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We bolievo that the use of 13C lr bol lag of Common mot8bolic coatmoo motabolic compounds much as glucose, gr l rc tore 8odlum acetate enriched in ro li r bly known raouats of hrve beon produced. As a coosequunce, tho Los Ahnos Scientific kb Or8tOry ir nov r88dy for and doslros t o do 8 ovolopnontal study for tr8c.r lo bio lol y and medlclno. or utillzrtloa of an orgrnlc coapound lrbolod w i t h 13C u ter lr ~ mcontaining 1% in OXCOS ~ over natural r bund ~ nco.. corpoumds dot ect rb lo by ..tho& 8uch u mass rpo c tr ocr try or such8r ugootlc tomom81)C. ud which mry iafluonco tho in brsrtb of humrns following ingestloo of(u
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of conccra (humor) be used kcr ru o tho required dat8 connot oxcoss 13C. Fol lai ag iagortioa of that utOri81, broath sampler 2-1 c and acetat.-lr2-&) a t approxiutoly so ata percoat 13c will be studied i o duplicate rl th six hu u a vol unt w n. volunteers for tho lnltl8l studios rill bo USL wployoos 811 kn0~lOdge8ble i o the details of the study 8nd the anmo ch8racter'- of cwpliaoce with P.H.S. policy, a copy of our implooonting guidolines and 8 copy of the coaso ~ tfora roquired by the University of Tbs review cornrafttee met la of flcl rl rerrfoa oa October 18, 1971. Z t concluded tbat tho propomod rtudi88 involvo very litt lo rimk t o humans, ifray at 811, and th8t tho 8tudios areos8eat i alto the for your fnfo~mrtior~.Uo would rpproclatr any r u ~ # or tl on ro r critic ha you u y have.
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The La8 Ala808 Scientific Irb or8tory of the University of Acomic Energy Commission will comply with the principles of the Public Health Service policy with reg8rdto research involving human subJects which requires8 review in dopa dent of the investigator or director to safeguard the rights 8nd wolf arc of those subjects. to the i ~ lti8tlo aof this research, in order to in sure adequ8te 8af8guafds. Group rev ims mad decision. will be c8r ried out in (2) tho approprlreoae~r at thor dl to dr uwod t o obtain in for nod consent, nod (3) the risk. aDd potential benefit. of the propomd It 8s sure s the Divirrion of Biology 8nd Nediclno information and 8dviCe between the review group 8nd the investigator or director,pr rti cula rly to de81 vitb proposed changes i n rese8rcb design, and with emergent problems which may alter the investigation rc it ur tio a with regard to the criterir cited rbove. The institution mill assure itself that its policies and the8dViCO of its review groups are f oll wed. It will also provide whatever professional welfare of huun8ub ~ oct sinvolved :a res el r ch. Records of group t0vi.v rod docision on the w e of human rub j ect s rad of iaforaed consent rill be derr ~ ope dand kept by the hst it uti on.
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'I. ID biological research it eventually becomes dcsirrble that :- the results of laboratory exparimentation be applied to human rad the relief of human ills. A basic distinction must M dr8ra Y between tt8OrrCh projects Whom rim Is essentially therapeutic, and clinical research whose object is purely scientific 8nd without potential value tothe research subject. clinical resoarch projects who is not legally competent rodin 8uch mental 8nd physical state 8s t o be able to exercise fully hi8 power of c bo ice to p8rticiprtc in the research pro j oct. Conmittee is unable to anticipate the necessity of the use of minor chrldron or rdultm who for on. ronion or 8nOthor are unable t o provldo Lnroraod ao mont for tho proceduror t o be carrlmd out. secured prior t o the actual investigative activities. project at ray time, without stated cause. In th leU b oratory, no buman subject will be used in Written con re at for the rese8rch procedures rill alray ~be I The subject is free to withdraw from participation in the The investigator must terminate the experiment if find lng s iodicrte the pro b8bil it y of injury to the research subjects. Reserrch projects involving human subjects will rl wry s be t o rerults not rvrilrblr by othor aeinr. They rill be bared up00 baled g8 of re rul t8 of raiaal ox peri ment at ioa rad scientific evaluation of the problem under study SO that the anticipated mult s justify the performance of the experiment. It i. mot antic ipa tod that infliction 02 pain and suffering, Or the production of demonstrable Injury or disability in the tmearch subject crn ever be condonod. Ib.ertch involving human mubjectrr can be carried out only
