11.01 – Research Oversight and Risk Management

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Scope: NMSU System

Source: ARP Chapter 11 | Research and Intellectual Property

Responsible Executive: Provost & Chief Academic Officer

Responsible Administrator:

Last Updated: 04/12/2019

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Cross-Reference:

ARP Chapter 11



Revision History:

09/01/2023 Title change form "provost and senior vice president for academic affairs" to "provost and chief academic officer"
04/12/2019 Amendment approved by Chancellor
03/13/2019 Amendment approved by Chancellor
2017 Recompilation, formerly Rule 5.94.30
03/14/2011 Amendments approved by Board of Regents
07/20/2010 Amendments approved by Board of Regents
07/29/2009 Amendment ratified by Board of Regents
07/14/2009 Amendment approved by Administrative Council

PART 1: RESEARCH FUNDING AND RESEARCH INSTITUTES


  1. State University Research Fund: The State University Research Fund is the designated university fund where indirect (facilities and administrative) cost recovery earned by the university is deposited.  Funds to support academic research from the State University Research Fund are relatively scarce and must be used in a variety of ways (e.g., to support research, to stimulate new research, to support public service, and to support scholarly endeavors as well as the necessary administration).  In general, it is desirable to keep the administrative costs at a minimum and, therefore, make available to the faculty as much support as possible for nonrecurring research expenses.  It is the underlying philosophy to use this research support in a flexible manner in keeping with college and department priorities.  Encouragement is given to the faculty to secure outside support for research, at the same time recognizing that it is important to provide some support to scholarly pursuits which may not attract outside funding.
  2. University Research Institutes:
    1. University Research Institutes are units that primarily perform externally funded research.  They are formed by the vice president for research in consultation with the provost and chief academic officer.  Generally, these units will report to the vice president for research; at the time of creating the institute, the reporting line for the unit must be determined by the provost and chief academic officer and the vice president for research
    2. University Research Institutes may be created by the university in anticipation of outside funding.  They revert to college status or cease to exist if external funding does not materialize.  A University Research Institute may receive some support from the State University Research Fund.  Except for the Physical Science Laboratory and the Water Resources Research Institute, University Research Institutes do not directly retain a percentage of indirect cost recovery resulting from their activity.
    3. Upon the recommendation of the vice president for research with concurrence of the provost and chief academic officer, a University Research Institute may revert to College Research Institute status, be reorganized, or be dissolved, and the following list modified accordingly.  University Research Institutes, all of which currently report to the vice president for research, are listed below.
      1. Energy Research Laboratory
      2. Institute for Applied Biosciences
      3. New Mexico Space Grant Consortium
      4. Physical Science Laboratory
      5. Water Resources Research Institute
  3. College Research Institutes: College Research Institutes are research units formed at the discretion of a college, reporting to the college as the dean directs, and relying on the college for support.  College Research Institutes do not directly retain a percentage of any indirect cost recovery resulting from their activity.

 

PART 2: UNIVERSITY RESEARCH COUNCIL


The University Research Council was established to foster research at the university.  It serves as an advisory body to the vice president for research and proposes policy and rule updates related to research, which if approved by the vice president for research are taken forward to the president for formal review and approval action.  The University Research Council provides leadership in fostering a culture of research and in enhancing the university’s distinction in research, scholarship, and creative activities among faculty, staff, and students.

