Discussion: Informed Consent in Practice and Research
Rosie, 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.
Rosie 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. Rosie 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 Rosie participation in the study. Rosie enthusiastically agrees to participate, saying she is sure that the clinician will know what is best for her. The clinician smiles and tells Rosie that a nurse will be in with a research consent for her to sign.
Consider why Rosie may have waived her right to informed consent. Despite her comments, the clinician may want to continue explaining the informed consent process.
Patients must understand their right to receive information about a procedure and that the procedure (or the outcome of the procedure) has risks and burdens, and that data are collected for research purposes.
Medical decision-making can be an extremely challenging experience for patients and their loved ones. Balancing various potential outcomes with levels of risk can be daunting for someone who is also dealing with the emotional stresses of illness. Gaining the patient’s “true” informed consent is a critical step for health care professionals to ensure that the best decisions can be made.
Post a comprehensive response to the following:
For each scenario, decide if informed consent was obtained properly. If it was, then explain why you think it was. Be specific. If it was not, then explain where in the informed consent process a procedure was not followed. Be specific.
HLTH 3100
Week 3 Discussion Scenarios
Scenario 1:
John is scheduled for an outpatient hip replacement. He meets with the surgeon one
week prior to the surgery. The surgeon explains the procedure and then reviews the
risks and benefits with John. On the day of the surgery, while John is being prepped for
the procedure, a nurse walks in to obtain his consent to treat. To verify, the nurse asks
John if the doctor explained the procedure, including the risks and benefits? John says
“no.”
Scenario 2:
Marcus is scheduled for an outpatient rhinoplasty to correct a deviated septum. He
meets with the surgeon one week prior to the surgery. The surgeon explains the
procedure and then reviews the risks and benefits with Marcus. She asks Marcus if he
has any questions? Marcus shakes his head, indicating “no.” When Marcus gets home,
his wife asks him about the appointment. He tells her that he didn’t understand
everything the doctor said. On the day of the surgery, while Marcus is being prepped, a
nurse walks in to obtain his consent to treat. To verify, the nurse asks Marcus if the
doctor explained the procedure, including the risks and benefits. Marcus says “yes.”
Scenario 3:
Juan is scheduled for a laparoscopic Lap-Band placement surgery. He meets with the
surgeon one week prior to the surgery. The surgeon explains the surgical procedure
and how the Lap-Band is used. She asks Juan if he has any questions? Juan says “no.”
On the day of the surgery, while Juan is being prepped, a nurse walks in to obtain his
consent to treat. To verify, the nurse asks Juan if the doctor explained the procedure,
including the risks and benefits. Juan looks surprised and replies, “what risks?”
Scenario 4:
Eloise 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. Eloise sits down
and begins reading and filling out the forms. Ten minutes later, a nurse walks into the
waiting room and calls Eloise’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 Eloise. Eloise
consents to be treated. After the procedure, Eloise pays her copayment and then
leaves. The next day, one of the office staff begins scanning patient paperwork. He
notices that Eloise’s informed consent form is not signed.