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Leader of Industrial Hygiene Group, LASL USL, aad formerly Staff Physic ira, USFM 8od Alt or a atc Health Divisioa bidet, US, TIT. Re vier Procedures Rese8rch rill be given institutional review and approval prlOr t o tbt submission of research proposals. If necess8ry, subsequent reviews will be cr r ried out by tbe Committee if this is rat rr at ad by dehys in instituting research, or if a rapidly changing SCi mt if lC area requires raaoserrmeat of risks. pla a to assess all possible hazards, and t o see thata11rp prop ria to arrogurrdr am provided. It re co unites that in any nod ical ohor ~ ~ nuio rt hat c rl # Irl hrbre, uvrn from rupp o a od ty rout i n * procedures, the physicians of the XD dust ria1 Uedlclae Group of LASL ort be facilities of the Los Alamos Medical Center are close The Committee rill require written informed consent from the research subject himself, We can not con rider circumstances which would require use of arc rc rr ch 8UbjeCt who is a minor, or rho for other physical or legal re8soa is i a capable of giving informed CoDlient. The Committee will review the rdoquacp of tho consoat io light of the tl Bk S to the subject aod the circumstances of research, 8ad as to whether the information gl ve o the subject is 8 fait state mat of the procedure, its por rl ble benefits, rnd Its relative weights of ?Inks .ad b ne fits of the procedures tothe subjects, and the motlv8tion of the subjects in rubrnittiag t o them. it u y still prescribe conditions or ra strict i oar on the conduct of Caultteo i s 8ubl)ect to furt bor approprimto reviww or ro j ect ioa by tho Coraltt.0 88 lu rth orl afon u tio a 18 dovolopad. hb oratory approptiate T8Vi.r or TUJeCtlOQ in cplte of fu v orr ble rct loa br The Review Committee rill independently examiae t h e rero8rch Although tho Committee m y give 8favorable over811 recoaseeadrti
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WISENT TO ACT AS SUBJECT YoR x a ~ aof penoa(s) rho will porfora procodure(s) or in ve at lg8 thr rtudy will hy tn with tho nral tnrortlnn o f a,hR o f andlum acetato dissolved in 200cc of 8neutral mpueoua aolution. Of tha 3. tho ingestion broath marplcs will be obtained a t varying interval8 up mctcr s8mpLe bulb inside his mouth and or haling while tho stopcock i ojwn. Thore will a ko bo base line sample8 talrea before the study - be collected by uaing atrndrrd techniquoa. It l a oxpected the atudy I rill terminate after oight hours '.'
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.elected by him t o perform the following procedure(s) or investigation(s) a t tollowing an ovem/ight fast, the p ii ent will by mouth SO t o 100 g of glucose dissolved i n about 10 percent aqueous solution and containing 2 t o S percent carbon-13 at a11 carbons of t h e glucose. Breath samples of a few secunds each w i l l be collected by simple exhalation intoa rube a t zero time (before ingestion) and every half-hour afterwards for the subsequent 3 hours. Blood samples of 2to 10 m l each will be taken at the same times and, when directed by the physician, at4 and 5 hours after ingestion. The reasons for the investigation and further details of the procedure(s), 8s I understand that the procadure(s) and investigation(s) described according t o paragraphs 1 and 2 involve the following possible risks and discomforts: A few patients and several animals have been given-. ing about 1 percent of a l l carbon. carbon conpounds enriched by a few percent i n carbon-13 without any evident ill effects.Slight (less than 5 percenr) differences i n biochemical reaction rates of most molecules containing carbon-13, compared with t h e more comrnon carbon-12, have been found experimentally and should have no significant physiological effect under the conditions of the present study. The discomforts should be those usually expected from an oral glucose tolerance test requiring multiple collections of venous 4. 1 understand that I may terminate my participation in the study a t any time.
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CONSENT TO ACT AS SUEJECT FOR CLINICAL INVESTIGATION selected by hint t o perform the following procedure(s) or investigation(s) a t Following an overnight fast, the patient will take by mouth 50 t o 100 g of glucose dir ro lv td in about 10 percent aqueous solution and containing 2to5 percent carbon-13 8t a l l carbons of the glucose. Breath samples of a few seconds each w i l l be collected by staple exhalaticn i n t o a tube a t zero time (before ingestion) and every half-hour 8f teru ard s for the subsequent 3 hours, Blood samples of 2to 10 ml each will be taken the same times and, when directed by the physician, at4 and 5 hours after ingestion. The teasons for the investigation and further details of the procedure(s), a s I understand that the procedure (8) and investigation(s) described according t o pan graphs1 and 2 involve the following possible risks and discomforts: ing abcut 1 percent of a l l carbon. carbon calcpoonds enriched by a few percent i n carbon-U without any evident ill effects. S l i g h t (less than 5 percent) differences in biochemical reaction rates of most molecules containLng carbon-13, compared with t h e more common carbon-12, have been found experimentally and should have no significant physiological effect under the conditions of the present rtudy: The discomforts should be those usually expected from an oral glucose tolerance test requiring multiple collections of venous A few patients and several rnik ls have been given 4. I understand thatI may terminate my participation in the study at any time.