  1. Vision: The University Research Council, in concert with the Office of the Vice President for Research, seeks to create and maintain a culturally-diverse and ethically-driven academic environment that promotes excellence in research through a university that:
    1. Acknowledges and celebrates innovation in research
    2. Promotes and nurtures interdisciplinary research and collaborative research partnerships as well as individual scholarly research,
    3. Sustains and maintains the founding core principles of the university,
    4. Advances collective representation among faculty, staff, and students to the administration through peer review of university funding programs, and
    5. Supports the role of research in creating a university experience that enriches the lives of students and helps them to become well-informed individuals, lifelong learners, engaged citizens, and productive employees and employers.
  2. Mission: The University Research Council assists the vice president for research in formulating recommendations and policies specifically affecting the university’s research community.  Formally advisory in nature, the University Research Council provides a forum for internal discussion, initiates the development of policy, rules and procedures on research matters, gathers and disseminates information to the faculty, and provides a faculty voice to the university administration on matters pertaining to research.  While it is recognized that research represents only one component of the academic enterprise, the University Research Council focuses on facilitating and enhancing research-related activities at the university.
  3. Goals: The University Research Council will work with faculty, administrators, and students to achieve these goals:
    1. Encourage research and creative activities,
    2. Improve the institutional environment for research,
    3. Strengthen the interdependence between research areas and creative activities, and
    4. Increase public awareness of New Mexico State University research.
  4. Duties and Responsibilities: While adaptive to changing priorities facing research endeavors, the University Research Council  has the following specific duties and responsibilities:
    1. Recommend to the Faculty Senate policies it deems appropriate with respect to research activities, facilities, personnel, and patents,
    2. Consult with and advise the vice president for research on the stimulation of and support for research activities, including policies for investment of funds in university research endeavors,
    3. Provide strategic research direction to the vice president for research ,
    4. Assist in the evaluation of research programs within the university, and advise on new research centers and institutes and the performance evaluation of existing centers and institutes,
    5. Recommend policies that will foster strong and mutually productive relationships among departments and research groups,
    6. Be an advocate for the faculty on governmental, industrial, and other private sector and foundation support of the research programs of the university,
    7. Support enhanced mechanisms for faculty to benefit financially from technology transfer and commercial application of research results for the public benefit,
    8. Facilitate training for faculty on research grant management and indirect cost mechanisms,
    9. Review and make recommendations to the vice president for research on internal research grants and awards, and
    10. Work with the vice president for research in enhancing procedures for submissions and review of research proposals.
  5. Structure and Membership: The structure of the University Research Council consists of the complete University Research Council membership, an elected chair and executive committee, and appointed subcommittees established to address specific issues.
    1. Eligibility for Membership: To be eligible, a faculty member must have at least a 25% allocation of effort assigned to research and creative activity and a successful track record in research and scholarship activity.
    2. Members: The complete University Research Council membership consists of:  the officers of the Council (chair, chair-elect, immediate past chair), two faculty members from each college (three from Arts and Sciences), one faculty representative from the library, one representative from each university research institute reporting to the vice president for research, and one representative from the faculty senate.  The vice president for research may appoint additional members to represent specified research activities.
    3. Term:  Members will serve two-year terms on the council, beginning on July 1 of the year of selection, except for the chair-elect (see below).  The terms of college representatives will be staggered such that one person will be selected each year (two in one year and one the next year from the College of Arts and Sciences).  Members are eligible for reappointment.  If a member is unable to complete a term, the appropriate college dean or, for university research institutes, the vice president for research will arrange for a replacement to fill the position.  Selection procedures for faculty representatives will be determined by the individual colleges.
  6. Chair and Other Officers
    Each year in August or September, the membership will elect a member to serve as chair-elect (who also serves as vice chair) for one year, as chair for the following year, and on the executive committee as past chair for the next year.  The member elected as chair-elect will serve a three-year term on the University Research Council beginning on the following July 1.  If a college representative is elected as chair-elect, the college will be permitted to select an additional representative to complete the unexpired term.  In the event that an officer is unable to complete a term, the membership will elect a member to fill vacancies.  The chair will convene and conduct regular University Research Council meetings on a monthly basis.  When the chair is unavailable, the chair-elect or another member designated by the chair will assume these duties.
  7. Executive Committee
    1. Membership:  The executive committee will consist of the chair, chair-elect (who also serves as vice chair), immediate past chair, and faculty senate representative.
    2. Responsibilities:  Responsibilities include, but not be limited to: preparing the meeting agenda, appointing subcommittees, and delivering charges to the subcommittees.
    3. Nominating Committee: Early in the spring semester, the Executive Committee will appoint a nominating subcommittee charged with the task of selecting nominee(s) for chair-elect and filling other office vacancies for the coming year.
  8. Resource and Administrative Support: The Office of the Vice President for Research will serve as the office of record for the University Research Council.

