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You are designing a clinical study to test a new computerized cognitive training program for ADHD against an inactive placebo program. Apply the ethical principles of informed consent and fairness in placebo studies to draft the specific sections of the research protocol addressing: (1) what information must be disclosed to participants before the study begins regarding their group assignment, and (2) what opportunity must be offered to control group participants after the study concludes.
Question: You are designing a clinical study to test a new computerized cognitive training program for ADHD against an inactive placebo program. Apply the ethical principles of informed consent and fairness in placebo studies to draft the specific sections of the research protocol addressing: (1) what information must be disclosed to participants before the study begins regarding their group assignment, and (2) what opportunity must be offered to control group participants after the study concludes.
Sample answer: In the study protocol, the informed consent section must specify that participants will be notified beforehand that they will be randomly assigned to either the genuine cognitive training program or an inactive placebo program, with their specific assignment remaining concealed until the experiment ends. Additionally, to ensure ethical fairness, the post-study protocol must outline that participants who were assigned to the placebo control group will be offered the opportunity to receive the actual computerized cognitive training program after the study has concluded.
Key points:
- Apply informed consent by requiring upfront notification to participants that they will receive either the genuine treatment or an inactive placebo.
- Note that the specific assignment is concealed from the participants until the experiment concludes.
- Apply the principle of ethical fairness by offering control group participants the opportunity to receive the actual treatment after the study ends.
Rubric: Answers must be graded on whether they correctly apply the principles of informed consent and fairness. Specifically, the student must apply the following details: 1) upfront disclosure that assignment will be to either a genuine treatment or an inactive placebo; 2) concealment of specific assignment until the end; and 3) the opportunity for control participants to receive the genuine treatment after the study.
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Research Methods in Psychology - 4th American Edition @ KPU
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