RESEARCH PARTICIPANTSAnd the Evolution of Their Protection

In the beginning...

♦Prior to World War II researchers had little concern for the treatment of human participants in research studies

♦There were no formal protections for individuals involved in research

1948....The Nuremberg Code Standards for physicians to conform to when

carrying out experiements with human subjects

♦The Nuremberg Code was the result of judgement concerning war crimes involving 23 Nazi physicians and administrators who conducted medical experiments on concentration camp prisoners♦These prisoners died or were

permanently affected as a result of these experiements

10 Standards of the Nuremberg Code

♦ Volunteers freely consent to participate♦Researchers fully inform volunteers

concerning the study♦Risks associated with the study are

reduced where possible♦Researchers are responsible for

protecting participants against remote harms

Nurmemburg Code cont.♦ Participants can withdraw from the

study at any time♦ Qualified researchers conduct the

study♦Cessation of the study if adverse effects

emerge♦Society should benefit from study

findings♦Research on humans should be based

on previous animal or other previous work♦A research study should never begin if

there is a reason to believe that death or injury may result

POST NUREMBURG CODEThe abuses continue....

♦ There continued to be abuses of humans in research after 1948♦ Some of these abuses occurred in

the following studies:♦Tuskeegee Syphilis Study 1932-1972♦Willowbrook State School 1963-1966♦ (Viral Hepatitis)♦Milgram Obedience Study early

1960's

TUSKEEGEE SYPHILIS STUDY1932-1972

♦ The US public health service was trying to document the natural progression of syphilis

♦399 participants who were already infected with syphilis were recruited for the study - the participants did NOT know they had the disease

♦Participants were told they were being treated for “bad blood” and denied any treatment for syphilis

♦ Participants were disadvantaged, rural black men

WILLOBROOK SCHOOLSTUDY: Viral Hepatitis

Willowbrook was a school constructed in 1938 for “mentally retarded” children.It did not open for this purpose until 1947 when the New York State Department of Mental Hygiene took over the building.

Between 1963 and 1966 a very controversial study was conducted at Willowbrook.

The subjects (all ‘mentally retarded’ children) were deliberately infected with the Hepatitis virus. Early subjects were fed extracts of stools from infected individuals, and later sujects received injections of more purified virus preparations.

Researchers justified their actions by claiming that the students were likely to contract the virus anyway while attending this school, and it was better to have them medically supervised and in a study.

WILLOBROOK SCHOOLcont.

During the course of these studies, the ‘main’ area of Willowbrook (with unaffected children) was closed to new patients; parents found that the only way to have their child admitted to the school was to agree to their participation in medical studies. Many parents claimed not to have been told exactly what the research studies being done involved.

More ScandalsIn 1972 Geraldo Rivera, conducted a series of investigations at Willobrook and uncovered deplorable conditions which included: overcrowding; inadequate sanitary facilities, and physical abuse of residents by staff.

After a class-action lawsuit was filed and settled, it still took several more years before all of the violations were corrected.

In 1983, the State of New York announced plans to close Willowbrook; in 1987 the last child residents left the school permanently.

MILGRAM OBIDIENCESTUDIES

As a result of the happenings in Nazi Germany, Stanley Milgram (a PhD. Student at the time) devised a series of experiments to answer the question “Could it be that Eichmann and his million accomplices in the Holocaust were just following orders? Could we call them all accomplices?”

Milgram began his work at Harvard and initial research was done between 1961 and 1962.

In response to a newspaper ad offering $4.50/hour, an individual was asked to take part in a psychology experiment investigating memory and learning.

The individual was introduced to a “stern looking” person in a white lab coat and a “pleasant and friendly” co-subject. They were then told that on was the ‘teacher’ (participant) and one was the ‘learner’.

Milgram cont.The learner was taken to a room and strapped in a chair and an electrode was placed on his arm. The learner was really an actor and was not actually receiving any shocks, although the teacher thought that he was.

The teacher was instructed to read a list of two word pairs and ask the ‘learner’ to read them back. If the learner got the answer incorrect, the teacher was supposed to shock the learner starting at 15 volts.

