Should Medical Experimentation on Humans Be Permitted
When the Subject Is Not Informed?
Annotated BibliographyScarlett C. Taylor
Second Year Law Student
The University of Dayton School of Law
Spring 2001
INTRODUCTION
This annotated bibliography addresses the issues that arise in the area
of Medical Experimentation on humans. Many experiments bring up the
question of whether the patient was even aware of the experiment. This
annotated bibliography pulls from sources that address the impact of
uninformed experimentation on subjects. One major purpose of this
bibliography is to demonstrate the negative effects of uninformed
experimentation and the abuse of certain groups such as minorities and
women.
Medical experimentation on human subjects has become a popular topic
recently with the emerging issue of cloning human embryos. Many people
find this method of research to be morally compromising. However, medical
experimentation on humans in the United States dates back further than
issues of cloning. In fact, in the past experimentation on humans has
posed many moral questions beyond the actions taken within the experiment.
For example, why are certain groups used consistently as uninformed
subjects? How does deception in experimentation affect the relationship
between the health care institution and the targeted group? Will the
exclusion of one group from experimentation eventually equal the exclusion
of that same group for treatment? Also, does the government or any other
entity have the right to designate any one group of people as disposable
and therefore acceptable to experiment upon without consent?
One issue that is important for people to understand is that medical
experimentation without consent is not something that only happened in the
past. It still continues today. The most common groups to be targeted are
women and minorities. What are the implications of this? Are these groups
disposable and therefore ok to abuse? Or is it just that traditionally
these groups have no political voice and therefore will not be heard? Is
our government hoping that Americans will look at the historical and
present "abuse" of women and minorities and have the "better you than me
attitude?" What efforts have been made to stop non-consensual
experimentation?
In recent years, the government has publicly apologized for
non-consensual experimentation such as the Tuskegee Experiment, which used
black males as a control group to test the effects of syphilis. Of course
the government has formally stated that scientists must have informed
consent when conducting research. But, this becomes a thin line to draw
when there is controversy over exactly what is research and what is
considered practice. Our government has made tremendous efforts to
denounce studies such as the Tuskegee Syphilis Study; however, the
government has not made any major steps toward preventing these types of
experiments on certain groups. In fact, there are laws that prevent
military soldiers from a remedy when they have suffered as the result of a
non-consensual experiment.
In conclusion, the issue of human medical experimentation has a long
history in the United States. Medical experimentation has become more
regulated in recent years. However, many people are still uninformed as to
the abuse of certain groups as a result of these experiments. As you will
see, the amount of regulation that the government can place on
experimentation also depends on the amount of funding that the government
is contributing to the project.
Looking at the past abuses of certain groups, should the United States
continue this policy of experimenting on humans? What about when the
experimentation is uninformed? How could the United States possibly
regulate experiments and ensure that the participants are giving informed
consent? Does the "good of the overall population" outweigh each
individuals right to control what happens to his or her body? What if you
were a member of the "disposable" group?
ANNOTATIONS
U.S. v. Stanley, 107 S.Ct. 3054, 1987.
This is a case dealing with medical experimentation within the U.S.
Army and the remedies available to those who have been experimented on
without their knowledge or consent. In this case, a serviceman volunteered
to take part in an experiment testing the effectiveness of protective
clothing against chemical warfare. Stanley volunteered in 1958, and during
this year he was secretly administered L.S.D. by the Army on four separate
occasions. As a result of this exposure to L.S.D., he suffered severe
personality disorders and was discharged from the Army. In 1975, Stanley
received a letter from the Army asking for his cooperation in a study of
the long-term effects of L.S.D. on volunteers who participated in the 1958
tests. This was the first time that Stanley had been notified that he had
been exposed to L.S.D.
The main issue in this case is whether Stanley has a remedy here
against the Army. This is an issue due to the Federal Tort Claims Act (FTCA),
which precludes government liability for injuries to servicemen resulting
from activity incident to service. Justice Scalia, in his opinion, held
that no remedy is available to Stanley for injuries that arose out of the
course of activity incident to military service.
This case is informative because the facts are very clear and the main
issues that the court struggles with are well outlined. It also adds a
unique perspective to U.S. citizens who are victims of medical
experimentation. The FTCA basically grants the military the power to
experiment on its soldiers without consent. However, the opinion simply
refers to cases such as Bivens without explanation. This creates a
situation where the reader must stop reading the current case to try to
skim Bivens and figure out what exactly this court is talking about.
Although this case is an "easy read" it does not lay out the precedent for
current problems that victims of medical experimentation face when seeking
a remedy.
**total pages read 21
Delagado & Leskovac, Informed Consent in Human Experimentation:
Bridging the Gap Between Ethical Thought and Current Practice, 34 UCLA Law
Review 67 (Oct. 1986).
