Reference no: EM133709836

Problem

I. Explain how the Henrietta Lacks case led to modern informed consent laws.

II. Casey, 58, volunteers to participate in a research study conducted by the ABC Biomedical Research Imaging Center. The research is examining a new form of mammography screening for women who have multiple risk factors and have had a least one abnormal screening for breast cancer in the past. The study offers a stipend and free mammography screening to study participants.

Casey is sitting in a room when the clinician leading the study walks in to discuss informed consent with her. He introduces himself and then starts to explain the new mammography screening and purpose of the follow-up visits. Casey stops him midsentence and tells him that she does not need to hear the details of the procedure and that she is sure that everything will turn out fine. The clinician is impressed with the ease with which the consent was obtained and offers Casey participation in the study. Casey enthusiastically agrees to participate, saying she is sure that the clinician will know what is best for her. The clinician smiles and tells Casey that a nurse will be in with a research consent for her to sign.

Would Casey's actions be considered "waiving" her informed consent rights? Should the clinician have continued to explain the procedure despite Casey's statements?

III. Mark presents to the emergency room with a high fever and listlessness. After running tests, the initial diagnosis for Mark is sepsis, and the doctors decide to start treatment with intravenous antibiotics. Prior to starting treatment, Mark, who is legally a minor, refuses stating that "God will heal him." Although the family is deeply spiritual, Marks sister agrees that he needs to be treated, but he continues to refuse. The doctors and nurses continually try to explain the severity of Mark's situation, but he refuses.

What is the next step? In this situation, what do the nurses and doctors need to do to ensure that Mark has been given legal informed consent?

IV. Emma arrives at the outpatient clinic to have a carcinoma (skin cancer) removed from her nose. The receptionist hands her a packet of paperwork and tells her she needs to complete all the paperwork and sign all forms that require a signature. Emma sits down and begins reading and filling out the forms. Ten minutes later, a nurse walks into the waiting room and calls Emma's name. Eloise stands up and tells the nurse that she is almost finished filling out the paperwork. The nurse smiles and says she can finish it later. Right before the procedure, the doctor explains the procedure to Emma. Emma consents to be treated. After the procedure, Emma pays her copayment and then leaves. The next day, one of the office staff begins scanning patient paperwork. He notices that Emma's informed consent form is not signed.

Do we know if informed consent was acquired for Emma? Explain. What additional information is needed?