NORTHERN ILLINOIS UNIVERSITY MODEL

ON

POLICIES AND PROCEDURES

[FOCUSING ON HUMAN SUBJECT RESEARCH]

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The Office of Research Compliance, Integrity & Safety

The Office of Research Compliance, Integrity & Safety (ORCIS) at NIU was established to help researchers and the University as a whole, to achieve and maintain ethical principles and maintain compliance with federal, state and university regulations governing research. The office acts as a liaison between the Vice President for Research (the Institutional Official designated with oversight of compliance) and the various committees required to monitor research activities.

Specifically, ORCIS assists the NIU research community in maintaining high ethical standards and adhering to regulatory requirements by:

  • Identifying research-related compliance risks and alerting our research community about those risks
  • Working with our research community to manage and minimize research risks
  • Providing education about regulatory requirements and best practices used to comply with them
  • Providing education and training that promotes an ethical research environment and the Responsible Conduct of Research
  • Handling instances of non-compliance or misconduct in accord with University policy and federal guidelines

In pursuit of these objectives and fulfillment of our mission, ORCIS shares the core values of the Division of Research and Innovation Partnerships:

  • Excellence
  • Ethical and accountable conduct
  • Academic integrity and regulatory compliance

Compliance

The Office of Research Compliance, Integrity, and Safety houses the mandated federal review boards for research. These include the Institutional Review Board (IRB) which handles protections and approvals for research involving human subjects, the Institutional Animal Care and Use Committee (IACUC) which is responsible for protections and approvals regarding research with animals, and the Institutional Biosafety Committee (IBC) which is the authority for protections and approvals with research involving biohazards. If your research may involve one or all of these areas please contact our office for assistance.

Animal Research

Northern Illinois University is committed to conducting quality animal research in an ethical and responsible manner to further science and improve the health of society. Veterinary and compliance oversight is administered through the Office of Research Compliance, Integrity & Safety, while animal care and animal resources are provided by the Department of Biological Sciences and Department of Psychology in order to meet the animal research needs of the research community.

NIU Institutional Animal Care and Use Committee (IACUC)

The NIU IACUC, through the experience and expertise of its members, is charged with the responsibility to oversee the entire Animal Care & Use program at NIU. The IACUC is composed of NIU faculty, staff, a community representative who has no other affiliation with NIU and an attending veterinarian. The IACUC is responsible for reviewing all research, teaching and training activities that involve the use of live, vertebrate animals and sets forth institutional policies governing such activities.

The committee's functions include:

  1. Review and approve, require modifications in (to secure approval), or withhold approval of proposed activities related to the care and use of animals.
  2. Inspect, at least once every six months, all of the institution's animal facilities, including all satellite facilities, using the Guide for the Care and Use of Laboratory Animals (Guide) as the basis for evaluation.
  3. Review, at least once every six months, the institution's program for humane care and use of animals, using the Guide as the basis for evaluation.
  4. Evaluate the qualifications of research personnel and provide appropriate training and education as deemed necessary.
  5. Make written recommendations to the Institutional Official regarding any aspect of the institution's animal program, facilities, or personnel training.
  6. Suspend activities involving animals if the IACUC determines that the activity is not being conducted in accordance with the institution's policy and applicable provisions of the USDA Animal Welfare Act Regulations, the PHS Policy and the Guide.
  7. Review and investigate reports of potential non-compliance with regulations governing the care and use of laboratory animals and take corrective actions as necessary.

Training & Education Requirements for Animal Research

Evidence of Skills and Experience

Animal users must provide evidence of skills and experience with the procedures listed in their IACUC Protocols. Additional training may be required at the discretion of the IACUC.

Mandatory Animal User Training

Federal regulations and guidelines require animal users to complete basic training in animal care and use legislation, IACUC function, ethics, animal handling and procedures used in IACUC protocols. Animal users are always encouraged to participate in additional relevant training if they feel it may benefit their projects.

