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.

Statement of Purpose; Definition of Policy
1. One of the most important academic responsibilities of the University of ��ӰԺ is the generation of knowledge through research and creative activity. The necessity for the maintenance of ethical standards in research is self-evident.
2. This rule applies to all research and is also intended to comply with the Federal Research Misconduct Policy stated in 65 FR 76260 (Dec. 6, 2000), as applicable to institutions receiving research funding from federal agencies or departments, and the implementing policies and regulations of those federal agencies or departments, such as 42 CFR 93.
3. Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
  (a) Fabrication is making up data or results and recording or reporting them.
  (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
  (c) Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit.
  (d) Research misconduct does not include honest error or differences of opinion.
4. A finding of research misconduct made under this section requires that:
  (a) There be a significant departure from accepted practices of the relevant research community; and
  (b) The misconduct be committed intentionally, knowingly, or recklessly; and
  (c) The allegation be proven by preponderance of the evidence.
Campus Faculty Committee to Hear Cases of Research Misconduct
1. There shall be a Standing Committee on each campus of the University which shall have jurisdiction to hear any case involving a charge of research misconduct brought against a member of the academic faculty or staff under these regulations.
2. Each campus faculty or other body delegated this authority by the Board of Curators shall, by written rule, establish the number of members of this Committee, the apportionment among divisions within the campus, and the method of selection of the members and alternates.
3. Members of this Committee shall be elected from the eligible professors on continuous appointment. If there are no eligible professors within the electoral unit, then the members shall be elected from the eligible associate professors on continuous appointment.
4. Persons who devote more than fifty percent of their time to administrative duties shall not be eligible for membership on this Committee.
5. The Chancellor of the campus shall appoint from among the members of the Committee a chairperson pro tempore, who, if a meeting is necessary, shall call the first meeting of the Committee, at which time the Committee shall elect from among its members a chairperson and a secretary to serve at the pleasure of the Committee. At least two-thirds of the members, or their alternates, must be present to constitute a quorum for the conduct of any business of the Committee including the conduct of the hearings referred to in these regulations.
Initiation and Transmission of Allegation(s) of Research Misconduct
1. Any person who receives allegations of research misconduct must promptly forward them, in writing, to the dean or director of the academic unit in which the accused individual is located, or on campuses with no schools or colleges to the Vice Provost for Research.
2. The dean or director or Vice Provost for Research to whom a written allegation(s) of research misconduct is submitted shall promptly provide the Vice Chancellor for Academic Affairs/Provost, the accused individual (hereinafter referred to as Respondent) and the chairperson of the department in which the Respondent is located with a copy of the written allegation(s).
General Procedural Rules for Addressing Allegation(s) of Research Misconduct
1. These procedures have three principal phases: an inquiry assessing whether the allegation has substance and an investigation is warranted; an investigation which formally develops the factual record, leading to findings of fact, recommending conclusions as to whether research misconduct occurred and proposing remedies; and a determination by the Chancellor as to whether research misconduct occurred and directing what action, if any, shall be taken..
2. Federal funding agency review. If the allegation involves federally funded research or the application for federally funded research, notice must also be provided to the appropriate federal funding agency or agencies. The University will fully and continually cooperate with the federal funding agency during its oversight review or any subsequent administrative hearings or appeals. This includes providing all research records and evidence under the institution’s control, custody, or possession and access to all persons within its authority necessary to develop a complete record of relevant evidence.
3. The Vice Chancellor for Academic Affairs/Provost may elect at any point to dismiss the allegation(s) of research misconduct and to terminate the inquiry/investigation. If this is done, notice of such termination must be provided to the parties named in C.2. within 30 days, and if the allegation involves federally funded research or the application for federally funded research notice must also be provided to the appropriate federal funding agency or agencies, including a report of such planned termination, with a description of the reasons therefore, and the appropriate federal funding agency will then decide whether further investigation should be undertaken.
  
