Certification for IRB Professionals (CIP) Practice Exam

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Which of the following is an example of exculpatory language in a consent form?

  1. "Participation is voluntary, but you waive your right to legal redress for injuries"

  2. "You may withdraw at any time without repercussions"

  3. "All research findings will be kept confidential"

  4. "Please feel free to ask questions about the study"

The correct answer is: "Participation is voluntary, but you waive your right to legal redress for injuries"

The statement "Participation is voluntary, but you waive your right to legal redress for injuries" is an instance of exculpatory language in a consent form because it attempts to limit the liability of the researchers or the institution conducting the study. Exculpatory language is phrased in a way that relieves responsibility or liability from one party (in this case, the researchers) regarding harm or injury that may occur as a result of participating in the research. Such language can be problematic as it may influence a participant's decision-making process, suggesting that by participating, they give up their rights to seek compensation for any injuries. The other options present elements that are essential in consent forms but do not constitute exculpatory language. The voluntary nature of participation without repercussions, confidentiality assurances, and encouragement to ask questions represent the ethical considerations expected in informed consent but do not seek to absolve liability. These practices support participant understanding and autonomy, ensuring that individuals are informed and feel safe in making decisions about their involvement in research.