MEMORANDUM ON OBSERVATIONS ON VOLUNTEERS FROM PENITENTIARY

From: W. J. H. Butterfield Professor Everett I. Evans

In regard to your memorandum of December 10th, and our
conversations of December 11th, you will remember we thought it
advisable that I draw up a document concerning experiments with
human volunteers.

This seems to me altogether right and proper, as I am the person
to be held responsible for planning and carrying out the various
series of observations made. It should first be recorded that the
objective of the overall plan to use prisoner volunteers here was
accepted as mutually beneficial to the State of Virginia
authorities, the Penitentiary Officials and ourselves, and the
Deptartment of Defense. I cannot speak for the benefits accorded
the state officials etc., but I can say that without the original
idea, and its being followed through, most valuable and important
scientific information would have been denied us. I would
therefore like to emphasize at the outset that the information
derived from the trials with which I was concerned could not have
been secured without the prisoner volunteers.

The following questions arise with regard to these observations.

i. Why did we need to use prisoner volunteers?

ii. What procedures did they suffer, and why?

iii. Were these procedures dangerous; a threat to life, or a
threat to health?

iv. What are the broader sociological implications of these
trials?

v. Security measures with prisoner volunteer trials.

These questions may be taken up in turn.

1. Why did we need to use prisoner volunteers?

The observations required could not be made on volunteers from
the experimental group, because these people were needed, active,
in the laboratory while the subjects were needed at rest in bed.
The only remaining sources of volunteers were; medical students,
patients or the general public. It was impossible to countenance
using medical students, because the tests were of necessity
conducted over many months, July - December 1951, and medical
students could not be taken from classes over such a period of
time. Furthermore, all the volunteers could not be housed at the
same time during students vacation without chaotic overloading of
laboratory facilities and using all the burn unit beds. Those
facts denied us the possibility of having used medical students.

Concerning patients being asked to volunteer, this may be
dismissed immediately by pointing out that we needed healthy (not
convalescent) subjects. Concerning using the general public as a
source for volunteers, there are several problems. The first is
that the chances of getting fit young working men to take off
four to five weeks from work, without pay, seemed remote; it is
also contrary to national economic drives for production. The
physical and dietary status of unemployed persons would be
suspect. Thirdly, there was always the chance that volunteers
from the general public might withdraw from the tests, and ruin
the controlled conditions, due to business, illness in the
family, or discontent. Previous experience has shown that
volunteers from the general public are frequently idle people
looking for kudos, who become unwilling subjects, although the
procedures here were not serious, whenever outside distractions
arise. This is only reasonable.

On the other hand, when the opportunity arose to volunteer, very
many prisoners immediately asked to be considered, nor did any
withdraw after the first groups returned to the penitentiary.
Several men stated that "they expected to die", but "were willing
to risk it", although, as will be shown, this fear was entirely
ungrounded! The reasons that the prisoners volunteered must have
been a mixture of desire for a change of routine, the desire for
increased parole, and so on. Less materialistic considerations
appear to be related to atonement and a desire to be of service.
These questions will be considered in greater detail later.

2. What procedures did the subjects suffer, and why?

The volunteers were divided into three groups of four men. The
first and second groups were subjected to bed rest, and repeated
needles. They were also given a standard liquid diet and two of
them received a new drug, 11 - 17 Hydroxy-corticosterone.
However, it should be noted that this substance has been given to
other normal persons and its properties are well defined. The
very nature of the experimental procedures was such that all
changes induced were made under constant surveillance, so that,
had any profound, dangerous or untoward effects resulted, they
would have been detected. Other subjects in this group received
ACTH and others still received intravenous infusions of standard
therapeutic solutions, saline and glucose. All these compounds
are well known, safe, and well documented.

It may be asked why, if these substances had already been used,
they needed to be studied again. This can be answered simply by
saying that the exact combination of observations, all made at
the same time, was unique. They were required to provide
invaluable data on persons in bed, bandaged in the fashion of
burned persons, BUT NOT BURNED. For how else should we separate
the effects of bed and bandage on the one hand, and burn on the
other, in evaluating identical observations made on burned
subjects? (Note that, if sick people can sustain such
observations without risk, why not the prisoners?) So, for
reasons of comparison, the very large number of tests were made
daily on these subjects using methods identical with those used
for burned patients.

The second and third groups of prisoners also undertook to be
burned (heat) when the above studies were complete. The burns
were shallow and were of small extent. (1/2" diameter circles.)
They were inflicted on the forearms. It may be remarked here that
the investigator himself has inflicted larger and deeper burns on
himself two years ago, in an earlier study. All the burns (except
1) were no worse than blister burns. They were treated with
various well known and well tested therapeutic substances, which
were tried here for the first time in the therapy of flashburns
similar to those which might result from atomic bomb attacks.

Finally, various other information was derived from these trials.
The subjects provided data regarding the palatability of liquid
diets, and offered to test a new burn bandage, which test was
required urgently by the Department of Defence.

3. Were these procedures dangerous to life or health?

It may be said that, although in their ignorance the men expected
risks to their lives, actually none of the procedures in itself
could have been dangerous to life. Complications dangerous to
health were watched for carefully, none were seen.

By the time they were discharged from the study, all the
prisoners were either completely recovered from their procedures
or were progressing satisfactorily to the firm healing of their
small forearm burns. The only hazards to health, therefore, are
comparable to those of cigarette or hot fat burns, where the
statistical chances of long term complications are far lower than
injury on the roads or in places of work.

From the start, the writer recognized the risk of some unforseen
accident, a fall, a broken needle, an infected burn, but all
these complications were averted.

