Application for the use of X
ﺍﻟﺴـــــــﻼﻣﺔ 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. 1 Revision 1 - 2010 ﺍﻟﺴـــــــﻼﻣﺔ 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.” 2 Revision 1 - 2010 ﺍﻟﺴـــــــﻼﻣﺔ ﻭ ﻣﻌﺎﻟﺠﺔ ﺍﻟﻤﺨﺎﻃﺮ،ﺍﻟﺼـــــﺤﺔ ﺍﻟﺒـﻴــﺌــﻴﺔ ENVIRONMENTAL HEALTH, SAFETY & RISK MANAGEMENT ﺳﻴﺘﻢ ﺍﺟﺮﺍء ﻓﺤﻮﺹ ﺍﻟﺤﻤﻞ، ﺍﺫﺍ ﻛﺎﻧﺖ ﻫﻨﺎﻙ ﺍﻣﻜﺎﻧﻴﺔ ﻟﻠﺤﻤﻞ ﺧﻼﻝ ﺍﻟﺪﺭﺍﺳﺔ. "ﻻ ﻳﻤﻜﻨﻚ ﺍﻟﻤﺸﺎﺭﻛﺔ ﻓﻲ ﻫﺬﻩ ﺍﻟﺪﺭﺍﺳﺔ ﺇﺫﺍ ﻛﻨﺖ ﺣﺎﻣﻼ ﻳﺠﺐ ﻋﻠﻴﻚ ﺍﺧﺒﺎﺭﻧﺎ ﻋﻦ ﺍﻣﻜﺎﻧﻴﺔ ﺣﺪﻭﺙ ﺍﻟﺤﻤﻞ ﻓﻲ ﺍﻻﻳﺎﻡ ﺍﻻﺭﺑﻌﺔ ﻋﺸﺮ ﺍﻟﺴﺎﺏﻗﺔ ﻟﻔﺤﺺ ﺍﻟﺤﻤﻞ ﻧﻈﺮﺍ ﻻﻥ. ﻗﺒﻞ ﺗﻌﺮﺿﻚ ﻻﻱ 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.” ﻳﻦ ﻟﻬﺎ ﺧﻼﻝ ﺍﻟﺪﺭﺍﺳﺔ ﻓﺎﻥ "ﺑﺎﻟﺮﻏﻢ ﻣﻦ ﻋﺪﻡ ﻭﺟﻮﺩ ﺩﻻﺋﻞ ﻋﻠﻰ ﺗﺄﺛﻴﺮﺍﺕ ﺻﺤﻴﺔ ﺳﻠﺒﻴﺔ ﻟﻠﺠﺮﻋﺔ ﺍﻻﺷﻌﺎﻋﻴﺔ ﺍﻟﺘﻲ ﺳﺘﺘﻌﺮﺽ ".ﺍﻟﺘﺄﺛﻴﺮﺍﺕ ﺍﻟﺼﺤﻴﺔ ﻋﻠﻰ ﺍﻟﻤﺪﻯ ﺍﻟﺒﻌﻴﺪ ﻻ 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: _________________ 3 Revision 1 - 2010 ﺍﻟﺴـــــــﻼﻣﺔ 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: _________________ 4 Revision 1 - 2010 ﺍﻟﺴـــــــﻼﻣﺔ 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 5 Revision 1 - 2010
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