Case studies (A – J)
The following scenarios have been drawn from various web sources and are intended to stimulate critical discussion about real life research ethical issues. They have deliberately been chosen from United States sources in order to encourage you to think about basic ethical issues, rather than focussing on our own taken-for-granted legal and institutional constraints (although the case-studies do sometimes involve US law).
It is in that spirit - trying to get down to basic ethical issues - that these scenarios were discussed.
All cases except (J), Kennewick Man, are anonymised.
(A) Ethical issues in research with children
(this scenario was discussed at the June workshop)
Dr. Morris Swakowski, an epidemiologist, is working with Beatriz Piacere, a post-doctoral fellow, on a research project involving asthma and wheezing in African-American and white adolescents. They have just completed a school-based study in which they found a very high prevalence of diagnosed asthma and wheezing in eighth graders.
In the literature, the most current research is investigating the association of asthma with exposure and allerges to dust mites and cockroaches. Dr. Swakowski and Beatriz want to find out whether asthma and wheezing are associated with exposure and sensitivity to dust mites and cockroaches in their research population - an urban/suburban community in the South with high humidity, which provides a favorable environment for dust mites. They also want to evaluate several low-cost interventions that could reduce the children's exposure to these two allergens.
This research is being conducted in collaboration with the large public school administration of the city. The school population is 40 percent African-American, and 28 percent of the children are on the free school lunch program.
The researchers decided to address the following questions:
· Do children with asthma or wheezing have higher exposures to dust mites and cockroaches compared with children who do not have asthma or wheezing?
· Do children with asthma or wheezing experience a decrease in symptoms in response to exposure to the interventions, compared with children who are not exposed to the interventions?
The two investigators agree on the sampling strategy: children who, in the previous school-based study, self reported either 1) diagnosed asthma 2) wheezing symptoms with no asthma diagnosis, and 3) no wheezing symptoms and no asthma diagnosis. After parents have given their informed consent, the children will be brought to the health clinic, enrolled, and given a skin prick test for twelve different allergens. Skin prick tests are done to determine whether the children are allergic to specific allergens including cockroaches and dust mites, which may be triggers for their wheezing attacks. Dust mite and cockroach allergen levels also will be measured in their homes.
Half the participants will receive the environmental interventions at the start of the study, and the rest will receive the interventions at the end of the study. The interventions are plastic bedcovers to reduce the dust mite population and cockroach motels to reduce the number of cockroaches.
In discussing the research design with the pediatrician and the nurse working on the project, the researchers become aware of the issue of anaphylactic shock. The risk of anaphylactic shock from the skin prick test is 1 in 1 million in the general population. Although the risk to the child occurs only at the time the test is conducted, possible consequences include death. If a child begins to go into shock, the standard treatment is immediate administration of epinephrine, which will stop the reaction if a sufficient dose is given. However, the administration of epinephrine is best done by trained staff in a hospital setting.
The nurse in the study is very concerned about this risk of anaphylactic shock. However, she considers that the study might benefit the symptomatic children. If some children have unknown allergies that trigger their asthma or wheezing, this study would benefit them by identifying the allergens that trigger their wheezing attacks. However, the risk of anaphylactic shock is a risk for the control group to be used to answer the first question. Children in the control group will gain little from participating in the research, and it will actually put them at risk. The researchers must consider whether it is necessary to drop the control group.
Discussion Questions
· What are some of the ethical and risk concerns with the protocol?
· How would you suggest that the investigators address these concerns?
(B) Do the Ends Justify the Means: The Ethics of Deception in Social Science Research
(this scenario was discussed at the June workshop)
Part 1
Ann Smith is a social psychologist who wants to study attitude change. She submits a proposal to her institution outlining details of a study that will examine the attitude change of participants following a workshop on environmental issues. Smith plans to identify attitude change by administering a pre-test and a post-test. She is worried, however, that the participants will recognize that she is looking for changes in their attitudes and that this knowledge will influence their answers on the post-test. To address this problem, she plans to disguise the issues she is most interested in; when she administers the tests, she will give a very broad explanation that does not fully disclose the nature of the study. Her proposal includes these procedures and an explanation of why she believes they are necessary; she also includes a plan to "debrief" the subjects (tell them the real purpose of the study) after they finish taking the second test.
Part 2
For a study on conformity to group norms, Ann Smith constructs a survey designed to measure attitudes toward a controversial topic. The research proposal she submits describes her study procedures: She will use as subjects students in a large introductory psychology course she teaches. She includes the following paragraph in her syllabus? "One of the requirements of this course is your participation in a psychology experiment, through which you will be introduced to the methods of psychological research. If you prefer not to participate in the experiment, you may instead complete a 50-page research paper on a psychology topic of your choosing." She will bring two groups into the laboratory, ostensibly simply to obtain their attitudes on the survey. One group will be encouraged to discuss responses to the survey freely amongst themselves; the members of the other group, acting as controls, will take the survey independently. In the first (experimental) group, Smith will "plant" several confederates instructed to advocate loudly one side of the issue in question. Based on the results of similar studies, Smith believes that the majority of responses given by subjects in this experimental group will conform to the position advocated by the confederates, indicating the powerful influence of the group norm. Following the experiment, all subjects will be debriefed as to the true purpose of the experiment.
Discussion Questions
§ Is deception of subjects ever justifiable? If so, under what conditions?
§ Can such questions as these be answered without deceiving subjects? Do potential benefits of such experiments outweigh psychological risks to subjects? At what point, if ever, do benefits of such experiments outweigh costs?
§ If the consequences for subjects are positive (in Case 3, for example, if subjects who helped feel good about themselves, and subjects who did not help resolve to do so in the future), can the researcher conclude that the deception was justified?
