unless otherwise indicated, this rule applies to all transactions by the University of ��ӰԺ System, its administration, and four universities and all of their component parts (hereafter referred to as "University" or "UM System"), regardless of whether or not those transactions are research related, and is intended to comply with the Foreign Assets Control Regulations (“FACR”) at 31 CFR §§ 500-599, the International Traffic in Arms Regulations (“ITAR”) at 22 CFR §§ 120-130, the Export Administration Regulations (“EAR”) at 15 CFR §§ 730-799, the Foreign Trade Regulations (“FTR”) at 15 CFR § 30, and other similar regulations to which export controls or sanctions apply.
Scope and Compliance Policy
1. This rule applies to all University employees, students, contractors, consultants, and any other persons acting on behalf of or at the direction of the University.
2. No person may do or facilitate anyone doing any of the following on behalf of the University:
  1. Engaging in transactions prohibited by the Foreign Assets Control Regulations (FACR) or other sanctions programs administered by the U.S. Department of the Treasury, unless otherwise authorized;
  2. Exporting items, technical data, or defense services subject to the ITAR other than as authorized by the U.S. Department of State;
  3. Exporting items, technology, or software subject to the EAR other than as authorized by the U.S. Department of Commerce; or
  4. Violating any other U.S. export control law or regulation.
3. All persons must be mindful of export control requirements across all University activities. This includes, but is not limited to, the considerations listed below. This list is only illustrative, and compliance will be determined by applicable statutes and regulations in place at the relevant time, so all persons should seek guidance whenever activities may involve exports or involve interactions with countries, persons, or entities subject to sanctions.
  1. Performing any service of value for a person or entity located in a sanctioned destination (regardless of that person’s citizenship) may be regulated by the FACR.
  2. The ITAR and EAR regulate the transfer of controlled items, technical data, technology, and software to foreign persons or destinations, in addition to regulating defense services. An export may include:
    
    1) An actual shipment or transmission out of the United States, including the sending or taking of an item out of the United States, in any manner;
    2) Releasing or otherwise transferring technical data or technology (including software) to a foreign person in the United States (a “deemed export”);
    3) Transferring registration, control, or ownership of any spacecraft, aircraft, vessel, or satellite by a U.S. Person to a foreign person;
    4) Releasing or otherwise transferring a defense article to an embassy or to any of its agencies or subdivisions, such as a diplomatic mission or consulate, in the United States;
    5) Performing a defense service on behalf of, or for the benefit of, a foreign person, whether in the United States or abroad; or
    6) The release of previously encrypted technical data.
  3. The following types of technical data, technology, and software generally may be exempt from export control regulations:
    
    1) Publicly available information. Technical data and technology may be considered publicly available when they are generally accessible or available to the public through sales at newsstands and bookstores; through subscriptions which are available without restriction to any individual who desires to obtain or purchase the published information; through second class mailing privileges granted by the U.S. Government; at libraries open to the public or from which the public can obtain documents; through patents available at any patent office; through unlimited distribution at a conference, meeting, seminar, trade show or exhibition, generally accessible to the public, in the United States; or through public release (i.e., unlimited distribution) in any form (e.g., not necessarily in published form) after approval by the cognizant U.S. government department or agency.
    2) Educational information. Technical data may be considered educational information when it is general scientific, mathematical, or engineering principles commonly taught in schools, colleges, and universities. Technology may be considered educational information when it is released by instruction in a catalog course or associated teaching laboratory of an academic institution.
    3) Fundamental Research. Fundamental research generally may mean basic and applied research in science and engineering, the results of which ordinarily are published and shared broadly within the scientific community, as distinguished from proprietary research and from industrial development, design, production, and product utilization, the results of which ordinarily are restricted for proprietary or national security reasons. Fundamental research should not be considered to apply to information and software received during the course of research. It should only be considered to apply to the technical data, technology, and software that arises from or is generated during the research. In order for technical data, technology, and software to qualify as fundamental research, the research:
    
    a. Must be conducted by an accredited institution of higher learning;
    b. Must take place in the U.S.; and
    c. The University and its researchers cannot have accepted other restrictions on publication of or access to scientific and technical information resulting from the project or activity.
University of ��ӰԺ Research Security and Compliance Team
1. UM Research Security and Compliance Team
  Each University within the UM System will have at least one designated export controls and sanctions point of contact (POC) who reports to the UM System Director of Research Security and Compliance. The UM System Director of Research Security and Compliance, research security contacts designated pursuant to CRR 330.120.C.1, and all POCs comprise the University of ��ӰԺ Research Security and Compliance Team (“UM RSC Team”). Additional personnel with compliance responsibilities related to export controls and/or sanctions may be consulted by the UM RSC Team or included within the UM RSC Team at the designation of the UM System Director for Research Security and Compliance.
2. Collaboration
  Recognizing both the necessity and administrative efficiencies gained, the UM RSC Team shall work in collaboration to meet the needs of the UM System.
3. Accountability and Alignment
  To ensure the accountability and alignment of the UM RSC Team, each Chancellor shall designate one of that University’s Vice Chancellors to work with the UM System Director for Research Security and Compliance, who will jointly approve the following as it relates to the POCs and other export controls and/or sanctions professionals at each institution:
  1. Recruitment and hiring decisions
  2. Disciplinary and termination decisions
  3. Annual performance evaluations and compensation decisions.
  For situations in which concurrence is not reached, the collective decision will be made with the President.
Strategies
1. The Director of Research Security and Compliance, in collaboration with the UM RSC Team, will develop the export compliance strategies for the UM System to establish, document, and implement processes needed to ensure that the University, and its personnel, remain in full compliance with applicable U.S. export control and sanctions related laws and regulations while still achieving its academic and global outreach missions.
2. These strategies are outlined in an Export Compliance Management Program (ECMP) which operationalizes this policy, establishes processes, reiterates its commitment to compliance, and provides information and guidance to the University community.
3. Each university has the flexibility to develop university specific export compliance and sanctions strategies and procedures after consultation with the Director of Research Security and Compliance and so long as the strategies are not in conflict with or interfere with the UM System export compliance strategies.
Implementation
The University of ��ӰԺ Research Security and Compliance Team is responsible for the implementation of the export controls and sanctions compliance strategies for the UM System.