The generator had switches ranging from 15 volts to 450 volts; each was labelled (e.g. Slight shock; DANGER – severe shock).The teacher was to increase the shock each time the learner missed a word.

After several voltage increases, the actor started to bang on the wall that separated him from the subject (i.e. the teacher), and complaining about a heart condition. At times the worried ‘teacher’ would question the ‘experimenter’ (i.e. man in the lab coat) often asking who would be responsible for any harmful effects on the ‘learner’. Upon receiving the answer that the experimentor assumed all responsibility, many of the subjects then continued to shock the learner, even though the were uncomfortable doing it.

Milgram cont.This study would not be allowed today as it would be deemed unethical.The possible psychological harm to the subject is the major stumbling block in Milgram’s research.

However, many important things were learned from the Milgram Obedience study.

The theory that only ‘monsters’ or ‘sadistic’ people would inflict cruelty was disproven.

Milgram’s findings show that ultimately 65% of the ‘teachers’ punished the learners to the maximum voltage.

None of the subjects stopped before reaching 300 volts!

Further studies showed that proximity of ‘teacher’ to ‘learner’ or ‘experimenter’ to ‘teacher’ affected the likelihood of maximum shock delivery. However, 32% of participants still delivered the full shock even when they were required to hold the hand of the ‘learner’ while doing it.

RESEARCH STANDARDSThe Progression of Regulations Through the 1900's

Canada (NSERC and SSHRC)

The Memorandum of Understanding

Canada 1998

Tri-Council Policy Statement

U.S.A. 1979

The Belmont Report

U.S. Military 1948

The Nuremburg Code

THE BELMONT REPORT1979

♦ The US National Commission for the Protection of Human Subjects of Biomedical and Beharioral Research was created to identify ethical principles and develop guidelines♦ They developed 8 guidelines,

including the need for informed consent, assessment of risks and benefits, and selection of appropriate subjects

TRI COUNCIL POLICYEthical Conduct for Research Involving Humans

♦ The Medical Research Council first made ethics guidelines in 1978 and then in 1987♦The MRC, NSERC and the SSHRC

adopted a policy (hence ‘tri council’) in 1998♦As a condition of funding, the

councils require that researchers and their institutions apply the ethical principles of the policy

TRI COUNCIL cont.Guiding ethical principles:

♦Respect for human dignity♦Respect for free and informed consent♦Respect for vulnerable persons♦Respect for privacy and confidentiality♦Respect for justice and inclusiveness♦Balancing harm and benefits♦Minimizing harm♦Maximizing benefits

* PRESENTLY BEING UPDATED TO ADDRESS NEW DEVLOPMENTS IN RESEARCH ETHICS *

ETHICS CASE STUDYZIMBARDO’S PRISON EXPERIMENT

♦College students who answered a city newspaper ad for participants in a study of prison life were personally interviewed, given a battery of personality tests, and completed background surveys that enabled the researchers to pre-select only those who were mentally and physically healthy, normal and well adjusted

♦They were randomly assigned to role-play either prisoners or guards in the simulated prison setting constructed in the basement of Stanford University's Psychology Department.

Zimbardo cont.The major results of the study can be

summarized as follows:♦many of the normal, healthy mock prisoners suffered

such intense emotional stress reactions that they had to be released in a matter of days; most of the other prisoners acted like zombies totally obeying the demeaning orders of the guards

♦ the distress of the prisoners was caused by their sense of powerlessness induced by the guards who began acting in cruel, dehumanizing and even sadistic ways.

♦The study was terminated prematurely because it was getting out of control in the extent of degrading actions being perpetrated by the guards against the prisoners -all of whom had been normal, healthy, ordinary young college students less than a week before.

Zimbardo cont.What do you think???

♦ Do you see any ethical concerns in the design and approach of this study?♦How could the ethical issues be

addressed?♦Are there any issues of bias in this

study?♦Give an example of a study in which

there is a bias in its construction (does not have to be a real study, can just be an example of poor study design)

PLEASE WRITE A BRIEF DESCRIPTION OF THE ZIMBARDO STUDY IN YOUR NOTES, ALONG WITH THE

ANSWERS TO THE ABOVE QUESTIONS!