CIR Application Number

A.Please submit copies of approved authorizations from the following:

Colorado Multiple Institutional Review Board (COMIRB)

Radioactive Drug Research Committee (RDRC)

  • UniversityHospital Radiation Safety Committee
  • General Clinical ResearchCenter (GCRC)

Note: This application will be rejected if any one of the above is omitted. If one of the above is not required, you must attached signed correspondence from the respective committee which states why it is non-applicable.

B. This form is for New Applications, Renewal Applications, and Minor Amendments, please check:

New Application

Renewal Application

  • Amendment Request:

Possession increase Yearly increase Location of Use

THIS APPLICATION MUST BE TYPED (available in MS Word format from the HSD web page)

1. ______

Principal Investigator (Refer to EH&S Radiation Faculty PositionDepartment

Safety Manual, sec. 2.4.2, 2.4.10, 2.4.12, 2.4.13)

2. ______

UCDHSC BUILDING(S) where radioactiveLaboratory number(s)Laboratory # where the Radio-

materials will be stored and/or used, i.e.,(Example: MS 0845)active Fume Hood is located,

BiomedicalResearchBuilding (BRB),if required for proposed use.

ResearchCenter 1 NorthTower (RC1-P18),

ResearchCenter 1 SouthTower (RC1-L18)

Note: use on UniversityHospital property requires application to the UniversityHospital Radiation

Safety Committee.

3.a

Name(s) of co-investigator(s) (Should be faculty)Title and Position

4.a. __b. ______

Name(s) of individual(s) working with radionuclide under this Name of Radiation Worker

authorization (Radiation Workers). (Refer to HSD Radiation

Safety Manual, sec. 2.4.8, 2.4.10, 2.4.13)

c. _____ d. ______e. _____

Name of Radiation Worker Name of Radiation Worker Name of Radiation Worker

5.a. b. c. ____d. _ e. ____

Radioisotope requestedHalf-life ofPrincipal radiation Type of decay Compounds

(File one form for eachRadioisotopeenergy (give energyAlpha, Beta,

radioisotope requested)in MeV)Gamma

6.a. b. c. ___

YEARLY LIMIT in mCi: POSSESSION LIMIT in mCi:Radioactivity to be used per

TOTAL radioactivity requested forTOTAL radioactivity to have on-handexperiment (mCi), “experiment”

use during one year. This periodat any one time (this includes work-being as defined in item

runs from July 1 through June 30.ing and storage of waste materials).12. below

7.a. Are you presently authorized as a Principal Investigator with other radioisotopes? (please check)

YES 01. Radioisotope, milliCuries Yearly limit, milliCuries Possession limit

2. Radioisotope, milliCuries Yearly limit, milliCuries Possession limit

3. Radioisotope, milliCuries Yearly limit, milliCuries Possession limit

NO 0If no, you must pass the UCHSC certification test given by HSD. Date of certification:

7.b. Also, complete your formal radioisotope training, laboratory and clinical experience. You may wish to attach an additional page and copies of any training certificates. (NOTE: If experience/training documentation is not attached, this application may not be reviewed by the Committee. Below is NRC Form 313M Supplement A Equivalent.)

7.c. Training Received in Basic Handling Techniques for Radioactive Materials (SEE EXAMPLE BELOW):

Field of Training

A

/ Location and Date(s) of Training
B
For Example…
/ C. Lecture or Laboratory Courses (Hours) / D. Supervised Laboratory Experience (Hours)
a. Radiation Physics and Instrumentation / CaseWesternResearveUniversity, Cleveland, OH
UCHSC, Denver, CO / 1 Hour
1 Hour / 5 Hours
b. Radiation Protection / CaseWesternResearveUniversity, Cleveland, OH
UCHSC, Denver, CO
National Institute of Health, Baltimore, MD (attached certificate) / 4 Hours
2 Hours
40 Hours / 20 Hours
c. Mathematics Pertaining to the Use and Measurement of Radioactivity / CaseWesternResearveUniversity, Cleveland, OH / 1 Hour / 1 Hour
d. Radiation Biology / WeisCenter for Research, Geisinger Clinic, Danville, PA / 5 Hours / 3 Hours
e. Radio-pharmaceutical or Chemistry / Colorado State University, Fort Collins, CO / 3 Semester Hours / 3 Hours

7.d. Experience with Radiation and Radioactive Materials (SEE EXAMPLE BELOW):

Radionuclide(s) / Maximum
Amount (mCi)
Respectively / Where Experience was Gained
For Example… / Duration of Experience / Type of use
For Example…
I-125, S-35, P-32 / 1, 10, and 5 mCi / Case Western Researve Univeristy, OH / 1984-1989 / Labeling cells and nucleic acids for biochemical and molecular analysis.
P-32, S-35, C-14 / 2, 10, and 0.6 mCi / National Institute of Health, Baltimore, MD / 1989-1991 / In vitro protein labeling and sequencing. CAT assays.
P-32, S-35, H-3, I-125 / 5, 10, 20, and 1 mCi / WeisCenter for Research, Geisinger Clinic, Danville, PA / 1991-1995 / End labeling oligonucleotides. Cell incorporation assays using tritiated thymidine. And cAMP kit assays.
I-125, Na-22 / 1 and 0.25 mCi / University of Colorado Health Sciences Center, Denver, CO / 1995- Present / Na/H exchange assays. Iodination of growth hormones.

8. Describe methods and precautions which will be used to protect radiation workers from internal/external radiation exposure. Be specific (Refer to HSD Radiation Safety Manual, Sec. 3.4.3, 3.4.4, 3.4.5, pages 54-79 ).