 

PART 3: COUNCIL OF ASSOCIATE DEANS FOR RESEARCH (FORMERLY COUNCIL OF RESEARCH CENTERS)


The Council of Associate Deans for Research is an advisory group to recommend research policy, rules and procedures and to coordinate operational research procedures among the colleges, university research institutes, and central research administration.  It is chaired by the vice president for research.  The council is composed of the associate deans for research of each of the colleges, the director of the Physical Science Laboratory, and the university research council chair, who serves in an ex officio capacity.

 

PART 4: INSTITUTIONAL REVIEW BOARD


Administrative authority for the protection of human subjects at New Mexico State University has been delegated by the president to the vice president for research.  The Office of the Vice President for Research oversees the Institutional Review Board, which has been established to regulate university research involving human subjects, consistent with federal law and university policies, rules and procedures.  Prior to submitting an application to the Institutional Review Board, principal investigators must familiarize themselves with all provisions in ARP Chapter 11, any supplemental procedures issued by the Institutional Review Board, guidance available online from Research Integrity and Compliance, and the federal Office of Human Research Protections.  Procedures may be amended from time to time by the Institutional Review Board with the approval of the vice president for research.

  1. Membership
    1. Institutional Review Board members are appointed by the vice president for research for renewable three-year terms, upon recommendation from, but not limited to, the institutional review board chair and the director of Research Integrity and Compliance. All members of the Institutional Review Board appointed by the vice president for research will be voting members.  A list of the current officers and membership of the Institutional Research Board as well as detailed application procedures are available from Research Integrity and Compliance.
    2. The Institutional Review Board chair is appointed by the vice president for research and serves as the link between the Office of the Vice President for Research and the Institutional Review Board.  A vice chair will be appointed to conduct business if the chair is unavailable, or has a conflict of interest.
    3. The composition of the Institutional Review Board will consist of individuals sufficiently qualified through their experience, expertise, and diversity, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.  The Institutional Review Board will not consist entirely of men or entirely of women, or entirely of members of one profession.
    4. The Institutional Review Board will primarily be composed of representatives from the colleges and departments most concerned with projects involving human subjects. It will include at least:
      1. one member whose primary concerns are in scientific areas,
      2. one member whose primary concerns are in nonscientific areas, and
      3. one individual who is not employed by or otherwise officially affiliated with the university and who is not part of the immediate family of a university employee.
    5. If the Institutional Review Board reviews research protocols that involve a vulnerable category of subjects (e.g. children, prisoners, persons with disabilities), the Institutional Review Board will include one or more individuals with professional expertise regarding the protection of these subjects.
    6. The vice president for research or designee and the director of Research Integrity and Compliance are ex-officio non-voting members of the Institutional Review Board.  A representative from the Office of the University General Counsel serves as a non-voting consultant to the Institutional Review Board as necessary.
    7. The Institutional Review Board may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the Institutional Review Board.  These individuals will be non-voting members.  Such non-voting members may include, but not be limited to, expert consultants external to the university and/or additional representatives of the university.
  2. Functions and Responsibilities
    1. The Institutional Review Board will assure complete and adequate review of research activities involving human subjects, and will be able to determine the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
    2. No member of the Institutional Review Board will participate in the initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the Institutional Review Board.
    3. The Institutional Review Board must periodically, at least every three years, review university policies and procedures relating to human subjects in research, and make recommendations to the vice president for research.
    4. The Institutional Review Board must review all research activities involving human subjects or data related to human subjects. Additionally, the Institutional Review Board has authority to approve, require modification of, or to disapprove proposed research activities involving human subjects.
    5. Research activities must be reviewed by the Institutional Review Board for compliance with established federal regulations related to the protection of human subjects, as issued by the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, and contained in the Code of Federal Regulations 45, Part 46.
    6. Research covered by these regulations that has been approved by the Institutional Review Board may be subject to further appropriate review and approval or disapproval by officials of the university.  However, those university officials may not approve the research if it has not been approved by the Institutional Review Board.
    7. The Institutional Review Board will provide advice and guidance to investigators regarding the protection of the rights and welfare of human subjects.
    8. The Institutional Review Board must ensure that the principle investigators and other researchers have been certified in the ethical principles of using human subjects in research.
    9. Where necessary, the Institutional Review Board will serve as a referral board for complaints from subjects of research. Any complaint from a research subject must be reported promptly to the principal investigator and to Research Integrity and Compliance.
    10. The Institutional Review Board must require that information given to subjects as part of informed consent is in accordance with federal regulations as indicated in the Code of Federal Regulations 45, Part 46.  The Institutional Review Board may require that information in addition to that specifically mentioned in Code of Federal Regulations 45, Part 46, be given to the subjects when, in the Institutional Review Board’s judgment, the information would meaningfully add to the protection of the rights and welfare of the subjects.  Documentation of that process must also be required.  The Code of Federal Regulations outlining requirements for the protection of human subjects is available by contacting the Office of the Vice President for Research.
    11. The Institutional Review Board will notify investigators in writing of its decision to approve, require modification of, or to disapprove the proposed research activity.  If the Institutional Review Board disapproves a research activity, it must include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.
    12. The Institutional Review Board will annually review the status of research covered by these regulations and has the authority to observe or have a third party observe the consent process and the research. The Revised Common Rule eliminated the need for continuing reviews. Researchers working with agencies that did not adopt the changes in the Revised Common Rule must continue to follow their agency’s specific guidelines.
    13. The Institutional Review Board is authorized to suspend or terminate approval of research that is not being conducted in accordance with the Institutional Review Board’s requirements or that has been associated with unexpected serious harm to subjects.  Any suspension or termination of approval must include a statement of the reasons for the Institutional Review Board’s action, and must be reported promptly to the principal investigator, to appropriate university officials, and to the federal Office of Human Research Protections.
    14. If a research subject registers a complaint, the investigator must attempt to relieve the complaint by explanation or by a change of procedure.  Written Institutional Review Board approval is required for procedural changes. Any complaint from a research subject must be reported promptly to the principal investigator and to Research Integrity and Compliance, which may have additional reporting requirements.
    15. It is the responsibility of the Institutional Review Board to determine whether applications that involve more than minimal risk to human subjects are of sufficient scientific merit to answer the proposed research questions or hypotheses.