§ How might conducting experiments that involve deception of subjects affect the researcher?
(C) Ethical Issues in Longitudinal Research with At-Risk Children and Adolescents
(this scenario was discussed at the June workshop)
Dr. Judy Brewster, long interested in the effects of exposure to maladaptive environments on development, plans to design a study to examine resilience. Why are some individuals able to fend off the deleterious consequences associated with stressful environments and adverse circumstances, while others are not? What characteristics are associated with adaptation to such environments? To learn more about the characteristics associated with resilience to environmental insult, Judy will study fourth, sixth and eighth graders who have been exposed to violence within their communities.
Youths will be assessed at six-month intervals for a period of four years. Assessments will be conducted in school through group-administered written surveys and individual interviews of approximately one to two hours in length. The amount and frequency of exposure to community violence will be measured, as well as short- and long-term psychological (anxiety, depression, perception of social support), behavioral (academic achievement, risk engagement) and adaptational (psychological and behavioral coping) responses. Aside from assessment interviews, participants will have no contact with the researcher.
Ms. Rosen, the principal of a private parochial school, has agreed to allow her school to participate in the study. She is eager to assist her students and suggests that Judy begin at once. When Judy asks for advice on how to approach parents for their permission, the principal says that it is not necessary, as the school supports the study. Judy is unsure of how to respond. She recalls that ethical guidelines do not require parental consent to conduct evaluations of educational curricula; however, she is not evaluating a curriculum.
Judy explains to Ms. Rosen that her funding agency and university institutional review board require that she obtain parental consent. Ms. Rosen notes the difficulty in obtaining responses from every parent in the fourth, sixth, and eighth grades; she suggests that a letter be sent to parents advising them that the study will be conducted and asking them to return the permission form if they do not want their child to participate.
Discussion Questions
§ What are Judy's responsibilities to the students, parents and Ms. Rosen, if any?
§ What are the potential consequences of not obtaining consent for the students, parents, Ms. Rosen, and Judy, if any?
§ Given the potential consequences, should Judy obtain parental consent?
§ Are there alternative methods of obtaining consent? What are the advantages and disadvantages of each?
§ How should Judy obtain parental consent?
(D) Issues in informed consent
(this scenario was discussed at the June workshop)
A grant has been given by a US university to the research unit of a Ministry of Health of a West African Country to conduct a double blind study to evaluate the impact of periodic doses of high dose Vitamin A on the incidence of diarrhea and ARI in children less than five years of age. A traditional leader and council of elders governs the community in its daily affairs though the national government retains control of tax collecting, the police, military, etc. To inform the community of the impending study the village was called together by the chief and council. In a festive environment, the investigators described the study and answered all question from members of the community and council. After the description, and question and answer period, the village chief and council met briefly and gave their approval. Shortly thereafter, in accordance with the guidelines provided by the Institution Review Board of the university, the principal investigator and his field staff began going house to house to obtain signed informed consent from the parents giving permission for their children to participate in the study. The mothers (usually the one at home during the visit) said that the chief had already approved and therefore they did not need to sign anything; besides they usually do not sign anything because they cannot read what they are signing. On the second day the field team making the home visits was summoned to the chief's house where they were politely informed that approval had been give for the study and it was both unnecessary and unacceptable to seek individual signatures. That the chief/council had approved was enough. When the field staff said that they were required by the grant agreement obtain signed informed consent form they were told that if they insisted on doing so they would have to leave the community.
A summary of the study design is as follows: high dose vitamin A capsules or placebo would be administered in a double blind fashion every four months for one year to children from 6 months to 5 years. A record of morbidity (diarrhea and ARI) and mortality data would be measured by weekly and blood samples would be drawn (less than 2cc) at 0, 6, and 12 months for Vitamin A status.
Discussion Questions
· How should this problem be handled by the field investigator? The donor?
· How critical is informed consent in this setting?
· Is informed consent culturally bound or is it a universal principal that cannot be compromised?
· Are there circumstances when informed consent is unnecessary?
· Does it protect the investigator and/or the subject
(E) Anonymity: two case studies
(scenario was discussed at the March workshop)
First case study
‘Mira Walton’ spent two years in Melanesia conducting a broadly defined community study in a rural village with a population of about 1,500 people. She returned to the United States and wrote a 500-page monograph in which she included specific instances of conflicts of interest and dispute settlement in a variety of contexts: broken marriage contracts; instances of alleged encroachment of farming on neighbours' lands; a case of theft; a charge of mismanagement of community resources which was made against the village headman; family feuds; and blood feuds. Following the conventions of the American Anthropological Association, Walton decided that the village and its location should be disguised and that pseudonyms should be used for all individuals mentioned in the published ethnography.
A year after publication of Walton's ethnography, which was three years following her departure from the field, she returned to the community of study, taking along copies of the book. These copies were distributed to the people who had been most helpful during her original research project. Most of these individuals were literate and readily understood the contents of the book. Walton asked and received permission to conduct further study in the village. She settled into her task.
Six months later, a meeting was called by one of the elders in order that the community members might discuss the book about them with Walton. Walton was surprised by the first remarks concerning the book; namely that, although she had done an accurate job of characterizing the situations of dispute settlement and the overall political structure of the village, they were surprised that she had (1) got the name of the village wrong, and (2) not accurately named the individuals involved in the disputes. More than 60 people were at the meeting, representing of the families in the village. Their murmurings indicated strong agreement that she should have given the actual name of both the village and individuals. Furthermore, she was explicitly told that in the next book she should be more careful to use the correct village name and use the correct names of villagers who asked her to do so or who gave permission for her to do so.