‫ الســـــــالمة و معالجة المخاطر‬،‫الصـــــحة البـيــئــية‬
ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT
RESEARCH APPLICATION FORM TO USE
X-RAYS ON HUMAN RESEARCH SUBJECTS
NOTES
-
-
This form must be completed and submitted, along with any supporting documents, to the
Institutional Review Board for any study that involves the exposure of human research subjects
to X-Ray Radiation.
If assistance is needed in completing this form, contact the Health Physics Services Division of
EHSRM at 2360.
PART 1 (APPLICANT INFORMATION)
Principal Investigator:
Faculty Position:
Department/Division:
Title:
Phone/Pager:
Email:
URSC Licensed Radiation Authorized User:
Co/Investigator(s):
Project Title:
Expected Start Date:
Expected Project Duration:
PART 2 (EXPOSURE’S PURPOSE)
Only Diagnostic Radiation will be given to subjects.
The radiation given in this study is:
[ ] Yes
[ ] No
[ ] Only related to this study
[ ] Part of the subjects’ routine medical care
An official, signed statement confirming this information shall be provided by the Principal
Investigator, and attached to this form.
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‫ الســـــــالمة و معالجة المخاطر‬،‫الصـــــحة البـيــئــية‬
ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT
PART 3 (X-RAY RADIATION USE)
Describe each type of X-Ray 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 effective dose equivalent or effective dose in mrem, refer to Appendix A for typical
doses. Use additional sheets as needed.
If the radiological procedure included in your research is not listed in Appendix A, the doses used in
the table below shall be supported by documents from reliable sources.
Radiation Procedure
# of times or films
Effective Dose Equivalent
or Dose Equivalent
Per Procedure
Location where the radiological Procedures will take place:
If outside AUB, describe reason:
PART 4 (STUDY POPULATION)
Are Minors included? [ ] YES
[ ] NO
If yes, explain the need to include minors:
Are women of child bearing potential included?
[ ] Yes
[ ] No
If yes, explain how non-pregnancy is assured:
If yes, the Consent Forms must contain the following statements:
“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.”
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‫ الســـــــالمة و معالجة المخاطر‬،‫الصـــــحة البـيــئــية‬
ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT
‫ سيتم اجراء فحوص الحمل‬،‫ اذا كانت هناك امكانية للحمل خالل الدراسة‬.‫"ال يمكنك المشاركة في هذه الدراسة إذا كنت حامال‬
‫ يجب عليك اخبارنا عن امكانية حدوث الحمل في االيام االربعة عشر السابقة لفحص الحمل نظرا الن‬.‫قبل تعرضك الي اشعة‬
".‫نتيجة الفحص في هذه الفترة هي غير دقيقة‬
PART 5 (RADIATION RISK STATEMENT)
A radiation risk statement must be included in the Consent Form. The statement shall be approved
by the University Radiation Safety Officer and shall correlate the total radiation received by the
subject to the average annual dose that a person receives annually due to environmental radiation (~
300 mrem).
The statements shall also include the following sentences:
“Although there are no proven harmful effects from radiation levels the patient will be exposed to
during this study, long term effects on his/her health cannot be ruled out with certainty.”
‫" بالرغم من عدم وجود دالئل على تأثيرات صحية سلبية للجرعة االشعاعية التي ستتعرضين لها خالل الدراسة فان‬
".‫التأثيرات الصحية على المدى البعيد ال يمكن الغاؤها يشكل مؤكد‬
PART 6 (SIGNATURES)
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: ____________________________ Date: _________________
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‫ الســـــــالمة و معالجة المخاطر‬،‫الصـــــحة البـيــئــية‬
ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT
Radiation Safety Approval
APPLICANT INFORMATION
Principal Investigator:
Faculty Position:
Department/Division:
Title:
Phone/Pager:
Email:
URSC Licensed Radiation Authorized User:
Co/Investigator(s):
Project Title:
Expected Start Date:
Expected Project Duration:
FOR UNIVERSITY RADIATION SAFETY COMMITTEE USE
The approval of the radiological procedures described in this form will be considered preliminary if
issued by the University Radiation Safety Officer, and full if issued by the University Radiation
Safety Officer and the chairman of the University Radiation Safety Committee.
The University Radiation Safety Officer has reviewed this application.
Comments: ________________________________________________________________________
__________________________________________________________________________________
Signature: __________________________________________________ Date: _________________
The University Radiation Safety Committee has reviewed this application.
Comments: ________________________________________________________________________
_________________________________________________________________________________
Chairman of the University Radiation Safety Committee: _____________ Date: _________________
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‫ الســـــــالمة و معالجة المخاطر‬،‫الصـــــحة البـيــئــية‬
ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT
Appendix A
Typical Doses associated with Radiological Procedures
Use the table below to provide the effective dose equivalent for each procedure listed in Part
3.
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 Environmental Health, Safety & Risk Management department if you need
assistance, ext. 2360/78.
Reference: The British Journal of Radiology, May 1997
Procedure
Effective Dose Equivalent
mSv (mrem)
Single Radiographs
Skull AP or PA
0.03 (3)
Skull LAT
0.01 (1)
Chest PA
0.02 (2)
Chest LAT
0.04 (4)
Thoracic Spine AP
0.4 (40)
Thoracic Spine LAT
0.3 (30)
Lumbar Spine AP
0.7 (70)
Thoracic Spine LAT
0.3 (30)
Thoracic Spine LSJ
0.3 (30)
Abdomen AP
0.7 (70)
Pelvis AP
0.7 (70)
Dental Panoramic
0.011 (1.1)
Cephalometric
0.017 (1.7)
DEXA
0.01 (1)
Complete Examinations
IVU (6 films)
2.5 (250)
Barium Swallow (24 spot images, 106 s
1.5 (150)
fluoro)
Barium Meal (11 spot images, 121 s fluoro)
3 (300)
Barium Follow (4 spot images, 78 s fluoro)
3 (300)
Barium Enema (10 spot images, 137 s fluoro)
7 (700)
CT Head
2 (200)
CT Chest
8 (800)
CT Abdomen
10 (1000)
CT Pelvis
10
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