 

PART 5: INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE


  1. Membership
    1. Voting members of the Institutional Animal Care and Use Committee are appointed by the vice president for research upon recommendations from the Institutional Animal Care and Use Committee chair and the director of Research Integrity and Compliance. Alternate members who may substitute for a member who will be absent from a meeting may also be appointed by the vice president for research.  Alternates must receive the same training as members.  If an alternate member attends a meeting with the primary member, the alternate does not count for quorum purposes, nor have voting rights.
    2. The Institutional Animal Care and Use Committee chair is appointed by the vice president for research, and serves as the committee liaison to that office.  The committee chair is a continuous appointment by the vice president for research, subject to annual confirmation.  A vice chair will be selected by the committee to conduct business in the absence of the chair, or in place of the chair if and when the chair has an application before the committee or other conflict of interest.
    3. The term of membership on the Institutional Animal Care and Use Committee is a twelve-month renewable period.  It is not uncommon for members to serve at least two years; the committee chair and Research Integrity and Compliance may recommend such renewal to the vice president for research.
    4. The Institutional Animal Care and Use Committee must include at least five members, at least one of whom is a community member that are not otherwise affiliated with the university.  The committee must include a doctor of veterinary medicine with training or experience in laboratory animal science and medicine and program authority and responsibility for activities involving animals at the university, a practicing scientist experienced in research involving animals, a member whose primary work concerns are nonscientific (examples include an ethicist, a lawyer, a member of the clergy), and a community representative who has no other affiliation with the university and has no immediate family affiliated with the university.  No more than three members may come from the same college or administrative unit of the university.
    5. The vice president for research or designee, the director of Research Integrity and Compliance, and the biosafety officer will be ex-officio non-voting members of the Institutional Animal Care and Use Committee.
  2. Functions and Responsibilities: All use of vertebrate animals must be reviewed and approved in advance by the Institutional Animal Care and Use Committee to ensure the necessity of animal use and high standards of humane treatment.  Animal research must be conducted by adequately trained persons using all necessary measures to prevent, minimize and alleviate pain and distress to an animal.  Measures will be taken to ensure that no animals in the university’s care will experience severe or unrelieved pain and/or distress.  All university employees involved in animal use for teaching or research purposes must be certified by the Institutional Animal Care and Use Committee and must participate in the occupational health and safety program for animal workers.  Details of these requirements can be obtained from the institutional animal care and use committee chair or from the director of Research Integrity and Compliance.  The office of record for Institutional Animal Care and Use Committee activities is Research Integrity and Compliance, within the Office of the Vice President for Research, which is responsible for compliance with federal agency reporting requirements.

