Historical Cases of Unethical Research



Historical Cases of Unethical Research

Serena Marsden & Melissa Melander

University of North Dakota

 

There have been historical eases of unethical research that have contributed to how we work with participants today. We will discuss what some of these historical cases were and how they have contributed toward present values and ethics in research. The cases we will look at are the unethical Nazi experiment, the Stanley Milgram's experiment, the Tuskegee Syphilis study, the Willowbrook study, and the Laud Humphrey's "Tearoom Sex" study. These studies led to the creation of the Belmont Report and the Institutional Review Board (IRB) which were formed to protect human subjects involved in research.

 

The history of research ethics begins with the tragic history of research abuse by Nazi doctors during World War II. A total of sixteen German physicians practiced unethical medical experiments on Jews, gypsies, and political prisoners. In 1947, out of this horror, came the Nuremberg Code and other international codes of ethics written to protect research participants. Under this code, the physicians were convicted for crimes against humanity. This also led to standards in research requiring that subjects participate voluntarily and are informed of the risks of the research.

 

Next is the Stanley Milgram's experiment. Stanley Milgram was a psychologist from Yale University. He conducted a study on the conflict between obedience toward authority and ones personal conscious. He examined justification for acts of genocide offered by those accused at the World War II, Nuremberg War Criminal trials. Their defense was based on "obedience" and that they were just following their supervisor's orders.

 

This experiment demonstrated how people reacted toward an authority figure while giving an apparent electrical shock. In the experiment, so called "teachers" (who were unknown subjects of the experiment) were recruited by Milgram. They were asked to administer an electrical shock of increased intensity to a "learner" for each mistake he made during the experiment. The fictitious story given to these "teachers" was that the experiment was exploring effects of punishment (for incorrect responses) on learning behavior. The "teacher" was not aware that the "learner" in the study was an actor merely faking discomfort as the "teacher" increased the intensity of the electric shocks. The shocks were administered by the "teacher" starting at 15 volts. When the "learner" gave an incorrect response, the volt would increase by 15 volts intervals. Some teachers went to the maximum of 450 volts. At times the "teacher" questioned the experiment but continued even though some were obviously extremely uncomfortable in doing so. This study raised many questions about how the subjects could bring themselves to administer such high shocks. More important to our interests are the ethical issues it raised itself.

 

In 1932, the Tuskegee Syphilis Study was a 40-year project administered by the US Public Health Service in Macon County, Alabama. The American Government promised 400 men free treatment for bad blood which had become an epidemic in the county. The treatment was never given to the men and was in fact withheld. The study

sample was made up of poor African American men who were told that they had "bad

blood". These men did not receive standard treatment for syphilis even when penicillin was available later during the study. The men in the study were not informed of the research design and it's risks to them.

 

The Tuskegee Study symbolized the medical misconduct and blatant disregard for human rights that takes place in the name of science. The investigators were not mad scientists; rather they were government physicians, respected men of science, who published their reports of the study in medical journals. The subjects of the study bear witness to the premise that the burden of medical experimentation has historically been borne by those least able to protect themselves. The government doctors who participated in this study failed to obtain informed consent from the subjects. The study's unethical features did not come to light until 1972 when Jean Heller who broke the story. By this time, over one hundred of the infected men died and others suffered from serious syphilis related conditions. The case never came to trial. Each participant only received $37,500 in damages, and the heirs of the deceased received $15,000.

 

From 1963 to 1966, the Willowbrook Study involved a group of children diagnosed with mental retardation, who lived at the Willowbrook State Hospital in Staten Island, New York. These innocent children were deliberately infected with the hepatitis virus; early subjects were fed extracts of stools from infected individuals and later subjects received injections of more purified virus preparations. Investigators defended the injections by pointing out that the vast majority of them acquired the infection anyway while at Willowbrook, and it would be better for them to be infected under carefully controlled research conditions.

 

The study's purpose was to study the history of the disease when left untreated and later to assess the effects of gamma globulin as a therapeutic intervention. Gamma Globulin is proteins in human blood plasma, which include most antibodies. The antibody substances are produced as a protective reaction of the body's immune system to the invasion of disease producing organisms. When a patient is injected, it creates a rapid but temporary immunity in patients who have been exposed to disease. This study generated a variety of concerns, such as the deliberate infection of the children and the attempts to convince the parents to enroll them in the study in exchange for admission to the hospital (which was deliberately short of space).

 

In the mid-1960s, Laud Humphreys, a sociologist, recognized that the public and the law enforcement held stereotypical beliefs about men who committed impersonal sexual acts with one another in public restrooms. "Tearoom sex", as fellatio in public restrooms is called, accounted for the majority of homosexual arrests in the US. For his PhD dissertation at Washington University, Humphreys decided that is was important for society to gain a better understanding of who these men were and what motivated them to seek quick, impersonal sexual gratification. He set out to answer this question by means of participant observation and structured interviews. Humphreys stationed himself in "tearooms" and offered to serve as a "watchqueen". The "watchqueen" would be the person who would keep an eye out for law enforcement or would cough if a stranger were approaching the area. He observed hundreds of acts and gained the confidence of some of the men he observed. He disclosed his role as a scientist and persuaded them to tell him about their personal lives and motives. To avoid bias, Humphreys secretly followed some men and recorded the license numbers on their vehicles. A year later, Humphreys showed up at their private homes and claimed to be a health service interviewer. He asked them questions about their marital status, race, job, and other personal questions.

 

Humphreys' findings destroyed many stereotypes. He found that 54% of the men were married, and 38% were neither bisexual nor homosexual. Most of the men were successful, well educated, economically stable, and highly praised in the community. Only 14% of the men he observed were homosexual and part of the gay community ().

 

Humphreys' research was administered in the mid- 1 960's before the IRB was in existence. There were members of Washington University who objected to Humphreys research stating that it unethically invaded the privacy and threatened the social standing of the subjects. Some faculty went so far as to petition to the president of the University to rescind Humphreys Ph.D. degree. The uproar caused fist fight among faculty and the exodus of department members to other Universities.

 

So what became of all this in regards to ethical research? In 1979, the federal government developed regulations of ethical principals underlying the current regulations and standards that are contained in the Belmont Report. It was the capstone of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It outlines the ethical principals upon which the ethics of a research study are evaluated in the United States. The Belmont Report embodies the moral consensus upon which stand our present US Federal regulations governing the ethics of human subjects research conduct with Federal funds from the majority of Federal agencies. Our present regulations formulize The Belmont Report's requirements for informed consent and establish another Commission recommendation that formalized and extended the existing peer review system of that time, which has matured into the Institutional Review Board (IRB) system that we have today.

 

The role of the IRB is to protect the rights and welfare of individual research subjects. This goals is accomplished by having the IRB assure that the following requirements are satisfied:

 

1. risk to subjects are minimized

2. risk to subjects are reasonable in relation to anticipated benefits,

3. selection of subjects is equitable, i.e. fair

4. informed consent is sought form each subject or his/her legally authorized

representative,

5. informed consent is appropriately documented,

6. when appropriate, the research plan makes provisions for monitoring data

collection,

7. privacy and confidentiality of research subjects is appropriately protected, and

8. when some or all of the subjects are likely to be vulnerable to coercion or undue

influence, additional safeguards have been included.

 

The IRB has to approve that these requirements are followed before they approve a

research study and must review these documents on, at the least, an annual basis.

 

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download