Running head: WILLOWBROOK CONFLICT BETWEEN RESEARCH AND ETHICS Willowbrook Conflict Between Research and Ethics July 05, 2010 Willowbrook Conflict Between Research and Ethics The Willowbrook State School for children with mental retardation became notorious for and a prime example of a conflict between research and ethics when the details of a research project and the treatment of the residents.
Willowbrook initially opened as a new hospital serving WWII veterans however this changed when in 1951, “the hospital was established as the Willowbrook State School for people suffering from mental disabilities” (Starogannis & Hill, 2008, p. 87). Willowbrook continued to serve as a fronted rehabilitation facility for the mentally developmentally delayed from 1956 -1971. Residents of the facility were subjected to more than rehabilitation as purported in the name of the facility. Mistreatment, terror, and even traumatic events have occurred within the walls of this school and documentation of many of the acts exists.
The hepatitis study involved the residents of Willowbrook and the topic of the conflict between research and ethics. The research conducted at Willowbrook State School for children with mental retardation began in 1956 and involved the residents and administration of a live hepatitis virus to those selected or entered the research project. “Hepatitis studies were conducted at the Willowbrook State School for children with mental retardation from 1956 – 1971 because Hepatitis was a major problem at Willowbrook.
Given the unsanitary conditions that the children lived in, it was virtually inevitable that children would contract Hepatitis” (Ethics in Mental Health Research [EMHR], n. d. ). Consent obtained for the research project came about as a study described and explained to participants however many were enrolled into the study as the experimental area of the facility were the only spaces available in an area in which parents or legal guardians were anxious or possibly desperate to enroll a person into the school. Parents were told that if they wanted their child to be admitted to Willowbrook, and skip the long waiting list, they would have to consent to these medical experiments” (Starogannis & Hill, 2008, p. 88). Methods and appropriateness of acquiring consent for the participants to be included in a research study when the only access to admission to the facility was placing the child in experimental facility. “In the Willowbrook research, parents had been asked for and had provided consent in an era when that was not uniform practice” (NAP, 2004).
At the time the research, guidelines for research did not exist as these do today and protection for the participants of the study was not as prevalent as today. “The Willowbrook Class as they were to become called, consisted mostly of children and adolescents (but some adults as well), perhaps the largest proportion of profoundly retarded children of any New York institution in the day, and certainly the highest proportion of African-American and Puerto Rican patients in the state” (Starogannis & Hill, 2008, p. 7). An increase in population resulted from families bring children to the facility from throughout New York as they received little or no help from governmental agencies in the challenges encountered a child with special mental and/or physical needs, which then contributed to overcrowding. This overcrowding contributed to the spread of hepatitis in the facility and ultimately the hepatitis studies of Willowbrook State School for children with mental retardation.
Thus far, the research has indicated the research findings invalid or without positive aspects. The information gleaned from the studies did ultimately lead to future success: “New York’s Willowbrook State School Researchers infected some of the child participants 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 and that 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” (NAP, 2004). This research does not downplay the egregious acts of the research or coercing family members or guardians to consent to the research study through allowing entry into the school via the experiment venue. The residents of the school suffered while being exposed to a live hepatitis virus and while living in severely unsanitary conditions with undertrained and unsupervised staff that performed acts of violence on residents of the school. Children were sitting on the floor, some nude covered in feces, rocking back and forth making pitiful sounds. Willowbrook was a state school, yet there was very little education happening. This was simply a dumping ground for the city’s unwanted children. The staff, overwhelmed and under-supervised, resorted to prison-style control tactics: disruptive residents were confined in solitary ‘‘pits’’ and left for hours or were beaten with keys and sticks” (Starogannis & Hill, 2008, p. 89).
Evidently the research setting was not the optimal setting; the research was performed during a time when guidelines were nonexistent. Protection of the residents was put aside to reach for a vaccine that would aid many more than were affected which places into question the ethical behaviors of the determining entities. A misguided attempt by researchers to justify the administration of a live hepatitis virus into otherwise healthy children seen was determined acceptable by the physicians of the facility as well as many government agencies. This study was designed to follow the natural progression of a disease—in this case viral hepatitis. Children with disabilities were intentionally infected with the virus and then studied during the progression of the disease. A particularly disturbing aspect of the research was that it was reviewed and approved by the New York State Departments of Mental Hygiene, Mental Health, the Armed Forces Epidemiological Board, and the New York University School of Medicine, in addition to the Willowbrook School.