Northern Illinois University animal users fulfill federal requirements by participating in the following mandatory animal user training:

  1. Annual IACUC Training Seminar
    All animal users are required to attend the annual Institutional Animal Care and Use Committee Training Session, which is held annually in October or November. If you are unable to attend the session, you must complete ONE of the following five options in order to meet annual training requirements:
  2. View the video recording of that year’s Annual IACUC Training Seminar (videos are available for checkout Office of Research Compliance or from Animal Care Supervisors in Department of Biological Sciences or Department of Psychology)
  3. Complete the CITI training module, “Working with Animals in Biomedical Research – Refresher”
  4. Complete the CITI training module, “Working with the IACUC”
  5. Provide evidence of comprehensive animal user training completed at another institution within the past
    year
  6. Provide evidence of alternate, specialized training relevant to the animal user’s IACUC protocols
  7. Animal Handling Workshops
    Please contact Dr. Corinna Kashuba to arrange one of the following handling and technique workshops:
  8. Rat or Mouse Handling and Technique Workshop: New animal users who intend to conduct studies in rats and/or mice must participate in the corresponding Rat and/or Mouse Handling and Technique Workshop.
  9. Additional Species: New animal users conducting research on other species will receive appropriate
    species-specific practical training as needed from the attending veterinarian or a designated expert in
    that species.

A new animal user is defined as an individual who has not previously conducted animal research, teaching or testing at NIU.

  1. CITI Training for Animal Users
    All animal users must complete mandatory online CITI Training as listed below. Additional, species-specific training modules may be required at the discretion of the IACUC. Comprehensive, documented animal user training completed at another institution may be accepted in lieu of mandatory CITI Training at the discretion of the IACUC.
  2. Animal users must register as an NIU affiliate on the CITI Training website and complete basic courses in animal care. Detailed instructions for registering can be found here
  3. Enroll and complete the mandatory modules as follows:
  4. All animal users:
  5. "Working with the IACUC"
  6. Animal Users conducting surgery:
  7. "Working with the IACUC"
  8. "Aseptic Surgery"
  9. Animal Users conducting any study with the potential to cause "more than momentary pain
    and distress" in mice or rats:
  10. Working with the IACUC"
  11. "Minimizing Pain and Distress"
  12. IACUC Members:
  13. "IACUC Community Member" (if you are a community member on the NIU IACUC)
  14. "Essentials for IACUC Members" (all other members)

IACUC Review Process

  1. Complete the online IACUC form.
  2. Submission to IACUC. The form is submitted online. It is routed to the Chair of the department for "electronic signature" then routed to the ORCIS
  3. Initial Review. The protocol will be reviewed by a designated IACUC member to ensure that it is complete and prepared correctly. If the initial reviewer has questions, recommendations, or concerns, the submitter will be notified by the Research Compliance Coordinator and asked to respond to the questions in writing. The protocol is held until a response is received.
  4. Formal Approval. The final submitted protocol is presented at a convened quorum of the IACUC for a full committee review and vote. The committee’s decision to approve or disapprove the protocol is noted in the minutes; the committee may approve the protocol pending modifications, in which case the protocol will be approved upon receipt of the requested modifications by the Research Compliance Coordinator. The committee may also table the protocol and request major modifications, in which case the protocol will be re-submitted to the convened IACUC for review pending receipt of the revised protocol.
  5. Notification of Approval. Assuming approval by a convened quorum of the IACUC, the Research Compliance Coordinator will send the investigator written notification stating approval of the protocol. No protocol may ever be initiated, including the ordering of animals, until written approval is received.
  6. Notification of Disapproval. The reasons for disapproval will be given to the investigator who may request a meeting of a convened quorum of the IACUC or resubmit a revised protocol.

Proposed Significant Changes to an Active Protocol

Proposed significant changes to an active protocol must go through the same protocol approval process as described for the new protocol submissions.

