ethical issues 1. ethical behavior 2. the nuremberg code 3. irb

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Ethical Issues 1. Ethical Behavior 2. The Nuremberg Code 3. IRB

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Ethical Issues

1. Ethical Behavior

2. The Nuremberg Code

3. IRB

Ethical behavior (definition)

Behavior is ethical insofar as it follows the rules that have been specifically oriented to the welfare of the larger society and not to the self-interest of the professional

To act unethically is to act unprofessionally

Ethical research

There's no such thing as perfectly ethical research

In fact, all research is inherently unethical to some degree

This is because you're using the most powerful tools science has to offer in getting at truth or some needed change, and with your results, somebody's going to be proven wrong or lose out in the power struggle

Ethical research

There's also no such thing as totally harmless research

Somebody, usually your subjects, is going to be harmed, either psychologically, socially, physically, or economically

Their privacy is invaded to get any useful information (why do research on the obvious, surface characteristics of people?), and this is psychological harm

Social Harm

Socially and physically, we are harming them by taking up their time with our “silly” research

Economically, we are exploiting them by not paying them for their contribution

We, the researchers, will go on and become famous writing a book about them, but they will always remain lowly research subjects

Ethically, research is just a whole awkward and asymmetrical situation overall.

Political Regulation of Research

Historically, governments have had to put serious restrictions on researchers. In fact, the origin of codes of research ethics can be traced to the NUREMBERG CODE, a list of rules established by a military tribunal on Nazi war crimes during World War II. 

Ethical Horror Stories

Dr. Josef Mengele (“Angel of Death”) Nazi doctor In the name of medical research, people were

infected with diseases New drugs have been tested Administered poisons Exposed to extreme temperatures and

decompression

Josef Mengele did a number of medical experiments, using twins

These twins as young as five years of age were usually murdered after the experiment was over and their bodies dissected

Mengele injected chemicals into the eyes of the children in an attempt to change their eye color

He stitched twins together, castrated or sterilized twins. Many twins had limbs and organs removed in macabre surgical procedures, performed without using an anesthetic.

Ethical Horror Stories

Josef Mengele

Josef Mengele and the other camp doctors - masterminds of the horrors of Holocaust - were found to be psychologically normal

They were men of fine standing, cultured, husbands who morning and night kissed their wives, fathers who tucked their children into bed

Tuskegee Syphilis Study

The deliberate failure to treat a group of African American males in Macon County (near Tuskegee), Alabama who had syphilis begun in 1932 and ended, by unfavorable publicity, in 1972

The study involved 600 black men--399 with syphilis and 201 who did not have the disease

Subjects were told that they were treated for "bad blood," a local term used to describe several ailments, including syphilis, anemia, and fatigue.

In truth, they did not receive the proper treatment needed to cure their illness

Tuskegee Syphilis Study

Tuskegee Syphilis Study

In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.

Tuskegee Syphilis Study

The U.S. Public Health Service (PHS) began using penicillin to treat syphilis in 1943

Despite this effective treatment, penicillin was deliberately withheld from the subjects

PHS repeatedly distributed lists of names of subjects to local physicians and instructed the physicians not to give penicillin to these subjects

Aspirin was given in an attempt to discourage subjects from seeking treatment elsewhere

As reported by the New York Times on 26 July 1972, the Tuskegee Syphilis Study was revealed as "the longest nontherapeutic experiment on human beings in medical history.”

All of the subjects died eventually Subjects did not suspect that no one cured

them

Tuskegee Syphilis Study

Study was sponsored by government

During the 1940s, 800 pregnant women, the poor patrons of a pre-natal clinic at Vanderbilt University, were given a "cocktail" including a tracer dose of radioactive iron

The objective of the experiment was to determine the iron requirements of pregnant women

Incidents of malignancies in the children of the women subjected.

Fernald School in Massachusetts (1950s)

Experiments conducted by researchers from the Massachusetts Institute of Technology

Mentally retarded boys in the school's "science club" were fed radioactive calcium and iron with their breakfast cereal

Boys who agreed to participate received club privileges, including extra milk and trips to baseball games and the beach.

University of Cincinnati (1971)

In a long-running experiment, 88 poor, uneducated African-American patients with incurable cancers were exposed to heavy doses of full-body radiation

University of Cincinnati (1971)

Experiment was sponsored by the U.S. military None of the subjects gave informed consent, they

thought they were receiving treatment for their cancer Subjects experienced nausea and vomiting from

acute radiation sickness, pain from burns on their bodies, and some died prematurely as result of radiation exposure

Subjects were not provided palliatives against the side effects of nausea and vomiting because the researchers did not want the drugs to interfere with their data collection

Injections of cancer cells (1963)

22 chronically ill patients in the Jewish Chronic Disease Hospital case

Objective was to learn if foreign cancer cells would live longer in debilitated

non-cancer patients than in patients debilitated by cancer Research funded by American Cancer Society

Injections of cancer cells (1963)

The subjects were not told that the injection contained cancer cells

The physicians "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer

Hospital administration tried to cover-up lack of consent, and some written consents were fraudulently obtained after the fact

Senator John D. Rockefeller issued a report revealing that for at least 50

years the Department of Defense has used hundreds of thousands of military personnel in human experiments and for intentional exposure to dangerous substances (mustard and nerve gas, ionizing radiation, psychochemicals, hallucinogens)

