Obtaining Informed Consent in Clinical Teaching Situations

Informed consent is, first and foremost, an ongoing process or dialogue with patients who are engaged in shared decision making about their care. It is not simply executing a document that outlines the technical terms of a proposed treatment or surgery with a laundry list of possible adverse consequences. True informed consent is a candid exchange that allows the patient an adequate opportunity to ask questions and obtain sufficient information to make a reasonable and informed decision.

The basic principles governing informed consent and informed refusal apply to healthcare practitioners in all settings—including academic medical centers and any teaching location.

The principles also apply to advanced practice clinicians (APCs). (APCs include nurse practitioners, certified registered nurse anesthetists, certified nurse midwives, certified midwives, and physician assistants.) State legislatures and licensing boards have greatly expanded the permissible scope of practice for APCs, including the types of authorized procedures they can perform that require informed consent. Consult state scope of practice laws and regulations for guidance.

(For a complete discussion on the principles of informed consent and informed refusal, see our articles “Informed Consent: Substance and Signature” and “Informed Refusal.”)

Patient Safety Strategies

These strategies can help mitigate risk when obtaining a patient’s informed consent in a clinical teaching situation:

• Have the responsible practitioner (that is, the person who is authorized to perform the procedure) and the learner (for example, a fellow, resident, intern, or student) visit the patient together, prior to the procedure. During the ensuing discussion with the patient and family, the responsible practitioner should clarify the learner’s role in the procedure. Detailed descriptions are not necessary, but the patient must understand that the procedure is a collaborative team effort and that the responsible practitioner will need assistance.
• Spell out the learner’s qualifications as strongly as possible to reinforce the patient’s confidence. During the bedside discussion, it is helpful if the patient observes the responsible practitioner treating the learner as a colleague and conducting the discussion in a spirit of collaboration and respect.
• Clarify that the responsible practitioner will be present at all times in a direct supervisory capacity and immediately available throughout the procedure to provide technical support and guidance as necessary.
• Inform the patient of the identity of all personnel present for the procedure, including surgical nursing and technical support. This is especially important if product representatives will be present for purposes of observation. Failure to inform the patient fully could lead to an allegation of breach of privacy, possible complaints to the state licensing board or administrative agencies, and even civil litigation depending upon the nature and extent of the circumstances.
• Prepare for some patients to insist on having the responsible practitioner perform the procedure without any participation by the learner. Under these circumstances, the responsible practitioner can:
• Comply with the patient’s wishes.
• Refuse to participate in the patient’s care (if permitted by the organization’s policies and consistent with the applicable standard of care).
• Encourage the patient to consent by explaining that it is in everyone’s best interest for the procedure to be performed by the whole team.

Document Informed Consent

Practitioners who do not fully inform patients, or imply that they will perform the procedure or render the care personally and then delegate substantial parts of the procedure or care to the learner, are putting themselves and the organizations they serve in significant jeopardy. In the event of an untoward outcome—even when a consent form has been used—such cases are usually difficult to defend in civil or administrative venues and may expose the practitioner to enhanced economic damages beyond traditional verdicts or awards usually associated with professional liability claims.

To avoid this type of situation, make certain that documentation in the patient’s record accurately reflects the disclosure made to the patient prior to treatment. In a teaching situation, the consent for treatment should always include the name of the learner as well as the responsible practitioner.

Given the nature of teaching institutions—where individuals in training participate in patient care to varying degrees—the informed consent process is more complex and can present additional liability risks. CMS provides the following “Example of a Well-Designed Informed Consent Process”¹ for hospital surgical or invasive procedures or patient examinations by learners, regardless of whether anesthesia or sedation is used. The discussion includes:

• Whether practitioners other than the operating practitioner—including but not limited to residents and medical, advanced practice provider, or other applicable students—will be performing important tasks related to the surgery or examinations or invasive procedures for educational and training purposes, in accordance with the hospital’s policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices, and placing invasive lines. Examinations or invasive procedures conducted for educational and training purposes include, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law.
• For surgeries in which residents will perform important parts of the surgery, discussion is encouraged to include the following:
• That it is anticipated that physicians who are in approved post-graduate residency training programs will perform portions of the surgery, based on their availability and level of competence;
• That it will be decided at the time of the surgery which residents will participate and their manner of participation, and that this will depend on the availability of residents with the necessary competence; the knowledge the operating practitioner/teaching surgeon has of the resident’s skill set; and the patient’s condition;
• That residents performing surgical tasks will be under the supervision of the operating practitioner/teaching surgeon; and
• Whether, based on the resident’s level of competence, the operating practitioner/teaching surgeon will not be physically present in the same operating room for some or all of the surgical tasks performed by residents.

Note: A “moonlighting” resident or fellow is a post-graduate medical trainee who is practicing independently, outside the scope of his/her residency training program and would be treated as a physician within the scope of the privileges granted by the hospital.

• Whether, as permitted by State law, qualified medical practitioners who are not physicians will perform important parts of the surgery or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges by the hospital.

It should also be noted that various states have enacted legislation or adopted administrative regulations governing informed consent. State-specific rules have different requirements and should be consulted for a more detailed understanding of the law applicable to your practice.

Assistance and Further Information

For assistance with informed consent issues, contact Patient Safety and Risk Management at (800) 421-2368 or by email.