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The Office for Research Committee Support (ORCS)

The ORCS at University of Colorado Denver oversees the Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), and various Radiation Safety Committees (CIR, huCIR, RDRC, RPOC).

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The Office for Research Committee Support (ORCS)

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  1. Bldg. 500 Room N 3025 Mail Stop F489 mark.douse@ucdenver.edu 303-724-1056/303-724-1057 The Office for Research Committee Support (ORCS)

  2. Three Research FocusesOne Office • Institutional Animal Care and Use Committee (IACUC) • Institutional Biosafety Committee (IBC) • Radiation Safety Committees (CIR, huCIR, RDRC, RPOC) http://www.ucdenver.edu/research/ORCS/Pages/default.aspx

  3. The Institutional Animal Care and Use Committee (IACUC) • The IACUC oversees all aspects of the animal care and use program including the review, approval and post-approval monitoring of protocols and amendments for animal studies. • The IACUC is a requirement of the Animal Welfare Act (AWA) and the committee exists to oversee all aspects of the animal care and use program

  4. The Institutional Biosafety Committee (IBC) • Responsible for ensuring that activities at the university that involve the following are in compliance with the National Institutes of Health (NIH) Guidelines for Research involving recombinant DNA molecules and all other applicable federal, state and local requirements • recombinant DNA products • transgenic animals • infectious/biohazardous materials • use of human tissues (outside of clinical applications) • biologically produced toxins • Select Agent toxins • ??? • Clinical Trials involving Human Gene Transfer or Live Vaccine investigational compounds may require IBC review. There is a separate application process for clinical trials subject to IBC review, and the IBC review must occur before IRB review & approval may proceed.

  5. Radiation Safety • Comprised of 4 separate committees that each oversee a different aspect of radiation safety at the university • All 4 committees are coordinated via the ORCS office • Committee on Ionizing Radiation (CIR) • Committee on Ionizing Radiation for Human Use (huCIR) • Radioactive Drug Research Committee (RDRC) • Radiopharmaceutical Oversight Committee (RPOC) • Any use of radiolabeled compounds for human or non-human applications requires EH&S radiation safety training and applicable committee certification/approval

  6. DURC & IRE • Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. • The Institutional Review Entity (IRE) reviews all studies that are considered to be DURC.

  7. A few more acronyms • IRC = Industry Review Committee • Evaluates whether requests to use CU animal/research facilities by users outside of the institution are appropriate and consistent with one or more of the University’s missions. Pre-approval of the request by the Industry Review Committee is required before submission of protocols to other review entities • Relevant for those working with/running start-ups, etc. • SEC = Scientific Ethics Committee • Reviews & approvals all research using Human Fetal Tissue (HFT). Reviews are in coordination with other applicable research committees • Animals on Campus Committee • Sets guidelines, requirements, & procedures regarding the presence of animals on CU campuses in accordance with state/federal law. Recognizes and addresses health & safety risks of unrestrained animals on campus

  8. eSirius Protocol Management • eSirius is a new protocol management system for IACUC & IBC protocols (non-clinical trials) • All IACUC submissions, and all new or renewal IBC submissions must be in this system • For IBC amendments and clinical trial submissions, please contact the IBC Coordinator for directions https://esirius.researchadmin.ucdenver.edu/esirius3g/

  9. OFFICEOF RESEARCH COMMITTEE SUPPORTTeam • Director- Dr. Mark Douse Mark.Douse@ucdenver.edu • IBC Coordinator- Jill Garvey IBC@ucdenver.edu • IACUC Team- • IACUC Coordinator Ellen Tayler iacuc@ucdenver.edu • Research Monitor- Dr. Carol Palmer Carol.Palmer@ucdenver.edu • IACUC Administrative Specialist– Laura Richardson Laura.Richardson@ucdenver.edu • Radiation Safety Committees Coordinator- Denise Davis Denise.Davis@ucdenver.edu

  10. Environmental Health and Safety for DFAs and Administrative Professionals

  11. Our Mission • The goal of the Department of Environmental Health and Safety is to protect and promote the research and teaching enterprise of the University of Colorado Denver | Anschutz Medical Campus. Our customers are: • Researchers (faculty and staff), • Those who support the research enterprise (Admin staff, Facilities, Police, etc. • Students and academic programs

  12. The mission of the Division of Biosafety is to promote the safe, secure and responsible work with biological materials whether in research or in teaching.   The goal is that the science, the researcher, the teacher, the student, the public and the environment are not adversely affected.

  13. The Division of Hazardous Materials Management ensures the safe use, management, and disposal of chemicals through researcher training, chemical safety outreach, emergency response services, and assistance to the research community. Working to build strong relationships with researchers and students ensures compliance with the appropriate federal, state, and local regulatory requirements for laboratory and general environmental applications.

