B-158690, APR. 26, 1966, 45 COMP. GEN. 649

B-158690, APR. 26, 1966, 45 COMP. GEN. 649

PERSONAL SERVICES - PRIVATE CONTRACT V. GOVERNMENT PERSONNEL - RESEARCH SUBJECTS THE SERVICES OF HUMAN BEINGS THAT ARE NOT SELECTED ON THE NORMAL BASIS OF EMPLOYEE QUALIFICATIONS AS RESEARCH SUBJECTS IN THE PERFORMANCE OF "IN- HOUSE" MEDICAL RESEARCH BY GOVERNMENT PERSONNEL WHO WILL NOT DIRECT OR CONTROL THE ACCOMPLISHMENTS BY THE INDIVIDUAL, BUT RATHER MEASURE OR RECORD RESEARCH EXPERIMENT RESULTS--- THE PARTICIPATION OF THE INDIVIDUAL A NECESSARY BUT NEUTRAL ELEMENT--- MAY BE SECURED BY CONTRACT ON A FEE BASIS, THE UNIQUE SITUATION NOT ESTABLISHING AN EMPLOYER-EMPLOYEE RELATIONSHIP, THE SUBJECTS WILL NOT BE ENTITLED TO LEAVE, RETIREMENT, SALARY, TENURE, OR ANY OTHER NORMAL INCIDENTS OF EMPLOYMENT, AND THERE IS A REASONABLE BASIS TO DETERMINE IT WOULD BE MORE ECONOMICAL, FEASIBLE, OR NECESSARY TO PROCURE THE SERVICES OF SUCH PERSONS FOR RESEARCH PURPOSES BY CONTRACT; THEREFORE, THE SERVICES NORMALLY PERFORMED BY GOVERNMENT PERSONNEL MAY BE MADE THE SUBJECT OF AN INDEPENDENT-CONTRACTOR RELATIONSHIP RATHER THAN AN EMPLOYER-EMPLOYEE RELATIONSHIP.

TO THE SECRETARY OF THE ARMY, APRIL 26, 1966:

THE LETTER OF MARCH 4, 1966, OF JOHN A. GOSHORN, MAJOR GENERAL, USA, YOUR DIRECTOR OF PROCUREMENT, POINTS OUT THAT IN THE PERFORMANCE OF "IN-HOUSE" MEDICAL RESEARCH CONDUCTED BY GOVERNMENT PERSONNEL THE ARMY SOMETIMES FINDS IT NECESSARY TO USE HUMAN BEINGS AS RESEARCH SUBJECTS. HE POINTS OUT THAT VOLUNTEERS FROM AMONG AVAILABLE GOVERNMENT PERSONNEL ARE USED BUT THAT COMPELLING REASONS EXIST TO USE PRIVATE PARTIES SECURED UNDER CONTRACTS AND ON A FEE BASIS, THE FEE TO BE FROM APPROXIMATELY $3 TO $50 DEPENDING UPON THE INCONVENIENCE, RISK, AND DURATION OF THE PARTICULAR EXPERIMENT. THE LETTER STATES THAT IT IS NOT FEASIBLE OR ECONOMICAL TO OBTAIN THE REQUIRED SUBJECTS THROUGH AN INDEPENDENT CONTRACTOR AS WAS AUTHORIZED IN 15 COMP. GEN. 738.

FURTHER, IT POINTED OUT THAT THE HUMAN SUBJECTS WILL BE REQUIRED IN SHORT RESEARCH EXPERIMENTS DEALING WITH THE CLINICAL USE OF INVESTIGATIONAL DRUGS; THE CONTROLLED EXPOSURE TO BIOLOGICAL SUBSTANCES, RADIATION, OR CHEMICALS; AND THE EXPOSURE TO CONTROLLED HIGH OR LOW TEMPERATURES OR TO ABSOLUTE SILENCE OR CONTROLLED NOISE. THE EXTENT OF THE CONTROL AND SUPERVISION IS EXPLAINED BY GENERAL GOSHORN AS FOLLOWS:

SUBJECTS ARE NOT SELECTED ON THE BASIS OF NORMAL EMPLOYEE QUALIFICATIONS. EDUCATION AND TRAINING ARE NORMALLY IMMATERIAL. SUBJECT MAY HAVE FULL TIME EMPLOYMENT AND ENGAGE IN THE EXPERIMENT WHILE ON LEAVE OR DURING OTHER OFF DUTY TIME. THE GOVERNMENT IS NOT INTERESTED SO MUCH IN WHAT THE SUBJECT PRODUCES THROUGH HIS EFFORTS, AS IN MEASURING AND EXAMINING THE SUBJECT'S REACTIONS TO A SET OF CONDITIONS INDUCED BY THE GOVERNMENT. THE GOVERNMENT EXERCISES NO CONTROL OVER THE SUBJECT'S REACTIONS IN THE SENSE OF DIRECTING THE SUBJECT HOW TO REACT, AND IN FACT THE EXPERIMENTATION IS VALID ONLY IF HIS REACTIONS ARE PURELY INDEPENDENT AND OBJECTIVE.

PAYMENT IS NOT BASED ON INDIVIDUAL QUALIFICATIONS NOR IS IT PREDICATED AS MUCH ON A TIME BASIS AS UPON THE RISK AND INCONVENIENCE WHICH THE SUBJECT WILL ENCOUNTER. HOWEVER, THE DURATION OF THE EXPERIMENT DOES HAVE A BEARING ON THESE FEATURES AND HENCE UPON REMUNERATION.

THE GOVERNMENT DOES NOT DIRECT OR CONTROL THE SUBJECT AS TO RESULTS RECORDS THE RESULTS OF ITS OWN EXPERIMENT IN WHICH THE PARTICIPATION OF RECORDS THE RESULTS OF/ITS OWN EXPERIMENT IN WHICH THE PARTICIPATION OF THE INDIVIDUAL IS A NECESSARY, BUT NONETHELESS NEUTRAL ELEMENT. ONE SUBJECT MAY REACT ONE WAY WHILE ANOTHER MAY REACT MUCH DIFFERENTLY. THESE VARIED REACTIONS, IF PRESENT, BECOME A PART OF THE RESULT IN WHICH THE GOVERNMENT IS INTERESTED, BUT ARE NOT RELATED IN ANY MANNER TO THE "EFFICIENCY OF PERFORMANCE" BY THE SUBJECT, TO THE REMUNERATION RECEIVED OR TO ANY WORK STANDARD WHICH THE SUBJECT IS EXPECTED TO ACHIEVE. FURTHER, THE GOVERNMENT DOES NOT DIRECT THE SUBJECT AS TO THE DETAILS AND MEANS BY WHICH CERTAIN PREDETERMINED RESULTS ARE TO BE ACCOMPLISHED. THE GOVERNMENT DOES DIRECT THE SUBJECT TO TAKE CERTAIN ACTIONS, FOR EXAMPLE, WHERE TO SIT, WHICH DRUG TO TAKE, AND HOW LONG TO STAY IN THE COLD ROOM; BUT THESE ARE NOT DIRECTIONS OF THE MEANS TO ACCOMPLISH A SPECIFIED RESULT; THEY ARE MERELY A DESCRIPTION OF THE PRECONDITIONS WHICH THE SUBJECT MUST MEET BEFORE HIS PARTICIPATION IN THE EXPERIMENT WILL BE OF ANY VALUE TO THE GOVERNMENT. HAVING FULFILLED THESE PRECONDITIONS THERE IS NO METHOD, COURSE OF ACTION, WORK PERFORMANCE, OR SERVICE REQUIRED OF THE SUBJECT WHICH, IF CARRIED OUT BY HIM, WILL CONSTITUTE HIS ACHIEVEMENT OF A SPECIFIED RESULT, OR HIS PRODUCTION OF A WORK UNIT. IF THE SUBJECT FULFILLS THE PRECONDITION, THE GOVERNMENT IS NOT INTERESTED IN ANY PERFORMANCE OF WORK BY THE SUBJECT; IT IS INTERESTED ONLY IN EXAMINATION AND MEASUREMENT OF THE RESULTS OF THE PRECONDITIONS IMPOSED ON THE SUBJECT AS REQUIRED BY THE RESEARCH.

