Minutes of Meeting of the Human Use Review Committee and References

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The rubjoct of a ruit8ble nrmc lor tho committee was first disctr8red. Tent;r=!vsly it was 8gtacd to use the name givan above--Human Use Revlaw Corntxittm. A draft of a letter from Mr. Hcyman tc Dr. Tottor of DDM an& a proporad consent farm w e r e reviewed since Dr. Voelt h8d 8uggerted dealing directly with DBM on the Carbon 13 rtudy. i s also attached to the letter. It WYAS noted that a brief statement of qualification will be roquircd from each committee w.cmbct iot ft.clurion In Ih4 Ic;:~:. ItWAS reportcd that the Laooratc~:y Director has requastod that a iasu1:y .r.anbcr from the tiriioersity of Sew Mexico XIedicaI School be added to the coifimittcc. Tho lottor outlinrr thr Carbca 13 study. A o:s:cner.t w i l l be zacdcd in tho in3ri:ution.l guideliner wiil revise and corn;>icte the dratt k t t c r to Dr. Totter *ad will asrcmble Harry F. Scbulto, Secretary

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The Lor, Alaros Sclootific Laborritor California oy s rating uodet Rim Corrfrac human subjects which roquiras a review in&p.ndeat of the investigator or director t o 88feguard the right8 rod welfare of those subjects. of the USAEC that it rill e8tabllsb and I8iDtah rdvirory groups to the initiation of this research, in order t o iasura adequate reference t o (1). the rights and r clf are of the individuals involved, (2) the appropriateness of the methods u8.d too b tr in informed consent, nad (3) the risks and potential benefits of the proposed I t rssures the Division of Biology and Slediciom The institution agrees toa continuing exchange of information and advice between the review group rnd the ln vest l gator or director, particularly to deal with proposed cbrnges i n rcncorch design, and with emergent problems which may alter the investiKotiOn81 situation with regard tothe criterlr cited8bOVO. The iast ltu tio o will assure itself that its policies and the rdvlce of its review groups arc fol law ed.It rill 8180 provide wb8tever prof e as ional attention or facilities are required to safeguard theria bts and welfare of huam subJocts Lnvolvod i n remarch. Recordm of group review and dec iri on on tbe us0 of human 8U bJ OCt8 and of inforaed consent will bo dev01op.d and kept by the institution. 8-n Studtoo Rmiw Committoo

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LOS ALXMOS SCIE ~ IFIC UNIVERSITY OF CALIF GUIDLLISES FOR RESEARCH 1.WOLV between tererrch projrctr rhwo 81. lr Ommoatlr11y tborrputicr and tBe relief of huuu ills. without pot err ti al value to the research rub j act. I n this Labor8tory, no human subject will bo used i n cl in l cal resotrch pro j oct s rho is not 1Ot8lly cornpotent and in his power of choico t o p8rtjclpmte in the research project. Committee is ua8ble to anticipate the n8cessity of the use of minor children or rdult8rho for one rorso ~or r not hsr are unablo t o provide Informed coasont €or the procoduros t o be carried out. Written consent for the rare arch procrdures rill rlways b. The subject is frre to withdraw from part ici patton in the project a t any time, without stated cause. The investigator must terminate the experiment i f findings indicate the probrbility of injury t o the rt3St8rCh subjects. Roserrch projects involving human subJect r will always be non - trivial,in some wry re lov rn t to hua anita rir n an&, and lr r ding to results not mv ril able by othor me8ns. knowledge of results of animal ex peri a oat at loa rod sciontif i c ev8lu rti on of tho problem uador study so that tho antic ip at rd results justify the porformrrnce of the mxporireat. I t is oat s at ici pr todt hrt iaf llc tl on of pain end suffer lag, or the product ioa of demonstr8bk injury or disability in the Committee coruirts of tho following: by rcio nt if lc8ll y qur li fia d persons and undor competent madlcrl " i(

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larder of Indu8tri81 Hygiene Group, LASL I I I. Roview ~ roc odu res revlows rill be c8rrlod out by thr Committoo if this is rrrr81btod by SZEZ :e=&!! PCR reassessment o f risks. s a fog ur rds are provided. emergencies that might mrlse, eval from supp mod lp routine procedures, the phy8icirns of the Industrial Wodiclno Group of LASL or tho fr c ili tier of the Los Alrmos 3kdIc81 Center are close by and immediately av atl able. The Committee will require written informed consent from the research subject himself. We caa not consid or circumstances which would require use of a research sub j oct who t u & minor, or who for consent. The Committee rill review the 8doqurcy of the con rr nt in light cbf the risk8 to the sub f oct rad tho circumrtrncas of research, and as t o whether the information given the sub j oct 1s afair statement of the procedure, lts pOS8ible benofito, and its The Review Committee rill lndepeadeatly oxrmine t h e re8oarah rel8ti ve weights of rlrkm 8nd be a of it r of tho procodurms totho subjects, and the a ot iv8tloa of the rubj8ct8 1%s ub mit ting to tmp. Committoo i8 subject t o further appropriate nrtaw or rejrctioo bl

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sub j oct ' 8 aamo : Drto: 8Dd / Or such asmimtrntr, as ary be selected by him t o perform the fol lori acetate d is so lv odin 200cc of a neutral aqueous solution. the ingestion brorfh samples will be obtainad r t varying inter v rh Up to eight hours b y holding tho neck of a n evrcuatmd 5Occ 118~ss pec tro - mofer srmple bulb inaide hi8 mouth rad oxhaling while the stopcock i8 open. There rill also be base llno samples trken before tbe study be collected by u8ing standard techniquem. rill terminate r ft or eight hours The study will begin with the or81 ingestion of 2.50 of sodium During tho in vo stig rtl on8ever rl blood and urine specimons may 8kl It is oxpectod the study Although c8rboa-13 18 8 8t8blo rod arturrlly occur ria g iaotopo fort is unknown. umually oxpoctod from tbm pro v lowly dor cr lk d procoduro rod blood Theroforo DO mpocific parniblo ri8k8 ceo bo predict ad Thm dlacomfort, mxcludlo# direct drug toxiaitiw, r hould bo' flaw.