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CAXCER BOARD MEETING 3 11) & poval of Minutes: It waa moved by Dr. Beil, seco ~ d c dby Dr. Greenberg, 8 land carried by the Board that the minuter of the meeting of Wednesday, April 23 Reconsideratfan of Protocol far Experimental Proetdures 8: Laboratory of now place a motion before thz Boazd that they be Chairman reyucrted that a member who had voted . It was 00 moved by Dr. Bell, reconded by Dr. Eostick, and 4 %for reconsideration of these procedures. The Board agreed that Dr. Bierman be called to diaccss h i e request a) Transplantation of Malignant Melanoma: D r . Bierman: It is know11 that any given carcinoma throws cff many more emboli than ever grow. Auto?ay rhovrr that cancer cells metastasize and a r e held in abeyance in many inrtaneea. minimum number of cells necessary for growth and t b c conditions which may alter rate of gzowth. transplanted tumoro. ond environmental coniiition8 which affect growth to these qoestions. Dr. Greenberg: Regardless of how thir experiment might be conducted, f a large variability would 'be expected. and to get any meaningful rtsu3t8 would require a large series of patients, not a selected h ~ dful. The question arises as to the n e rate of growth. rate of increase in Kite OF This expc~rtmentalprocedure i e aimed at finding an anrwer I want to emphasize that ody terminal patients will
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University of California at S a n Frmcixo great valuc to warrant the resenrsh 9n humans 7 Dr. Bierman: Yes. I have. These patients are doorirad to die of their discwe and ac?.:king !;novm c a n be done for them. the accumulation of Paowledge w i l l eventually help people. Dr. Stone: In a study of the large number of breast c a s e s seen at this hospital, there were found to be so many va:-ia51es thzt only gcaeral conclusions could be drsun. I thin!: you would Lave to be azouiid here a hundred years to gain any valusble information on mtlanomas. affecting growth, fu a suZicicnt number of anir=als to gEin same data. Dr. Bierrnarr: If w e were to find that by eha.nqing conditions of growth we could change the amber of cells necessary for gtowth, we wouli? bave 8 meanm for stopping early spread of lcrions. Dr. Stone: Raferring to point 9 in the decisions of the W a r Crimes Tribunal, could you bring the cxptrrimont to an aad? Dr. Bierman: Yes; you could cut out the lesion. Dr. Stone: You couldn't stop the metastases. Dr. Bierman: The patient already ha. metastarts. Iie is already tarminal. Dr. Stone: That doerrn't matte$, I can't see where in a y scnae the Codes of Ethics. Dr. Wood: I wonder lf a somewhat comparable study couldn't be done with tho Brown-Pearce carcinoma l a rabbits. I would like to see something llkc that.done before getting into anything like this. as I a m not convinced that the number of cellr i s :important in melanoma. of melanoma where with a small $rima-, either excised er noncexcised, following an apparent latent period of variable time, o showcr oz myriad of inttaatases will Suddenly appear. This would imply that factors other than number of cells m a y be of much greater importance. necessary or the condltions for growth. Am3 you still.feel that you want to do this ? I do not think this cornpa-cs vith Xu y tm berg. Perhaps; this study nil1 not do any ,003 for the patients, but You don't know the number of cells
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University of California at San Francisco to clestroy the hezxzicpcdetic system. Of course thct rlss d.zs:tsys the individuzl. Xn : r i n d s it hes teea found thilt some 1 . ~ 5 ~ 12!=s.:s can 3 c save the individual. This Is 23 abhtion e:q?rirnect. ?7e could find out: 1) 'does leukemia reside in the hematopoietic system; 2 ) does leukemia reside in the bone marrow; 4) information of radiological interest, tlthough that docs not seem 5) can cross-transfusion do in man what i t does ir. animals; 6 ) trarsfusion of splenic tissue might be 05 some intortst from a to be of interest here; national security point of view. Dr, Stone: I havea't changed my point of view. Dr. Stone: ft has been proven that transfusions do l i t t k 2003 in raciation human beings is entirely beyond the rphcre of common sense. Dr. Bogtickt I can r e t 'one point in. . favor of ws c phildsophically - os against your melanoma :proposal. The patient might poasibvf benefit from this, whereas in the melanoma experiment there would be no benefit, even i f it worked. ' Y s s this been done on mouse leukemia?' So long as I have eontrol So much can be done on animals that to even c?;:sidrr doing it on Dr. Wood: I think phi1orophica!~y this type of problem ia acctptable. providing you can control the after effttts. One i a going out to destroy the hematopoietic system, which apparently Ir the one in the production of leukemia: I think t u 5 might have considerable merit and we might mustard would be prefzrable. n e w of the risks from radiation, agfuts such as nitrogen I would hazard a guess ihA any rceppearance
