A-68585, FEBRUARY 27, 1936, 15 COMP. GEN. 738

A-68585: Feb 27, 1936

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EXPERIMENTS - USE OF HUMAN SUBJECTS - NONPERSONAL SERVICE BASIS THERE IS NO LEGAL OBJECTION TO THE USE OF HUMAN SUBJECTS IN LIEU OF ANIMALS BY THE BUREAU OF CHEMISTRY AND SOILS. 1936: THERE WAS RECEIVED YOUR LETTER OF DECEMBER 5. FORMAL AGREEMENTS HAVE BEEN EXECUTED AND RENEWED FROM YEAR TO YEAR IN ACCORDANCE WITH THE PROVISIONS THEREOF. A NEW AGREEMENT WAS ENTERED INTO FOR THE FISCAL YEAR 1935. WHICH WAS RENEWED FOR THE FISCAL YEAR 1936. THE AFORESAID RESEARCHES HAVE PROVEN MOST SATISFACTORY AND HAVE BEEN ACCOMPLISHED EFFICIENTLY AND EXPEDITIOUSLY. IT IS BELIEVED REMARKABLE RESULTS HAVE BEEN ATTAINED. THE EXPERIMENTS PREVIOUSLY CONDUCTED HAVE BEEN BASED ON THE USE OF ANIMALS. IT IS NOW HIGHLY DESIRABLE TO TEST CERTAIN OF THE INSECTICIDES TO HUMAN SUBJECTS.

A-68585, FEBRUARY 27, 1936, 15 COMP. GEN. 738

EXPERIMENTS - USE OF HUMAN SUBJECTS - NONPERSONAL SERVICE BASIS THERE IS NO LEGAL OBJECTION TO THE USE OF HUMAN SUBJECTS IN LIEU OF ANIMALS BY THE BUREAU OF CHEMISTRY AND SOILS, DEPARTMENT OF AGRICULTURE, IN EXPERIMENTS AND INVESTIGATIONS REQUIRED BY LAW UNDER A NONPERSONAL SERVICE CONTRACT WITH AN EDUCATIONAL INSTITUTION PROVIDING FOR NO PAYMENT OF SALARY, AND FOR NO PRIVITY BETWEEN THE GOVERNMENT AND THE HUMAN SUBJECTS SELECTED BY THE EDUCATIONAL INSTITUTION. 14 COMP. GEN. 404 DISTINGUISHED.

COMPTROLLER GENERAL MCCARL TO THE SECRETARY OF AGRICULTURE, FEBRUARY 27, 1936:

THERE WAS RECEIVED YOUR LETTER OF DECEMBER 5, 1935, AS FOLLOWS:

THE BUREAU OF CHEMISTRY AND SOILS OF THIS DEPARTMENT HAS FOR SEVERAL YEARS BEEN CONDUCTING TOXICOLOGICAL AND PHARMACOLOGICAL RESEARCH ON FOODS, FEEDS, INSECTICIDAL AND FUNGICIDAL MATERIALS AND SPECIAL CHEMICAL CONSTITUENTS DERIVED FROM PLANT AND OTHER MATERIAL, IN COOPERATION WITH THE DEPARTMENT OF PHARMACOLOGY OF THE SCHOOL OF MEDICINE OF STANFORD UNIVERSITY WITH HEADQUARTERS AT SAN FRANCISCO, CALIFORNIA.

BEGINNING WITH THE FISCAL YEAR 1932, FORMAL AGREEMENTS HAVE BEEN EXECUTED AND RENEWED FROM YEAR TO YEAR IN ACCORDANCE WITH THE PROVISIONS THEREOF. A NEW AGREEMENT WAS ENTERED INTO FOR THE FISCAL YEAR 1935, WHICH WAS RENEWED FOR THE FISCAL YEAR 1936, AS PER COPIES OF THE AGREEMENT AND CORRESPONDENCE HEREWITH.