  (a) The Vice Chancellor for Academic Affairs/Provost shall notify the federal granting agency, if any, if he/she ascertains at any stage of the inquiry or investigation that any of the following conditions are met:
  (1) Health or safety of the public is at risk, including an immediate need to protect human or animal subjects;
  (2) Resources or interests of the federal granting agency 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 research misconduct proceeding;
  (6) The University believes the research misconduct proceeding may be made public prematurely so that the federal granting 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.
4. Confidentiality. 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. Provided, however, that:
  (a) If the allegation of research misconduct involves federally funded research or the application for federally funded research, the University must disclose the identity of respondents and complainants to the appropriate federal funding agency.
5. 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.
6. Reputation, respondent. The University shall undertake to the fullest extent reasonable all practical efforts, if requested and as appropriate, to protect or restore the reputation of persons alleged to have engaged in research misconduct but against whom no finding of research misconduct is made.
7. Reputation, others. The University shall undertake to the fullest extent reasonable all practical efforts to protect or restore the position and reputation of any complainant, witness, or committee member and to counter potential or actual retaliation against these complainants, witness, and committee members.
8. Notice. Any notice required under these Procedures may be given:
  (a) By delivering such notice in person.
  (b) By mail addressed to the last home address currently on record with the administrative unit within which the respondent is employed or associated, or by email to the respondent’s University email address. Failure of any person to have a current correct home address on record with the administrative unit within which he/she is employed shall not be construed to invalidate such notice. If served by mail and the party is thereafter required to act or initiate some proceedings within a prescribed period after service, three consecutive calendar days shall be added to the prescribed period.
Inquiry into allegation(s) of research misconduct (“inquiry” means information gathering and fact-finding to determine whether an allegation of an apparent instance of research misconduct warrants an investigation).
1. Criteria warranting an inquiry. An inquiry is warranted if the allegation:
  (a) Falls within the definition of research misconduct under this section; and
  (b) Is sufficiently credible and specific so that potential evidence of research misconduct may be identified.
2. Notice to respondent and custody of research records. At the time of or before beginning an inquiry, the University must make a good faith effort to notify in writing the presumed respondent, if any. If the inquiry subsequently identifies additional respondents, the University must make a good faith effort to notify them in writing. To the extent it has not already done so at the allegation stage, the University must, on or before the date on which the respondent is notified or the inquiry begins, whichever is earlier, promptly take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner, except that where the research records or evidence encompasses scientific instruments shared by a number of users, custody will 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.
3. Review of evidence. The purpose of an inquiry is to conduct an initial review of the evidence to determine whether to conduct an investigation. Therefore, an inquiry does not require a full review of all the evidence related to the allegation.
4. Inquiry, how conducted. The dean or director or Vice Provost for Research shall, within five consecutive working days following her or his receipt of the written submission of an allegation(s) of research misconduct, appoint an ad hoc committee consisting of three faculty members, none of whom shall be members of the Standing Committee referred to in Section B hereof, to inquire into whether or not the allegations warrant an investigation. No person with a real or apparent conflict of interest in the matter of the inquiry shall participate in the inquiry. Members of the ad hoc committee shall be professors on continuous appointment, or, if there are no eligible professors, associate professors on continuous appointment. In naming the members of the committee, the dean or director or Vice Provost for Research should take into consideration their knowledge of the academic area under inquiry. The dean or director or Vice Provost for Research shall turn over to the committee all information in her/his possession related to the allegation(s). The ad hoc committee shall inquire into allegation(s) of research misconduct and prepare a written report, conforming to federal funding agency requirements, if applicable, setting forth its findings and conclusions regarding each allegation. The report shall include a description of evidence reviewed and a summary of relevant interviews conducted. The ad hoc committee shall submit its written report along with all documents considered by the Committee to the dean or director or Vice Provost for Research and the Vice Chancellor for Academic Affairs/Provost within forty-five (45) consecutive calendar days of its appointment unless for good cause additional time is allowed by the Vice Chancellor for Academic Affairs/Provost to complete the inquiry and report. If the inquiry takes longer than sixty (60) days to complete, the record of the inquiry shall include documentation of the reasons for exceeding the sixty (60) day period. The Vice Chancellor for Academic Affairs/Provost shall provide the respondent with a copy of the ad hoc committee's report.
5. Opportunity to comment. The University must provide the respondent an opportunity to review and comment on the inquiry report and attach any comments received to the report. Upon receiving the report of the committee, the Vice Chancellor for Academic Affairs/Provost shall notify the respondent that he/she may request an informal conference with the Vice Chancellor for Academic Affairs/Provost to discuss the allegation(s) and the committee's report. Said informal conference should occur within seven consecutive working days after receipt of the committee's report by the Vice Chancellor for Academic Affairs/Provost.
6. Notice of the results of the inquiry.
  (a) Notice to respondent. The University must notify the respondent whether the inquiry found that an investigation is warranted. The notice must include a copy of the inquiry report and include a copy of or refer to this section.
  (b) Notice to complainants. The University may notify the complainant who made the allegation whether the inquiry found that an investigation is warranted. The University may provide the full report or any relevant portions of the report to the complainant for comment.
  (c) Notice to others. The University may notify other individuals and organizations as mutually agreed upon by the Vice Chancellor for Academic Affairs/Provost and the accused academic faculty or staff member.
7. Reporting to federal funding agency on the decision to initiate an investigation.
  (a) If the allegation involves federally funded research or the application for federally funded research, the University must, within thirty (30) days of finding that an investigation is warranted, provide the funding agency with the written finding by the responsible institutional official and a copy of the inquiry report which includes the following information:
  (1) The name and position of the respondent;
  (2) A description of the allegations of research misconduct;
  (3) The funding agency support, including, for example, grant numbers, grant applications, contracts, and publications listing the funding agency’s support;
  (4) The basis for recommending that the alleged actions warrant an investigation; and
  (5) Any comments on the report by the respondent or the complainant.
  
