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From: Paul Meyer Subject: Human subject experiments i n c using air tagged with 13N and peration with the U.S. Navy The Human Subjects Cormittee, in its Decenber 15, 1981 meeting, apprbved, i n principle, the use of human subjects i n the-continuation of this U.S. Navy funded research. satisfy the corn it tee ' s request for radiation dose calculations, I am stating dose estimates below which are based on Hazards Control's Health Approval is sought for use of 1313 and 41Ar. To The following breathing gas mixtures w i l l be used: Using the previously measured specific activities for 13N and 41Ar, the expected dose fora 120-minute exposure for modes a). and b) above are: A revised version o f the operational safety procedure No. 194, Supplement 27, dated August 1980, is being circulated to the reviewers. The experiments a r e scheduled to start on April 26, 1982. your written approval before that date. I would appreciate L a LAWRENCE UVERMORE MBORATO
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TO: Paul Meyer Kathy Shingleton, Health Physics Group eHazards Control Oepartment Dose Due to Inhalation of l3N, l5O, a n d 41Ar Inhalation o f 13N, 150, and 4lAr by humans will result in the doses listed in the tables below. gas is 1 mCi/liter, and the radioactive gas will be evenly dispersed in the It is assumed that the specific activity of each A closed-circuit rebreathinq system will be utilized. All doses are 13N - 1 min. 30 min. 120 min. Please note that the maximum permissible lung dose ,s se. at 5 redquarter, not to exceed 15 rem/year. If I can be of further assistance to you, please call me on Ext. 2-5172.
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HUMAN SUBJECT EXPERIMENTS WITH The purpose of this study is t o measure the rate of nitrogen and Argon uptake and elimination i n the body o f normal healthy humans. . The experiments will involve breathing of I3N and 41Ar labelled air for no more than 120 minutes. . Any required change i n operations that a it ers the scope o r significantly decreases'safety control will not be made until a revision o r supplement to this procedure has been signed by the person authorized t o approve this OSP. Any required change i n operations that does not decrease the safety control may be made with the joint concurrence o f the LINAC Operations Manager and the Hazards Control Safety Team Leader. 1. This procedure authorizes the exposure of human subjects t o the a ) Breathing ofair tagged with 13N and 41Ar for up t o 120
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I Oper at ion a 1 Sa f e ty Estimates of the radiation dose from 13N a n d 41Ar activities i n the breathing mixture are based on calculations by Hazards Control I s Health Physics Group (see letter from K. Shingleton of April 12, 1982). The dose per mCi per liter for 13N is c 1000 mr and for 41Ar: 6400 mr. To obtain extimates o f the expected dose we take the gas mixes and decay activities into account as seen below: The breathing gas concentrations will be: Half lives (TlI2)for the isotopes are 13N: 10 min. and 41AR: 109 min. Time elapsed from beam shut-off to administration will be min. for 120 minute exposure. With this in mind we obtain the estimates at t=20 To generate the '3N isotope, high-purity r$ is irradiated with ionizing environment, NO2 and N20 forms. The concentration is controlled by minimizing the presence of O2 in the nitrogen. Some trace o f O2 always i s present and in this The Operational Controls in paragraph F will reduce the above hazards t o an acceptable level.