  14. The Division of Research Safety and Industrial Hygiene (RSIH) promotes safety through education and outreach. ​RSIH provides guidance, services, and training covering laboratory safety, indoor air quality, exposure controls, and personal protective equipment.

  15. The Division of Radiation Safety, under the direction of the various faculty committees, develops, implements, and supervises a comprehensive radiation safety program for the purpose of keeping radiation exposure to University personnel, members of the public, and the environment As Low As Reasonably Achievable (ALARA) and in compliance with Local, state, regional, and federal regulations.

  16. The Division of Occupational Health promotes a safe work environment for all by focusing on promotion of health, prevention of illness and injury, and protection from occupational hazards. We provide an integrated approach to delivery of quality occupational health medical surveillance and clinical services, such as health hazard assessment, injury/illness investigation, vaccines and bloodwork, and assuring compliance with legal, regulatory and ethical standards.

  17. We are all CU…. But we all came from somewhere….

  18. 1 PhD 10 Masters 12 professional certifications 2 NCAA Division I athletes 2 military veterans Numerous scholarly publications New grads to 20+ year employees

  19. EHS strives to be a proactive organization We accomplish this by….. ….being members on every research committee at the University ….working with schools, departments and divisions to assist in the reception and departure of faculty …..communicating with Grants & Contracts regarding new research being proposed …..providing PIs and departments with letters of support for proposed research.

  20. Key Partnerships The overall health and safety of all employees and our greater community necessitates EHS maintaining strong relationships with individual employees, work units, divisions, department and schools. In addition to the faculty and research staff, we regularly partner with: • Administrators • Facilities Management and Operations • University Police • AHEC (at the Denver campus) • UCH, Children’s Hospital of Colorado and Denver Health

  21. How Can DFAs and Administrative Personnel Help EHS and their Work Units? • Be aware of the general training requirements pertaining to laboratory personnel. • Contact EHS when new employees (faculty, research staff, students, etc.) are coming on board. • Contact EHS when employees are leaving or moving to another work unit. • Report accidents, spills, and injuries to EHS.

  22. Standards for Safety & Compliance EHS is responsible for interpreting and applying a variety of safety and compliance standards promulgated at multiple levels • Local, State, or Federal laws and regulations • Funding agency’s policies • Institutional standards

  23. External Partners in Safety & Compliance • EHS is in frequent communication with a variety of local, state and federal organizations. • All of these organizations (and more) have visited the campus in the recent past – either for audits and inspections, or courtesy visits. • Although EHS is frequently the point of contact, all of these organizations have full authority to visit any lab, at any time.

  24. Funding Agency Standards • 4.1.12 Health and Safety Regulations and Guidelines • 29 CFR Part 1910.1030, Bloodborne Pathogens, Exposure Control & Needlestick Safety • 29 CFR Part 1910.1450, Occupational Exposure to Hazardous Chemicals in Laboratories • Biosafety in Microbiological and Biomedical Laboratories, CDC and NIH, HHS. (current edition) • 4.1.20 EPA Resource Conservation and Recovery Act (RCRA) and Clean Water Act. • 4.1.23 Public Health Security and Bioterrorism Preparedness and Response Act (Select Agents) • 42 CFR Part 73 (CDC) • 9 CFR 121 & 7 CFR Part 331 (USDA) • 4.1.32 USA PATRIOT Act & ”Restricted Persons” 4.1.24 NIH Guidelines for Research Involving Recombinant DNA Molecules, (including Human Gene Transfer Research) 4.1.24.2 Institutional Biosafety Committee

  25. Institutional Standards • Administrative Policy Statement (APS) #2027, Code of Conduct. Nov 17, 2016 from the CU President’s Office • EHS is specifically charged with developing, implementing, and enforcing a comprehensive safety program. The safe workplace include training compliance, PPE usage, and safe handling of hazardous materials. • Food and Drink In Lab Areas • Food and drink are expressly prohibited in all laboratory areas. • Minors in Labs • Minors entering or working in lab areas must get parent/custodian approval and have restrictions on activities and locations where they can work. • Occupational Health • Enrollment in occupational health is required for nearly all laboratory work. • PPE and Lab Attire Guidance Document

  26. EHS Training Modulesucdenver.edu/ehs_training

  27. Despite Everyone’s Best Efforts Accidents Happen • Contact EHS no matter how small the incident is. • If an EHS response is needed immediately, using University Police to contact EHS is encouraged. • Workers Comp reporting is handled through University Risk Management. EHS can facilitate this process, but is not the lead. www.ucdenver.edu/ehs

  28. Take Away Messages • EHS is a campus-wide resource that serves all employees of the University – even those individuals not working in a lab or clinic setting. • Our department is made up of individuals that are subject matter experts. Call us even if you are not sure EHS is the right place to start – chances are, if we are not, we know who is. • Help us, help you – we don’t know what we don’t know!

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