 

PART 6: INSTITUTIONAL BIOSAFETY COMMITTEE


A. General Principles

The university, through the Office of the Vice President for Research, has established the Institutional Biosafety Committee which oversees the use of biohazardous agents and/or recombinant nucleic acid molecules by university faculty and staff, or at university facilities.  University researchers using or planning to use these materials and methods must submit the scope of their projects to the Institutional Biosafety Committee for approval.

 

B. Definitions

  1. Biohazardous Agents
    1. Any microorganism (including but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substance, or naturally occurring, bioengineered, or synthesized component of any such microorganism or infectious substance that is capable of causing: (a) death, disease or other biological malfunction in a human, an animal, a plant or another living organism; (b) deterioration of food, water, equipment, supplies, or materials of any kind; or (c) a deleterious alteration of the environment.
    2. Any toxic material or product of plants, animals, microorganisms (including but not limited to bacteria, viruses, fungi, rickettsiae, or protozoa), or infectious substances, or a recombinant or synthesized molecule (whatever the origin and method of production), which includes any poisonous substance or biological product that: (a) may be engineered as a result of biotechnology; (b) produced by a living organism; or (c) is an isomer or biological product, homologue, or derivative of such a substance.
    3. Infectious or pathogenic biological agent defined by: (a) U.S. Centers for Disease Control (CDC as biosafety level 2 or above, or (b) U.S. National Institutes of Health (NIH) as risk group agent 2 or above.
    4. Regulated biological agent or toxin as identified by the Federal Select Agents Program pursuant to the Code of Federal Regulations (CFR) in (a) 42 CFR Part 73; (b) 9 CFR Part 121; or (c) 7 CFR Part 331.
  2. Recombinant and Synthetic Nucleic Acid Molecules:  As used in the context of the NIH Guidelines:  molecules that are (a) constructed by joining nucleic acid molecules and that can replicate in a living cell, i.e., recombinant nucleic acids; (b) nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or (c) molecules that result from the replication of those described above.

C. Membership

  1. Voting members of the Institutional Biosafety Committee are appointed by the vice president for research, after consideration of the recommendations from the institutional biosafety committee chair and Research Integrity and Compliance.
  2. The institutional biosafety committee chair is appointed by the vice president for research and serves as the committee liaison to that office. The committee will select a vice chair to conduct business in the absence of the chair, or in place of the chair if and when the chair has an application before the committee, or other conflict of interest.
  3. The term of membership on the Institutional Biosafety Committee is a twelve-month renewable period.  It is not uncommon for members to serve at least two years.  The committee chair and the director of Research Integrity and Compliance will make a recommendation for renewal of membership on the committee to the vice president for research.
  4. The Institutional Biosafety Committee chair is a continuous appointment by the vice president for research, with an annual confirmation from the committee to the vice president for research.  The biosafety officer is a continuous position appointment.  The biosafety officer is a professional position that reports to the director of Research Integrity and Compliance.
  5. The composition of the Institutional Biosafety Committee should include at least eight members employed by or otherwise affiliated with the university and two community members that are not otherwise affiliated with the university, with the following expertise and/or job duties:
    1. recombinant DNA technology,
    2. molecular biology,
    3. biological safety,
    4. public health and epidemiology,
    5. virology,
    6. microbiology,
    7. infectious diseases,
    8. animal scientist,
    9. plant pathogen or plant pest containment principles,
    10. laboratory technician/non-doctoral, or
    11. facilities management.
  6. The community members should represent the interests of the surrounding community with respect to health and protection of the environment and should be knowledgeable in the basic principles of microbiology and recombinant nucleic acid technology, or capable of assimilating these principles within the context of their applicability to the surrounding community and the general public. Individuals with the following expertise and/or job descriptions should be considered:
    1. officials of state or local public health or environmental protection agencies, or
    2. individuals involved in medical, occupational health or environmental concerns in the community.
  7. The Institutional Biosafety Committee may also include ex-officio non-voting members who may be invited to serve when their expertise is required and can supplement the deliberations of The Institutional Biosafety Committee.  These members must include, and are not limited to, biosafety expert consultants external to the university, and/or additional representatives, usually administrative, from such departments as Environmental Health and Safety; Employee Health Services; Research Administration; Office of the University General Counsel; Facilities and Services; and/or Planning, Design and Construction.