Although parental consent was given, the consent was based upon the school’s declaration that there was room for new students at the school only in the experimental unit” (“Trends”, 2007). The determination of appropriateness of the study by the physicians involved as well as the government agencies questions the ethics on both sides of the children in the middle of the research by making the determination that the lives of those children were not as important as the research. Arguments question the few versus many attitudes of those in the positions to make the decision to continue with the research. Among the major points of discussion were the infecting of healthy institutionalized children and the adequacy or appropriateness of the process for securing parental consent (permission) during some stages of the study. In the 1970s, controversy over the ethics of this study reached medical journals, major newspapers, and Congressional hearings” (NAP, 2004). The attitudes of the persons in positions of power to modify, monitor, order cessation, or place protection for the residents of Willowbrook and the participants of the hepatitis tudies made the decision to allow the research to continue using the mentally and physically challenged residents. The physicians, state of New York, and Willowbrook administration did not challenge the use of children who were at the discretion of the adults charged with the safe and secure environment of all residents. The accountability and responsibility rests on the shoulders of the researchers and those who approved the research. On a personal note, the research topic and approach occurred in a time in which there was very little if any guidelines and scrutiny of the research project.
Allowing free reign of any use of a human subject in research denotes the respecting of human life and protection of the basic human rights. In today’s research venue respect for and protection of the participant is deemed the utmost concern of research activities. In the time of the hepatitis studies, few guidelines were in effect therefore the use of children for these studies was deemed acceptable. The use of children and especially those who are mentally and physically challenged or disabled is a subject that is not entered into as easily as this research study.
Protection of all participants is a priority and “one such protection is the appointment of independent advocates to ensure that safeguards are in place and that children are not exposed to unjustified risk of harm” (Gustavsson & MacEachron, 2007, p. 85). Had the children in the hepatitis studies had access to an advocate it may have made a difference in the treatment received. However, without the hepatitis studies there may not have been a vaccine developed. This case was and still is today a topic of ethics studies as to why the study was approved, allowed to continue for the length of time, and why no one investigated the school sooner.
Many ethical questions remain. This writer has the viewpoint of supporting research however not at the risk of children not being aware of the treatment received and not having access to an advocate to assist the child. This advocate may be a parent, guardian, or a social worker to advocate for the child’s best interests. Respecting a research participant’s basic human rights and providing protection for privacy, confidentiality, and the right to refuse to participate. Promoting research participant autonomy is one of the most important aspects of research.
Guidelines set forth today by the Office of Human Research Protections (OHRP) offer protections not negotiable and must be followed explicitly. The need for protection and ethical treatment in a research project will aid in participant compliance and if needed ongoing participation and treatment. In the case of the Willowbrook, hepatitis studies the implementation of the OHRP guidelines would certainly have assisted the children of Willowbrook. The unfortunate treatment and use of children in this research study is an atrocity and unethical in this writer’s opinion.
As a manager or leader in this case, implementing the use of social workers and other advocates to stand as a voice for those who are unable to speak or verbalize discontent with the project. “The 1960s hepatitis testing on developmentally disabled children at Willowbrook–experiments that were so egregious that procedures to ensure the protection of human subjects became a requirement for anyone receiving federal research support and one such protection is the appointment of independent advocates to ensure that safeguards are in place and that children are not exposed to unjustified risk of harm.
It is urgent that professional organizations such as the National Association of Social Workers (NASW), the Child Welfare League of America, the Children’s Defense Fund, and other groups expand their efforts on behalf of children used as research subjects” (Gustavsson & MacEachron, 2007, p. 85). The ability to refuse to participate is a right of all research participants advocate for those who are unable to represent him or herself. Questioning the research topic and goals then deciding to proceed is a priority for participants.
As the manager of the Willowbrook School, investigating the hazard sand risks for the children involved is the responsibility of a prudent leader. Providing safe and ethical treatment to all residents of the school is the responsibility of the manager and as the manager accountable for the care and treatment of those living within the walls or confinement of the school without hesitation to cease activity deemed by the manager as unethical or unreasonable.
In conclusion, the Willowbrook hepatitis studies did not protect the rights of all residents and allowed treatment and research to be performed on unsuspecting children and coerced parents and guardians to believe the only admittance to the school was to the experimental area to advance the development of a vaccine for hepatitis. Consent was obtained from parents in an era when this was not the norm. Protecting and promoting the rights of all human research subjects is observed by all research facilities.
The Belmont report of 1979 brought into present the need for research subject’s protection and ethical treatment. According to the Belmont report, 1979: Application of the general ethical principles to the conduct of human subjects research leads to the following requirements: Respect for Persons •Informed consent •Protecting privacy and maintaining confidentiality •Additional safeguards for protection of subjects likely to be vulnerable to coercion or undue influence Beneficence IRB assessment of risk/benefit analysis including study design •Ensure that risks to subjects are minimized •Risk justified by benefits of the research Starogiannis, H. , & Hill, D. (2008). Sex and gender in an American state school (1951-1987): the Willowbrook class. Sexuality & Disability, 26(2), 83-103. The National Academies Press (2004). The ethical conduct of clinical research involving children. Retrieved June 25, 2010, from http://www. nap. edu/openbook. php? record_id=10958=50 Trends in rehabilitation and disability. (2007). In (Ed. )