In this section it is important to emphasize the positive side of
the health question. Four prisoners had prophyllactic dental
care. One prisoner was provided with advice and therapy
concerning a possible amoebic liver abscess, another was found to
have evidence of early alcoholic cirrhosis, for which dietary
advice was given and explained. Another prisoner asked for a
check on his blood count, due to a strong family history of
leukaemia; this was provided, and arrangements made for him to
visit Doctor Watson James at intervals after his release. Another
prisoner was investigated for syphilis, another for diabetes
insipidus and yet another for early Van Recklinghausen's disease.
Finally, one man with five children, expecting an early release
asked for information about birth control; he was instructed and
advised to speak to his own doctor on arrival home. It may
therefore be said, with some justification, that the gains by the
application of health care to these men far outweighed the
hazards they faced.

4. The broader sociological implications of these trials.

Although the scientific inquiry involved here yielded some
invaluable and in every case original information on old drugs
and new agents, bandages etc., this was all concerned with a
limited field of human endeavor. There were, overlying it all,
broader social implications. Each group of men were addressed by
the writer on admission to the ward and it was explained to them
that, in our view, by volunteering for, albeit minor, suffering,
they had shown initiative not only to help themselves but to help
society. In so far as the latter point was continually stressed
to them, it seemed that an important feature of rehabilitation
was emphasized. Secondly, these men, granted that they were
carefully selected, were able to show nurses, patients, doctors
and orderlies, etc. by their demeanor and cooperative attitudes,
that some men, after receiving punishment for their offences,
have it in them to behave decently. This served to emphasize that
this type of criminal need not be ostracised automatically by
society, which would make their return to crime more likely.
Contrary wise, it seemed important that, by the relationships
they established with people brought into close contact with them
here, that these men may perhaps have come to recognize that
cooperation with society engenders good relations and fair
treatment. (These were the points discussed with Professor
Womack).

V. Security with prisoner volunteer trials.

A few words must be added concerning the problem of security in
such trials as these. This naturally falls into several
categories. If prisoners hear that they may volunteer, from the
newspapers, and if they go from prison to hospital, then at least
most of the prison inmates must know that the trials are
underway. From time to time men discharged from jail can carry
this information away. Secondly, the men selected have been those
who were due for release soon, and several subjects are now "at
large"; the reasons for their early release being noted at the
Welfare Board. Other information "leaks" that the trials are
going on include the patients on the wards at the time the
prisoners are in hospital; these patients may talk to visitors
during their hospital stay, or after their discharge from
hospital. Furthermore, no one from doctors, nurses to orderlies
outside the project have been sworn to secrecy: in fact such a
move would be impossible and foolish because of the excitement it
would engender.

Another feature of the security problem is the nature of the
experiments. This can be concealed in part, but since the
subjects must know the risks etc., they must know the form of the
trials. In every case, the men have been asked not to talk about
the nature of the experiments, though no doubt, they have told
their cellmates the generalities of the affairs. Certainly, they
signed no documents saying they wouldn't speak of their being
volunteers. You will see later that I think such an oath might
occasion sadistic practices. Anyway it would be impossible for
them to conceal the form of their participations from other
prisoners, family, prison authorities etc. However, the detailed
results of the trials, from the scientific point of view, are
completely secure and naturally will remain so.

It seems to me that, regarding "security" in this type of
experiment, one can only hope for security of results. That the
trials are going on must now be known to thousands of people and
to the audience of at least one radio program. It is my view that
the best ways to circumnavigate any unpleasantness over these
trials are -- the least said the better, and the more emphasis on
the sociological implications rather than experimental
implications the better. My views about the overall guiding
principle for conducting prisoner trials are referred to below. I
believe those views meet any "unpleasantness" quite squarely.

CONCLUSIONS

These trials, which yielded invaluable information on many
subjects, were designed to minimize suffering and the risks
involved were very small. The men knew that they could withdraw
from the tests any time but they did not. Actually one man was
released from jail during the final trial, but asked to have his
release deferred to see the experiments through, despite his
natural desire to return home to wife and children.

Based on my experiences, certain general points may be set down
regarding our using prison volunteers for human trials.

a) Although the men may expect high risks, the proceedures should
be explained to them, beforehand, and the actual risks made clear
to them.

b) They must always feel free to contract out of the trials.

c) With the type of men so far selected, the importance of their
behavior in influencing people towards a more pleasant attitude
to a punished man can be stress from the outset, and is not
without effect.

d) One can only hope for security of experimental data in these
trials. To demand any other security will only awaken curiosity.
It is far better to be open about this type of experiment -- see
below.

However, no complete list of hard and fast general rules about
any human volunteer experiments can be laid down. It is obviously
best if the investigator has undergone the various procedures
himself. But if the risks to life are high, the men must know it
and be free to refuse the risks without loss of face. In every
case, every attempt must be made to minimize suffering.

However, by far, the most important principle and aspect involved
is the attitude of the experimenter. If he is sadistic, the
results of prisoner volunteer trials could be catastrophic. If he
is a sympathetic doctor, he will know within whether the demands
he is making on his volunteers are justified. This applies to all
clinical research.

The only cast iron suggestions I can make are these. All human
beings exposed to trials, dangerous or otherwise, can withdraw,
and have a chance for protest. In any human experiment, the
subjects must know the risks, and any human experiment must
undertake to be open to inquiry and, if necessary, investigation.
Here is a way to separate sadistic from humanistic
experimentation.

Since the risks involved here were low, since the investigator
himself had suffered all the procedures himself and since the
gains were high, this investigator faces these trials with a
completely clear conscience, nor does he fear any inquiry.

This memorandum is based on a progression of thinking over the
last six months. If you agree, I would like a copy to be lodged
in Colonel Wood's office, lest any difficulties arise for which I
stand responsible after my return to England.

W.J.H. Butterfield