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cipate i n a study of angiography. YOU have que, the contrast agent is If you decide t o participate, w e - will perform an angiographic procedure (mronary, cerebral, uther,) by meafls of a venous in j don of contrast agent, employing x-rays produced a t the Stanford Synchrotron Radiation Laboratory.- You will be given injectians into a vein of a radiographic contrast agent, as eployed i n routine clinical practice. The injection may be given directly into a vein in the arm or m y be given into a vein in-the chest. I n the latter instance a flexible, hollaw tube, called a catheter, will be inserted into a vein in an extremity or the neck, and the catheter is then advanced into the chest so that its t i p is in a central vein adjacent t o the intake chamber ( r i g h t atrium) of the heart. The contrast agent will then be administered using aper injector, ata rate up t o 20 ml/sec and a t a dose of up t o 0.75 ml/kg of body weight per injection. Follwingthe injection, sd ng digital radiographs will be
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reaction to the iodine . . . may cause locai discanfort. ~ m o n gthe CaTlpliCations of the procedure are . There are risks related t o radiation exposure inherent in any x-ray examination, including'delayed wncer and genetic change. The exposure frankhis Ation bill carry with it a risk equivalant to that fran approximately 4 months of natural background radiation. exarriiridtion, approximately eight t o ten radiographs (x-ray p-ictures) will be remrded, and the x-ray exposure of each is similar t o the exposure It would be impractical and even misleadirig t o describe in detail a l l of the possible risks and CCm pli CationS which might result fran the proceteam who will be per fo hg the study. cedure as is planned f o r your individual case. Any questions should be discussed w i t h a member of the angiography .. This person will review the proPotential benefits that m y be accrued t o YOU relate to information aut
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Your decision whether or not to participate W i l l not prejudice you or your medical care. If you decide t o participate, you are free to .withdraw your consent and t o discontinue your participation a t any time yitt - nut prejudice t o you or effect on your medical care.. If you have any questions, we expect you to ask us. If you have any additional questions later, we w i l l be pleased to txy to answer than. I n the event of physical injury that arises solely out of the negligene -of,:theemployees of Stanford UI LiVerS it Y or Of the Stanford University Medical Center or its staff i n t&s study, reimbursanent for expensese.. ... incurred for necessary rredical trea.tment and hospitalization is J-kdical Center Mttee for the Protection of H m Subjects a t 851 Welch Road, Roam 115, Pal0 Alto, California, 94304. For further infO ~ tiOn, Please call 497-5244 or write the In addition, if you
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. . and any drug or device to be utilized; be given a description of any explanation of any-benefits to the subject reasonably to be expected, if applicable; be given a disclosure of ani appropriate alternatives, drugs, or devices that might be advantageous t o the subject, their relative r i s k s and benefits; be informed of the avenues of medical treatrent, if any, available t o the subject ~ t e rthe experiment i f axnplications &odd arise; be given an opportunity t o ask any questions concerning the experiment o r the procedures involved; be instructed that Consent t o pdrticipate in the medical experiment may be withdrawn a t &y time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the opportunity to decide t6 consent or not t o consent t o a medical experiment without the htemention of any element of force, fraud, deceit, duress, coercion &r undue influence on the subject's decision. YOUR SIGNAW INDICATES THAT YOU HAVE READ AND UNDERSAND THE ABOVE INFokFlATICN, THAT YOU HAVE DISCUSSED THIS S"DY WITH THE PRINCIPAL INVESTIWTcR(S) AND/OR HIS OR HER STAFF, AND THAT YOU HAVE DECIDED-TO
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