Protocol Renewals and Annual Review of Active Protocols

At the end of each year, all investigators with active protocols will be asked to confirm that their protocols are active and that no changes have been made without the review and approval of the IACUC. Every three years, there will be a new, complete review of the IACUC protocol using all the criteria for initial review.

Resources for Animal Research

Organizations

  • American Association for Laboratory Animal Science (AALAS)
  • American College of Laboratory Animal Medicine (ACLAM)
  • Americans for Medical Progress Educational Foundation (AMPEF)
  • Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC)
  • Public Responsibility in Medicine & Research (PRIM&R)
  • Foundation for Biomedical Research (FBR)
  • Institute for Laboratory Animal Research (ILAR)
  • National Association for Biomedical Research (NABR)
  • National Biosecurity Research Center for Animal Health Emergencies

Government

  • National Institutes of Health
  • Office of Laboratory Animal Welfare (OLAW)
  • U.S. Department of Health and Human Services
  • U.S. Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care
  • U.S. Food and Drug Administration
  • USA Fish and Wildlife
  • Centers for Disease Control and Prevention Home Page

General Resources

  • Animal Welfare Information Center
  • Lab Animal Magazine
  • NetVet & Electronic Zoo
  • NetVet: Veterinary Government and Law Resources
  • IACUC.org
  • AVMA Disaster Preparedness – Related Links
  • Information Resources for Adjuvants and Antibody Production: Comparisons and Alternative Technologies

Alternatives & Other Animal Welfare Topics

  • ALTWEB
  • Animal Welfare Information Center
  • Assessing the Health and Welfare of Laboratory Animals
  • Bibliography on Alternatives to the Use of Live Vertebrates in Biomedical Research and Testing (from the US National Library of Medicine)
  • Center for Animal Welfare
  • Center for the Documentation and Evaluation of Alternative Methods to Animal Experiments (Germany)
  • Centre for the Study of Animal Welfare
  • Information on Alternatives Databases
  • National Agriculture Library Animal Use Alternatives Thesaurus
  • The Interagency Coordinating Committee on the Validation of Alternative Methods/The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods
  • InterNICHE
  • Model Organisms for Biomedical Research
  • Netherlands Centre Alternatives to Animal Use
  • NORINA
  • University of California Center for Animal Alternatives
  • TextBase (database of books on laboratory animal science)

Policies and Regulations [sample from NIU website]

To assist in finding what you're looking for, select from the following categories:

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General Policies

  • Export Control
  • National Science Foundation (NSF) Requirements
  • Research Conflict of Interest Policy
  • ResearchData Management Policy
  • NIU Intellectual Property Policy
  • NIU Responsible Conduct of Research (RCR) Policy
  • NIU Research Misconduct Policy
  • NIUControlled Substance Policyand Procedures
  • Federal Controlled Substance Act
  • Illinois Controlled Substance Act

Policies Regarding Animal Research

NIU policies
  • Policies and Procedures Pertaining to Activities Involving the Use of Animals
  • Animal Welfare Assurance A3166-01
  • NIU Occupational Health Program
Federal regulations
  • Animal Welfare Act and USDA Regulations
  • USDA Animal Care Policy Manual
  • Public Health Service Policy on Humane Care and Use of Laboratory Animals
  • Guide for the Care and Use of Laboratory Animals
  • OLAW Regulatory Guidance
  • U.S. Government Principles for Utilization and Care of Vertebrate Animals Used in Testing, Research and Training
  • Health Research Extension Act of 1985
  • AVMA Guidelines for the Euthanasia of Animals: 2013 Edition

Animal Research (IACUC) Forms

  • IACUC Application(Required)
  • Internet browser compatibility
  • General instructions and help with the form
  • IACUC Risk Assessment Form
  • IACUC Health Questionnaire Form
  • Accident Incident Report Form

Human Subject Research

The Office of Research Compliance and Integrity promotes the protection of human subjects in research by requiring Institutional Review Board (IRB) approval for all research projects that meet the definition of human subject research.

