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1. The Declaration of Helsinki(1964)declared the prim s cy of the rights of the individual in human experimentation and set forth specific implementing guidelines.Following this,the United States Department of Health,Education, and Welfare, and also the American Association of Medical Colleges,began to evolve standards for the performance of human ex peri mc ntz tion. The AAMC sent a draft for a code on ethics to the deans of all medical co1le ; c s in January,1965, and recommendcztions wcrs made at the annual m ce ting of thp AilMC that year that medical schools shou lb abide by the proposed guidelines. Service,informed the heads of all institutions conducting research with Public tic n res ecr cli or research training grants in support of clinical rcs ear cI1 2r.d investigation involving human beings shall be awarded by the Public Healtk Service only v hcn tire grant ee has indicated in ttie application the manner ir. which ttie grant ee ’ s institution will provide prior review of the judgenen; of the principal investigator or program director by a committee of his in st it u - tion c ll associates. From 1966to1969,a general statement vas included 11, such grants stating that the applying institution complied with the PHS re q Ki re - ments.In1370,all such grants had for the first time on the front pa ~ c ,i box item for the dare of approval or pending approval of such grants.Grants also contained a page relative to human experimentation whicll required fiirti.:r dates and re vim process. In 1.iardi Of1971, the Food and Drug Admin j st ration of the Department of
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acceptable numbcr was one such committee member. for human experimentation, Research Committees around the country and tothe AAMC, a draft copy of their revised standards.The only previous publication from DHEI.: -had been the ' blue pamphlet,published on May 1, 1969. These revised new codes then went through a number of further drafts,and are now in a final form, The National Inst. of ~ lth. had a series of meetings around the country during September,1971, at which representative members of faculty research committees discussed are being incorporated into the final DHEW Policy on Protection of Human Sh be ct s and,itis hoped that this will be available for everyones guidance early in In1970,they forwarded to all Faculty Cm it tee The above review would suggest that this whole area of human experimentation has be2n slowly evolving during the past five to six years.All concerned have been involved in this trial and error process,trying out new standards for practicality,changing the requirements as the practices indicated, and really only now is a comprehensive guidance code ready for public review. The extent to which institutions have responded to these requirements has been quite varied all over the country,perhaps in part because the implementing mc chan is xs were largely left unspecified. It should be pointed out that physicians and others involved bin human clinical investigation in the United States have ex - treme ly high standards and,that even without such formal codes of ethics,the) had been aware of their responsibilities in this area. Even at the present time,the rear2probably a number of investigators who are not aware of the various DHEI! requirements,particularly if their work is not grant campuses,n great deal of para - medical investigation is undertaken wit lr out an
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awareness of the requirements for human ethics. Many hospitals thoughout the country do not have the knowledge of the requirements in this area that a university medical center has, and there i s probably far less stringent supervision of what is often clinical investigation. BACKGROLTND TO THE UNIVERSITY (I?CINCINNATI MEDICAL CENTER FACULTY COMIT TEE kt a Faculty Council meeting on September 10, 1964, Dr. Grulee requested Dr. Gall to undertake appropriate institutional policy for human clinical investigation. The committee made responsible f o r this was to be called t h e Cm it tee on Research. This committee formulated some guide lines which were presented to the Faculty Council on November 12, 1964. The committee then worked at evolving such guidelines, and the following recommendations were made on October 11, 1965: -- (quoted) " T h e Committee on Research met on October 11, 1965. Discussion was limited to the conduct of human experimentation in the University of Cincinnati Medical Center. Because of a growing national interest in the ethics and monitoring of human experimentation expressed by both granting agencies and by the public, and because of the increasing evolution of more rigid policie. related to justification, hazards, and patient communication in human e x p c r i - mentation in Research Centers in this country, the Committee has become concerned with the protection of investigators at this Center and the status of the Center itself. The following recommendations are submitted to Faculty 1. Statement. It is agreed that in departments wherein human experimentation is carried out, the responsibilities, planning, and conduct should rcmain in accordance with the Committee's recommendation to Faculty 2. Recomnend3tion. It is rcconi-nended t h a t wlicn human expzriini.ntntic1:: a s opposed to progressive medical practicc is conducled, documentation for
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pernianent record be made with the form provided b y the Research Committee through the Dean in October, 1965. This forn should be approved and filed i n the Departmental Director's office. If the opinion of the Research Committee is desired, the original should be forwarded to the Committee and a copy kept in the Departmental Director's office. Special points which are to be emphasized are: 3. Informed patient consent. 4 . Special attention re medical student volunteers. In discussion Dr. Gall again emphasized the importance of -careful planning of such studies and indicated that the recommendations of our comnittee and those of the AAMC were essentially the same.II This canmittee, under Dr. Gall's chairmanship, then functioned f r m 1966 on. They made available to tlie faculty in 1967 a statement of principles for the University of Cincinnati Nedical Center. Dr. T o m Gaffney was chairmsn Evelyn Hess was then appointed as pro tern chairman in September, 1969, and documenting informed consent was utilized by the investigators. Prior to that time, general consent forms had been used, but all patients at all times had been quite fully informed verbally about the project and they were always asked for their agreement to participate in the project. The project was first formally submitted to the Faculty Committee on Research in March, 1966. This part of the project was entitled Protection of Humans with Stored Autolo)-ous Marrow. The ccrnmittee requested further information and suggested that. the irradiation part of the projcct be subnitted for review, Thc protocol x a $ therefore revised by Drs, Friedman a n d Saengei- and resubmitted to the co-.~iittc~i' in March, 1967. It was reviewed in detail by commiLtee members and thcre v a s
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a committee meeting with the investigators and Dr.Gall,in a letter to Dr. Grulee i n May of1967, recommended approval with the proviso that the in fu sio2 of stored marrow constitute a supportive measure. parts of the protocol be rewritten,particularly in relation to the plan of It was also suggested that investigation. Dr. Friedman, who was the principal investigator, went tothe University of Tennessee at the end of 1967. Dr. Ted Sil b erste in replaced of six monthly follow - up sheets for clinical investigation came into more general use. One of these was sent to the in ves i gators and i t was brought At about this time,the systenr to the chairman ’ s attention that there was now a new investigator and that some aspects of the study were changed as indicated by the investigator. Accordingly,in October1970,a request was made to submit an up - t o - date protocol.This the investigators did. It was reviewed by the FR C and some revisions wzre requested.A revised protocol was submitted in March of 1971, and after a series of meetings and reviews,a second revision was requested, This was submitted in July, 1971. This protocol related to the eighty - tvo patients who had been in the study since 1960 and related to the Phase I and Phase I1 parts of the study. It was i;ot an approval for Phase I11 studies, and i t was in fact,suggested to the investigators that a new protocol rc late d to such studies be submitted to the committee,With this agreement,Dr. Gru lee sent a letter of approval to the investigators in August, 1971. 4. BACKGROLTND TO GRANT APPROVALS: This research proposal had,of c curse,been submitted to the DOD initial lh with yearly reports since the initiation of the project. The entire total bod; irradiation protocol,including all of the therapeutic,metabolic,chemical, he Eat ol s gic,in mu no logic, and psycho logic studies was incorporated as one of t be component i for the General Cl in Sca1 Rcsenrcli Center grant submitted to the NIH in1966.Therc was a site visit and a con c il visit on this grant
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application and mans aspects of the radiation project were presented to the scientific review committees.This NIH grant was given full approval and was funded. This GCRC grant has come up for renewal in1970, and again all aspects of the radiation study were incorporated.This NIH grant was also Faculty Corn it tee on Research