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Hugo is a graduate student working on a research study that is seeking to explore the efficacy of a new medicine for the prevention of chemotherapy-induced peripheral neuropathy.  As part of his duties, he is asked to make himself available during participant recruitment to clarify any questions that the recruitment personnel or the participants may have. On one of these occasions, a research nurse named Phoebe is obtaining informed consent from a young adult named Simon. 

The informed consent form includes information on the purpose of the study, a double-blinded, randomized intervention trial to test the efficacy of a medicine for the prevention of chemotherapy-induced peripheral neuropathy.  The form explains the risks and benefits of participation at length, including the anticipated side effects of the new medicine. 

The benefits are thought to outweigh the risks.  The participants in the treatment arm of the study may benefit from the medicine's hypothesized prevention of chemotherapy-induced peripheral neuropathy. Participants in both groups will receive close monitoring of neuropathy symptoms and evidence-based care while being in the study. Finally, the form explains that the information collected may help to lead to the discovery of an agent that may reduce chemotherapy-induced peripheral neuropathy, of which there are currently no none effective preventative treatments. 

As Phoebe is reviewing the informed consent form, Simon appears somewhat uncomfortable and apprehensive. Hugo thinks that his response may be related to the surroundings and/or situation. They are sitting in the exam room shortly after Simon learned of the treatment options for advanced stage colorectal cancer and the doctor left without answering all of his questions. Simon also has additional oncology appointments shortly after the consent discussion. 

Hugo is also struck by Simon's interaction with Phoebe. He nods and his occasional brief responses sound more like someone receiving a set of instructions than an indication of understanding.

During the time it takes to complete the informed consent form, which is quite lengthy, Hugo begins to wonder whether Simon truly understands the research study and his part in it.  Hugo also questions whether Simon understands what randomization is and how this technique will affect him as a research participant. Hugo is distracted from his thoughts by movement from across the room. Simon is ready to place his signature on the informed consent form. He seems to be eager to do so. The form states that study subjects have the right to refuse to participate and that they may withdraw at any time, but Hugo begins to question whether Simon truly has a choice in giving his consent. Do the benefits from this study, overwhelm any concerns he may feel regarding being in the study?

Hugo is unsure how to address his discomfort with the informed consent process that he has just witnessed and he begins to deliberate about what course of action he should take to address his concerns.

Discussion Questions:

1. How could the informed consent form or the process of obtaining informed consent be modified to address Hugo's concerns?

2. What types of questions or techniques could have Phoebe provided to assess Simon's understanding of the study?

3. How would you describe “randomization” to a prospective study participant?

4. How would you respond to a participant who says “can we skip the rest of this and sign the form” during the informed consent discussion?