  (b) The University must provide the following information to the federal funding agency on request:
  
  (1) The institutional policies and procedures under which the inquiry was conducted;
  (2) The research records and evidence reviewed, transcripts or recordings of any interviews, and copies of all relevant documents; and
  (3) The charges for the investigation to consider.
8. Documentation of decision not to investigate. The University will keep sufficiently detailed documentation of inquiries to permit a later assessment by the appropriate federal granting agency, if any, of the reasons why the institution decided not to conduct an investigation. If the allegation involves federally funded research or the application for federally funded research, the University will keep these records or copies of these records in a secure manner for at least seven (7) years after the termination of the inquiry, and upon request, provide them to the appropriate federal granting agency.
9. During the course of the inquiry, the Vice Chancellor for Academic Affairs/Provost will take interim administrative actions, as appropriate, to protect federal funds and ensure that the purposes of any federal financial assistance are being carried out.
Investigation of Research Misconduct
1. Criteria warranting an investigation. An inquiry's purpose is to decide if an allegation warrants an investigation. An investigation is warranted if there is:
  (a) A reasonable basis for concluding that the allegation falls within the definition of research misconduct under this section; and
  (b) Preliminary information-gathering and preliminary fact-finding from the inquiry indicate that the allegation may have substance.
  
  (1) Time. The investigation will begin within thirty (30) days after the Vice Chancellor for Academic Affairs/Provost determines that an investigation is warranted.
  (2) Notice to federal funding agency. If notice to a federal funding agency is required by the agency, the Vice Chancellor for Academic Affairs/Provost will notify the agency of the decision to begin an investigation on or before the date the investigation begins and provide an inquiry report that meets the requirements of section E.7.a. herein.
  
  (c) The Vice Chancellor for Academic Affairs/Provost will appoint a Relator to gather evidence of the alleged research misconduct and to present the evidence to the Hearing Committee.
  
  (1) Custody of the records. To the extent it has not already been done at the allegation or inquiry stages, the Relator will take all reasonable and practical steps to obtain custody of all the research records and evidence needed to conduct the research misconduct proceeding, inventory the records and evidence, and sequester them in a secure manner, except that 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. Whenever possible, the Relator must take custody of the records:
  
  (a) Before or at the time the institution notifies the respondent; and
  (b) Whenever additional items become known or relevant to the investigation.
  
