Attachment 4

 
United States Government
Memorandum

To:       Dr. Charles L. Dunham, Director
          Division of Biology and Medicine

From:     Bertram H. Schur
          Associate General Counsel

Subject:  Use of Human Volunteers in Biomedical Research

This is in reference to a proposed memorandum to bring to the
attention of the General Manager the contemplated new AEC
biomedical research project involving the use of human volunteers. 
As we understand it, convicts, college students, and other
individuals, twenty one years of age or alder, will be invited to
volunteer, and monetary consideration will be paid for their
services.  These individuals will ingest or will be injected with
promethium-147 or plutonium-237.  This program will be conducted
for AEC by the Hanford Occupational Health Foundation.  You have
asked for our views.

From the legal standpoint, there are two areas of potential risk
which should be considered in the use of human volunteers in
experiments:

1.   Risk of adverse effects from the radiation experiments
properly carried out; for example, the risk that the intended
dosage of 0.1 roentgens might cause some pathological condition in
certain individuals.

2.   Risk of injury from negligent conduct in the course of the
experiment; for example, the risk that an experimenter might be
negligent in the operation of the radiation source and give dosage
of 1.0 rather than 0.1 roentgens causing injury to the volunteer.

It is our opinion that each volunteer should sign a written,
witnessed agreement in which he or she states that he or she is in
sound mental and physical condition anmd is participating in the
experiment on his or her own volition, that he or she understands
that what is being done is for experimental purposes and not for
the treatment or diagnosis of the individual, and that he or she
understands the the nature, procedures, and probable effects of the
experiment.  In addition, the agreement should set forth the nature
and purpose of the experiment, the procedure to be used (including
a description of the individual volunteer's participation or use in
the experiment), the known possible risks, if any, and the
arrangements, if necessary, for possible termination of the
experiment or research (e.g., if the volunteer later desires to
with draw from the experiment).  It would be advisable if the
ageement also negated any inference that the paid volunteers are
employees of the contractor for purposes of the experiment.  The
agreement should be signed only after the volunteer has had an

				 1

opportunity to ask questions.  Assuming complete understanding and
no unequal bargaining factors (e.g., pressure on prisoners to
submit), such an agreement would protect against liability for
unauthorized invasion of the person.

The consent form may also contain language absolving the contractor
and the AEC from responsibility for injuries to  a volunteer
resulting from the experiment.  This would probably be binding on
the volunteer if no negligence occurs.  It is doubtful, however,
that the clause can be so drawn as to be binding on the volunteer
if negligence causes the injury.  Not only is the law uncertain on
this point, but we can not be sure to what law will apply. 
(Developments in the field of conflicts of law have been such that
it is not clear whether the law of the State of Washington would be
applied in every case; for example, a volunteer residing in some
other state when his injury first becomes apparent might contend
that that other state has the most significant contacts with the
claim and that its law should be applied.)

Whether or not language absolving the contractor and the AEC from
liability - either with or without mentioning negligence - should
be incorporated in the consent form is a matter of policy.  It may
well be that the Commission would prefer not to attempt to add any
special provisions designed to eliminate or minimize possible
liability.  In this regard, it should be borne in mind that the
consent agreement itself, without specially added language, would
probably be considered as tantamount to a disclaimer of liability
for injuries resulting from the experiment properly carried out -
that is, where no negligence occurs.

We understand that the contractor has no special view with respect
to the obtainment of any special disclaimer agreements, and, also,
that liability insurance is available at a reasonable premium;
presumably, the contractor and (illegible) are exploring the
advisability of obtaining such insurance.


cc:  Chester G. Brinck, RL (illegible)
     Dr. Wm T. Doran, Jr., OS

				  2


		   For Reference See (15bb01.gif)


				  3