Memo to W Gough, Subject: Planned Human Angiography Experiment

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TO : WILLIAM GOUGH SUBJECT: PLANNED HUMAN ANGIOGRAPHY EXPERIMENT This memo is to inform you of the planned second series of "Iodine Dichromography" experiments with human subjects to be carried out The experiments will be carried out by the same reseach team which performed the original experiments last year. The exposure control hardware and the medical and experimental protocols are unchanged. The medical protocols and informed consent material have been reviewed and re-approved by the Stanford University Human Subjects Committee. A copy of the approval is included herewith. The present plan is to use four subjects, one of whom participated in the first experiment, commencing Friday, April 24, and at the rate of one per day through Monday, April 2 7 . Since the original experiment, the safety interlock system has been further analysed by our engineering staff and design changes proposed which are intended to improve the reliability of the system. These designs have been subjected to critical review by interlock designers from both SLAC and LBL. Today, those reviewers met with SSRL engineering and safety personnel and a SLAC safety representative. They reported the results of their analyses. The conclusion of the review meeting is that the personnel protection interlock design provides adequate radiation protection to the experimenters and angiography subjects. At the same meeting the operational and check-out procedures were confirmed to be identical to last run. Since the previous review of the experimental conditions and protocols resulted in a low hazard classification, and since no changes of conditions or procedures have been made, we believe that that rating is still in effect.

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OFFICE MEMORRNOUM STRNFORD UNIVERSITY OFFICE MEMORfiNOUM STRNFORD UNIVERSITY FROM: Chairman, Rdministrative Panel on Human Subjects in Medical Research The Panel approved human subjects' involvement in your research project on January 6, 1987. The expiration date o f this approval is January 5, 1988. I f this project is to continue beyond that date, please submit an updated proposal in advance for the Panel's re-approval. If this proposal is used in conjunction with any other human experimentation or i f i t is modified in any way, it must be re-approved for these special circumstances. In addition, the Panel requests prompt notification o f any complications which may occur during any experimental procedure. Rll continuing projects and activities must be reviewed and r e - approved at least annually by the Panel. Panel approval o f any project is for a maximum period o f one year. I t is the responsibility o f the investigator to resubmit the project t o the Panel for annual I nvest igat ional Neu Drugs: N ,

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TO: WILLIAM GSUGH This mem a is to in form you of the planned.second series of " Iodine Dicht - omo graph y " experiments with human subjects to be carried out The experiments w'i11 be cat - r - i ed out by the same res each team which pet - formed the original experiments last year.The expos ut - e control hardware and the medical and ex pet - i mental pt - o bo cols are unchanged. The medical protocols and informed consent material ha.ve been reviewed and t - e - approved by the Stanford University Human Sub.jects Committee.A copy of the a ppt - oval is included herewith. The present plan is t o use four subjects,one of whom participated in the first experiment,commencing Friday,April 24, and at the rate of one pet- day through Monday, April 27. been further analysed by out- engineering staff and design changes

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inter loc l : : desi in er - s from both SLAC and LEL. personnel and a SLAC safety representative.Theyt - epot - ted the results of their - analyses.The conclusion of the review meeting is that the personnel protection interlock design provides adequate r - adi ation protection to the experimenters and angiography subjects. fit the same meeting the operational and checkout p t - oc edu res wet - e confirmed to be identical to last run. Since the previous review of the experimental conditions and p t - o to col c,resulted in a low hazard classification ? and since no changes of conditions or procedures have been made,we believe that that rating is still in effect. A. Bien en stock