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A - nur her and ages : Corm al,patient, either. Sixteen health subjects Per Year ; ages 20 t o 65. Criteria for selection and exclusion. Source of subjects(including patients),and how they will be approached. Healthy subjects with no history or X-ray of chronic or recent cardiopulmonary disease. Healthy subjects annOunCements posted on bulletin board satU.C., Sari Francisco and Lawrence Livermore Labs, Livermore, California. Minors and Pregnant be exD. Will subjects be paid or otherwise compensated ? If SO, what amount? and what is the reason for ,payment? Healthy subjects will be compensated $50 for the time and travel involved. E.Location vhere tro ce dure s will be carried out.Linear Accelerator Building, $ 194, Lawrence Livermore Laboratories, Livermore, California. .<. , ~ teg sto ln sure that part icj pati on by subjects will be kept confidential. Anonymity of documents and data. B . Provisions to in sure anonymity of documents and data. C. Frovision for controls over access to documents and data. h’hat publications might be helpful to the committee in consideration of this application ? (Answer only if these might expedite review.) Data will be identified by number and available to authorized personnel only. Data and documents will be stored in a locked file. XI.Outline of activity (circle OPTION you will use in responding) : FIRST OPTION: Provide answers in spaces following A-F below(add sheets, when needed). SECOND OPTIOA’: Provide answers in attached summary statement(reference,if over one page). A.Background or rationale foi this activity. To determine the respiratory effects of low levels of ozone in healthy adults a t rest and during exercise.2 See additional sheet. C.Fro ce dure s involved. Which of these will be performed only for the purposes of this activity,e.g., See additional sheet. D. Identify alternate procedures,ifany, not proposed for this activity that might be advantageous to the subject E.If any deception(withholding complete information) is required for the validity of this activity,explain why this is necessary and attach debriefing statement. F.Nature and amount of risk (include side effects), or substantial stress or discomfort See additional sheet. and persist,daily interview by phone will be made until all symptoms have abatedTo be as sua ed by University of Washington. 2 . Xrrange.-erts for fin an cia i responsibility for
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A doctor will bc prc s cnt throughout the expcrimcnt and wi.11question the subject at least once daily until all symptoms are,gone. The subjects retain the right to withdraw from the study at any point. will be paid $50 per two-hour exposure session. deriving from participation in the study. The rights to withdraw from the test a t any time and to withhold information from non-medical persons without additional consent are protected. The subject ' s welfare is protected by the presence of the physician before and during the test, and by the availability of emergency hospital treatment if the need arises. The subject ' s identity and all information about him or her are t o remain confidential. There are no personal benefits Signature of investigator Date I voluntarily consent to participate in this study.Ihave had an opportunity to ask Signature of s u bj ec t Date Copies : Subj ect
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A . Will another organization or agency be involved(Veterans Adminis t ration II ospital,Dc part m cnt of Social and Health Services, or others)? Nantc of othcr organization or agency : 1. Status of review by Radiation Safety Committee (RSC). ATTACH OXE COPY of approval.1 Ifyes,name,proposed dosage,status with Food and Drug Administration, and Ih'D number. EIJ CW SE ONE COPY of available toxicity data. Ifyes, names and dosages. 1. If nc,explain why a iiritten consent form will not be used. 2. I f no, is a statement attached describing what participants will be told ? - -- Participants must be informed of all elements of VII.G. below. tear off, d o not submit to Research Services). Name, psi tion,department, and telephone number of investigator ? Copy for subject ? Signature and date lines to be completed by subject(and legal guardian, The following elements of consent expressed inlay terms: if subject is amino ; or is legally incompetent),and investigator ? Purpose - - benefits to .$e expected or knowledge hoped to be gained ? Procedures to be followed, including identification of those which will be performed only for the purposes of this activity,and tim c Nature and amount of risk, or substantial stress or discomfort Appropriate a1ternate procedures that might be advantageous or avail - Costs the subject may in ned i atc ly or ultimately Le forced t o bear and what re im burs cm cnt of costs or othcr compensation the subject will rcccivc as thc result of p ~ rti c ip.lt ion in this activity ? Voluntary nature of pr tic ip ~ tio nand freedom to withdraw at any As suran cc that subject ' s identity will remain confidential ?