RESEARCH APPLICATION FORM
TO USE X-RAY RADIATION WITH HUMAN SUBJECTS
This form may be used only for Diagnostic X-ray of human subjects. Submit the completed form, with any supportive documents, to
the Institutional Review Board. A copy must be sent to the Health Physics Services (HPS). For more information, or if you need
assistance in completing the form, kindly contact HPS at ext. 2360/3
1. APPLICANT INFORMATION
Principal Investigator:
Department/Division:
Phone/Pager:
URSC Licensed Radiation User:
Co-investigator/s:
Project Title:
Expected Start Date:
Faculty Position:
e-mail:
Expected Project Duration:
2. DOSE RECEIVED & BRIEF DESCRIPTION OF RADIATION USE
Describe each type of radiation procedure (e.g. AP chest x-ray, DEXA scan, etc.) and the number of each type of procedure or film that
the human subject(s) will undergo. If various subject groups receive different exposures, provide detailed information for each group.
For each procedure, provide the entrance skin dose and the effective dose equivalent or effective dose in mrem, see attached sheet. Use
additional sheets as needed.
Radiation Procedure
# of times or films
Skin Entrance Dose
Per Procedure
Effective Dose Equivalent
or Dose Equivalent
Per Procedure
3. LOCATION(S) WHERE RADIOGRAPHIC PROCEDURES WILL BE PERFORMED
_______________________________________________________________________________________________
4. TYPE OF X-RAY PRODUCING DEVICE (Check all that applies)
[ ] Radiographic
[ ] Dental
[ ] Bone Densitometer
[ ] Fluoroscopic
[ ] CT
[ ] Other (Specify):____________________________________
5. ARE WOMEN OF CHILD-BEARING POTENTIAL INCLUDED?
[ ] Yes
[ ] No
If yes, explain how non-pregnancy is assured and the Consent Form must contain the following statement: “You may not participate in
this study if you are pregnant. If you are capable of becoming pregnant, a pregnancy test will be performed before you are exposed to
any radiation. You must tell us if you may have become pregnant within the previous 14 days because the pregnancy test is unreliable
during that time.”
______________________________________________________________________________________________
6. ARE HUMAN SUBJECTS BELOW THE AGE OF 18 INCLUDED?
[ ] Yes
[ ] No
If yes, explain the need to include subjects below the age of 18.
______________________________________________________________________________________________
7. RADIATION RISK STATEMENT
A radiation risk statement must be included in the Consent Form. The statement should correlate the total radiation received by the
subject to the average annual dose that a person receives annually due to environmental radiation (~ 300 mrem) and it must contain the
following statement; “Although there are no proven harmful effects from the radiation levels that you will be exposed to during this
research, long term effects on your health cannot be ruled out with certainty.”
I, the Principal Investigator, understand that I am responsible for this project and I agree to abide by the University Radiation
Safety Regulations as stipulated by the Radiation Protection Handbook.
Signature of Principal Investigator: ______________________________
Date: _________________
I, the Department Chair, have reviewed the feasibility and scientific merit of this proposal.
Signature of Department Chair: ________________________ _______ ___
June 2003
Date: _________________
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RESEARCH APPLICATION FORM
TO USE X-RAY RADIATION WITH HUMAN SUBJECTS
Give the skin entrance dose and the effective dose equivalent for each procedure listed in item 2. You may
use the below listed approximate values for common adult procedures or other values if obtained from a reliable
source, such as from publications (cite reference and provide copy of dosimetry information from the reference).
Contact the Health Physics Services if you need assistance, ext. 2360/3.
Chest (two films)
Hands or wrists (per film)
Arm or elbow (per film)
Foot or ankle (per film)
Tibia or knee (per film)
Dental periapical or bitewing (per film)
Skull (per film)
Cervical spine (per film)
DEXA bone density scan
June 2003
Effective Dose Equivalent
(mrem)
6
1
1
1
1
0.2
20
3
1
Entrance Skin Dose
(mrem)
100
70
160
300
20
200
350
100
6
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