FOR EXAMPLE….

  1. Workers will maintain their exposure as low as practical.
  1. Film badge and ring dosimeters will be worn on the lapel of the lab coat when in the lab.
  1. No food or drink is allowed in the laboratory.
  1. Hands, shoes, coat, and skin will be surveyed before leaving the laboratory.
  1. Only goggles, lab coat, double gloves, no open toed shoes, and long pants will be allowed.
  1. Protective barriers will be used to provide shielding and reduce potential exposure.
  1. Radioactive work will be performed within the confines of an approved certified fume hood.
  1. All work areas will have absorbent with non-permeable backing.
  1. Absorbent will be tapped around the circumference with caution radioactive materials tape to designate work area.
  1. Equipment, cold storage, and waste storage areas will be placarded with caution radioactive materials labels.
  1. Bench top plexiglass shields 1 cm thick, pipette shield, plexi waste bins, and plexi glass storage boxes will be used.

ETC….

8.b. Will the compound listed in item 5.e ever be in a volatile or unbound form ? yes no

9. What instruments are available for radiation monitoring? Caution: The instruments listed here must be capable of detecting the radiations of the isotope requested! (Refer to HSD Radiation Safety Manual, section 3.4.3.1, 3.4.3.2, pages 54-60). Also, specify the frequency of monitoring. Documented surveys must be performed weekly, or monthly if quantities in use never exceed 0.2 mCi. Each PI, except those using only H-3, must OWN a portable radiation survey instrument.

FOR EXAMPLE….

  1. Standard wet swab test of 12 designated work areas in the lab conducted weekly or immediately following each experiment and counted in liquid scintillation.
  1. Liquid scintillation counter Beckman LS 6500.
  1. Auto gamma counter Packard 6000.
  1. Liquid scintillation used is Packard Auto Gold.
  1. Portable survey instrument: Ludlum pancake geiger Model 3 with 44-9 probe and a compatible probe Model 44-3.

ETC….

10. Planned methods of disposal. Please list anticipated waste forms (solids, bulk liquids, deregulated vials, radioactive vials, animals, etc.), volume of each waste form generated per month, and the % of total radioactivity used that is expected to appear in each waste form. (Refer to UCHSC Radioactive Waste Disposal Procedures Manual). RADIOACTIVE WASTE DISPOSAL IS FREE OF CHARGE. You must clearly identify and justify any procedure that produces radiocontaminated organic solvents, or other radioactive wastes that may be classifiable as a regulated hazardous waste.

10.a Anticipated waste forms, volume, and activity:

Waste Type / Volume Generated per Month / % of Total Radioactivity / Requires Disinfecting*
Dry Solids / (cubic feet) / yes no
Aqueous / (gallons) / yes no
Scintillation vials, (Please list Cocktail brand name if applicable) / (# of trays) / yes no
Biological (non-carcass) / (cubic feet) / yes no
Biological (carcass) / (type and number of animals) / yes no
Organic (please justify in the comments section below) / (gallons) / yes no
Other / yes no

* If you check yes, please explain the method used to disinfect the waste in the comment section below.

10.b Will you produce any chemical-radioactive mixed wastes (see the Radioactive Waste Disposal Procedure Manual , Section II.G Waste Definition and Types and Section IV for classification)? yes no

10.c Will any infectious radioactive wastes that require disinfection and collection as biological non-carcass material (see the Radioactive Waste Disposal Manual , Section IV.7 and IV.10 for classification of Biological Non-carcass wastes)? yes no

Comments:

11. Do you subscribe to the HSD radiation film badge service?

1

YES 0NO 0 Film badge will not detect the radioisotope requested.

(Film badges are not required for pure beta emitters with maximum energies less than 0.5 MeV.)

DO NOT WRITE BELOW THIS LINE - FOR HEALTH AND SAFETY USE ONLY

Principal InvestigatorHas successfully completed the following modulesMentor form

Co-InvestigatorHas successfully completed the following modules

Radiation Workers

Has successfully completed the following modulesWIT form

Has successfully completed the following modulesWIT form

Has successfully completed the following modulesWIT form

Film badge service -0 Film badge service not necessary with this radioisotope.

0 Film badge service has been ordered, Group # ______.

Signature of HSD reviewer: ______Date:

ITEMS 12 thru 14 intentionally omitted

NOTE: ANY change in this protocol, with certain specific exceptions (consult the HSD Health Physicist for details) requires the submission of a NEW APPLICATION to the Committee on Ionizing Radiation.

15. STUDY CLASSIFICATION (check one):

Basic human research (tracer studies, etc., with a compuound not being developed as a radiopharmaceutical)

IND (Investigational New Drug Application)

Routine Nuclear Medicine Procedure being used for research purposes

16. DOSE SCHEME:

Dose administered in mCi ______.Number of Doses administered per subject: ______.

Number of Subjects per year: ______

Chemical and physical form of dose: ______

Route of administration (IV, etc. ): ______

17. DOSE PREPARATION: Describe the chemical and physical handling steps involved in preparing the dose, along with any radiation safety precautions that will be observed in preparing and transporting the dose.

By my signature below, I agree that all radioactive materials procured as a result of this application will be used only as specified above, and in accord with the guidelines of the HSD Radiation Safety Manual, as well as all other applicable UCHSC policies and procedures, the UCHSC radioactive materials license, and state and federal regulations.

18. ______

Signature of Principal InvestigatorDate

19. Signature(s) of co-investigator(s) listed under item 3, page 1.PI's telephone ext.

______PI's mail container

______

HSD-RSF-013 Rev. 0a1