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Declassified record · U.S. Department of Energy

Protocol for Human Subject Research - re Interagency Agreement No. Y01-CB-40302, Exploration of the Use of a Proton Beam in Densitometry (Heavy-Ion Radiography)

Dated
Jun 30, 1978
Document type
Agenda
Length
8 pages
Open the original scanArchive record OSTI ID 904338 · public domain

Document text

Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.

Page 5

COllSEIlT TO ACT AS SUBJECT FOR XESEARCH AtlD It l VE STIG k TlC NS UflUER III TE RACE I ICY A CREE I IT YO1-CB-40302 Your physician suspects that you have a problem involving Tnam persort(s) who wi11 perform diagnostic procedures t investigations) - and/or associates who may be selected by him t o perform the followirtg studies using heavy-ion radiography a t the Berkeley BEVALAC. the medical wing o f the accelerator, tho procedure w i l l be as follows: Areas Qf rho body that are to be exposed toa stream of particles will be prdprrsd. This may involve local cleansing o f the skin; application of a neutral paste containing glycerol or a similar aycn,t t o raniove air bubble; smooching of hair ; and, i n some cases, shaving of a local area. One o r more packets containing gelatin or water may be attached extern ally to the outside contour or the body. during the process. In an alternative procedurc, the parr of the body t o bc studied may be irmcrsed in vat cr solution while thc picture is Position in sw ! l 1 be similar to routine X-ray diagnostic shots and will require hcl ding the appropriate position for a short per icd of tine, and waiting while thc pictures arc developed. The procedurc then may be rcpeatcd I'I*WJoiiothcr cxposure angle. The entire time, including waiting,xi11 be less than thrce hours. Onc to five pictures will be takcn using s': particles(actual exposure is only a fr act io ii of a sccond). 'i'lwre viiI1 be no special sensation o r discomfort ,frcm tlic particles w These ill remain attached Rcprescntstivc pictures t/i 1 1 be transnii t ted to t.a pati en r ' r . ;~hysiciaii.

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2. The procedures arid investigations iisted above havc been explained to me during the procedure, and I may ask further questions and clarification from him at any time (see further explanation on attrched page), 3. I understand that the procedures and investigations described sbove involve the following possible risks and discomforts: a. Tlic comblncd dose of irradiation from the particles that will be used will result in a radiation dose comparable to that received in X-ray diagnosis f o r my condftion. Together with the previous.X-rays I have received i t the hospital, total dose wlll be less than that received in X-ray diagnostic procedures and would be due to the necessity of renwining still for short perlods of time whlle in a somewhat restrained b. Any discomfort I may experience would ha similar to that in routine These studies wlll rcsult in information leading toa bettei understanding o f my disease and m y help In plannlng treatment. I understand that I may terminate my particlpation in the study at any time. Pat i en t s rfgnrture

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Many persons dcvclop tumors of the s o f t tissues o r bones of the A number of tests are available now, including X-ray radiography and xeroradiography. The X rays obtained w i t h these tcchnlques sonietlmes show the boundaries of soft - tissue tumars and a change in density whcre bone i s involved. However, i t would be desirable to refine these procedur3s to beccme m res cns it l ve and t o perform the procedures with less radiation Pati en is are asked to participate voluntarily In a medical research radiography i s performed using ncvr typos of rad fat ion, accelerated carbon beams and accelerated hnlium beams. beams resolve finer detail at less radiation dose than high rasoluti,un X-ray human pat imi t s . Preliminary work has shown that these ltowevcr, itis necessary t o study these procedures further in From prc vio us research work, we know that the radiation dose received Noduring thls procedure will be comparable to that with ordinary X-rays. subjective sensations o r demonstrable late effects wi11 be produced by th ls It Is sn tlc ipa ted that diacjcostfc procedures will be improved a5 are - sult of your co-operetion and that other individuals for whom this procedure

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BCRXUEY: DONNW LABORATORY AND WNNER PAVILION CONSENT TO ACT AS SUBJECT FOR RESEARCH AND INVESTIGATIONS Your physician suspects that you have a problem involving Patient ' s name Date lname person(s) who will perform diagnostic procedures S investigations) and/or associates who may be selected by him t o perform the following diagnostic studies using heavy-ion radiography atthe Berkeley BEVALAC. A t the medlcal wing of the accelerator,the procedure wlll be as follows : a. Areas ofthe body that are to be exposed to a diagnostic stream of particles will neutral paste containing glycerol or a similar agent t o remove air bubbles; . smoothfng of hal r ; and, i n some cases, shaving of a local area. One o r more packets containing gelatin or water may be attached externally to the outside contour o r the body. These will remain attached during the diagnostic process. In an alternative procedure, the part of the body t o be studied may be immersed i n water solution while the picture is being taken. This may Involve local cleans f ng of the skin; application of a b. Positioning will be similar to routine X-ray diagnostic shots and will require holding the appr opr fate position for a short period of time, and waiting while. the pictures are developed. exposure angle. The entire time, including waiting,will be less than three hours. (actual exposure is only a fraction of a second). The procedure then may be repeated from another diagnostic pictures w l ll be taken using * particles c. There will be no special sensation or discomfort from the particles or the .. d. Results will be transmitted to the patient ' s physiclair.