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but that is only a guess. matter. Thrt settles it. Since Dr. Stone will not chmge his positioa. it doesn't mustard as Di. Wood has suggested. Or. Bierman left the meeting. Dr. Greenberg that permission for the proposed transplaztation of malignant melanoma be denizd. carried by the Board, D r . Shimkin not voting. Mter brief dircussion, it was moved by D r . Low-Beer moved that permission for temporary destruction of the hematopoietic system be cbnied. ambiguous, and the moticln i Q - 3 9 declared out of order due to ambiguity. Dr. Bostick and D r . Low-Bcrr commented that there was lack of knowledge regarding animal expel-i'neetation, and suggested that recommendation be made to Dr. Bierman that z systomatic study be undertaken with animals. It was also pointed out that : h c e is no praof that cross-transfusion o r other efforts are successful 5 szving the lives of aim als erposzd to lethal doses of radiation, and D r . Stsne repsrted that no mtans mere found to save the scientists who were accidsntally exposed to lethal doses of radiation at proof was available on the effects in animals. attention of the Board lo the ethics of the proposal, that there must be proof of effectiveness in animals before an experiment can be tried on humans. Dr. Boldrey quoted from the minuter of the April meeting, when Dr. Jonea reported that experiments on animals were not adequate to j u s t ~ yexperimenta on humans in this regard. Dr. Low-Beer moved that permirrion for this eq eri ment be denied as adficicnt animal experimental data are not mailable to a e ' Board. This was seconded by Dr. 13ostick and carried by the Board, Dr. Shimkin not This *:;as siconded by Dr. Bell and put It was decided that the question put to the Board for vote was 3r. Bell suggested that the proposal be set aside until adequate Dr. Greenberg called the 3) Review and Reconsideration of Cytso-gy Program: Dr. Wood explained that U. S. Public Health Service and one from the State of California Department of Public Health. T h e program has interlocked with that of Dr. Farber at the County Hospital. At the present time the U. S. Public Health Service ha8 approved one Trainee in Cytology f a r Dr. Farber for the coming year, and two grant applications for Dr. Traut. & addition. one grant from the California Department of Public Health ha. been approved. Dr. Wood reported that at the present time it is mutually agreeable with Dr. Rinehart and Dr. Traut that the Cancer Research Institute ahould be responsible for the program admfnistratively rather than the Division of Obstetrits and Gynecology, a s in part years, at least until ruch time
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University of California at San Francisco continued but feels the 21.321a x 1s no longer a functioa of Gyn~co?og;rand should Moon. who will participate in the program for the coming year, would have sufficient time to accept both teachina responsibilities 3ad the final screening of slides. Dr. Bostick commented +bat of all the men in the Division of Pathology, D r . Moon would be his choic:e for this responsibility. It w t s moved by Dr. Bostick h a t approval be giv:m, with D r . Traut'e permission. for transfer of the aaministrative responsibility for the Cytology Program to the Director of the Cancer Research Institute. This w2s seconded by Dr. Bensm and carried by D r . Shimkin stated that Cytology should be part of the School cf Mcdicine program, and asked if it would be possible to have a f u l l time nppointnizn: with tenure for Dr. Moon, and Dr. Shimkin comrnented that thz physician in charge of such an important program should aot be ct the le-?el of Fe1lo.x. activity will become prog;-::ssivc!y mor: acute in the years immediately ahead, and an attempt should be mada now to outlinz permanent plaas. suggested that a resolution 'be forixulatcd for apprwal by the Cancer Board providing that: Wherzae the Cytology activity is a continuing function both as to teaching and diagnosis as *:;ell as rr,search, all proper steps be taken to set up the program on a permanent basis as a regular University function. Such would entail the development of a proper University budget for the main part of the program, to which variour grants could be added as warranted by expansion of its research activities. The Board agreed to such a rerdution, the wording to be clarified by Dr. W o o d arid D r . Shimkin, to be submitted to the Cancer Bawd at its June meeting. An applicition for a senior Damon Runyon k.ello.vshi'j i3 pending for The problem of this 4) Applications for Funds: Dr. Bostick. and carried by the Board that, if funds a r e available, the S U m of $3,500. be granted to Dr. Greenberg for support of the project %letabolism b) Dr. Donald R. Smitlb: Dr. Shimkin pointed out that the aim of this proposed experiment - "Carcinoma of the Prortate - A clinical and laboratory study" - it too broad and that Dr. Huggins has already progressed beyond the studies proposed. He ab0 commsnted that bilateral adrenalectomy has been approved by the Board as a surgical procedure to be supported from the Bed Fund of the Arncricrn C m c c r Society Institutionll Grant. agreed by the Board that this rtudy might be incorporated a8 part of the Institutional Grant program. but no other funds were to be granted.
