Columbia University
NewYork-Presbyterian Hospital
New York State Psychiatric Institute
Version 5
October 2012
Joint Radiation Safety Committee
JRSC APPLICATION FOR THE USE OF RADIATION IN RESEARCH
STUDIES INVOLVING HUMAN SUBJECTS
Note: All research activities involving the use of ionizing radiation in human subjects must be
approved by the Columbia University or New York State Psychiatric Institute Institutional
Review Board.
Please refer to the Radiation Safety Program website
(http://www.ehs.columbia.edu/RadiationJRSC.html) for helpful information in completing this
Application, including:

Radiation Dose Estimates for Human Research Protocols Using Nuclear Medicine
Scans, CT Scans and/or General Radiographic Examinations:
http://www.ehs.columbia.edu/RadiationHumanDoseEstimates.html

Guidelines for the Use of Radiation in Studies Involving Human Subjects:
http://www.ehs.columbia.edu/RadiationFormsMC.html
Contact the Columbia University Medical Center Radiation Safety Program office at (212)
305-0303 for additional information.
Please check one of the following boxes:
□
□
New Application
Amendment
If this Application is submitted as an Amendment to a previously approved Application, it
must be submitted with a cover letter indicating what information in this Application has been
changed and the rationale for each change.
I. STUDY
Study Title [Please use same study title used on the related IRB protocol]:
_________________________________________________________________________________
_________________________________________________________________________________
IRB Protocol Number [Please attach copy of the related IRB protocol or IRB protocol modification
(if applicable)]: _______________________
Brief Description of Intent of Study:
Justification of the Use of Radiation and Description of Proposed Use:
II. PERSONNEL
PRINCIPAL INVESTIGATOR
Name: ____________________________________________ CU Title:__________________
First
MI
Last
Office Address: ________________________________________________________________
Department or Service
Tel No.(__)_____________________
Building
Room No.
Cell No. (__)______________________
E-mail Address _______________________
Provide C.V.
CLINICAL AUTHORIZED USER [A physician authorized by the JRSC to administer radioactive
materials to humans, if the Principal Investigator is not a Clinical Authorized User and the study
involves the administration of radioactive materials]
Name: ____________________________________________ CU Title:__________________
First
MI
Last
Office Address: ________________________________________________________________
Department or Service
Tel No.(__)______________________
Building
Room No.
Cell No. (___) ____________________________
E-mail Address ________________________
PHYSICIAN LIAISON [A licensed physician, if the Principal Investigator is not a physician and
the study involves the use of only radiographic procedures]
Name: ____________________________________________ CU Title:__________________
First
MI
Last
Office Address: ________________________________________________________________
Department or Service
Tel No.(__)_____________________
Building
Room No.
Cell No. (__)______________________
E-mail Address _______________________
2
Provide C.V.
CO-INVESTIGATORS [list all]
Name: ______________________________________ CU Title:_________________________
Name: ______________________________________ CU Title: ________________________
Provide C.V. for each Co-Investigator
III.
STUDIES USING RADIOPHARMACEUTICALS FOR RESEARCH
[IF YOUR STUDY DOES NOT USE RADIOPHARMACEUTICALS, SKIP TO SECTION
IV. COMPLETE THIS SECTION ONLY IF YOUR STUDY USES
RADIOPHARMACEUTICALS FOR RESEARCH. DO NOT INCLUDE PROCEDURES
ORDERED AS ROUTINE STANDARD OF CARE. HOWEVER, STANDARD OF CARE
PROCEDURES THAT WOULD NOT HAVE BEEN ORDERED EXCEPT AS A
REQUIREMENT OF THE RESEARCH PROTOCOL SHOULD BE INCLUDED.]
A. RADIOPHARMACEUTICALS TO BE USED IN THIS STUDY
If any subject is to receive radiopharmaceuticals in your study, complete the following information
for each radiopharmaceutical to be used:
Radiopharmaceutical
Chemical Form
Minimum Pharmacological
Dose (µg)
Supplier
Location where radiopharmaceutical will be administered: ______________________________
What supporting documentation are you using to provide information on the preparation and
evaluation of each radiopharmaceutical?
□
□
□
Drug master file
IND
Manufacturer insert
Please attach such documentation to this Application.
B. RADIATION DOSE TO SUBJECTS FROM RESEARCH STUDY PROCEDURES
Complete the following table for each radiopharmaceutical identified in the table in Section A
above, assuming that each dose will be received by a representative subject in your study. List
3
sources from the published literature or other valid studies to support the dosimetry. Add a table for
each additional radiopharmaceutical.
Radiopharmaceutical
Name:
Organ/Tissue
Absorbed Dose
per
Administration
(mGy)
Total No. of
Administrations
per Study
Total Dose for
Study (mGy)
Effective Dose Per
Study (mSv)
Critical
Organs/Tissues1
Active Blood-forming
Organs (red marrow)
Lens of the Eye
Gonads
Whole Body
1 List
three organs or tissues receiving the highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1):
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
IV.