Your project requires IRB review if it meets both of the following criteria:

It meets the definition of "research"
It involves human subjects

Collaborative research with other institutions

If you are collaborating with other researchers on a single study conducted at multiple sites and the principal or lead investigator for the project is not affiliated with Northern Illinois University, NIU may choose to designate the IRB of one of the other sites in the study as the IRB of record for the project. Although you would not then be required to complete the full IRB review process, you must contact the Office of Research Compliance, Integrity & Safety (815-753-8588, ) so that the appropriate agreement can be drafted.

New faculty/staff/students with existing research projects

If you are new to Northern Illinois University and are still recruiting subjects or continuing to analyze identifiable research data from human subjects that were collected while you were at your previous institution, you will need to obtain IRB approval from NIU’s IRB before resuming work on your project.

Research is defined as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." Research encompasses work that is conducted on or off campus, in person or online and includes questionnaires, interviews, tests, observations, surveys and other experimental methodologies, regardless of the content or routine nature of the topic and whether the work is a preliminary (such as pilot studies) or a fully developed study.

  • Systematic investigation: the use of step-by-step, purposeful procedures in order to reduce partiality (error) in the data and increase control over the results, allowing the knowledge to be applied to populations and settings different from the ones from which it was collected. Through this process, the researcher is seeking underlying principles or laws of nature that can predict future outcomes.
  • Generalizable knowledge: new information that has relevance beyond the population or program from which it was collected because impartial procedures were used and the information is intended for professional presentation outside the classroom setting.

Here are some examples of projects that do NOT meet the definition of research because they do not contribute to generalizable knowledge:

  1. Projects that are conducted only as a classroom assignment and will not be shared outside of the student’s department.
  2. Projects whose results will only be used for evaluation of the effectiveness or acceptance of an existing program.
  3. Projects whose data will only be shared with clients or stakeholders, such as an evaluation of a community’s attitudes about a proposed new program or service.

Please note that research conducted for a thesis or dissertation does contribute to generalizable knowledge, as the thesis or dissertation will be made available to other scholars.

Human Subject: 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. individually identifiable private information (information that is not publicly available).
  3. Intervention: includes both physical procedures by which data are gathered (for example, heart rate, weight measurement, blood sample) and manipulations of the subject or the subject's environment that are performed for research purposes (for example, placement in one of three learning conditions, use of a room with and without a mirror present, application of different muscle development therapies).
  4. Interaction: includes communication or interpersonal contact between investigator and subject (for example, interviews, focus groups, surveys – including mailed and on-line).

Private information: includes:

  • information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,
  • information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record, g.p.a.), or
  • information provided specifically in response to data collection (for example, responses to a survey).

Training & Education Requirements for Human Subject Research—(please note that university must subscribe to this CITI training program and only can log in if the institution is registered)

Training in human subjects research is a required part of conducting research studies with humans. As part of an initiative to increase standards in human subjects research knowledge, ALL researchers will be required to complete the CITI training program before running participants in studies, or to provide documentation of equivalent training. Below is a link to the CITI online tutorial that is provided by the Collaborative Institutional Training Initiative. Instructions are also posted. The required course most researchers should complete is “Social & Behavioral Research - Basic/Refresher, Basic Course.” After required modules have been completed in full, you will be able to print out a Completion Report for your records. CITI Online Human Subjects Research Tutorial Instructions for CITI Online Human Subjects Tutorial (PDF) IRB 101 workshops are also offered on campus periodically. These workshops DO NOT meet the requirement for human subjects training but instead are designed to aid researchers in completing the IRB application accurately and thoroughly and to answer questions about the review process. These workshops will be scheduled at the beginning of each academic year in August and September. A schedule of these workshops will be available on this web page prior to the beginning of each fall semester.