Results

Hepatitis Studies at the Willowbrook State School for Children with Mental Retardation
James M. DuBois
From 1956 through 1971, residents at the Willowbrook State School for Children with Mental Retardation were infected with live hepatitis in order to develop a vaccine. Parents gave permission for their children to participate in this study, often because it guaranteed acceptance into the overcrowded facility.

Obtaining Informed Consent to Participate in Research from Mentally Retarded Adults
Celia B. Fisher
A researcher obtains informed consent from mentally retarded adults who maintain the legal right to consent to such decisions and permission from legal guardians when necessary (with assent from the participants). Fisher presents this as an example of best practice.

Potential Inability to Provide Informed Consent Due to Substance Abuse
Celia B. Fisher
Researchers develop creative ways to evaluate the consent of participants whose capacity to give truly informed consent may be compromised due to substance use and/or other comorbid disorders. Fisher presents this as an example of best practice.

Making Everyone Feel Like a Winner
Celia B. Fisher
To minimize distress and the potential for distrust of staff, investigators researching aggression in boys with conduct disorder do not disclose the purpose of the low-risk research but rather present the study activities as a game. Fisher presents this as an example of best practice.

Differing Perceptions of Risks and Benefits
Emily E. Anderson
A researcher conducts a non-therapeutic study with young adults with Tourette’s Syndrome and their families. The participants’ perceptions of risks and benefits differ from those of the researcher.

Withholding Study Purpose
Emily E. Anderson and James M. DuBois
A researcher wants to test an intervention to prevent child abuse among pregnant women in drug treatment programs but feels that revealing the true aim of the intervention may upset women already in difficult life circumstances (and limit enrollment). She asks her institution’s IRB for permission to tell potential participants that the study is a parenting skills development rather than child abuse prevention program.

Huperzine
Angela Dunn and James M. DuBois
While in the early stages of Alzheimer’s disease, Bernadette enrolls in an experimental drug study that will not begin until she is the late stages of the disease. Once Bernadette reaches the advanced stages of Alzheimer’s and her cognitive capacities are impaired, her family members learn of the study and file a complaint with the hospital’s IRB, claiming that Bernadette never would have agreed to participate in this study.

A Sign from the Heavens
Angela Dunn and James M. DuBois
Roger, who was diagnosed with schizophrenia 20 years ago, wants to enroll in an experimental drug study based on the recommendation of his psychic.

A Living Wage?
James M. DuBois
A researcher tries to determine the appropriate amount to pay participants in a study comparing psychotherapy and pharmaceutical treatments for bipolar disorder.

It's All the Same
James M. DuBois
A psychiatric researcher feels that a research coordinator recruiting patients for drug trials may be giving participants false hope about the experimental treatments being tested.

Studying Vulnerable Individuals
James M. DuBois and Angela Dunn
Mark would like to conduct research for his dissertation at a group home for developmentally disabled persons where he has worked as a social worker for several years.

Seifromax
James M. DuBois
A clinician-researcher who is participating in a multi-site study of an anti-depressant for adolescents refuses to prescribe the drug off-label to patients whose parents do not consent to enroll them in the clinical trial. One parent complains to the IRB.

Severe Emotional Disturbance Studies
James M. DuBois
Dr. Randall has proposed two studies involving children with severe emotional disturbance (SED), one involving a control group and the other random assignment into foster care.

Observing Self-injurious Behavior
Gerald P. Koocher and Patricia C. Keith-Spiegel
In order to get baseline data for an experimental study on self-injurious behavior in autistic children, participants were observed without intervention unless the child was engaging in behavior that would cause permanent injury. The authors present this case as an example of best practice.

Splitsville
Gerald P. Koocher and Patricia C. Keith-Spiegel
Parents disagree over enrolling their son in a research project using aversive conditioning to eliminate his cocaine addiction.

Disulfiram
Peter Finn
A researcher designs an experiment to test the effectiveness of disulfiram alone versus in combination with three other treatments (alcohol education, relapse prevention, or Alcoholics Anonymous). Subjects are volunteers who have sought treatment for alcoholism elsewhere but cannot afford to enter a clinic program.

Confidentiality and Using Community Members as Interviewers
Joan E. Sieber
Unanticipated problems arise when a researcher employs community members as interviewers for a survey of black teenage crack users. Sieber presents this as an example of good research practices.

Political Points
Brian Schrag
A researcher is unsure how to disseminate potentially controversial findings regarding needle exchange programs and HIV infection rates.

Music Therapy
Brian Schrag
A participant in a low-risk, non-therapeutic study on the genetics and pathophysiology of schizophrenia appears confused. The graduate research assistant collecting data from her is unsure if she is competent to consent to research participation.

Heightened Protections in Clinical Trials
James M. DuBois
A researcher recommends additional protections for participants in clinical trials that pose any risk of severe decline or relapse.

Psychosis Inducing Experiments
James M. DuBois
The director of an advocacy groups asks your hospital’s ethics review board to discontinue all washout and psychosis-inducing studies.

Proposed Study of the Natural Course of Schizophrenia with Self-Help Supports
Jean Campbell
In response to the suggestions of advocates, mental health consumers, and researchers that people with mental illness suffer more from the disabling effects of psychotropic medications, institutionalization, and other treatments than from the disease itself, government scientists propose a study of the natural course of schizophrenia.

Motivating Research Participation
Jean Campbell
A researcher struggles to recruit sufficient numbers of mental health consumers to participate in an evaluation study of county mental health services before and after a major reorganization of the delivery system.

Ensuring Fair Representation of Minority Children in Research
Emily E. Anderson
A multi-site study comparing several treatment modalities for children with ADHD using random assignment seeks to ensure fair representation and access to research benefits for minority children given issues of potential overdiagnosis and underrepresentation in care.

Maintaining Privacy in Recruitment
Emily E. Anderson
You want to conduct research with recovering alcoholics and must consider how best to protect participant anonymity during recruitment.

Placebo Trials with Prevalent but Unproven Treatments
Emily E. Anderson
At a residential treatment center for persons with mental retardation, lithium is frequently used to treat aggressive and self-injurious adolescents. However, this use of the drug has never been systematically tested on this population. Investigators propose a placebo-control experimental design but some staff members believe this is depriving patients of an established treatment.