D. Functions and Responsibilities

  1. The Institutional Biosafety Committee is responsible for reviewing all applications submitted by research investigators and their laboratory staff members, teaching faculty, and visiting scientists (collectively defined as PI for principal investigator) whose activities involve:
    1. any biohazardous agent as defined above which can cause disease in humans,
    2. any biohazardous agent which will be introduced into any animal,
    3. any non-exempt recombinant nucleic acid molecules (exempt experiments are defined in the current version of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleci Acid Molecules,
    4. any large scale production of viable organisms containing recombinant or synthetic nucleic acid molecules, or with the potential to produce toxic or hazardous substances (as defined in the current version of the NIH Guidelines, or
    5. any possession, use, or transfer of the select agents listed on the current National Select Agents and Toxins Registry, which includes HHS Select Agents and Toxins (42 CFR Part 73), USDA Biological Agents and Toxins (9 CFR Part 121), or Plant Pathogens (7 CFR Part 331).
  2. The Institutional Biosafety Committee will minimize the risks to the health, safety, and wellbeing of laboratory employees, the public, and the environment regarding the use of biohazardous agents, non-exempt recombinant or synthetic nucleic acid molecules, and large-scale production of recombinant or synthetic nucleic acid molecules.
  3. The Institutional Biosafety Committee recommends policies to guide Principal investigators, the biosafety officer, the NMSU offices of Research Integrity and Compliance, and Environmental Health, Safety and Risk Management in the administration of the university’s biosafety program with regard to the acquisition, use, transfer, storage, disinfection, disposal of agents, and emergency response procedures for all biosafety activities.  The Institutional Biosafety Committee must ensure that such activities meet best practices standards consistent with safety of personnel, the general public, and the environment, in ways that best facilitate relevant research or teaching activities at the university.
  4. The Institutional Biosafety Committee is vested with the authority to comprehensively review, and approve research applications with or without modifications, or withhold approval of all or any part of an application with regard to biological aspects of the research or activity.  The Institutional Biosafety Committee may make recommendations for corrective action on protocols.
  5. If the biosafety officer’s review of a suspected or alleged violation of any university policy, rule or procedure, or of any external regulation that involves “biosafety activities” indicates that the violation is of a serious or continuing nature, the biosafety officer will report such to the Institutional Biosafety Committee.  The Institutional Biosafety Committee holds the authority to suspend any project in which serious or continuing violations have been reported.  The Institutional Biosafety Committee will notify and coordinate with the affected investigator to rectify the situation.  If further action is needed, the Institutional Biosafety Committee will inform Research Administrative Services, which will comply with appropriate federal agency reporting requirements.
  6. Upon request, the Institutional Biosafety Committee will review and comment on proposed biosafety regulations, including but not limited to federal, state, and local policies.  When appropriate, the Institutional Biosafety Committee will formulate draft policies and procedures for approval by the vice president for research and other institutional officials as needed.
  7. The Institutional Biosafety Committee annually reviews the effectiveness of the Biosafety Program and makes recommendations to the vice president for research.
  8. The Institutional Biosafety Committee verifies that NMSU research conducted at a non-NMSU facility has been approved by the external facility, and adheres to NMSU biosafety requirements.