  (i) Documentation. The Relator will 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.
  (ii) Interviews. The Relator will 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 the investigation.
  (iii) Pursue leads. The Relator will 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.
2. Notice to the respondent. The Vice Chancellor for Academic Affairs/Provost will notify the respondent in writing of the allegations within a reasonable amount of time after determining that an investigation is warranted, but before the investigation begins. The Vice Chancellor for Academic Affairs/Provost will give the respondent written notice of any new allegations of research misconduct within a reasonable amount of time of deciding to pursue allegations not addressed during the inquiry or in the initial notice of investigation.
3. Other notifications.
  (a) If the Vice Chancellor for Academic Affairs/Provost decides on the basis of the inquiry to proceed with an investigation, the Chancellor will forward to the funding agencies with which the respondent has active awards formal notification that an investigation will be undertaken at the same time that the respondent and other University parties are informed.
  (b) During the course of the investigation, the Vice Chancellor for Academic Affairs/Provost will take interim administrative actions, as appropriate, to protect federal funds and insure that the purposes of any federal financial assistance are carried out.
  (c) During the course of the investigation, the Vice Chancellor for Academic Affairs/Provost will promptly apprise the appropriate federal funding agency, if any, of any developments which disclose facts that may affect current or potential agency funding for the individual(s) under investigation or that the agency needs to know to ensure appropriate use of federal funds and otherwise protect the public interest.
  (d) During the course of the investigation, the Vice Chancellor for Academic Affairs/Provost will take reasonable steps to ensure an impartial and unbiased investigation to the maximum extent practicable, including participation of persons with appropriate scientific expertise who do not have unresolved personal, professional, or financial conflicts of interest with those involved with the inquiry or investigation.
4. Investigation time limits.
  (a) Time limit for completing an investigation. The University will endeavor to complete all aspects of an investigation within one-hundred-twenty (120) days of beginning it, including conducting the investigation, preparing the report of findings, providing the draft report for comment in accordance with section F.5. herein and sending the final report to any appropriate federal agency.
  (b) Extension of time limit. If unable to complete the investigation in one-hundred-twenty (120) days and if the federal granting agency so requires, the University will ask the granting agency for an extension in writing. If the granting agency permits an extension, it may direct the institution to file periodic progress reports. If the granting agency does not require its permission for an extension, the decision whether to grant an extension will be made by the Vice Chancellor for Academic Affairs/Provost.
5. Opportunity to comment on the investigation report.
  (a) The University will give the respondent a copy of the draft investigation report and, concurrently, a copy of, or supervised access to, the evidence on which the report is based. The comments of the respondent on the draft report, if any, must be submitted within thirty (30) days of the date on which the respondent received the draft investigation report. The investigation committee will consider and address the comments before issuing a final report.
  (b) The University may provide the complainant a copy of the full draft investigation report or any relevant portions of that report. The comments of the complainant, if any, must be submitted within thirty (30) days of the date on which the complainant received the draft investigation report or relevant portions of it.
6. Procedure: Statement of Charges; Request for Hearing; Answer.
  (a) If the Vice Chancellor for Academic Affairs/Provost decides on the basis of the inquiry to proceed with an investigation and formal Charge, the Respondent shall be notified in writing by the Relator (that official selected by the Vice Chancellor for Academic Affairs/Provost to represent the University in the misconduct proceeding) of the allegation(s) of research misconduct and the basis therefore, stated with reasonable particularity and called the Charge, and of the right to a hearing by the appropriate Faculty Committee together with a membership roster of the Committee. This notification initiates formal charges and must be given by the Relator to the Respondent within thirty (30) consecutive calendar days after the Vice Chancellor for Academic Affairs/Provost receives the report of the ad hoc committee. If the respondent desires a hearing, the Respondent shall give written notice of this request to the Relator within fourteen consecutive calendar days from the receipt of formal notice of the Charge. The respondent shall also send copies of this request for hearing to the Chairperson of the Committee. The Relator shall thereupon file a copy of the Charge with the Chairperson of the Committee. Failure by the respondent to make a timely written request for a hearing shall constitute a waiver of the respondent's right to a hearing before the Committee, and the Vice Chancellor for Academic Affairs/Provost shall proceed to make his/her report and recommendation to the Chancellor regarding disposition of the matter.
  (b) The respondent shall file a written Answer to the Charge with the Chairperson of the Committee within seven consecutive calendar days after respondent makes her/his written request for a hearing. Respondent shall also send a copy of her/his Answer to the Relator. Such Answer shall specifically admit or deny the allegations contained in the Charge. A failure to answer or to deny an allegation of fact in the Charge may be considered by the Committee as an admission of such fact.
  (c) No person with a real or apparent conflict of interest in the matter of the investigation shall participate in the investigation.
7. Hearing by Committee.
  (a) If the respondent makes a timely written request for a hearing by the Committee, the Chairperson shall notify in writing the respondent and the Relator of the date, time, and place of hearing before the Committee, which shall be within a reasonable time but not more than thirty consecutive calendar days after the date of the receipt of the request for hearing.
  (b) Any request for continuance shall be made by the respondent or Relator in writing to the Chairperson, who shall have discretionary authority to continue the hearing upon determining that the request is timely and made for good cause.
  (c) In accordance with standing University policy in personnel matters, such hearings shall not be open to the public. Except for such simple announcements as may be required, covering the time of the hearing and similar matters, public statements and publicity about the case by the Relator, the respondent, or the Committee, will be avoided until the proceedings have been completed, including final appeal.
8. Conduct of Hearing. The Chairperson shall preside at the hearing, call the hearing to order, call the roll of the Committee in attendance, ascertain the presence or absence of the respondent and the Relator, read the notice of hearing, read the Charge and Answer, verify the notice of the Charge to the respondent, report any continuances requested or granted, establish the presence of any advisor or counselor of either party, call to the attention of the respondent and respondent's advisor any special or extraordinary procedures to be employed during the hearing, and permit the respondent to suggest or object to procedures. Formal rules of evidence shall not be required. The burden of demonstrating an adequate case in support of the allegations contained in the Charge shall be with the Relator.
  (a) Opening Statements.
  (1) The Relator shall make opening remarks outlining the general nature of the case. Such remarks shall not be considered as evidence.
  (2) The respondent may also make an opening statement to the Committee about the Charge, either at this time or at the conclusion of the Relator's presentation, at the Respondent's election. Such remarks shall not be considered as evidence.
  