THE AFORESAID RESEARCHES HAVE PROVEN MOST SATISFACTORY AND HAVE BEEN ACCOMPLISHED EFFICIENTLY AND EXPEDITIOUSLY, AND IT IS BELIEVED REMARKABLE RESULTS HAVE BEEN ATTAINED. THE EXPERIMENTS PREVIOUSLY CONDUCTED HAVE BEEN BASED ON THE USE OF ANIMALS, AND IT IS NOW HIGHLY DESIRABLE TO TEST CERTAIN OF THE INSECTICIDES TO HUMAN SUBJECTS. THE ONLY SATISFACTORY MEANS AVAILABLE TO THE BUREAU TO CONDUCT THESE TESTS IS TO PLACE A FEW PERSONS IN THE UNIVERSITY HOSPITAL WHERE A SATISFACTORY AND ACCURATE CONTROL CAN BE MAINTAINED. SAID PATIENTS WILL BE IN THE HOSPITAL FOR PERIODS OF SEVEN DAYS EACH, AT A HOSPITALIZATION EXPENSE OF $3.50 PER DAY, AND BLOOD AND URINE EXAMINATIONS AT $1.00 PER DAY, THE HOSPITAL TO ASSUME ALL RESPONSIBILITY FOR THE PATIENTS, CONDUCT THE TEST, RECORD AND MAKE THE RESULTS AVAILABLE TO THE BUREAU FOR ITS RESEARCHES. AN ATTEMPT WAS MADE TO USE "OUT PATIENTS" OF THE HOSPITAL, WHICH, HOWEVER, PROVED UNSATISFACTORY, FOR THE REASON THAT COMPLETE COOPERATION OF THE PATIENTS COULD NOT BE OBTAINED. THE METHOD NOW PROPOSED IS TO REIMBURSE THE HOSPITAL AT THE RATE OF $3.50 PER DAY FOR THE HOSPITALIZATION OF EACH PATIENT, AND $1.00 PER DAY PER PATIENT FOR BLOOD AND URINE EXAMINATIONS, THE FIRST EXPERIMENTAL TEST TO BE ACCOMPLISHED ON NOT MORE THAN TEN PATIENTS. THE ESTIMATED EXPENDITURE FOR THESE TESTS WILL NOT EXCEED $350 FOR THE CURRENT YEAR, REIMBURSEMENT TO BE MADE TO THE HOSPITAL UPON SUBMISSION OF DULY ITEMIZED AND CERTIFIED VOUCHERS.

IN SUBMITTING THIS CASE, WE ARE NOT UNMINDFUL OF YOUR DECISION OF NOVEMBER 21, 1934, TO THE FEDERAL TRADE COMMISSION (14 C.G. 404), BUT IT IS BELIEVED THAT THE RULE LAID DOWN IN THAT CASE IS NOT FOR APPLICATION IN THE INSTANT MATTER SINCE NO MONEY WILL BE PAID TO THE INDIVIDUALS ON WHOM THE TESTS ARE MADE, THE ONLY COSTS IN CONNECTION WITH THE TESTS BEING TO THE HOSPITAL TO REIMBURSE IT FOR THE WORK PERFORMED UNDER THE COOPERATIVE AGREEMENT.

YOUR DECISION IS REQUESTED WHETHER THE PROPOSED EXPENDITURE IS AUTHORIZED.

COPIES OF THE AGREEMENTS ARE ENCLOSED HEREWITH.

THE DEPARTMENT OF AGRICULTURE APPROPRIATION ACT 1936, APPROVED MAY 17, 1935, 49 STAT. 265, UNDER THE MAIN HEADING,"BUREAU OF CHEMISTRY AND SOILS," AND SUBHEADING "SALARIES AND EXPENSES," PROVIDES IN PART AS FOLLOWS:

FOR ALL NECESSARY EXPENSES CONNECTED WITH THE INVESTIGATIONS, EXPERIMENTS, AND DEMONSTRATIONS HEREINAFTER AUTHORIZED, INDEPENDENTLY OR IN COOPERATION WITH * * * UNIVERSITIES * * * INCLUDING THE EMPLOYMENT OF NECESSARY PERSONS AND MEANS IN THE CITY OF WASHINGTON AND ELSEWHERE * * * AS FOLLOWS:

