Re: Ethics and Safety - Pediatric Studies

[a.zapantis@qut.edu.au (Alex Zapantis)]

>I am being asked to evaluate the radiation safety aspects of a research
>proposal, in which children (post-surgical) up to 10 years of age will be
>given two doses of Technetium 99m sestamibi (9.25 MBq/kg, and then
>27.7  MBq/kg).
>
>Australia's advisory body, the National Health and Medical Research
>Council, does not set specific limits for paediatric exposures in research.
>

G'day Mark

The NH&MRC does recommend maximum doses to children in research. Look at
"Administration of Radiation to Human Subjects in Medical Research (1984)",
one of the NH&MRC Radiation Health Series.

With respect to children, it first specifies that children should be
excluded from research except where "problems specific to those groups are
being investigated........the information can not be obtained by other
means, and the risks are minimal." 

With respect to doses "In the case of irradiation of children or other
persons incapable of giving informed consent, approval of the regulatory
authority must be obtained where estimates of effective dose equivalent
exceed 0.5 millisievert. For babies,infants or fetuses, approval of the
regulatory authority must be obtained where estimates of effective dose
equivalent exceed 0.1 millisievert."

Of course all other requirements (eg ethics committee, minimisation of
individuakl and collective dose) are also stipulated.

The document is only a couple of pages long. Would you like me to fax it to
you Mark??

Regards


                I know that you believe you understand what you think I said 
                but I am not sure that what you heard is actually what I meant.

                        Alex Zapantis
                        Radiation Safety Officer                               
                        Queensland University of Technology          
                        Health & Safety Section                             
                        Locked Bag No.2
                        Red Hill Qld 4059
                        AUSTRALIA

                        Ph     : 61 7 864 3566
                        fax     : 61 7 864 3993
                        email  : a.zapantis@qut.edu.au