  (b) Relator's Evidence.
  
  (1) Relator's witnesses are to be called and identified and evidence or written statements or reports introduced as appropriate.
  (2) The Committee may question witnesses or examine evidence at the conclusion of Relator's presentation. Respondent may question the Relator or witnesses.
  
  (c) Respondent's Evidence.
  
  (1) Respondent's witnesses are to be called and identified and evidence or written statements or reports introduced as appropriate.
  (2) The Committee may question witnesses or examine evidence at the conclusion of respondent's presentation. Relator may question the respondent or witnesses.
  
  (d) Rebuttal Evidence. The Committee shall permit the Relator or the respondent to offer any matter in rebuttal of the other's presentation.
9. Rights of Committee. The Faculty Committee shall have the right:
  (a) To determine the relevancy and admissibility of any evidence offered at the hearing.
  (b) To permit a stipulation of agreed facts by the Relator and the respondent.
  (c) To permit the incorporation in the record by reference of any document, affidavit or other exhibit produced and desired to be incorporated in the record by the Relator or the respondent.
  (d) To question witnesses or evidence introduced by either the Relator or the respondent at any time.
  (e) To call additional witnesses.
  (f) To dismiss any action or permit informal disposition at any stage of the proceeding if agreed to by Relator and respondent.
  (g) To permit at any time amendment of the Charge or Answer so as to include matters which may come to the attention of the Committee before final determination of the case, provided, however, that in such event the Committee shall grant to the respondent or the Relator such time as the Committee may determine reasonable under the circumstances to answer or explain such additional matters.
  (h) To dismiss any person from the hearing who interferes with or obstructs the hearing or fails to abide by the rulings of the Chairperson of the Committee.
  (i) To have present a legal advisor to the Committee, who shall be designated by the General Counsel of the Board of Curators.
10. Parties' Rights Upon Hearing.
  (a) A Relator appearing before the Faculty Committee for a hearing pursuant to formal notice of a Charge shall have the right:
  (1) To be present at the hearing, which right may be waived by failure to appear.
  (2) To have present any legal or other advisor or counselor and to consult with such advisor or counselor during the hearing.
  (3) To present evidence by witnesses and by properly identified written statements or reports in support of the Charge.
  (4) To hear or examine evidence presented by the respondent.
  (5) To question witnesses present and testifying for respondent.
  (6) To make any statement to the Committee in support of the Charge.
  (7) To be informed in writing of the findings and conclusions of the Committee on the Charge.
  
