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Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
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You are invited t o participate i n a study of angiography. You have already undergone angiography by the conventional_ - methcd, involving - arterial catheterization and the direct injection of contrast agents i n t o the arteries. We hape t o develop a means of visualizing these arteries without the necessity of physically entering than w i t h needles and +!-I :I-- tubes. ~n&e presently proposed technique, the contrast agent is injected into veins, instead of arteries; a procedure that is believed to be substantially safer. If you decide t o participate, w e - will perfom an angiographic procedure (coronary, cerebral, other, 1 by means of a venous injection of contrast ca' agent, employhg x-rays prc dud at the Stanford Synchrotron Radiation Laboratory.- You will be given injections intoa vein of a radiographic contrast agent, as employed i n routine clinical practice. The injection may be given directly intoa vein i n the armor may be given intoa vein in the chest. I n the latter instance a flexible, hollw tube, called a catheter, will be inserted intoa vein i n an extremity or the neck, and the catheter is then advanced into the chest so that its tip is ina central vein adjacent t o the intake chamber (right atrium) of the heart. me 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. Follcwing the injection, sd ng digital radiographs will be
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taken of the arterial structures being studied. probabiy rkquire 1/2 to 1 1/2 hours. the following:" severe allergic (anaphylactoid) reaction t o the iodine The procedure will &e risk of this procedure include < contrast agent: mechanical tear of a vein; local bleeding; impaired kidney function; reaction t o local leakage of dye. The procedure may cause local dis&ort. b l d clots, irregularities of the heart beat, heart attack and death. Among the carrplications of the procedure are * The likelihood of the serious CarpIiCations is believed to be less than There are risks related to radiatian *sure inherent i n any x-ray &amhation,- including delayed cancer and genetic change. The exposure fran this examination will carry with it a risk equivalant to that fran approximately 4 months of natural background radiation. examination, approximately eight t o ten radiographs (x-ray p-ictures) will be recorded, and the x-ray exposure of each is similar to the exposure 'bvolved i n an ordinaxy x-ray picture of -the heart region. It would be impractical and even misleadirig to describe in detail all of ' the possible risks and ccmplications which might r e s u l t fran the proceteam who will be performing the study. cedure as is planned for your individual case. Any questions should be discussed w i t h a member of the angiography Potential benefits that may be accrued t o you relate to information about
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the status ofithe arteries to be studied. Such accurmilated' without the necessity of performing injections, We can not and do receive any benefits fran this information might be pranise that you will in scientifi c- - journals will not reveal the !I,information will be provided to federal and regulatory agencies as ' %ere will be no fee charged for the non-invasive angiogram. Your decision whether or not t o participate w i l l not prejudice you or your medical care. withdraw your consent and t o discontinue your participation a t any time I f you decide t o participate, you are free t o i"without prejudice t o you or effect on your medical care, ' If you have any questions, w e expect you to ask us. later, we w i l l be pleased to try to answer them. If you have any additional questions . - I n the went of physical injury that arises solely out of the negligencx? of the ~tmployeesof Stanford University or of the Stanford University Meal Center or its staff in this study, reimbursement for expenses incurred f o r necesSary medical treatment and hospitalization is . filedial Center CXmdttee f o r the Protection of Human Subjects a t 851 For further information, please call 497-5244 or write t h e Welch Road, Room 115, Palo Alto, California, 94304. I n addition, i f you
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-1._are not satisfied with the manner i n which this study is king conducted, y& IMy'report any cunplaints to-the same telephone ncrmber and address. &r&ns who participate ina medical experiment are entitled to Certah These rights include but are not limited t o t h e subject's right be informed of the nature and purpose of the experiment; be given an and any drug or device t o be utilized; be given a description of any attendant disccmforts and risks reasonably t o be expected; be given an explanation of any - he fits to the subject reasanably t o be expected, i f applicable; be given a disclosure of any appropriate alternatives, drugs, or devices that might be advantageous to the subject, their relative risks and benefits; be informed of the avenues of medical treatn-ent, if any, available to the subject zfter the experiment i f canplications should arise; be given an opportunity t o ask any questions concerning the experiment o r the procedures involved; be instruct& that consent t o pa-rticipate i n the medical experiment may be withdrawn a t a& time and the subject may discontinue participation without prejudice; be given a copy of the signed and dated consent form; and be given the cpp rt unity . to decide to consent or not t o consent t o a medical experbent without the iiiterVention of any element of force, fraud, deceit, duress, coercim or undue influence on the subject's decision. &TION, THAT YOU HAVE DISCUSSED THIS STUDY WITH THE PRINCIPAL
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'. PARTICIPATE BASED CRJ THE INFORMATION PROADED. A COPY OF 'J!HIS EWM IS. Signature of Investigator or Witness