Document MoB3MpdQLz5xobD748N570yBL

DEPARTMENT OF ENVIRONMENTAL HEALTH KETTERING LABORATORY (5T31 872-5700 October 15, 1974 University of Cincinnati Medicai Center 3223 Eden Avenue Cincinnati, Ohio 45267 Mitchell R. Zavon, M.D. Medical Director Ethyl Corporation 451 Florida Baton Rouge, Louisiana 70801 . RE: Kehoe Lead Balance Studies in Humans . . Dear Mitch: Please find a draft of the scientific proposal and contract agree ment along with Dr. Kehoe's letter of confirmation for the proposed analysis of the Kehoe data. Perhaps I can negotiate any changes directly with your Ethyl Corporation lawyer while you are out of the country. The final instruments can then be approved either by mail or when you return in November. Have a safe trip.. Sincerely, SBG/hk Enclosure S L S I U C ^ > v i u s s , r n . u . Assistant Professor of Environmental Health (Toxicology) N 7501 c o l l e g e : o f m e d ic n e . e d e n a n d b e t h e s d a a v e n u e s LETTERING l a b o r a t o r y DEPARTMENT OF ENVIRONMENTAL HEALTH University of Cincinnati Cincinnati, Ohio 45267 October 15, 1974 Stanley B. Gross, Ph.D. Assistant Professor Department of Environmental Health University of Cincinnati Cincinnati, Ohio 45267 Dear Doctor Gross: I fully approve of the agreement proposed for submission to Ethyl Corporation for the completion of the work to be done with the data of my experiments on the behavior of lead in the human subject. . Sincerely yours, RAK:wb Robert A. Kehoe, M.D. Professor Emeritus of Occupational Medicine iO N 7501.01 CONTRACT PROPOSAL .KEHOE LEAD BALANCE STUDIES IN HUMANS Submitted by -University of Cincinnati, Department of Environmental Health Eden & Bethesda Avenues, Cincinnati, Ohio 45267 To Ethyl Corporation Medical Department 451 Florida Baton Rouge, Louisiana 70801 ___________ __ Stanley B. Gr/>ss, Ph.D. , Project Director Department of Environmental Health Raymond R. Suskind,'P^DV, Director Department of Environoental Health Robert S. Daniels, M.D. Interim Dean, College of Medicine Date: / # / ____________ /<<T O l i n o ,i).l N 7501.02 .Kehoe Lead Balance Studies in Humans Scope of Effort The lead balance studies carried out by Dr. Robert A. Kehoe, of this Department, date back to the late 1930's and involve twenty different sub jects. Six of these have been oral ingestion studies only and the remainder both oral and inhalation uptake studies. Four oral studies including E.B., I.F., M.R. and S.W. as subjects have been reported in the Harben lectures and in several other papers. The data reported, by comparison to the amount of information available from the studies, were very limited. Data on eleven of 14 subjects used in inhalation studies have been published also in a very limited way. The data obtained from the balance studies are currently stored in several different locations in the Department. This project proposes to as semble all the data from these balance studies for the purpose of analysis and publication as described below. Three types of analyses are anticipated. These are: 1. The statistical variations of the many measurements made in these studies including variations within an individual and variations among the different individuals; 2. changes in the health parameters measured during the different oral and inhalation exposures; and, 3. changes in the body burden of lead due to these exposures. From these analyses, we shall develop mathematical models to express the rates of change in such parameters as blood and urinary lead from measurements made at the beginning of exposure, during week-end periods of no exposure and at the terminations of the exposures. Models will also be developed, if possible, to predict changes during intermediate exposure rates. 000615 2 / -2- A tentative schedule of activities will be as follows: Phase 1. Detailed review of the data by Drs. Gross and Tsay leading to development of protocols. Phase 2 . Discussion with Drs. Kehoe, Suskind, Zavon, Sobel and Ter Haar leading to approval of protocols and of a priority listing of activities. The beginning of data pro cessing. Phase 3. Continue data processing. Quarterly reports. Phase 4 . Continued data processing. Draft of final reports and pub lication manuscripts. ' Phase 5. Final report and manuscripts. It is expected that phases 1 and 2 will be completed within 2-3 months. The time table for the remaining phases will be derived jointly by the 3rd month. Personnel Dr. Stanley B. Gross, of the