STUDIES USING RADIOGRAPHIC OR THERAPEUTIC RADIATION FOR
RESEARCH
[THIS SECTION SHOULD BE COMPLETED FOR ALL STUDIES USING DIAGNOSTIC
OR THERAPEUTIC RADIATION FOR RESEARCH. DO NOT INCLUDE STUDIES
ORDERED AS ROUTINE STANDARD OF CARE. HOWEVER, STANDARD OF CARE
PROCEDURES THAT WOULD NOT HAVE BEEN ORDERED EXCEPT AS A
REQUIREMENT OF THE RESEARCH PROTOCOL SHOULD BE INCLUDED.]
RADIATION DOSES FROM RESEARCH STUDY PROCEDURES
If any subject is to receive ionizing radiation (other than from radiopharmaceuticals) from any
procedure in this study, including those procedures that constitute standard clinical practice and are
specifically required by the research protocol, complete the following table for each procedure and
list sources from the published literature or other valid studies to support the dosimetry.
What procedures will the subject undergo as part of this study?
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□
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□
X-ray, including mammograms, DEXA scans and dental scans
CT Scan
Radiotherapy, including brachytherapy
Fluoroscopy, including cardiac catheterization
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X-rays, CT Scans, Radiotherapy
If any procedure involves the use of x-rays, CT scans or radiotherapy for research, complete the
following table for each procedure, assuming that each dose will be received by a representative
subject in your study. If your study involves more than one procedure, complete an additional table
for each.
Procedure
Name:
Organ /Tissue
Absorbed Dose
per Procedure
(mGy)
No. of
Exposures
per Study
Total
Absorbed
Dose per
Study (mGy)
Effective Dose
per Study (mSv)
Critical Organs/Tissue1:
Active Blood-Forming
Organs (red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1):
___________________________________________________________________________
___________________________________________________________________________
___________________________________________________________________________
Fluoroscopy
If any procedure involves the use of fluoroscopy for research, complete the following table,
assuming that each dose will be received by a representative subject in your study.
Procedure
Name:
Organ /Tissue
Maximum
Dose per
Procedure
(mGy)
Number of
Procedures
per Study
Critical Organs/Tissues1
Skin
Active Blood-Forming
Organs (red marrow)
Lens of the Eye
Gonads
Whole Body
5
Total
Maximum
Dose for Study
(mGy)
Total Maximum
Effective Dose for
Study (mSv)
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
Indicate the specific reference for each dose (e.g., ICRP Publication 80 Table 3.2.1): _________
_____________________________________________________________________________
_____________________________________________________________________________
V.
SUMMARY DOSIMETRY TABLES
Please provide the total radiation dose for this study (i.e, the sum of doses from all procedures listed
in Sections III(B) and IV above), assuming that each dose will be received by a representative
subject in your study.
Organ /Tissue
Total Dose for Study
(mGy)
Total Effective Dose for Study
(mSv)
Critical Organs/Tissues1
Active Blood-Forming Organs
(red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry data is available.
If the sum of doses from the research study procedures and from clinical standard of care used in
conjunction with such procedures could result in injury to the subject, describe here:
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
If any subject has received or will receive radiation doses, within 12 months of the subject’s
participation in this study, from additional studies that you have conducted or intend to conduct or of
which you have knowledge, complete the following table with respect to all radiation doses
administered within such 12-month period, assuming that each dose will be received by a
representative subject in your study. Replicate this table for each study.
Study Name
Organ /Tissue
Total Dose for
Study (mGy)
Critical Organs/Tissues1
6
Total Effective Dose for
Study (mSv)
Active Blood-Forming Organs
(red marrow)
Lens of the Eye
Gonads
Whole Body
1
List three organs or tissues receiving the highest doses for which dosimetry
data is available.
If the sum of doses from the research study procedures and from clinical standard of care used in
conjunction with such procedures could result in injury to the subject, describe here:
____________________________________________________________________________
____________________________________________________________________________
____________________________________________________________________________
VI. SUBJECT INFORMATION
A. ADULT SUBJECTS
How many adult subjects do you propose using in this study? _____________
Age range of subjects: From ______________ to _______________
How do you propose to establish and document the non-pregnant status of subjects of child-bearing
potential? ____________________________________________________________
___________________________________________________________________________
B. MINOR SUBJECTS
[Minor subjects are those under the age of 18.]
How many minor subjects do you propose using in this study?
Age range of subjects: From __________________ to _________________
Please provide the justification for using minor subjects in this study. _____________________
_____________________________________________________________________________
_____________________________________________________________________________
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VIII.
SIGNATURES
Each of the Principal Investigator and, if applicable, the Clinical Authorized User or Physician
Liaison certifies that the information provided in this Application is complete and correct and
agrees that he/she will:
A. Comply with all applicable federal, state and local laws and Columbia University policies
regarding the safe use of radiopharmaceuticals and the protection of human subjects in
research.
B. Perform the study in accordance with the Application and the related IRB Protocol.
C. Implement no changes in this Application or the IRB Protocol without prior IRB and
JRSC approval.
D. Promptly report any adverse effects from the use of the radiopharmaceuticals in the study
to the JRSC.
Principal Investigator:
_____________________________
Print Name
____________________________
Signature
__________
Date
____________________________
Signature
__________
Date
____________________________
Signature
__________
Date
Clinical Authorized User:
_____________________________
Print Name
Physician Liaison:
_____________________________
Print Name
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