A Staff Nurse’s Concern About Consent
Isabel Andretti was a staff nurse on the oncology unit at a large hospital where a double-blind controlled trial of a new medication was being researched. The researcher had talked with the potential participants and obtained consent. When Isabel went in to administer the first dose of the study medication to Mrs. Wilson, Mrs. Wilson asked, “Can you explain what this research thing is all about? I didn’t understand half of what that woman said when she was here.” Isabel said, “Tell me what you do know.” Mrs. Wilson explained, “Well, I am going to get this new medicine, but I wonder if it is dangerous. Do you think it is?” Isabel then said, “That is a good question, and you should have an answer before we start this. The best person to explain this is the researcher in charge of this project. We will wait to give you this medication until she has talked with you again and you have made your decision about participating. We don’t want you to agree to something you don’t understand.” Isabel immediately left the room and called the researcher. She explained to the researcher, “Mrs. Wilson, who signed the consent forms for the research project, just said that she did not understand what this was all about. She did not seem to understand that she might be receiving a placebo rather than the new medication, and she was concerned about whether the medication she would receive was dangerous. I know that you talked with her before, but she seems not to have been able to process the information. I am holding the first dose that was due to be given until you are able to talk with her again. When do you think you might be able to discuss her concerns with her?”
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