 

 

PART 7: RADIATION SAFETY COMMITTEE


  1. General Principles
    1. The use of radioactive materials and x-ray emitting machines at the university is regulated by federal, state, local and university entities.  The Radiation Control Bureau of the New Mexico Environment Department (Bureau) is the primary regulatory authority.
    2. The Bureau issues Radioactive Material Licenses and X-Ray Certificates of Registration that define the conditions for use of radioactive materials and/or radiation producing devices at university facilities.
    3. The university has established the Radiation Safety Committee to serve as a review and approval body for the use of radioactive materials on campus or for university research purposes, and to provide and enforce safety guidelines for the use of radioactive materials or sources and of x-ray generating equipment at the university.  University employees responsible for the use of radioactive materials in their research, operations, and/or teaching (whether conducted by employees, students, or others) must submit a proposal of their activities to the Radiation Safety Committee for approval.
    4. No program which would involve radioactive materials, nor any acquisition of radioactive materials, will be initiated until the proposal is approved by the Radiation Safety Committee.  All staff and students participating in activities involving radioactive materials must meet certain training requirements specified in the Radiation Safety Manual at Radiation Safety Program, and must work within the permit granted by the Bureau and the Radiation Safety Committee’s guidelines.
  2. Membership
    1. A minimum of three technical members of the Radiation Safety Committee are appointed by the vice president for research, after consideration of the recommendations from the radiation safety committee chair.  The members of the Radiation Safety Committee must be representative of areas of the university where personnel are using radioactive materials or radiation emitting equipment. The radiation safety officer, a regular position in Environmental Health, Safety mad Risk Management, is an official member of the Radiation Safety Committee.  All members of the Radiation Safety Committee, including the chair and the radiation safety officer, will be voting members.  The radiation safety officer advises the Radiation Safety Committee on every aspect of the radiation safety program.
    2. The radiation safety committee chair is appointed by the vice president for research and serves as the committee liaison to that office.  The committee will select a vice chair to conduct business in the absence of the chair, or in place of the chair if and when the chair has an application before the committee, or other conflict of interest.
    3. Members of the Radiation Safety Committee are appointed for two-year renewable terms.  The radiation safety officer is a continuous position appointment.  The Radiation Safety Committee may also include ex-officio non-voting members who may be invited to serve when their expertise is required and can supplement the deliberations of the Radiation Safety Committee.
  3. Functions and Responsibilities
    1. The Radiation Safety Committee advises the vice president for research on radiation safety policy, rules and procedures at the university.  The Radiation Safety Committee is responsible for reviewing and approving all applications from research investigators and teaching faculty whose activities involve the use of radioactive materials/sources and x-ray generating equipment.
    2. The Radiation Safety Committee is vested with the authority to thoroughly review and make recommendations to the vice president of research regarding:
      1. qualifications of applicants requesting permission to use or supervise the use of radioactive materials or radiation equipment;
      2. applicants’ training and experience in the context of the plans for the work requested, including consideration of the types and quantities of materials, and the methods of use;
      3. all training courses that an applicant, or first-time user, attends to overcome any deficiencies in training; and
      4. efforts of each applicant to maintain exposure as low as reasonably achievable (ALARA) when considering the use of byproduct material.
    3. The Radiation Safety Committee will (a) ensure that the users justify their procedures, exposure potential and that individual and collective doses will be ALARA; and (b) encourage all users to review current procedures and develop new procedures as appropriate to implement the ALARA concept.
    4. The Radiation Safety Committee will delegate authority to the radiation safety officer for enforcement of radiation safety policies and procedures.  If the Radiation Safety Committee overrules the radiation safety officer, it will record the basis for its action in the meeting minutes.
    5. The Radiation Safety Committee must regularly review, at least annually, radiation policies and procedures and their implementation, and make recommendations to the vice president for research.  A quorum for a meeting would require attendance of the chair, the radiation safety officer, and the committee member whose field of expertise is necessary to assure all safety aspects have been addressed.

