Description
Informed consent is an ethical concept that is integral to patient care. Seeking informed consent expresses respect for the patient, ensures protection for the patient against unwanted medical treatment and allows patients to have active involvement in their medical care. Obtaining informed consent requires a fund of knowledge regarding a disease process and options for treatment, as well as outstanding interpersonal and communication skills. Informed consent is a process of information sharing that allows patients to make informed choices, not simply a signature on a form. The process of obtaining informed consent is an important skill to teach and assess during medical education.
Teaching the components of informed consent and the interpersonal and communication skills necessary for informed consent can occur in years one and two or during clinical preparatory courses. Once in the third and fourth years of medical school, learners will have the fund of knowledge regarding a disease process and options for treatment to begin practicing informed consent in the simulated setting. Additionally, students should have the opportunity to watch excellent informed consent technique occurring during clinical rotations.
NOTE: This entire module is also available in PDF Format.
Learning Outcomes
This clinical skills module provides a framework for obtaining informed consent in a respectful and complete manner.
Following participation in this module, learners should be able to:
- Describe the components of informed consent
- Demonstrate effective communication strategies for obtaining informed consent
Best Practices
Information Sharing
In order to share the information necessary for a patient to make an informed decision regarding their health care, the consent process should contain the following elements:
- The procedure for which the patient is being consented: The procedure should be explained in detail, including positioning, incisions and the basic steps of the procedure.
- The indication for procedure: Why the procedure is being done?
- Benefits of the procedure: What are expected success rates? Why is this beneficial to the patient over other options?
- Potential risks of the procedure: Care should be taken not to over- or understate risks.
- Alternatives to the procedure: including no intervention.
- What to expect post-procedure: including pain, recovery, bleeding and would healing.
Communication
It is essential for learners to understand elements of communication that facilitate informed consent. Delivery of informed consent should have the following:
- A clear introduction: The learner should introduce themselves clearly with their name and the role they will play on the health care team.
- Development of patient rapport: The learner should be able to build rapport with the patient. This can be facilitated by maintaining eye contact, addressing the patient by name and expressing empathy and understanding, as well as respecting patient’s questions and choices.
- Accessible language: The learner should adjust the pace of speech, use accessible language, avoid medical jargon and explain any medical terminology as required.
- Invitation for the patient’s questions: The learner should ask if the patient has any questions regarding the consent form or the procedure.
- Avoidance of responses implying judgment: The learner should respect patient choices and avoid judgment related to them.
- Avoidance of false reassurances: The learner should not understate possible risks or give false reassurance of benefits or success of a procedure.
- Listening without interruptions: The learner should display outstanding listening skills.
- Verification of patient understanding: The learner should ask the patient to “teach-back” the information shared to verify patient understanding.
Case Scenario
Ms. Smith is a 50-year-old female with a complex right adnexal mass measuring 5x4x3cm. She has been experiencing right lower abdominal discomfort and on bimanual exam a fullness was appreciated on the right side. Ultrasound was performed, revealing the mass. Today, she will be consented for a laparoscopic right salpingo-oophorectomy. She has never had surgery before and states she is nervous about the procedure. She has questions regarding the possibility of no intervention.
Checklist
The following checklist may be used as a component of the training session and/or as a component of a performance assessment as part of an objective structured clinical examination.
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Done |
Not
Done |
| Clearly states the procedure for which consent is requested |
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| Correctly discusses the indication for the procedure |
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| Correctly states the benefits of the procedure |
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| Reviews the potential risks of the procedure |
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| Offers alternatives for the procedure, including no intervention |
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| Discusses post-procedure expectations |
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| Clearly introduces self, including role on team |
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| Establishes rapport with patient |
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| Uses accessible language and explains medical terminology where appropriate |
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| Invites patient’s questions |
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| Avoids responses implying judgment |
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| Avoids false reassurances |
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| Listens without interrupting |
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| Verifies patient understanding |
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Practical Tips
We suggest the concept of informed consent be introduced to learners early in medical training. Clinical exposure to physicians modeling outstanding informed consent practices is essential to learning. Videos of the informed consent process can also be used as a supplemental teaching tool if clinical exposure to the process is limited. Videos of learners performing informed consent with a standardized patient can also be reviewed individually or as a group and have a role for both teaching and assessment. Self-reflection is often an excellent tool to use in this setting. If you use the earlier case scenario and do not intend on evaluating their knowledge base, learners can be given fact sheets regarding adnexal mass and laparoscopic salpingo-oophorectomy prior to the exercise. The exercise can be used to evaluate their communication skills as they pertain to informed consent. The performance assessment may occur as part of an objective structured clinical examination at the end of the obstetrics and gynecology clerkship.
Resources
- Informed consent. ACOG Committee Opinion No. 439. American College of Obstetricians and Gynecologists. Obstet Gynecol 2009; 114:401-8
- Canadian OSCE
- Kempner S, Morgan H, Stern D, et al. Providing informed consent: a standardized case. MedEdPORTAL Publications. 2016;12:10427. http://dx.doi.org/10.15766/mep_2374-8265.10427
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