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					October 8, 2010                                                                              Page 1 of 4
Suggested Radiation Risk Statement Language for Protocol and Informed Consent:

Principal Investigator: (Name of Investigator)
Department: (Name of Department)
IRB #: (IRB No.)
Title of Project: "Title of Project”


For insertion in Section 11, “Risks and Risk Management” of the SLU IRB
Protocol on page __ of the version presented for RSC Review:
(Note: the blue highlighted text shows protocol specific language that has been inserted.)

Radiation Exposure:

This research study involves exposure to radiation from CT scans of the chest, abdomen, and
pelvis and whole body PET-CT scans. PET-CT scans combine a low dose CT scan and a PET
scan together at the same time. The radioactivity from the PET-CT scans will disappear from the
patient’s body quickly. Half of the radioactivity will disappear within about two hours and this
rate of disappearance will continue. Although some of the radiation exposure is necessary the
patient’s medical care, much of it is not necessary their medical care and is for research purposes
only. Although each organ will receive a different dose, using the standard way of describing
radiation dose, from participating in this research study, the amount of radiation exposure the
patient will receive from each CT exam is about 1,300 mrems and from each PET-CT scan is
about 1,600 mrems. The estimated maximum amount of radiation exposure the patient will
receive from the research related procedures is equal to a uniform whole-body exposure of up to
about 16,800 mRem in the first year during the treatment and follow-up; 10,000 mrems during
the second year of follow-up; 1,300 mrems during the 3rd year of follow-up, and 1,300 mrems
during the 4th year of follow-up. These estimates of the amount of radiation that the patient will
receive during this study are summarized in the following table.

                                                 Research      Research Related        Estimated
          Procedure Timeline                      Related     PET-CT Scans (with       Effective
                                                 CT Scans      F-18 labeled FDG)       Radiation Dose
 Treatment and 1st Year of Follow-up                 8                 4                 16,800 mrems
 2nd year of Follow-up                               4                 3                 10,000 mrems
 3rd year of Follow-up                               1                 0                  1,300 mrems
 4th year of Follow-up                               1                 0                  1,300 mrems
 5th year of Follow-up                               0                 0                       0 mrems
 TOTAL over the 5 year period.                      14                 7                 29,400 mrems

For comparison, the average person in the United States receives a radiation exposure of 0.3 rem
(or 300 mrem) per year from natural background sources, such as from the sun, outer space, and
from radioactive materials that are found naturally in the earth’s air and soil. Individuals who use
radiation in their work (technicians, radiologists) may legally receive up to 5,000 mrem of
radiation dose per year. The total radiation dose received from the research related CT scans
PET-CT scans during the first year is about is about 3.2 times the maximal annual radiation dose
that may be legally received by a radiation worker in the USA. Over the five year period, the
total research related radiation dose is about 6 times the radiation worker dose limit.
October 8, 2010                                                                                    Page 2 of 4
Suggested Radiation Risk Statement Language for Protocol and Informed Consent:

Principal Investigator: (Name of Investigator)
Department: (Name of Department)
IRB #: (IRB No.)
Title of Project: "Title of Project”


Saint Louis University officials have reviewed the use of radiation in this research study and
have approved this use as involving minimal risk and necessary to obtain the research
information desired. One possible effect that could occur at these doses is a slight increase in the
risk of developing a secondary cancer later in life. If the patient would like more information
about radiation and examples of exposure levels from other sources, they should ask the
investigator.



References (provided for informational purposes; do not need to include in IRB protocol):

    1.   Estimated effective dose of 1,300 mrem for a chest/abdomen/pelvis CT (with or without contrast) CT, from
         Duke Radiation Safety Committee website:
         http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/adults/default.asp

    2.   Estimated effective dose of 1,600 mrems for PET-CT (with low dose CT) whole body scan with FDG
         based on discussion with Saint Louis University Nuclear Medicine Physician, Medhat Osman, M.D., and
         comparison to Duke Radiation Safety Committee website for these procedures. The effective dose is based
         on approximately 1,000 mrems (100 mrems per 1 mCi of FDG administered, average dose of 10 mCi), and
         approximately 600 mrem effective dose due to low dose CT on the Saint Louis University Hospital PET-
         CT scanner.
October 8, 2010                                                                              Page 3 of 4
Suggested Radiation Risk Statement Language for Protocol and Informed Consent:

Principal Investigator: (Name of Investigator)
Department: (Name of Department)
IRB #: (IRB No.)
Title of Project: "Title of Project”




For insertion in Section 4, “What are the Risks?” of the SLU IRB Research Study
Consent Form on page ___, following the paragraph with the heading “_______”:
(Note: the blue highlighted text shows protocol specific language that has been inserted.)