Department, will serve as the Project Director and will be under the general supervision of Dr. Kehoe. Dr. Gross will be assisted by Ms. Susan Rasche, research technician and Dr. Jia-yeohg Tsay, postdoctoral fel low in biostatistics. Dr. Peter Gartside, Statistician in the Division of Epidemi ology and Biostatistics, will serve as a consultant to Dr. Gross and Dr. Tsay. Dr. Mitchell Zavon, Medical Director of Ethyl Corporation, will serve as Project Monitor. Dr. Raymond Suskind, Director of the Department and Drs. Bernard Sobel and Gary Ter Haar, of Ethyl Corporation, will serve in advisory capacities to Drs. Gross and Zavon. In the event that mathematic models will be developed to describe the kinetics of lead distributions, Drs. Stanley Day and Carl Evert of the University's Elec trical Engineering Department, will provide guidance for an engineering assistant who will develop the mathematical models from data provided by Dr. Gross using the E.E. Department's hybrid computers. Reports Quarterly reports will be due within 15 days after the end of the quarterly period. Several informal oral reports and/or consultations (at least one per month) -3- between the Department and the Corporation will be made during the 1st three months of the project. A final report will be due within 15 days after the termination of the study as planned or 30 days after an unscheduled termination. Termination of Project Because of the variable nature of this study, this project may be terminated when (1) the project greatly exceeds the scope of the original plans, (2) there is a lack of agreement concerning the protocols to be defined in the first 3 months of the project, (3) or by mutual consent or (4) there develops unacceptable delays in performance (30 days). BUDGET Personnel: Dr. Stanley Gross Dr. Jia-yeong Tsay Mrs. Susan Rasche Project Director Postdoctoral Fellow Research Technician Secretarial Assistance 507. 25% 507. 107. $ 8,508 2,500 4,248 720 $ 15,976 Fringe Benefits: 15.27. of Applicable Salaries (13,476) $ 2,048 Other Direct Costs: Computer Services Misc. Supplies (computer draws, folders, etc.) 1,000 400 $ 1,400 Overhead: 60.007. of Salaries (15,976) $ 9,586 Quarterly Amount TOTAL $29,010 $ 7,252.50 Any trips in connection with this study would be borne by Ethyl Corporation. 0 0 G615 4 A G R E E M ENT THIS AGREEMENT, made this _____ day of __________________ 1974, between Ethyl Corporation, Medical Department, 451 Florida, Baton Rouge, Louisiana, hereinafter called "the Donor", and the University of Cincinnati, hereinafter called "the University". . WITNESSETH WHEREAS, the Donor wishes The Department of Environmental Health (hereinafter called "the Department") to conduct a. study described in the attached Scope of Effort of the Kehoe Balance Studies in Humans; WHEREAS, the University has approved of this study by said Depart ment; NOW, THEREFORE, in consideration of the mutual promises hereinafter specified, IT IS AGREED: 1. The Department shall carry out such investigations within the limits of its available facilities and scientific interests. 2. The Donor shall pay the University therefore the sum of TwentyNine Thousand, Ten Dollars ($29,010) for the conduct of this study in four installments of Seven Thousand Two Hundred Fifty-Two Dollars and fifty cents ($7,252.50) at the end of each three month period of the project. 3. The name of the University or of the Department or of any member, officer or employee of the University or the Department, shall not be used in any advertising matter at any time during the progress of the work or thereafter. A written report shall be made of the findings and such a report or photostatic copy thereof may be used by the Donor as evidence of the facts established. If the findings are published in a scientific journal, the Donor shall be free to quote such findings subsequent to publication. KK 0000155 N 7501.03 4. The investigative work shall be planned and carried out by the University, and the University shall have the right to disseminate for the public good any information obtained. However, before the issuance of public reports or scientific publications, the manuscripts therefore will be submitted to the Donor for criticism and suggestion. IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their proper officer, respectively, who are hereby certified to have been duly authorized to execute the same. ETHYL CORPORATION BY UNIVERSITY OF CINCINNATI BY 0 6 i56