ATTACHMENT 5: 1956 CORRESPONDENCE BETWEEN LOS ALAMOS HEALTH DIVISION LEADER AND AEC DIRECTOR OF DIVISION OF BIOLOGY AND MEDICINE, 1962 MEMORANDUM FROM HEALTH DIVISION LEADER TO C.C. LUSHBAUGH, AND 1963 MEMORANDUM FROM LAS ALAMOS HEALTH DIVISION LEADER TO STAFF REPOSITORY _________________________ COLLECTION _________________________ BOX NO. ____________________________ June 18, 1956 FOLDER _____________________________ Dr. Charles L. Dunham Division of Biology and Medicine U.S. Atomic Energy Commission Washington 25, D.C. Dear Chuck: Two questions have recently arisen -- one of them specific, the other general -- wherein we need an opinion from you. The first of these concerns making reproductions of the Los Alamos Monitors' Handbook, LA-1835, several copies of which should be floating around your Division. This little booklet has certainly been at the top of the best-seller list among Los Alamos documents and the demand shows no sign of slackening. We recently received a request for 100 copies from the Army Chemical Center at Ft. Belvoir. I would guess that somewhere between 1000 and 1500 copies have so far been distributed outside of the Los Alamos. We are willing to continue reproducing and distributing this document for free unless someone else would like to take it over. We make no apologies for the fact that this document was prepared for our own Los Alamos monitors; it seems to be extremely popular elsewhere in spite of the fact that we did not hesitate to include some items which might be regarded as slightly controversial. If DBM wishes to authorize the reproduction and sale of this document from the GPO, we will be quite willing; otherwise, we will continue to distribute it at least to a limited degree essentially to those who request it. That was the easy question and requires little more than a 'yes or no' answer from you. The next one is rather tougher. We feel that the time has come when it would be extremely helpful if DBM should restate its position on the matter of the experimental use of volunteer human subjects. To the best of my knowledge, Shields made such a statement some years ago; I think that this was before I joined the company and I don't believe that I ever saw it in black and white. People like laboratory directors, however, are aware of it and are understandably apprehensive when they learn or suspect that some of their workers are serving as guinea pigs. I am bound to confess that we ourselves have from time to time indulged in experiments of this sort, most notably when we were studying the toxicity and toxicology of tritium. Furthermore, I am sure that you as a man with scientific training will agree that situations will arise when it become necessary to prove the validity of animal experiments with human administration. For your consideration I would like to suggest that you issue some sort of statement to - 1 - Dr. Chas. L. Dunham June 16, 1956 the effect that DBM does not object to the administration to human subjects of tracer doses of materials provided that a) the procedure is approved by the senior medical officer of the institution; b) that the subjects are bona fide volunteers be carried out under the supervision of a responsible physician who is licensed to practice in that locality. In the absence of such a policy, such experiments will be carried on ILLEGIBLE anyway and possibly with inadequate supervision. My hope is for a reasonable policy which will permit people to do such work as is necessary and not keep us suffering from mistakes and in the distant past. Certainly your statement need not urge people to do these things but should at least withdraw the Division's disapproval. Very sincerely yours, THOMAS L. SHIPMAN, M.D., Health Division Leader TLS/lca - 2 - UNITED STATES ATOMIC ENERGY COMMISSION WASHINGTON 25, D.C BM:CLD July 5, 1956 Dr. Thomas H. Shipman Los Alamos Scientific Laboratory P.O. Box 1663 Los Alamos, New Mexico Dear Tom: This is in response to your letter of June 18. Question 1 is answered easily. The Los Alamos Monitors' Handbook is a little gem and when it is revised in the light of what would appear to be impending changes in the maximum permissible levels for external exposures I would hope that you could continue to make copies available as you have in the past. Although it might relieve you somewhat of the responsibility if it were published here under Division of Biology and Medicine auspices I can see two good reasons why this would not be desirable. One, it would require official endorsement by a number of interested Divisions which might delay its reproduction, and two, being a Los Alamos document rather than a government document it would, as has been demonstrated in the past, be much more acceptable and palatable. As to your second question, I fail to see any particular problem with respect to the administration of tracer doses of materials to human volunteers with four