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operational Safety c.Procedure No. 194.29 Paul Meyer i s responsible for assuring that all work i s Derformed i n conformance w i t h this OSP and the LLNL Health 81 Safety Manual. h i s absence, the experiment will be terminated and a resp'onsible person will be trained f o r the experiment. AI1 participating employees are responsible for performing their work according tothe regulations of this OSP, They are expected t o take all reasonable precautions t o protect themselves and their fellow employees and t o perform only those tasks that they believe can b e accomplished safely. When participants have any doubt regarding the safety of any phase o f their work, they are expected t o cbeck with t h e project supervisor before proceeding. The Hazards Control Safety Team assists management t o institute and t o maintain a low-risk work environment. Control may request that management o r employees stop an operation when there appears t o be an imminent danger t o personnel o r property ( s e e Health & Safety Manual Section 1.06). 1. The target gases are: a) AR: Zero grade b ) N2: High purity nitrogen (silver colored bottles with pink
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2. Waste gas disposal is achieved with large volumn blower which pumps . gas from the site of the experiment to the outside of Bldg. 194 at . the roof level. - All humzn subjects shall receive a whole body radiation Scan by Hazards Control before and after inhalation of radioactive gases. The radioactive gases shall be filtered with a HEPA filter before inhalation by the subjects. A visual inspection of the filter cartridge gaskets and canister will b e made prior to filter from Hazards Control Respirator Service will be installed in the Only an approved and tested filter cartridge obtained Radioactive gas preparation: The evacuated target gas bottle, located in the 0' cave, is filled from a standard gas cylinder containing either high-purity nitrogen (N2) or Zero grade Ar. by L I NAC bremss trah 1 ung . Upon filling, the gas is being irradiated In the case of I$as target gas, any undesired by-products come from small oxygen concentrations in the gas bottle. This can lead, in principle, to NO2 and N20. Tests performed previously by Hazards Control personnel, found concentrations of less than 1 p p m o f NOq and less than 22 ppm of ~~0 in an irradiated sample. The breathing mixture will be tested for NO2 and ozone before it is
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Procedure No. 194.29 -5- r issued : 4/20/82 c ) Bleed radioactive gas as described below, into plastic bag. in plastic bag. f ) Navy personnel will continuously monitor and hold O2 The prepared and tested gas mixture is taken from Trailer 930 tothe subject i n Bldg. 194 in a plastic bag which i s then connected tothe breathing valve. The subject then breathes for 120 minutes from the bag. The exhaled gas i s passed through a soda lime trap to remove all Cop before returning to the bag. A concentration o f -20% O2 i s maintained inthe bag and monitored witha bio-marine oxygen deficiency meter or equivalent during use by Navy personnel. Atthe end ofthe 120 minute period the bag i s disconnected and the subject breathes room air with the washout being vented t g ' the outside o f iir e Safety Group (3)
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' In our opinion the pro ocol and safeguards described on the attached applfcatic are adequate to meet the standards of U.S. Navy i n regard t o experiments utilizing people; namely that the rights and welfare'of individuals will be' respected, that the individuals or those responsible for their care have given their informed consc and that potential benefits.outweIgh any risk involved. Revlew and approval by t h t ' PERIODIC REVIEW SUGGESTED: ANNUALLY:
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TITLE OF ESEARCH PROJECT: Tracer Gas Kinetic Studies for Decompression11. Table Design. 111. LOCATIOK 'EX STUDY WILL BE TEXFORYED. Laurence Livermore Laboratory, IV. A. The Livermore Committee will review the application before the ex per bents are begun. That committee has approved the FY81 proposal for human experiments. . V. APPROXPATE DATES OF ESELRCH: FROM: 7/81 TO: 9 / 8 2 VI. DESCRIPTION OF RESEARCH: * The project involves breathing a mixture of 20% oxygen and 80% Nitrogen fora period of up t o 120 minutes. Thg gas will also contain up t o 0.5 of radioactive gas breathing and for the up t o 60 minutes follow the subjects will be sitting in front of a radiation detection device by bombardmant of pure nitrogen with gamma rays and other tagged gases are either prepared on-site o r purchased. The radioactive nitrogen is prepared o n - site _ ... .:N ornal male volunteers from NHRI will be used. Up to toten subjects will _ - be studied, sme subjects a ay be studied twice. used and no pain wille qe rien ced. felt from the require nen c of breathing through a mouthpiece and remaining a single x-ray exposure for anatomic reference to the gas study. ,No medications will be Only very minor discomfort will be Some of the subjects will also be asked t o have - VXX. a. What arc the risks t5at nay or may not b e encountered by subjects ? The oaly risks inherent in the procedure are those arising from the s gcc i al gas breathed. Chemical risks arise from the possibility of creating noxious gases in the radioactive nitrogen preparation. Thtsr could itnclude ozone and nitrogen dioxide. The major risk is radiological, that is, the unavoidable exposure of subjects to ionizing radi a zion. The total dose of radiation from the studies is estimated tonsr exceed 0.5rad to the lungs and 0.01 rad tothe body (2). Thb Zsse can b e conpared tothe 0.18 rad l year of natural background eosxe of the total population; 0.026 rad for a single chest x-ray; 5.0 rad/year, the current federal satu tory limit for occupational exposure; and 4000 rad s in clinical radiation therapy (1).
