Ethics Tuskegee Syphilis Study Tuskegee Syphilis Study For

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Ethics

Ethics

Tuskegee Syphilis Study � Tuskegee Syphilis Study. For more than 30 years, health researchers

Tuskegee Syphilis Study � Tuskegee Syphilis Study. For more than 30 years, health researchers had followed black men diagnosed with syphilis but had neither informed them of their condition nor treated them for it (Heller, 1972; DHEW, 1973 a; Jones, 1992; ACHRE, 1995). � Revelations about this study contributed significantly to the passage in 1974 of the National Research Act (P. L. 93 -348). That Act explicitly provided for the creation of IRBs to review biomedical and behavioral research that involved humans and was funded by DHEW.

The Aversion Project 1971 s - 1989 s � Army psychiatrists aided by chaplains

The Aversion Project 1971 s - 1989 s � Army psychiatrists aided by chaplains aggressively ferreted out suspected homosexuals from the armed forces, sending them discretely to military psychiatric units, chiefly ward 22 of 1 Military Hospital at Voortrekkerhoogte, near Pretoria. � South Africa’s apartheid surgeons forced over 900 ‘sexual reassignment’ operations. � � Most of the victims were young, white males 16 to 24 year-olds drafted into the apartheid army. .

Dr. Aubrey Levin Head of the study, afterward became Clinical Professor in the Department

Dr. Aubrey Levin Head of the study, afterward became Clinical Professor in the Department of Psychiatry (Forensic Division) at the University of Calgary’s Medical School. He is also in private practice, as a member in good standing of the College of Physicians and � Surgeons of Alberta.

NY Willowbrook State School 1956 -1972 � Children were infected with a mild form

NY Willowbrook State School 1956 -1972 � Children were infected with a mild form of hepatitis during the initial stages of a study of the natural history, prevention, and treatment of viral hepatitis that extended from 1956 to 1972 � This study eventually contributed to the development of a successful hepatitis vaccine. � The Willowbrook research also contributed to the public debate over research ethics and the impetus for regulation

� � The Willowbrook research also contributed to the public debate over research ethics

� � The Willowbrook research also contributed to the public debate over research ethics and the impetus for regulation Major points of discussion were the infecting of healthy institutionalized children and the adequacy or appropriateness of the process for securing parental consent (permission) Researchers were well regarded and research oversight committees had reviewed some of the study proposals. In the Willowbrook research, parents had been asked for and had provided consent in an era when that was not uniform practice.

THE MONSTER STUDY, Wendell Johnson University of Iowa in 1939 Focus: wanted to discover

THE MONSTER STUDY, Wendell Johnson University of Iowa in 1939 Focus: wanted to discover the cause of stuttering by attempting to turn orphans into stutterers. � � � There were 22 young subjects, 12 of whom were non-stutterers. Half of the group experienced positive teaching whereas the other group dealt with negative reinforcement. The teachers continually told the latter group that they had stutters. No one in either group became stutterers, but those who received negative treatment developed self-esteem problems that stutterers often show. Johnson’s reputation as an unethical psychologist has not caused the University of Iowa to remove his name from it Speech and Hearing Clinics

John Watson, Father of behaviorism Goal: to see if fear was innate or a

John Watson, Father of behaviorism Goal: to see if fear was innate or a conditioned response. Exposed a 9 month old orphan to 9 items for two months with no conditioning. Then he would strike a suspended steel bar with a hammer when the baby touched the rat. The infant cried in fear when he heard the noise. After several times the infant became distressed when the rat was disaplayed. Albert associated the white rat with the loud noise and was producing the fearful or emotional response of crying. The child generalized his fear response to anything fluffy or white (or both). He was never desensitized to his fear. He left the hospital before Watson could do so.

Fernald School, Waltham, MA

Fernald School, Waltham, MA

� MIT scientists conducted a nutritional study for Quaker Oats. Boys voluntered to participate

� MIT scientists conducted a nutritional study for Quaker Oats. Boys voluntered to participate in a science club but were fed oatmeal & milk dosed with high levels of radiation.

Criticisms of unethical research practices in research involving children 1960 � � New England

Criticisms of unethical research practices in research involving children 1960 � � New England Journal of Medicine, 1966 Henry Beecher reviewed 22 studies 4 involved children. 1. Used multiple spot X-rays to study bladder filling and voiding in babies Involved the suturing of adult skin grafts to the 2. chest wall of a subset of children being treated for congenital heart disease to examine the effect of thymectomy on growth and development 3. Children with mental retardation who were given an antibiotic (for the treatment of acne) to determine whether it caused liver dysfunction (which it did) (Beecher, 1966).

Andrew Wakefield 1998 Clinical vaccine trail 12 patients in trial: 5 displayed developmental delays

Andrew Wakefield 1998 Clinical vaccine trail 12 patients in trial: 5 displayed developmental delays prior to receiving the MMR vaccine � 3 in the trial never had autism. � � Published results in 1998 The Lancet � Wakefield, misrepresented or altered the medical histories of all 12 of the patients whose cases formed the basis of the 1998 study � Britain stripped Wakefield of his medical license in May 2011 � http: //www. ageofautism. com/dr-andrew-wakefield/

Consequences of Unethical Clinical Trial � After publication vaccination rates dropped 80% by 2004.

Consequences of Unethical Clinical Trial � After publication vaccination rates dropped 80% by 2004. United States CDC reported more cases of measles in 2008 than in any other year. CDC reported that 90% of those infected had not been vaccinated or their vaccination status was unknown. Most of his co-authors withdrew their names from the study in 2004 after learning he had been paid by a law firm that intended to sue vaccine manufacturers -- a serious conflict of interest he failed to disclose.

Institutional Guide to DHEW Policy for the Protection of Human Subjects 1971 � U.

Institutional Guide to DHEW Policy for the Protection of Human Subjects 1971 � U. S. Department of Health, Education, and Welfare (DHEW) further formalized its policies on protecting human research participants in the. � forth six basic conditions for informed consent, including the condition that the discussion of participation describes risks and discomforts, expected benefits, alternatives to research participation, and freedom to discontinue participation at any time.

� Rules adopted in 1983 described “the mentally disabled” as a vulnerable population in

� Rules adopted in 1983 described “the mentally disabled” as a vulnerable population in need of additional—but undefined— protections by IRBs, and they required consent to research participation by a legally authorized representative (see the discussion in NBAC, 1998).

1927 Supreme Court Case Buck v. Bell” Justice Oliver Wendell Holmes declared “Three generations

1927 Supreme Court Case Buck v. Bell” Justice Oliver Wendell Holmes declared “Three generations of imbeciles is enough, ” and ruled that involuntary sterilization of the “feebleminded” — the long-sought goal of eugenicists — was to become the law of the land. In an 8 to 1 decision the Court legitimized Virginia’s law on sterilization which was not repealed until 1974.

www. nap. edu/openbook. php? record_id =10958&page=53

www. nap. edu/openbook. php? record_id =10958&page=53

� Top 10 Unethical Psychological Experiments � http: //listverse. com/2008/09/07/top-10 unethical-psychological-experiments/

� Top 10 Unethical Psychological Experiments � http: //listverse. com/2008/09/07/top-10 unethical-psychological-experiments/