[ RadSafe ] Some queries on research projects involvingradiation exposure to children and on radiotherapy

[parthasarathy k s]

Dear list members,


I shall greatly appreciate receiving responses to the following questions: (As our list has members from many countries, I expect to get answers from as many as possible)


1.   A.    1. what is the procedure to start a project
involving radiation exposures of children? 

       2. What is the institutional and
professional arrangement to ensure that the project is justified, ethical and
adequately designed? 

       3. How do the project proponents secure informed consent?
Have they to get it recorded in each case?
2.       

     B. Radiation dose delivery to patients in
radiotherapy involves many steps. Each patient will have a case sheet stating
the protocol for dose delivery. Records are maintained at each hospital. 
a)      Who audits the process? 
b)      How frequent is the audit?
c)       What is the role of the regulator? State(?) Federal (?)

d)      Who are all strictly responsible in case of a
misadministration?

I shall greatly appreciate receiving your response at the
earliest. PDFs of appropriate documentation or links to them will be of great help

Regards

K.S.Parthasarathy