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the projects '#Studyof Biochemical Changes in Certain Proliferative Lesiona Of the Skin'', "Study of Skia Tumors in and t~Chcmosurgicdl Therapy of Skin Cancer" were discussed briefly. It was the con8cnsur of opinion that a bfsto-pathologist -.vould be required to adequately carry out the proposed studies. It wav moved by Dr. Wood, reconded by Dr. Bootick. and carried by the Board that these applications be considered a t the June meeting, as they were received by the m e m b e r s too late for adequate study. In the meantime, fL was requested that Dr. Wood and Dr. Bostick investigate the proposed research. Dr. Shimkin suggested that all application. for Cancer Board funds be considered at '.he June meeting, rather than whenever received throughout the year. D r . Stone pointed out that the usefdners of these funds was due to their availability for projects as they develop. a) S u m m e r Students: Dr. Shimkin reported that he had received two applications from students to study during the aummer at the Laboratory of Experimental Oacology, one student having been accepted. He reported that applications had been received from two Stanford students, and aaked the Board if they would approve accepting students from other achoola. Dr. Boldrey moved that the 3oard approve the principle of accepting students from schools other than the University of California, providing student8 a r e nct available from the University of California. to by the Board. This proposal w a s agreed e meeting was adjourned.
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"The great weight O I tbe e+-dence before c e is ts the cffect that certain t y p e s of Rle&iCal e.rpe.rimer.ts en :?urr?.zn beings, k-:icn kept within results for the good of society that are ynp:-ocurzb,i; by othe - nt'Aods o r be observed in o r d e r to si::isfy .moral, ethical m.l legal coricapts: "1. The vo1un:ary consent of the h u m a n s*abjectis absolutely ess%ntial. This means tht the p+rson involved stodd have legal capacity to give consent; shculd be sa situated as t? bz &le to sxercise free power of choice, without :he intcrvzntion of any dement of force, fraud, deceit, dureas, overreaching, or other form of ulterior constraint o r coercion; and should have sufficient knowledge and comprehension af the elements of the subject matter invo:l-.-e2 a5 to enable him :o make an understanding and enlightened decision. This latter elezrrent seGciris that before the acceptance of an affirmati-..e decisioa by the rxpcrimcntal subject there should be made knewn to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be axpecttd; and the effects upon his health or person which may poseible c o n e from iis participation in the experiment. The duty and responsibility for asctrt2iair.g t h e quality of the consent r e s t s upon each iridividual who initiatts. directs, or engages in delegated to another with !Lmpunity. It is a personal duty and responsibility vhicb may not bc "2. The experiment should be such as to yield fruitful resultr for4 the good of society, unprocurable by other methoda or means of study, and not random and unnecessary in nature. "3. The experiment rhould be so designed and bared on the results Of inimal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results w i l l justify the performance of the experiment. translated by Heinz Norden.
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University of California zit San Francisco Special Collections Library, San Francisco CA "5. No experiment rlznuld be conductrd \;rhcie theri. is a a a priori reason to bclievr that death or disabling injury will occur; except, perhaps. in those e:cptriments where the eq eri xx n tal physicians -!so szz-fe as " 6 . The degree of risk to be taken s l o d d never exceed that determined 5y the humanita:riao im-poriance of the …
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