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Medical Experimentation and Informed Consent

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Should Medical Experimentation on Humans Be Permitted When the Subject Is Not Informed?
Annotated Bibliography

Scarlett 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

 

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Professor Vernellia R. Randall
Institute on Race, Health Care and the Law
The University of Dayton School of Law
300 College Park 
Dayton, OH 45469-2772
Email: randall@udayton.edu

 

Last Updated:
 03/10/2010

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