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DEPARTMENT OF RADIOLOGY of Diupostic Radiology (E-ct.61 o 1 ) of Nuclear Medicitie (Ext. 6173) Section of Therapeutic Radiology (EY~.6001) Rudiation Protectiotr Service (E-ct.503 1) Research orid Developretit Shop (Ert. 61 19) Chicago Tumor Institrite Director,Division of Biology and Medicine A t the 1 3 5 t h meeting of t h e Advisory Committee for Biology dyou concerning the investigation involving testicular radiation -o f volunteer subjects. cs - beli w the protocol for the Helsinki Convention and Htetrtza need for new knowledge in this area of such-4 a 7: the ACBM re cio vc a staff briefing at the136th meeting concerning L k pLloc-( .?L%P-' "-3r elating to in vestige t ions involving human subjects are not being adhered to&ZZ2?-2SE?J2~ /#owever, w e bel levo thatl part icu ln rly Biology and Gcdicine
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TH h UNIVERSITY OF CHICAGO DEPARTMENT OF RADIOLOGY action 4 Diagnostic Radiology (Ert. 61 o 1 ) Section of Medicul Physics (Eut. 60 1 4 ) Section of Nirclear Mediciiie ( a t . 6173) Scction of h dio logic uf Sciences (fit. 6101) Seaion of Therupelitic Radiology (Ert. 600 1 ) Research orid Developlent Shop ( f i t . 61 19) Chicago Tumor ltlrtitlrre Director, Division of Biology and Medicine Atthe135th meeting of the Advisory Committee for Biology and Medicine Commissioner Johnson asked us t o comment directly to you concerning the investigation involving testicular rad in tion of volunteer subjects. On the basis of information rec&ed at this meeting the ACBM believes. that the protocol for these experiments is i n accord with the Helsinki Convention and other recommendations concerning investigations involving human subjects. However, two questions remain: 1) Since viable spermatozoa may remain inthe seminal veNsiclos for weeks following vasectomy, is a sperm count showing no spermatozoa after vaso#my obtained before release ? 2) What previously unsubstantiated hypothesis forms the basis and justification for this experiment? That is, is the ren need for new knowledge in this area which is of such significance that investigations involving human volunteers are clearly indicated ? Since w e do not feel that we have sufficient information at this time in relation to these two points,were quest that I/ the ACBM rec 4ve a staff briefing at the136th meeting concerning this investigation in particular reference to these points. We would then be in8position to make a recommendation in relation to this project. We would like to reiterate that we see nothing at this point to indicate that the provisions of various recommendations relating to investigations involving human subjects are not being adhered to; sE:;=:Z!:?:Z3?2j& however, we believe thatl particularly with prisoner volunteers, there is. a burden- o f proof concerning the significance of the the sisto be tested, Very truly yours, Biology and hrcdicinc