  (b) A respondent appearing before the Faculty Committee for a hearing pursuant to formal notice of a Charge shall have the right:
  
  (1) To be present at the hearing, which right may be waived by failure to appear.
  (2) To have present any legal or other advisor or counselor and to consult with such advisor or counselor during the hearing.
  (3) To present evidence by witnesses and by properly identified written statements or reports for any defense the respondent desires.
  (4) To hear or examine evidence presented to the Committee.
  (5) To question witnesses present and testifying at the hearing.
  (6) To make any statement to the Committee in mitigation or explanation of the conduct in question.
  (7) To be informed in writing of the findings and conclusions of the Committee on the Charge.
11. Other Procedural Questions.
  (a) Procedural questions which arise during the hearing and which are not covered by these general rules, by 65 FR 76260 or by 42 CFR 93 shall be determined by the Chairperson, whose ruling shall be final unless the Chairperson shall present the question to the Committee at the request of a member of the Committee, in which event the ruling of the Committee by majority vote shall be final.
  (b) General Rules of Decorum. The following general rules of decorum shall be adhered to:
  (1) All requests to address the Committee shall be made to the Chairperson.
  (2) The Chairperson shall rule on all requests and points of order and may consult with the Committee's legal advisor prior to any ruling. The Chairperson's ruling shall be final and all participants shall abide thereby unless the Chairperson shall present the question to the Committee at the request of a member of the Committee, in which event the ruling of the Committee by majority vote shall be final.
  (3) An advisor or counselor shall be permitted to address the Committee and to question witnesses. An advisor or counselor may request clarification of a procedural matter or may object on the basis of procedure at any time by addressing the Chairperson after recognition.
  
