Human Investigations Involving Radiology Exposure (HIRE) Committee

Use of ionizing radiation in human research in any manner that does not directly benefit the patient/subject (i.e. beyond standard of care) must be approved by the Radiation Safety Committee (RSC), specifically the Human Investigations Involving Radiation Exposure (HIRE) subcommittee.

The main roles of the HIRE committee are:

Ensure the safe, effective use and proper design of research studies that involve the use of ionizing radiation
Provide estimates of radiation dose to subjects in those trials that convey the risk of participating in the trial or study, through proper consent language

The HIRE Committee

The HIRE committee is made up of medical physicists, health physicists, and practicing physicians. The current committee members are:

Allen Goode, MS, DABR (Chief Diagnostic Medical Physicist, HIRE Chairman)
Brigitte Kelly, RN (HIRE Research Coordinator)
Patricia Collins, PhD, DABR (Diagnostic Medical Physicist)
Andrew Polemi, PhD (Diagnostic Medical Physicist)
Michael Welling, MS (Radiation Safety Officer)
J. Fritz Angle, MD (Radiologist)
Klaus Hagspiel, MD (Radiologist)
Christopher M. McLaughlin, MD (Radiation Oncologist)

Does my study need HIRE Committee review?

No Radiation

If your study does not involve exposure to radiation (e.g. CT scans, X-rays, administration of radiopharmaceuticals) beyond standard of care, you do not need to include a radiation risk statement in the consent form. Standard of care means that the patient would receive the scan, X-ray, etc. even if they did not participate in the study.

Single X-Ray

If your study involves a single X-ray procedure that is listed below under “Uses of Ionizing Radiation That Do Not Need to Be Reviewed by the HIRE Committee“, you may insert the appropriate language provided. If you use the exact wording as listed, the protocol and consent form will not need to be reviewed by the HIRE committee. You must, however, send an email to Allen Goode arg2n@hscmail.mcc.virginia.edu. Please state in the email that your study does not require review and reference the consent language used.

Radiation Exposure for Research Purposes

If your study involves exposure to radiation for research purposes (other than those listed below), you will need to fill out one (or both depending on the study) of the following forms:

MRI Scan

There is no radiation exposure to a patient who receives an MRI scan, however, standard language is provided below for use in the consent form:

“MRI scanning is a painless procedure that only requires that you lie quietly on a padded table that gently glides you into a large magnet. While the scanner is performing your scan, you will hear some humming and thumping sounds. These are normal and should not worry you. Because of the magnetic field and radio frequencies, people with a heart pacemaker, brain, aneurysm clips, and some implanted metallic or electrical devices should NOT have an MRI. It is important that you inform the technologist if you have any of these metallic appliances. Please inform the technologist if you are pregnant or think that you may be pregnant. You also may need to have dye placed in your vein, and the technologist performing your scan will discuss this with you at the time of your scan.”

Uses of Ionizing Radiation That Do Not Need to Be Reviewed by the HIRE Committee

The following consent language may be used for ADULT protocols that involve a single X- ray procedure. These are procedures where the exposure to ionizing radiation results in a total effective dose to the study participant that is less than or equal to 300 mrem (millirem). (Note: mrem is a unit of measurement of dose; it describes how much energy is absorbed by the body from radiation). Please note that protocols that involve pediatric subjects may not use the below language and must submit to the HIRE Committee.

Abdomen CT (Single)

“This study involves radiation exposure from a single computed tomography (CT) scan of your abdomen. Although each organ will receive a different dose, the total effective radiation dose you will receive from this exam is approximately 8 mSv. For comparison this dose is roughly 16 % of the annual radiation dose safely allowed for a radiation worker such as the person performing your CT. The radiation dose described is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The precise risk from this dose is not known but is thought to be small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired. If you are pregnant you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Abdomen/Pelvis CT (Single)

“This study involves radiation exposure from a single computed tomography (CT) scan of your abdomen and lower torso. Although each organ will receive a different dose, the total effective radiation dose you will receive from this exam is approximately 12 mSv. For comparison this dose is roughly 24 % of the annual radiation dose safely allowed for a radiation worker such as the person performing your CT. The radiation dose described is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The precise risk from this dose is not known but is thought to be small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired. If you are pregnant you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Abdominal X-Ray (1 film)

“This study involves radiation exposure from a single abdominal x-ray. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 150 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Barium Swallow (24 images)