Other examples

Cold War Experiments

American Intelligence agencies believed that the Communists developed secret mind control/brainwashing techniques

This explains, but does not condone, the following abuses:

Cold War Experiments

1950’s, using code names like

Bluebird, Artichoke, the CIA, FBI, and U.S. military experimented with behavior-control devices and interrogation techniques (drugs, hypnosis, shock therapy, surgery, radiation) on unsuspecting citizens

If death or injury occurred these agencies provided cover-up

House Energy and Commerce Subcommittee (1986) Uncovered that during 30 years federal agencies had

conducted exposure experiments on American citizens

Injecting plutonium, radium, and uranium Feeding uranium to elderly patients during an

experiment at the Massachusetts Institute of Technology

Feeding patients real fallout from a Nevada test site U.S. Military employed former Nazi doctors /scientists

for conducting the experiments

The Nuremberg Code

Voluntary consent Fruitful results for the good of society Anticipated results will justify the performance

of experiment Avoid all unnecessary physical or mental

suffering No research should be conducted where

there is a reason to believe that death or disabling injury will occur

The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved

The Nuremberg Code

Proper preparation should be made-protect the research subjects against injure, or death

Research should be conducted only by scientifically qualified persons

During research the subjects should be at liberty to bring the research to the end

Research must be ready to terminate the research at any stage if there is possibility to hurt research subjects

IRB

Data: Anonymous _ Confidential __ Intentionally identified___

If anonymous or confidential, describe how anonymity or confidentiality will be maintained (e.g., coded to a master list and separated from data, locked cabinet, office, restricted computer, etc.). List all sites where data might be stored.

IRB

Who will have access to the data? Please be specific_____________

Will video tapes ___ audio tapes ___ photographs ___ be taken?

If yes, where will tapes or photographs be stored?

When will all research materials be destroyed?

IRB

How will subjects be selected or recruited and how will subjects be approached (or contacted)?

Describe any potential risks to the subjects, and describe how you will minimize these risks. These include stress, discomfort, social risks (e.g., embarrassment), legal risks, invasion of privacy, and side effects

Social Science Experiments

Social research might also put subjects at risk Three social scientific studies are cited most

often Laud Humphrey’s “Tearoom Trade” (1970) Stanley Milgram’s “Obedience to Authority”

(1974) Philip Zimbardo’s simulated prison

experiment (1972-1974)

Laud Humphreys and the Tearoom Sex Study He stationed himself in "tearooms" and offered to

serve as "watchqueen" He was able to gain the confidence of some of the

men he observed, disclose his role as scientist, and persuade them to tell him about the rest of their lives and about their motives

Humphreys secretly recorded the license numbers of their cars

A year later and carefully disguised, Humphreys appeared at their homes claiming to be a health-service interviewer and interviewed them about their marital status, race, job, and so on.

Humphreys' findings destroy many stereotypes

54% of his subjects were married and living with their wives

38% were neither bisexual nor homosexual: they were men whose marriages were marked with tension

24 % were clearly bisexual, happily married, well educated, economically quite successful, and exemplary members of their community

Another 24 % were single and were covert homosexuals

Only 14 % of Humphreys' subjects were members of the gay community and were interested in primarily homosexual relationships

Stanley Milgram’s “Obedience to Authority” Psychologist at Yale University, conducted a

study focusing on the conflict between obedience to authority and personal conscience

Germans are different Character flaw “Readiness to obey authority

without question, no matter what outrageous acts authority commands”

Everything in the experiment was staged except one person-subject

Milgram changed a lot in his initial script because people were obeying too much

Experiment

“Learner” is taken to a room where he is strapped in a chair to prevent movement and an electrode is placed on his arm. The "teacher" is instructed to read a list of two word pairs and ask the "learner" to read them back. If "learner" gets the answer wrong, the "teacher" is supposed to shock the "learner" starting at 15 volts

Experiment

The generator has 30 switches ranging from "slight shock" to "danger: severe shock“ The final two switches are labeled "XXX“ The "teacher" automatically is supposed to increase the shock each time the "learner" misses a word in the list. The "learner" was an actor who was never actually harmed

Results

“Two-thirds of this study participants fall into the category of ‘obedient' subjects, and that they represent ordinary people drawn from the working, managerial, and professional classes

65% of all of the "teachers" punished the "learners" to the maximum 450 volts

No subject stopped before reaching 300 volts

Results

The theory that only the most severe monsters on the sadistic fringe of society would submit to such cruelty is disclaimed

Ethical issues of Milgram’s experiment Milgram made a judgment about there is no

possible psychological damage to the subjects

Milgram interviewed subjects afterwards 83% said they were glad to participate 1.3% said they were sorry However, Milgram could not know that only

1.3% would be sorry

Zimbardo’s simulated prison experiment Subjects –males, undergraduate, paid

volunteers Role of either guard or prisoner Mock prison was constructed in the basement

of Stanford university Experiment was to have lasted for two weeks

but Zimbardo cancelled the study after 6 days because of possible harm

What went wrong?

Individuals became carried away with their roles

Guards behaved aggressively and dehumanizing toward prisoners

Prisoners behaved ether passively or were hostile

Subjects did consent to participate in the study, but they did not expect the consequences