provisos: one, that these are true tracer doses and fall well below be an order of magnitude or two of an amount which could result in something comparable to a continued maximum permissible body burden. The other three provisos are those you have suggested, namely, that the procedure be approved by a senior medical officer of the institution, that the subjects are bona fide volunteers and fully informed as to the procedure involved; and that the procedure be carried out under the supervision of a responsible physician who is licensed to practice in that locality. I think the context within which Shields made very strong statements decrying experimental use of volunteer human subjects was one in which there was tremendous pressure being put on both the AEC and the DOD to permit large doses of whole body radiation exposure in human volunteers, that is, hundreds of ILLEGIBLE to determine the dose levels at which nausea and vomiting would occur, impairment of work capacity and gross hematological change. Sincerely yours, REPOSITORY _________________ Charles L. Dunham, M.D. COLLECTION _________________ Director, Division of BOX No. ____________________ Biology and Medicine FOLDER ______________________ C. C. Lushbaugh, H-4 March 13, 1962 T. L. Shipman, H-DO STUDIES ON NORMAL SUBJECTS H: I can see nothing which makes your proposal any different from any studies which have been carried out in the past, with the possible exception of the fact that we are proposing to use smaller quantities of tracers than before. In all such situations, however, it is well to remind ourselves of the ground rules that were laid down in 1956. These required in addition to theoretical assurance of complete safety, (a) Basic approval by the Division Office, (b) the requirements that the subjects are bona fide volunteers and fully informed as to the procedures involved, and (c) That the procedure be carried out by or under the immediate supervision of a licensed physician. It seems to me that those ground rules were perfectly good when we drew them up in 1956 ad got approval from both Dr. Dunham and Mr. Bradbury, and they are just as good now as they were then. As I am already familiar with what you propose to do you can feel that the first requirement mentioned above has been complied with. I think it should be made plain that the subjects will volunteer as individuals rather than as members of any group or organization. As a matter of act I will be surprised if you do not have some subjects who will not be members of any particular group. This should discourage any organization from tying to extract any publicity value from the procedure. T. L. SHIPMAN, M.D. Health Division Leader TLS/mjt cc: Wright Langham OFFICE MEMORANDUM TO: Distribution September 3, 1963 FROM: T. L. Shipman, M.D., Health Division Leader SUBJECT: ADMINISTRATION OF TRACER DOSES TO HUMANS FOR EXPERIMENTAL PURPOSES SYMBOL: H In a memo dated July 12, 1956, I established the ground rules which would, of necessity, be followed in all experimental procedures involving the administration of tracer doses of radioactive isotopes to human volunteers. I would here like to restate these rules: 1. Each experiment which requires the administration of tracer doses to human volunteers must have the written approval of the Health Division Leader or his Alternate. 2. The request for such approval must contain a statement as to the maximum dose to be administered, together with a statement as to the maximum permissible dose for such material. 3. All subjects will be bona fide volunteers who are fully informed as to the procedure to be carried out. 4. The administration of any such doses shall be carried out only under the immediate and direct supervision of a physician licensed to practice medicine in the State of New Mexico. The only thing which has changed since this SOP was prepared is the fact that for the first time since 1947 Group H-4 will not have a licensed physician on its staff. For this reason it will be necessary if any such work is to be done to require the collaboration of the physicians on the staff in Group H-2. It is particularly important that section 4 above be followed to the letter in the event of any subcutaneous or intravenous administration of all materials. Generally speaking, Wright Langham has blanket authority to approve or disapprove such procedures, although all proposals in any way out of the ordinary have been discussed with me. REPOSITORY ___________________ COLLECTION ___________________ BOX No. ______________________ TO: DISTRIBUTION September 3, 1963 Section 2 above, however, must be carried out with each proposal for experiments involving humans with the required statement kept on file in the H-4 Group Office. T. L. SHIPMAN, M.D. Health Division Leader TLS/de Distribution: Wright H. Langham, H-4 Group H-4 Section Leaders Harry O. Whipple, M.D. Paul L. Flynn, M.D., H-2 Duane Drake, M.D., H-2