  (c) Record of the hearing. A taped or stenographic record of the hearing shall be taken. The notice, exhibits, hearing record, and the findings and determination of the Committee shall become the "Record of the Case," shall be filed in the Office of the President of the University of ��ӰԺ, and shall be available only for official purposes, and for the purpose of appeal be accessible at reasonable times and places both to the Relator and the Respondent. The "Record of the Case" shall be maintained for a period of seven (7) years. In the event of an appeal, no new evidence shall be taken in the case, but the appellate authority may remand the matter for further evidence to the Committee. Either party may have any such record reduced to writing for the purposes of appeal.
Chancellor Determination. After the adjournment of the hearing, the Committee shall make its findings and determinations by majority vote in executive session out of the presence of the Relator and respondent. Separate findings and conclusions are to be made as to each count of the Charge. Promptly after the hearing and, in any event, within ten consecutive days after receipt of the record, the Committee shall make its findings and conclusions in writing and transmit them to the Chancellor, to the Relator, and to the respondent forthwith.
1. Determination by Chancellor and Right of Appeal.
  (a) The Chancellor shall make a determination in the matter within thirty (30) consecutive calendar days after giving due consideration to the findings and conclusions of the Committee. The Chancellor shall notify the Relator and respondent in writing of her/his determination and disposition. If the Chancellor determines that the termination of an academic faculty or staff member is warranted, he/she must refer the matter to the Faculty Committee on Tenure for disposition pursuant to the Academic Tenure Regulations of the University, and the proceedings hereunder shall cease, and the appeal hereunder shall not be available.
  (b) The respondent or Relator may appeal the decision of the Chancellor to the President by filing a written notice of appeal with the President within seven consecutive calendar days after receiving notice of the decision of the Chancellor. A copy of the Notice of Appeal shall simultaneously be given by the respondent, to the Relator and Chancellor or by the Relator to the respondent and Chancellor. The appealing party may file a written argument confined to the issues and evidence previously submitted and contained in the record of the case for consideration by the President. Such memorandum must be filed with the Notice of Appeal, and the President may request a reply to such memorandum by the respondent or Relator. The President shall have the discretionary right to grant extensions of time.
  (c) The President shall review the record of the case and the appeal documents and may affirm, reverse, or remand the case for further proceedings.
  (d) If it appears that the President is unable to make his or her decision within 120 days from the date the appeal was filed and the allegation involves federally funded research or the application for federally funded research, an extension of that time period will be requested of the federal granting agency in writing with an explanation for the request.
2. Notification of Federal Granting Agency, if any. Once the committee has made its recommendation to the Chancellor, the Chancellor has reached a decision and determined an appropriate action, and any appeal has been acted on by the President, the full documentation of the process, including the record of the case and the appeal documents, will be forwarded to the granting agency, if applicable, and such other federal officials as required by federal law or regulation. The granting agency will then decide whether it will proceed with its own investigation or will act on the University's findings. Notice will also be sent to appropriate other parties.
  (a) Institutional investigation report. If so required by the federal granting agency, if any, the final University investigation report submitted to the federal granting agency will be in writing and include:
  (1) Allegations. Describe the nature of the allegations of research misconduct.
  (2) Federal granting agency or other support. Describe and document any federal granting agency or other research support, including, for example, any grant numbers, grant applications, contracts, and publications listing the federal granting agency or other support.
  (3) Institutional charge. Describe the specific allegations of research misconduct for consideration in the investigation.
  (4) Policies and procedures. If not already provided to the federal granting agency with the inquiry report, include the present institutional policy and procedures under which the investigation was conducted.
  (5) Research records and evidence. Identify and summarize the research records and evidence reviewed, and identify any evidence taken into custody but not reviewed.
  (6) Statement of findings. For each separate allegation of research misconduct identified during the investigation, provide a finding as to whether research misconduct did or did not occur, and if so:
  (7) Identify whether the research misconduct was falsification, fabrication, or plagiarism, and if it was intentional, knowing, or in reckless disregard;
  (8) Summary of the facts and the analysis which support the conclusion and consider the merits of any reasonable explanation by the respondent;
  (9) Identify the specific federal granting agency or other support involved;
  (10) Identify whether any publications need correction or retraction;
  (11) Identify the person(s) responsible for the misconduct; and
  (12) List any current support or known applications or proposals for support that the respondent has pending with other federal agencies or other sponsors.
  (13) Comments. Include and consider any comments made by the respondent and complainant on the draft investigation report.
  (14) Maintain and provide records. Maintain and provide to the federal granting agency upon request all relevant research records and records of the institution's research misconduct proceeding, including results of all interviews and the transcripts or recordings of such interviews as required by section F.11.c herein.
3. Parties to be notified of investigation results. The following is an illustrative list of parties to be notified as relevant of any determination of research misconduct in writing by the Chancellor within thirty (30) days after an investigation has concluded. If the appeal process has been invoked, this notification will take place, when the original determination has been sustained, within thirty (30) days of the final decision.
  (a) Appropriate campus officials
  (b) Sponsoring agencies, funding sources
  (c) Co-authors, co-investigators, collaborators
  (d) Editors of journals in which fraudulent research was published
  (e) Professional licensing boards
  (f) Editors of journals or other publications, other institutions, sponsoring agencies, and funding sources with which the individual has been affiliated
  (g) Professional societies
  (h) Where appropriate, criminal authorities

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. 6-27-24.

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, the Chancellors shall designate a Vice Chancellor to 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.
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) will be developed by UM RSC Team and maintained. This SPP will document 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 UM RSC Team is responsible for the implementation of the industrial security 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.

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. This rule applies to all transactions by the University of ��ӰԺ, 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 of the four universities within the University of ��ӰԺ System is responsible for designating a minimum of one compliance point of contact (POC) related to export compliance. The UM System Director of Research Security and Compliance and all POCs comprise 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 to meet the needs of the UM System.
3. Accountability and Alignment
  To ensure the accountability and alignment of the UM RSC Team, each Vice Chancellor for Research and the UM System Director for Research Security and Compliance are jointly responsible for approving the following as it relates to the POCs at each institution:
  1. Recruitment and hiring decisions
  2. Disciplinary and termination decisions
  3. Annual performance evaluations and compensation decisions.
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 will be 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.