Radiation Exposure:

This research study involves exposure to radiation from CT scans of your chest, abdomen, and
pelvis and whole body PET-CT scans. PET-CT scans combine a low dose CT scan and a PET
scan together at the same time. The radioactivity from the PET-CT scans will disappear from
your body quickly. That is, half of the radioactivity will disappear within about two hours and
this rate of disappearance will continue. Although some of the radiation exposure is necessary
for your medical care, much of it is not necessary for your medical care and is for research
purposes only. Although each organ will receive a different dose, using the standard way of
describing radiation dose, from participating in this research study, the amount of radiation
exposure you will receive from each CT exam is about 1,300 mrems and from each PET-CT scan
is about 1,600 mrems. The estimated maximum amount of radiation exposure you will receive
from the research related procedures is equal to a uniform whole-body exposure of up to about
16,800 mRem in the first year during the treatment and follow-up; 10,000 mrems during the
second year of follow-up; 1,300 mrems during each 3rd year of follow-up, and 1,300 mrems
during the 4th year of follow-up. These estimates of the maximum amount of radiation that you
will receive during this study are summarized in the following table.

                                                 Research      Research Related        Estimated
          Procedure Timeline                      Related     PET-CT Scans (with       Effective
                                                 CT Scans      F-18 labeled FDG)       Radiation Dose
 Treatment and 1st Year of Follow-up                 8                 4                 16,800 mrems
 2nd year of Follow-up                               4                 3                 10,000 mrems
 3rd year of Follow-up                               1                 0                  1,300 mrems
 4th year of Follow-up                               1                 0                  1,300 mrems
 5th year of Follow-up                               0                 0                       0 mrems
 TOTAL over the 5 year period.                      14                 7                 29,400 mrems

For comparison, the average person in the United States receives a radiation exposure of 0.3 rem
(or 300 mrem) per year from natural background sources, such as from the sun, outer space, and
from radioactive materials that are found naturally in the earth’s air and soil. Individuals who use
radiation in their work (technicians, radiologists) may legally receive up to 5,000 mrem of
radiation dose per year. The total radiation dose received from the CT scans PET-CT scans
during the first year is about is about 3.2 times the maximal annual radiation dose that may be
legally received by a radiation worker in the USA. Over the five year period, the total research
related radiation dose is about 6 times the radiation worker dose limit.
October 8, 2010                                                                                    Page 4 of 4
Suggested Radiation Risk Statement Language for Protocol and Informed Consent:

Principal Investigator: (Name of Investigator)
Department: (Name of Department)
IRB #: (IRB No.)
Title of Project: "Title of Project”




Saint Louis University officials have reviewed the use of radiation in this research study and
have approved this use as involving minimal risk and necessary to obtain the research
information desired. One possible effect that could occur at these doses is a slight increase in the
risk of developing a secondary cancer later in life. If you would like more information about
radiation and examples of exposure levels from other sources, you should ask the investigator.




References (provided for informational purposes; do not need to include in IRB protocol):

    1.   Estimated effective dose of 1,300 mrem for a chest/abdomen/pelvis CT (with or without contrast) CT, from
         Duke Radiation Safety Committee website:
         http://www.safety.duke.edu/RadSafety/consents/irbcf_asp/adults/default.asp

    2.   Estimated effective dose of 1,600 mrems for PET-CT (with low dose CT) whole body scan with FDG
         based on discussion with Saint Louis University Nuclear Medicine Physician, Medhat Osman, M.D., and
         comparison to Duke Radiation Safety Committee website for these procedures. The effective dose is based
         on approximately 1,000 mrems (100 mrems per 1 mCi of FDG administered, average dose of 10 mCi), and
         approximately 600 mrem effective dose due to low dose CT on the Saint Louis University Hospital PET-
         CT scanner.

				
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