Attachment 4 April 5, 1948 letter from C.J. Watson, M.D., Army Epidemiological Board to Dr. McLeod, with a copy to Dr. Stokes and others War Department Office of the Surgeon General ARMY EPIDEMIOLOGICAL BOARD United States Army April 5, 1948 Dr. Colin M. MacLeod New York University College of Medicine 477 First Avenue New York 16, N.Y. Dear Dr. MacLeod: I have given careful consideration in the past few weeks to the matter of using volunteers in penal institutions for experimentation, with particular reference to hepatitis. Three weeks ago I had a conversation with Mr. Durnquist, the Attorney General of the State of Minnesota, with respect to the possibility of conducting experimental work on volunteers in the Minnesota penitentiaries. Mr. Durnquist was favorably inclined to the idea and quite optimistic about its feasibility. Later I had a lengthy discussion with Dean Everett Fraser (Law School) and with Dr. Vold of the Division of Criminology of the Department of Sociology in the University. I asked them specifically whether a waiver signed by the volunteers would be legal at a later date, insofar as evidence of responsibility for disability or death was concerned. I asked this question both with respect to a waiver made out to the individual experimenter as well as to one assigned to the official agency sponsoring the research, that is to say, the army Epidemiological Board of the War Department. They did not believe that such a waiver would be of much value, although they stated that so far as they knew there was no precedent in law to determine in advance what might happen in case of a suit. They pointed out that a clever attorney at some later date might very well be able to overthrow such a waiver and get a judgment against an experimenter in case of a disability or even succeed in having him declared guilty of homicide in case of a death. Mr. Vold stated that there might be some recorded law ___ing on this whole matter in the state of Massachusetts. He pointed out that during the war volunteer prisoners were used for the testing "of synthetic blood serum", and that one or more deaths in addition to a number of severe illnesses resulted. He suggests one might get all the information about this from the Commissioner of Correction of the State of Massachusetts, State House, Boston. Mr. Vold also informed me of an interesting point that may have no bearing on the present matter; namely, that the brains of criminals executed in New York state are removed by law or at least COPIED: 12/2/94 RECORD Group: # 334 Entry: #14 File: Commission on Liver Diseases on Human Volunteers for Hepatitis Studies in Feb. 1945 Dr. Colin M. MacLeod April 5, 1948 by state prerogative, but that the body is not available for dissection unless it is unclaimed. While this is probably not germane to the problem of using volunteers for experimentation, Mr. Vold thought that it might be of interest to determine whether there is any written law concerning this prerogative and, if so, how it has been established. There is, of course, precedent for the use of volunteers for experimental purposes, as for example in Illinois and New Jersey. According to my legal friends, however, the responsibility for these experiments would devolve entirely upon the individual experimenter in case of a later suit or complaint. The mere fact that the warden or the state authorities give permission to the experimenter to ask for volunteers in no way removes his responsibility, not does it place any of it on the state. This at least is the interpretation that Dean Fraser put upon the question, although he admitted that he knew of no law by which any real decision could be reached in advance. I have given considerable thought to the matter of whether it would be advisable to approach individuals or groups in Congress with the idea of having laws passed relating either to payment of compensation for disability or release of the experimenter from liability. I am afraid that this would be a very dangerous course, and that it might in fact, injure clinical investigations generally. There is a very real possibility that unfavorable publicity would quickly result. Dean Fraser and his colleagues were in thorough agreement on this point. I have concluded then that any human experimentation must be carried out in the future as in the past, on the basis of the sole liability of the individual experimenter. I should be glad to hear from you or from others to whom copies of this letter are being sent as to any alternative approaches to the problem that the may have in mind. I think it would be well if someone could look in the Massachusetts experience as mentioned above. With kindest regards, Sincerely yours, C. J. Watson, M. D. CS/vr cc: Col. F. Rauer Dr. W. P. Havens Dr. J. Neefe Dr. J. Stokes Dr. J. Paul P.S.: I do feel strongly, however, that if the Army approves and finances a specific research involving human experimentation, with the intention of accepting and utilizing any practical results therefrom, it should be willing to obligate itself to the protection of the experimenter, at least to the extent of purchasing a special insurance policy for each project of this type, covering disability or death. (By this I mean one comparable to a malpractice policy , protecting the experimenter against later suit for compensation. Obviously, no publicity should be given to this.) COPIED: 12/2/94 RECORD Group: # 334 Entry: #14 File: Commission on Liver Diseases on Human Volunteers for Hepatitis Studies in Feb. 1945