AGRICULTURAL CHEMICAL INVESTIGATIONS: FOR CONDUCTING THE INVESTIGATIONS CONTEMPLATED BY THE ACT OF MAY 15, 1862 (U.S.C., TITLE 5, SECS. 511, 512), RELATING TO THE APPLICATION OF CHEMISTRY TO AGRICULTURE; FOR THE BIOLOGICAL, CHEMICAL, PHYSICAL, MICROSCOPICAL, AND TECHNOLOGICAL INVESTIGATION OF FOODS, FEEDS, DRUGS, AND INSECTICIDES AND SUBSTANCES USED IN THE MANUFACTURE THEREOF, INCLUDING INVESTIGATIONS OF THE PHYSIOLOGICAL EFFECTS OF SUCH PRODUCTS; * * *.

THE CONTRACT BETWEEN THE BUREAU OF CHEMISTRY AND SOILS AND STANFORD UNIVERSITY COVERING THE FISCAL YEAR 1935, WHICH HAS BEEN EXTENDED TO COVER THE FISCAL YEAR 1936, CONTAINS THE FOLLOWING PROVISION:

IN CONSIDERATION OF THE FACT THAT STANFORD UNIVERSITY IS FURNISHING FREE OF COST THE NECESSARY QUARTERS FOR THIS RESEARCH WORK, ALL HEAT, LIGHT, GENERAL JANITOR SERVICE, AND THE USE OF ITS APPARATUS AND SPECIAL EQUIPMENT WHEN SUCH USE DOES NOT INTERFERE WITH THE REGULAR REQUIREMENT OF THE SCHOOL OF MEDICINE, THE DEPARTMENT OF AGRICULTURE AGREES TO REIMBURSE STANFORD UNIVERSITY FOR SUCH SERVICES AND SUPPLIES AS MAY BE NECESSARY FROM TIME TO TIME IN THE CARE AND HANDLING OF THE EXPERIMENTAL ANIMALS FROM APPROPRIATIONS MADE AVAILABLE THEREFORE.

REIMBURSEMENT FOR "SERVICES AND SUPPLIES AS MAY BE NECESSARY FROM TIME TO TIME IN THE CARE AND HANDLING OF EXPERIMENTAL ANIMALS" IS SPECIFICALLY AUTHORIZED UNDER THE APPROPRIATION QUOTED.

THE USE OF HUMANS IN LIEU OF ANIMALS IN THE EXPERIMENTS AND INVESTIGATIONS REQUIRED BY THE LAW, REPORTED TO BE ESSENTIAL FOR THE COMPLETION OF THE EXPERIMENTS, IS PROPOSED ON A NONPERSONAL SERVICE BASIS ON SUBSTANTIALLY THE SAME BASIS AS FOR THE CARE OF THE ANIMALS, THAT IS, BOARD, ROOM, AND LABORATORY EXAMINATIONS. NO PAYMENT OF SALARY IS PROPOSED AND THERE IS NO PRIVITY BETWEEN THE GOVERNMENT AND THE HUMAN SUBJECTS SELECTED. THIS DOES NOT CONSTITUTE THE EMPLOYMENT OF PERSONAL SERVICES AND IS NOT OBJECTIONABLE FOR THE REASONS STATED IN THE DECISION YOU CITE, INVOLVING THE TEMPORARY EMPLOYMENT OF A PERSON TO HAVE HER HAIR DYED WITH AN ADVERTISED SOLUTION AND OF AN OPERATOR TO APPLY THE TREATMENT, OR THE DECISIONS CITED THEREIN INVOLVING THE EMPLOYMENT OF PERSONS FOR USE IN THE TRANSFUSION OF BLOOD.

YOU ARE ADVISED, THEREFORE, THERE APPEARS TO BE NO LEGAL OBJECTION TO THE PROPOSED PAYMENT. THE COPIES OF THE AGREEMENTS WITH STANFORD UNIVERSITY FOR THE YEARS 1933, 1934, AND 1935 ARE RETURNED, AS REQUESTED.