“This study involves radiation exposure from x-rays of your stomach. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 240 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Chest/Abdomen/Pelvis CT (single)

“This study involves radiation exposure from a single computed tomography (CT) scan of your torso. Although each organ will receive a different dose, the total effective radiation dose you will receive from this exam is approximately 16 mSv. For comparison this dose is roughly 32% of the annual radiation dose safely allowed for a radiation worker such as the person performing your CT. The radiation dose described is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The precise risk from this dose is not known but is thought to be small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired. If you are pregnant you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Chest CT (single)

“This study involves radiation exposure from a single computed tomography (CT) scan of your chest. Although each organ will receive a different dose, the total effective radiation dose you will receive from this exam is approximately 7 mSv. For comparison this dose is roughly 14 % of the annual radiation dose safely allowed for a radiation worker such as the person performing your CT. The radiation dose described is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The precise risk from this dose is not known but is thought to be small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired. If you are pregnant you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Chest X-Ray (PA)

“This study involves radiation exposure from a single chest x-ray. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 3 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Chest X-Ray (PA + lat)

“This study involves radiation exposure from chest x-rays. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 10 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

DEXA (Bone Mineral Densities)

“This study involves radiation exposure from a single DEXA (insert type of scan as shown below). As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about (use list below) of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Fontaine Imaging Center Hologic QDR Series Machines

For any one of the following scans – PA Lumbar Spine, Lateral Lumbar Spine, Hip, Whole Body or Forearm – use “less than 1 day”
For a pQCT – use “less than 1 day”

Note: If the machine or type of scan is not listed above, please contact Radiation Safety (2-4917) for further information.

Extremity (Hand/Foot) X-Ray

“This study involves radiation exposure from a single extremity (hand, foot, etc.) x-ray. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 1 day’s worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Head CT Scan

“This study involves radiation exposure from a single CT scan (x-ray) of your head. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 240 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Hip X-Ray

“This study involves radiation exposure from a single x-ray of your hip. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 100 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Knee X-Ray

“This study involves radiation exposure from a single x-ray of your knee. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 100 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Mammography (Standard 4 Views)

“This study involves radiation exposure from an x-ray of you breasts. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 40 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Pelvis CT (Single)

“This study involves radiation exposure from a single computed tomography (CT) scan of your lower torso. Although each organ will receive a different dose, the total effective radiation dose you will receive from this exam is approximately 5 mSv. For comparison this dose is roughly 10 % of the annual radiation dose safely allowed for a radiation worker such as the person performing your CT. The radiation dose described is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The precise risk from this dose is not known but is thought to be small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired. If you are pregnant you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Sinus Radiographs (3 View Plane Films)

“This study involves radiation exposure from 3 x-rays of your sinus. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 70 days’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”

Note: If a single sinus radiograph is required, then the radiation dose and calculated percentage of the yearly background dose may be reduced by a third and the consent risk statement adjusted accordingly.

MUGA Scan (Single):

“For this study you may receive a MUGA heart scan to image your heart chambers. This study requires the use of radioactive drugs to be injected into your body and then imaged with special cameras. While the nuclear medicine drugs are intended for your heart, other organs will receive some radiation dose. Although each organ will receive a different dose, the total effective radiation dose you will receive from just one of these scans is approximately 6.6 mSv. For comparison, this dose is 13% of the annual radiation dose safely allowed for a radiation worker such as the person performing your scans. This radiation exposure is not necessary for your medical care, nor does it include the dose from any of the other imaging studies that you have had or may receive, but is necessary to obtain the research information desired. If you are pregnant or breastfeeding you may not participate in this research study. It is best to avoid radiation exposure to unborn children since they are more sensitive to radiation than adults.”

Orbit Screening for MRI

“This study may involve radiation exposure from an x-ray of your head to ensure that there is no metal in your eyes prior to your MRI exam. As part of everyday living, everyone is exposed to a small amount of background radiation. Background radiation comes from space and naturally-occurring radioactive minerals. The radiation dose you will receive in this study will give your body the equivalent of about 2 weeks’ worth of this natural radiation. This radiation dose is what you will receive from this study only and does not include any exposure you may have received or will receive from other tests. The risk from this dose is considered small. This radiation exposure is not necessary for your medical care but is necessary to obtain the research information desired.”