Approved Radiation Risk Statements for Human Subjects Studies
Note: Please use the document titled “Estimated Effective Doses from Medical Procedures” on the EHS
Website (under “Forms”) to help determine the total amount of radiation the participant may receive.
Single Chest X-Ray:
You will be exposed to radiation in this study from a single chest x-ray. This radiation exposure is not
needed for your medical care. You are exposed to radiation every day. This radiation comes from the sun
and the earth. It is called background radiation. The amount of radiation you receive in this study is
about the same amount that you receive in less than two weeks from background radiation. The risk from
this radiation exposure is very low.
Radiation Exposure levels < 500 mrem:
You will be exposed to radiation in this study from [specify the procedures]. This radiation exposure is not
needed for your medical care. You are exposed to radiation every day. This radiation comes from the sun and the
earth. It is called background radiation. The amount of radiation you receive from this study is about the same that
you receive in [# months/years] from background radiation. The risk from this radiation exposure is very low.
Radiation exposure levels >500 mrem but < 5000 mrem:
You will be exposed to radiation in this study from [specify the procedures]. This radiation exposure is not
needed for your medical care. You are exposed to radiation every day. This radiation comes from the sun and the
earth. It is called background radiation. The amount of radiation you receive in this study is about the same
amount that you receive in [ # months/years] from background radiation. The risk from this radiation exposure is
low. Grade 8.2
Radiation exposure levels >5000 mrem [healthy volunteers excluded]:
You will be exposed to radiation in this study from [specify the procedures]. This radiation exposure is not
needed for your medical care. You are exposed to radiation every day. This radiation comes from the sun and the
earth. It is called background radiation. The amount of radiation you receive in this study is about the same
amount that you receive in [ # years] from background radiation. The long-term effect of concern from exposure to
radiation is an increase in the risk of getting cancer in your lifetime. By participating in this study, you will have a
moderate risk of developing cancer from this radiation exposure.
References:
Health Risks from Exposure to Low Levels of Ionizing Radiation: “Biological Effects of Ionizing Radiation (BEIR) VII,
Phase 2. National Academy of Sciences, 2006.
Health Physics Society.
“Radiation Aspects Of Informed Consent Statements For Clinical Research Projects In Which Radiation Exposure Is For
Research Purpose And Not For The Medical Benefit Of The Subject (Patients And Normals)”, University of Maryland,
http://www.ehs.umaryland.edu/rad/pdf/Required%20Consent%20Form.pdf, Accessed 3/3/2008
Guidelines for Radiation Statements, Johns Hopkins Medicine,
RSF-035 Human Use of Radiation Guidance, University of Texas Southwestern:
http://www.utsouthwestern.edu/vgn/images/portal/cit_56417/0/11/332383RSF-035__pdf.pdf, Accessed 3/3/2008