Attachment 2

   
						March 29, 1966
John Reich, Asst. General Counsel
Research and Development
Office of the General Counsel, HDQ
Chester G. Brinck
Chief Counsel
Richland Operations Office

USE OF HUMAN VOLUNTEERS IN BIOMEDICAL RESEARCH - (ILLEGIBLE)
CONTRACTS


GC: RHB

As the attached letters indicate, two Research and Development
programs involving internal administration of by-product materials
in human volunteers are contemplated.  Our occupational health
contractor, Hanford Occupational Health Foundation (HOHF), would
support our R&D contractor, Battelle Memorial Institute/Pacific
Northwest Laboratory (PNL).  In the "Whole Body Counting" program
the volunteers would be adult college students (Each paid $15.00)
or PNL employees, or both.  Inmates of our State penitentiary would
be the only volunteers in the second program.

Under the HOHF and PNL operating contracts - (illegible)- the
Commission would have a direct responsibility (as distinguished
from the Washington designated type involving the use of human
volunteers, such as AT (45-1)-1781 with the University of
Washington, where the contractor accepts sole responsibility for
the work and the manner and consequences of its conduct);
therefore, the matter has been referred to headquarters for
guidance (See enclosure 1).

Some time age we concluded and gave an "off-the-cuff" opinion that
it would be proper for HOHF to undertake its portion of the "Whole
Body Counting" in view of the dosage involved (0.1 to 0.15
illegible) and upon advice that Idaho Falls has made similar
studies using volunteer plant personnel.  We would think that the
use of a disclaimer would be reasonable protection against all
claims but those grounded in willful and wanton negligence;  In
Bailey v. Safeway Stores, Inc., 55 Wn (2d) 728, 349 p (2d) 1077
(1960), the court, after equating the doctrine of assumption of
risk and the maxim volenti non fit injuria, adopted the following
language from Emerick v. Mayr, 39 Wn (2d) 23, 234 p (2d) 1079
(1951): :Under the doctrine of assumed or incurred risk, it is the
rule that one who voluntarily exposes himself or his property to a
known and appreciated danger due to the negligence or another may
not recover for injuries sustained thereby.  65 C.J.S. 848,
Negligence, Sec. 174.  Walsh v. West Coast Coal Mines, 31 Mn (2d)
396, 197 p (2d) 233.  In order to invoke the doctrine, it is
essential that the plaintiff shall have exposed himself or his
property voluntarily.  The doctrine can apply only where a person
may reasonably elect whether or not he shall expose himself to a
particular danger.  Also, it is essential that the risk of danger
shall have been known to, and 

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3.  The volunteers must understand that what is being done is an
experiment and is not for treatment or diagnosis of their own
conditions.

To avoid the problem of (illegible) only volunteers over the age of
21 would be considered.

As to the type of volunteer (Convict, student or employee) we have
these few comments:  We have researched the point and believe that
the Washington (illegible) has a right to contract and consequently
would be bound by a disclaimer.  Cost, convenience and control are
policy factors in that the state penitentiary is about 65 miles
from Richland. Workman's compensation problems might be created by
the use of employees.  Local adult college students could be a
logical choice.

Attachments:  3
1.  Ltr.  DTD. 3/30/66 - Waggoner to Dunham
2.  Ltr. dtd. 3/11/66 - Norwood to Waggoner
3.  Ltr. dtd. 3/1/66 - Bruner to Robinson w/attach

bcc:  AM Waggoner, AMA
RD Wildman, R&D Div.
CN Zanger, H&S Div.
CG Brinck
RH Bennett
Subject File
Reading File



Chief Counsel

Bennett: bnc
Brinck

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