This article is divided into several parts. The first part talks about
the federal regulations concerning medical experimentation. Federal
regulations state that research cannot be carried out unless the
investigator has obtained the legally effective consent of the subject.
The second part talks about the reasons for protecting the policy on
informed consent for experimentation. One argument is that the researcher
and the subject have conflicting interests and as a result, the subject
could not be presumed to have consented. This article not only looks at
the current reasoning and arguments for protecting consent to
experimentation, but the author goes on to pose additional reasons. The
third section of the article looks at the remedies available to victims of
non-consensual medical experimentation and possible amendments to the
current rules, which would give victims greater protection.
This article is extremely informative and has many references to cases
and articles. Although lengthy, the organization of the article allows the
reader to pick and choose the relevant arguments and examples.
**total pages read 11
Shultz, From Informed Consent to Patient Choice: A New Protected
Interest, 95
Yale Law Journal 219 (1985).
This article is informative because it not only discusses the issue of
personal autonomy in medical experiments, but it also goes on to look at
cases where the emphasis on person autonomy and decision making in
research. This article also looks at the perspective of the doctor who
chooses to experiment on an uninformed subject. The article points out
that the doctors rationale may be that the patients consent was given when
the patient decided to place themselves in that particular doctor’s care.
This article is interesting because it not only points out the remedies
currently available to victims of medical experimentation, but also goes
one step further by pointing out the flaws in the current regulations.
**total pages read 6
Angelica Orb, Ethics in Qualitative Research, 1 Journal of Nursing
Scholarship 33, 93 (2001).
This article examines the ethical issues present in qualitative
research. The article starts off by looking at violations of human rights
in the name of scientific research. Experiments such as the Tuskegee
syphilis study and the study in which more than 1,000 pregnant women were
given diethylstilbestrol to prevent miscarriages. Both studies were
conducted without the informed consent of the subject. The remainder of
the article shows the related ethical issues and ethical principles that
are to be used in qualitative research.
This article is helpful when determining whether informed consent is
necessary. It overviews the role of doctors and nurses and the ways in
which their duty to science can conflict with their duty to the patient.
This article also addresses the pros and cons of using deception to obtain
some form of consent from the subjects. I like this article because it
focuses on the role of the researcher and suggests ways to solve the
conflicts that may be encountered in qualitative research. This article
does have a bibliography dealing with ethics in research.
**total pages read 8
Department of Health and Human Services Public Health Report 112: 33-36
(1997)
This article is divided up into two sections. The first section talks
about the continuing need for ethical principles and the second section
talks about distinguishing research from practice. In the first section,
the issue of public health practice and research is the main topic.
According to the author, situations where the benefits of a project
outweigh its risks should be the prerequisite for ethical research within
human subjects.
The second section distinguishes research from practice. This article
is interesting because most articles dealing with ethics in research
automatically assume that everyone has the same definitions of research
and practice. This article sets these two definitions apart and points out
problems when they can become confused. This article contains a
bibliography containing sources ranging from defining research to books
written on particular research experiments.
**total pages read 6
Isabel Wilkerson, Medical Experiment Still Haunts Blacks, New York
Times, June 3, 1991.
This article looks at the way in which minority communities have been
affected by non-consensual medical experimentation. The article begins by
looking at the Tuskegee experiment and then points out that today’s threat
to impoverished minority groups is not syphilis buy AIDS. However, because
of the mistreatment of minorities and women in past experimentation, there
is a lack of trust between blacks and the medical establishment and a lack
of blacks willing to participate in experimentation as a result.
This article is interesting because it points out how abusing certain
groups can lead to the complete self-exclusion of those groups in the
future. Most of the articles that I have come across look at the legal
effect or the ethical implications, but this article looks at the actual
impact that is has on the relationship between the "abused" and the
"abuser."
**total pages read 3
Stuart A. Nightengale, M.D., Current Issues in Human Subject
Protection: An FDA Perspective,
Sept. 3, 1996.
This is actually a folder of notes from a presentation given by the FDA
on medical experimentation. This folder is very extensive and contains
handouts, regulations, organizational charts, and various other tools for
explaining the FDA’s perspective on this area.
This folder I extensive and ranges from explaining the specifics of
certain non-consensual experiments to looking at regulations designed to
prevent these types of experiments, and looking at various issues such as
access to investigational drugs for treatment purposes. Although the
folder is very large, it is sectioned so that the reader can easily find
the areas his or her interest. Also, the reading is not overly
complicated. It is easy to read and understand although the concepts are
extremely complicated in some cases. There is not a bibliography for this
work.
**total pages read 50
|