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The procedur ---to be used will attecpt toy + zi ize the chance ofany ;h-fcalJr .sks and to prevent any radia. ,n exposure above the Tunt s:ated above.. The. radioactive nitrogen will be prepared using t - hi ques developed by P. Meyer. Only very pure nitrogen vill be exposed t o the- ga=a-ray source (LINAC'electron beam with heavy metal i;S+O+h:ely annlyzsed for ozone, nitrogen dioxide and N-13 activity - Only *en these analyses are corcpleted u ill the nitrogea-oxygea vented outside the laj building t o prevent any other exposure; Subject doses vill ba calculated by standard net hods (2) sinc'e the mjor - qo sur c is too localized and trans i eat to be directly measuredProcdurcs vill follow those established Last year. eqerc ' ents the measured ozone aad nitrogen dioxide were vel1 below specification in every case. shovad no detectable rd b tion dose occurred (less than 0.01 rad). Final internal do she try calculations showed luna doses i n the subjects of 0.30 to 0.45 rad, conpared tothe chosen limits of 0.50 Uhat be refit VUs d e = ctor the subject potentially realize ? Zter activation,samples of the gas will betaken and Expired gases will be directly External Oosimetry of test subjects No dfr z ct benefits vfll be realized by the subjects. bene fi z s nay be rcalkrd by U.S. Navy divers,a group that is ex?ecft', to pro viz r t5e 3a j or it y of subjects- The project is design & to provfde 2ata on the rate of nitrogen uptake and eli niz at fon in the''=-- body. Decompression sickness among divers of de coq res s ian S;rkcss is approached by adherence to decompress ion tables. rht are calcrr'lited t o match the rate of nitrogen removal with the razz of di7zr raturs t o normal pressure. .The study proposed will and azz ur-7ll accr_j'A rationally in the field - of experimental ZZor=& ksmt is attached as well as reference (2) and k.,-r~r.r-:7~=====-hSorzrory Memo t o Paul Meyer from C.B. Ozaki,
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r .- TO PARTICIPATE VOL LN TAY I LY PROJECT TITLE: .Tracer gas Kinetic Studies for Decompression I do hereby give my consent t o serve as a test subject in a ' joint Naval . The stud yMedical Research Institute - Lawrence Livermore Laboratory study. will involve ny tvice breathing a mixture of oxygen and radioactive nitrogen, argon, and / or kr pt on while sitting in front of a radiation detection device. I understand thac the study is designed t o measure how fast inert gas enters and leave sports of the human body. safer diver &conpression schedules. I also understand that this study will provide no direct benefit tome. This information is needed t o develop I have been informed that this study is voluntary and thatI may withdraw from it a t any time. investigators will answer any o thar questions I may have. My questions have been answered and I know that the I have been informed that the only discomfort thatI should expect will follow from up to2 hours of breathing through a mourhpiece and of remaining very still. I understand that there is a small risk of breathing a chemically harmful gas scch a s ozone or nitrogen dioxide.Ialso understand that I will receive a radiation dose from the study. I have been informed that this dose is within the ranges used i n medical procedures and less than the dose currently allowed by law for people who work with radioactive materials.I have been told that there is still a very mall risk of disease such a s cancer or leukemia from this amount of radiation. I have been told that the study will adhere to the intent of the Privacy (TYPED NAME, RANK, RATE OR GRADE) (TYPED NME, RANX, RATE OR GWE)
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TITLE OF RESEARCH p8OJECT : Tracer gas kinetic studies for decompression table design In our opinion t h s protocol 2nd safeguards described on the attached application are adequate t o meet the standards o f U.S. Navy i n regard t o experiments utilizing . people; namely that th2 rights and welfare o f individuals will be respected, t h a t the individuals o r those responsible for their care have g i v e n their informed consent and t h a t potcntizl benefits out:.reigh any risk involved. Review and approval by the Con it tee for th2 h2r2by requested. Ir j VEST I aT OR : PROGRAN CENTER DIRECTOZ: Harkk. BXUILEY, CUT, HC THE COl\li.lITTEE FOR THE PROTECT I8I OF HU WH SUBJECT OF THE A60VE NAYED PROTOCOL AS A RESULT OF ARE VIEU Oi\l PERIODIC REVIEW SUGGESTED: ANNUALLY: SEHI-amuAw: QUARTERLY:
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Proposal for Continuation of Joint Naval MedicallLawrence Livermore Experiment Decompression sickness, an occupational hazard of U. S. Navy deep sea divers,is thought to result from an excessive accumulation of inert gas (normally nitrogen)in the diver ' s body. Empirical procedures have evolved for the diver to slowly return to normal pressure after breathing gases a t many atmospheres ambient pressure. Some of these decompression procedures appear t o be unsafe; others seem t o be so …
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