 

PART 8: RESEARCH SECURITY OVERSIGHT COMMITTEE (RSOC)


  1. General Principles: Certain research data at the university is federally regulated, and all research data must be governed and protected according to applicable laws, executive orders, policies and procedures. A sub-set of this data is protected under one or more security regulations: FISMA, CUI, ITAR, and EAR, henceforth defined as Protected Data.  The proper protection, administration and oversight is paramount to satisfying NMSU’s contractual, legal, and federal security obligations.  The creation of a research security oversight committee (RSOC) is warranted due to the demanding regulations, the esoteric nature of the requirements, complexity in implementation, and administrative overhead necessities.  RSOC will play an instrumental role in developing and proposing sensible policies and procedures to protect data and to coordinate institutional improvements within the research community. RSOC will consist of university research stakeholders who help facilitate and assist principal investigators in meeting their respective grant or contract cybersecurity compliance requirements.  RSOC will operate under the NMSU’s governing ARP rule 15.62 (Protection of Federal Information; FISMA Compliance) directed by NMSU RPM 15.50 (Information Data Security), with governing compliance oversight from NMSU’s Chief Privacy Officer in an ex-officio capacity.
  2. Vision: To increase awareness of Protected Data requirements and expectations at NMSU, improve communication, coordination and collaboration within the Research-based realm, and to provide an advisory role to the VPR regarding strategic initiatives, policies, rules, standards and guidelines in these areas.
  3. Mission: To facilitate the growth of a Protected Data support infrastructure at NMSU, that is built on communication and collaboration between VPR units and college-level stakeholders and resources.  To collect and synthesize Protected Data compliance issues, and propose reasonable policies, rules and procedures to the VPR.  Accordingly, RSOC will:
    1. Assist principal investigators, proactively, to ensure that security stipulations included in grants and contracts are comprehended, considered and reflected in the proposal effort. This will facilitate compliance in the award and implementation phase.
    2. Promote awareness of Protected Data definitions and requirements at NMSU.
    3. Develop and disseminate training materials and compliance procedures for PIs and support staff.
    4. Marshall NMSU resources towards the establishment of a CUI-centric support infrastructure anchored around Anderson Hall.
    5. Work to expand Protected Data expertise in the Colleges.
    6. Evaluate existing NMSU policies and rules regarding Protected Data and propose Research-focused improvements.
    7. Ensure that support infrastructure meets required NIST standards such as NIST SP 800-171 for CUI work or as required by funding agency.
  4. Terms:
    1. CUI: Controlled Unclassified Information
    2. EAR: Export Administration Regulation
    3. FISMA: Federal Information Security Management Act
    4. ITAR: International Traffic in Arms Regulations
    5. NIST: National Institute of Standards and Technology
    6. PI: Principal Investigator
    7. Protected Data: Data consisting of one or more of CUI categories such as ITAR, EAR or proprietary information.
    8. RSOC: Research Security Oversight Committee
    9. VPR: The Vice President for Research
  5. Membership: The Research Security Oversight Committee will be comprised of no more than twelve voting members, including the following:
    1. The heads of the following offices, or their designee:
      1. Vice President for Research,
      2. Information and Communication Technologies,
      3. Physical Science Laboratory,
      4. Arrowhead Center, and
      5. International and Border Programs;
    2. Representatives from Research Support Units:
      1. A member from Research Administration Offices, appointed by the unit director.
      2. A member from Research IT, appointed by the unit director.
      3. The NMSU export control officer;
      4. A member from the Physical Science Laboratory security office, appointed by the unit director.
    3. NMSU Chief Privacy Officer (ex-officio, non-voting); and
    4. Additional members from the university colleges, when deemed necessary and appointed by the above voting RSOC committee members, not to exceed the maximum count of 12 committee members.
  6. Functions and Responsibilities: RSOC’s role is to provide guidance and advisory support to researchers involved with CUI or export control data and or systems.  To accomplish this, the committee will:
    1. Improve communications within the CUI and export control community at NMSU.
    2. Improve collaboration amongst stakeholders in order to reduce compliance burdens on the researcher.
    3. Improve coordination amongst support units and researchers to allow for timely and high quality proposal submissions, cost effective responses to customer needs, and proper management of CUI and export control data.
    4. Recommend development or amendment of NMSU policy, rules or procedures, as appropriate, to ensure compliance with CUI and export control.
    5. Review and recommend changes relating to the evaluation and monitoring of the CUI and export controlled technical data environment.
    6. Develop and disseminate awareness and training material regarding CUI and export control protection requirements system-wide.
    7. Promote the establishment and growth of CUI trained liaisons at the colleges.
    8. Foster the growth of CUI and export control expertise at the college level.