Skip to main content
Sign In

University of Colorado Denver

Environmental Health and Safety, University of Colorado Denver
 

Committees


Institutional Biosafety Committee

E-mail: IBC@ucdenver.edu

The University Biosafety Committee provides review and approval of all recombinant DNA research, including Human Gene Transfer clinical trials, and review and approval of all Select Agents Research. Protocols are reviewed and overseen for compliance with the National Institute of Health (NIH) Guidelines and federal Select Agents Regulations.

IBC Compliance Note:  NIH Guidelines

The IBC meets monthly to review to and approve Biosafety Applications.

Responsibilities of the IBC

  • Review and approval of research involving recombinant DNA materials, including transgenic animals, plants and Human Subjects Gene Transfer clinical trials for regulatory compliance, safety, and containment of biological materials.
  • Review and approval of Biosafety Authorization Forms for work with infectious biological materials for regulatory compliance, safety, and containment of biological materials.
  • Review and approval of Biosafety Authorization Forms for all work with Select Agents Toxins for regulatory compliance, safety, and containment of SA materials.
  • Incident Reporting and Investigations for incidents involving infectious or recombinant DNA materials.

Biosafety Authorization Forms

 You can download any form as a Word Document, fill it out and send it directly to the IBC at IBC@ucdenver.edu

If you have questions about what types of forms are required please contact IBC@ucdenver.edu.

NIH References

Committee on Ionizing Radiation (CIR)

The Committee on Ionizing Radiation exists to provide guidance to the radiation safety program. The Committee on Ionizing Radiation establishes program policies for the safe handling of radioactive material and radiation producing machines. The committee is comprised of no fewer than five but no more than nine members from the Executive Faculty, and shall designate a Chairperson that the Chancellor appoints. Meetings are held no less than once every calendar quarter. Some of the services that the committee provides are:

  • Assuring that any authorized Principal Investigator using radioactive materials is qualified by training and experience, has the facilities and equipment to handle the materials safely.
  • Assuring observance of all safety standards established or regulated by the CDPHE Division of Radiation Control, the U.S. Nuclear Regulatory Commission (NRC), and other regulatory or standards-setting agencies.
  • Exerting a priori control over all acquisitions of radioactive materials to ensure compliance with the UCD license, and keep records of the receipt, storage, use, transfer and ultimate disposal of all radioactive materials used at UCD.
  • Keeping records of the monitoring of personnel, effluents of air and water, and areas potentially affected by the use of radionuclides and other source of ionizing radiation such as x-ray tubes.

To use radioactivity on campus, you must go through the review process by submitting your application to the CIR. The application must be submitted electronically and must contain all of the information required in the current version of the appropriate application form. All persons are required to complete UCD specific mandatory training before receiving authorization as Principal Investigators or working unsupervised with radioactive materials.

  • For more information about the CIR and the review process please go to section 2.4 of the Radiation Safety Manual.
  • To Apply for a radioactive materials license you will need to fill out a Radioactive Materials Authorization Application for Non Human Use. Go to the Radiation Safety Forms page to access the application.

If you have any questions please contact the main office at 303-724-0345 or send an email to radappnh@ucdenver.edu.

Radioactive Drug Research Committee (RDRC)

The Radioactive Drug Research Committee approves, reviews and advises protocols that conduct research involving radioactive drugs in humans. The RDRC approves protocols under the purview of the Food and Drug Administration in accordance with FDA regulation 21 CFR 361.1.

The Committee meets quarterly and is made up of at least five individuals as follows:

  • A physician recognized as a specialist in nuclear medicine [§ 361.1(c)(1)].
  • A person qualified by training and experience to formulate radioactive drugs [§ 361.1(c)(1)].
  • A person with special competence in radiation safety and radiation dosimetry [§ 361.1(c)(1)].
  • Individuals qualified in various disciplines pertinent to the field of nuclear medicine (e.g., radiology, internal medicine, clinical pathology, hematology, endocrinology, radiation therapy, radiation physics, radiation biophysics, and radiopharmacy) [§ 361.1(c)(1)].

Approved qualified investigators require both RDRC approval and the approval of the IRB before the study may begin. To receive a RDRC protocol approval, you will need to fill out a Radioactive Materials Authorization Application for Human Use. Go to the Radiation Safety Forms page to access the application.

If you have any questions please contact the main office at 303-724-0345 or send an email to Riad.Safadi@ucdenver.edu.

University of Colorado Denver

© The Regents of the University of Colorado, a body corporate. All rights reserved.

All trademarks are registered property of the University. Used by permission only.