By Richard Cahill, JD
Informed consent is, first and foremost, an ongoing process or dialogue with patients who are engaged in shared decision making. It is not simply executing a document that outlines the technical terms of a proposed course of 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 advanced practice registered nurses of all types and physician assistants/associates.) 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.
Patient Safety Strategies
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. The strategies that follow can help mitigate risk when obtaining informed consent in a teaching institution.
- 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 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 respect.
- Clarify that the responsible practitioner will be present at all times in a direct supervisory capacity.
- Inform the patient of the identity of personnel present for the procedure. This is especially important if product representatives will be present. Failure to inform the patient could lead to a breach of privacy allegation.
- 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).
- Convince the patient 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 inform patients, or who 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 institutions they serve in significant jeopardy. In the event of an untoward outcome—even when a consent form has been used—such cases are difficult to defend.
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 learner as well as the responsible practitioner.
CMS provides the following “Example of a Well-Designed Informed Consent Process”1 for surgical procedures. The process includes:
- Whether physicians other than the operating practitioner, including but not limited to residents, will be performing important tasks related to the surgery, 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;
- 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 postgraduate 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. Those state-specific rules have different requirements and should be consulted for a more detailed understanding of the law applicable to your practice.
Richard Cahill, JD, is Vice President and Associate General Counsel for The Doctors Company
Assistance and Further Information
We also offer continuing education that provides complimentary training on informed consent. Our on-demand courses include the following:
- Making an Informed Consent an Informed Choice: Training for Healthcare Leaders. The Doctors Company complimentary CME.
- Making an Informed Consent an Informed Choice: Training for Healthcare Professionals. The Doctors Company complimentary CME.
- Centers for Medicare and Medicaid Services. State operations manual. Appendix A-Survey protocol, regulations and interpretive guidelines for hospitals. §482.51(b)(2). Example of a Well-Designed Informed Consent Process.
Revised February 21, 2020.
Kirsch M, Kasten S. What about learner’s roles in the operating room should be disclosed to patients? AMA Journal of Ethics. April 2018. https://journalofethics.ama-assn.org/article/what-about-learners-roles-operating-room-should-be-disclosed-patients/2018-04
Yates L. Clarifying Informed Consent. American Society for Health Care Risk Management. February 27, 2019.
The guidelines suggested here are not rules, do not constitute legal advice, and do not ensure a successful outcome. The ultimate decision regarding the appropriateness of any treatment must be made by each healthcare provider considering the circumstances of the individual situation and in accordance with the laws of the jurisdiction in which the care is rendered.