Dr. Z., a professor of clinical psychology at a medium-sized urban university, after receiving approval of the local IRB, ran an ad in the school newspaper seeking as paid subjects students who often felt depressed. After an extensive assessment battery and interview (for which all students were paid), 100 students were invited to sign up for a lengthy study that had to do with "monitoring of depressive feelings." Based on his review of the literature, Dr. Z had developed the hypothesis that a combination of regular physical activity and cognitive therapy involving the repetition of affirmations would decrease the frequency of depressive feelings. The study, which was double-masked, contained four randomly assigned groups (A masked study is one in which either the investigator, the subject, or both do not know the identity of the treatment group to which the subject has been assigned. A double-masked study is one in which neither the investigator nor the subject knows the identity of the treatment group):
• a control group;
• a group engaging in physical activity;
• a group receiving cognitive therapy; and
• a group both engaging in physical activity and receiving cognitive therapy.
 

Each student signed a consent form committing the student to two months of three half-hour sessions per week plus a follow-up session. The student would receive $10 per hour of participation. Half of the money would be received at the end of the two months; the other half would be received after the six-month follow-up.
 

By the luck of the draw, three of the students were assigned to the control group. Control group members simply met and talked about their feelings. Over the course of several weeks, one of the students in the control group became increasingly more depressed and unhappy, and eventually stopped showing up, and withdrew from school. She subsequently filed a grievance with the university and with the APA arguing that she had signed up for the experiment with hope that it would help her, but that instead it had harmed her.
 

A second student in the control group, after talking with a psychology graduate student, discovered that he was not receiving the treatment that was hypothesized to be most effective and demanded that he be given that treatment immediately. The investigator refused, and this student also filed a grievance insisting that his rights were being abrogated and his mental health endangered by the psychologist's refusal to treat him.A third student argued that she should be released from the study because it wasn't helping her and, further, that she had been coerced into participating in the experiment by a lack of money and the unrealized hope of getting better. She argued that she should be paid for her time to date because she had been paid in previous psychology experiments in which she had declined to continue when given the opportunity either to stop or continue.
 

Questions for discussion:
1. How would you evaluate/manage each of the students' claims?
2. If each student's request or grievance is allowed, what are the implications for research related to therapy (e.g., clinical drug trials)?
3. Before consenting to participate in research, prospective subjects must be provided all informational material necessary to making a decision to participate. What information should participants in this study be given as part of the informed consent process? What, if anything, was missing in this case?
4. Should the students have been informed about the structure of the design (i.e., that participants would be assigned to one of the four groups and that each group would receive a different experience that might affect the number and extent of depressive feelings)? Should the students have been allowed to choose the group they wished to be in? Why or why not?
5. Could Dr. Z have taken steps to avoid these difficulties?

 

Below is the framework:

 

Ethical Disagreements arise when: A problem-solving framework can: Analyzing Cases and Justifying Decisions structure debate, provide common framework NOT guarantee you'll arrive at the one right answer or will eliminate all disagreement Analysis: 4 key elements of the framework (Mnemonic device: So Far No Objections) Stakeholders: e.g., participants, researchers, sponsors, institutions, community Facts: e.g., anticipated benefits and risks, scientific merit, feasibility of design, costs Norms: e.g., Belmont principles, specific norms generated by IRBs, fair process Options: e.g., change study design, expand process of review and design, add oversight people have different and competing interests when they disagree about relevant facts e.g., probabilities of benefits or magnitude of harm when they disagree about ethical norms - e.g., different ideas of whether justice requires equal opportunity or equal outcomes help you to consider all relevant factors help you to exclude ethically unacceptable alternatives Justification If a study infringes on a norm that the law or professional ethics treats as a moral absolute, then you must modify it. When study will involve overriding or infringing on a prima facie norm or value ... First, clearly state the goal of your action that is, no what goods you aim to achieve - and state what goods or values you will be compromising Then, see if you can justify it using the following 5 tests O Justification Criteria 1. Effectiveness: Will the study (or policy or action) be effective in achieving the desired goal? 2. Necessity: Is the study necessary to achieve the goal or is there an alternative that won't infringe on a competing value? 3. Proportionality: Is the desired goal important enough to justify overriding another principle or value? 4. Least infringement: Is the study designed to minimize infringement on the value that conflict with it? 5. Transparency: Are you prepared to publicly justify your decision? (Based on Childress et al 2002)