A SUBJECT, SUCH AS HERE ENVISIONED, IS NOT EXPECTED TO BE ENTITLED TO LEAVE, RETIREMENT, SALARY, TENURE OR ANY OTHER NORMAL INCIDENTS OF EMPLOYMENT. IN SHORT, IT APPEARS THAT THE RELATIONSHIP BETWEEN THE GOVERNMENT AND THE RESEARCH SUBJECT WOULD NOT, UNDER USUAL CRITERIA, BE THAT OF EMPLOYER-EMPLOYEE. THE GOVERNMENT WOULD PAY THE SUBJECT A FEE IN EXCHANGE FOR AN AGREEMENT BY THE SUBJECT TO UNDERGO SPECIFIED RISKS OR INCONVENIENCES AND FOR A RIGHT TO EXAMINE AND MEASURE THE SUBJECT IN CONNECTION THEREWITH.

IT HAS BEEN PROPOSED THAT IMPREST FUNDS BE USED TO PAY THE FEE TO WILLING RESEARCH SUBJECTS (NOT GOVERNMENT PERSONNEL/--- A PROCEDURE WHICH IS CONSISTENT WITH THE SMALL AMOUNTS INVOLVED, THE SHORT DURATION OF THE SUBJECT'S PARTICIPATION, AND THE CONDUCT OF THE TYPE OF RESEARCH PROGRAMS CONTEMPLATED WHERE THERE IS LITTLE OPPORTUNITY FOR AN ELABORATE RECRUITMENT AND TIME-CONSUMING, EXPENSIVE PERSONNEL PROCEDURES. THE TIME AND EXPENSE INVOLVED IN PROCESSING APPOINTMENT AND SEPARATION PAPERS, REPORTING AND RECORD KEEPING WOULD FAR OUTWEIGH, IN MANY CASES, THE DURATION OF THE INDIVIDUAL'S PARTICIPATION IN THE RESEARCH AND THE REIMBURSEMENT WHICH WOULD BE PAYABLE. IT IS BELIEVED THAT APPROVAL OF THIS PROPOSAL COULD BE GRANTED IF IT IS DETERMINED THAT A CONTRACT FOR HUMAN SUBJECTS FOR MEDICAL RESEARCH UNDER THE CIRCUMSTANCES MAY BE CONSTRUED TO BE ONE FOR NONPERSONAL SERVICES. ACCORDINGLY, THE MATTER IS SUBMITTED FOR YOUR VIEWS.

IT HAS BEEN HELD THAT SERVICES NORMALLY PERFORMED BY GOVERNMENT PERSONNEL MAY BE PERFORMED UNDER CONTRACT IF IT CAN BE SHOWN THAT THE CONTRACTING OUT IS SUBSTANTIALLY MORE ECONOMICAL, FEASIBLE, OR NECESSARY BY REASON OF UNUSUAL CIRCUMSTANCES. THAT RULE IS TO BE APPLIED TO CONTRACT PROCUREMENT ON A STRICTLY JOB BASIS UNDER WHICH THE GOVERNMENT CONTRACTS FOR THE FURNISHING OF A PRODUCT OR THE PERFORMANCE OF A SERVICE WITH NO DETAILED CONTROL OR SUPERVISION OVER THE METHOD BY WHICH THE RESULT REQUIRED IS ACCOMPLISHED. 43 COMP. GEN. 390; 44 ID. 761. IT APPEARS TO US THAT UNDER THE CIRCUMSTANCES DESCRIBED IN THE LETTER FROM GENERAL GOSHORN A REASONABLE BASIS EXISTS FOR A DETERMINATION THAT IT WOULD BE MORE ECONOMICAL, FEASIBLE, OR NECESSARY BY REASON OF THE UNUSUAL CIRCUMSTANCES INVOLVED TO PROCURE THE RESEARCH SUBJECTS BY CONTRACT IN THE MANNER PROPOSED. THIS IS A UNIQUE SITUATION WHICH DOES NOT CLEARLY FALL WITHIN THE RULES FOR ESTABLISHING AN EMPLOYEE-EMPLOYER RELATIONSHIP. IN VIEW THEREOF, AND UNDER THE RELATED CIRCUMSTANCES, WE SEE NO OBJECTION TO A DETERMINATION THAT THE SITUATIONS HERE INVOLVED SHOULD BE MADE THE SUBJECT OF AN INDEPENDENT CONTRACTOR RELATIONSHIP RATHER THAN AN EMPLOYEE-EMPLOYER RELATIONSHIP AND PAYMENT MADE IN THE MANNER PROPOSED.