Enterprise Risk Management (ERM) Legal & Regulatory Patient Safety/Clinical Care

Informed Consent 101

Risk managers are aware that the informed consent process is not simply filling out a form for patients to sign. Patients need to be engaged with their providers and understand the proposed treatments recommended for improving their clinical outcomes. The informed consent process reduces the potential for liability that could include an allegation of negligence or inadequate informed consent. Requirements related to obtaining informed consent are guided by state statutes and regulations, case law and professional codes of ethics.

Here are answers to questions every risk manager should consider in establishing an effective informed consent process:

Basic requirements of valid informed consent?
Although laws differ from jurisdiction to jurisdiction, the basic requirements of a valid informed consent process are essentially the same. This means the provider must include discussions about the following:

  • Clinical indications for treatment, such as medications, especially “black box, off-label, or high risk” medications; invasive procedures; clinical trials and research or when recommending voluntary hospitalization; as with behavioral health patient needs
  • Description of what is involved with the treatment
  • Intended benefits and probable risks for the specific recommended treatment or medication, as well as any alternatives and the risks and benefits of those alternatives, including doing nothing or rejecting care
  • Risk of harm, including death, if it is an invasive procedure or one that involves anesthesia

Person accountable for obtaining informed consent?
State regulations and case law have established that the care provider performing the test or treatment is responsible for consent. This would also apply to Advanced Practice Professionals who obtain informed consent for the treatment, procedures and medications they order.

Nurses may verify or witness a patient’s signature based on the organization’s policy. The nurse evaluates if the patient or the legal representative is of legal age and makes certain the medical chart reflects the correct information. Risk Managers must be aware of state regulations relating to whom can legally provide informed consent for the patient.

The nurse, as patient advocate, should ask if the patient or legal representative has any questions about the procedure, treatment or medication.  If the patient or representative has questions, the nurse needs to notify the care provider performing the test or treatment for follow up with the specific patient or representative.

The bottom line is that the care provider is accountable for obtaining informed consent from the patient or legal representative. The consent must be documented clearly in the legal medical record to avoid creating potential liability for the enterprise.

Treating a minor child or guardian/surrogate decision maker?
State laws vary regarding the age and conditions for minors to consent including emancipated minors, “mature” minors (e.g., if married or pregnant), minors seeking mental health or addiction services, or living independently from parents. Risk managers need to be aware of their state laws when caring for minor-aged patients, ensuring that staff caring for minors is knowledgeable in specific state regulations.

Each state has differing requirements for appointment of a substitute decision maker for a patient. Surrogate decision makers (such as when a parent lacks capacity or competency, or court-appointed guardians need to provide a copy of the court documents or evidence of the patient’s advance directive or health care proxy; the documents need to be retained in the patient’s legal medical record and validated upon the patient’s subsequent admission(s).

A physician must determine the decision-making capacity of their patients. (Remember: competency (sometimes called legal capacity) is a judicial determination of legal status, made by a judge, not a physician, and denotes a person’s legal ability or inability; capacity (sometimes called clinical competency) is assessed by a physician, not a judge, and is a clinical opinion regarding a patient’s abilities to make health care decisions.) (1) 

Treating a minor of divorced parents?
State laws vary regarding decision making for minors of divorced parents, whether requiring both parents to agree on the medical decision, or allowing one parent to make decisions for medical and mental health treatment and medications. For divorced parents, risk managers should remind the clinicians to ask for a copy of the custody agreement as part of the initial intake to learn if one parent or both parents have decision-making authority. The risk manager is not making a legal judgement relating to the divorce or custody but simply asking for appropriate court divorce documents to support who has medical decision-making authority as well as identifying the managing conservator.  

Patient is hearing deficient or limited in English proficiency?
A qualified sign or language medical interpreter should be used for any patient who is deaf or hard of hearing or has limited English proficiency (LEP). The use of family or friends to translate for the patient is strongly discouraged; they may not be impartial, may not understand the medical discussion or terminology, may not use the patient’s own words when responding to questions or supplying information, and/or may not be comfortable asking sensitive or potentially embarrassing questions (consider a teenager asking her grandfather about his sexual history). Inappropriate/inaccurate translation increases the risk of potential patient harm and liability. Remember, communication is the root of most claims and litigation filed against an organization.

Best Practices for Clinicians

  • Use simple, plain language such as “don’t use” instead of “abstain from”.
  • Use lay terms instead of medical jargon, acronyms, abbreviations, or legalese such as “as needed” instead of “prn,” “at bedtime” versus “HS,” or “biopsy” rather than “bx.” 
  • Use a specific informed consent form for each of the high-volume procedures, high-risk medications, wound care or other treatments performed within the organization to provide the enduring material to the patient in addition to the one-on-one patient teaching.
  • Teach back to confirm a patient’s understanding by asking them to repeat the information or instructions in their own words, as if they are explaining it to a friend or family member. The purpose is not a test of their knowledge, but rather a test of how well the instructions were explained and gives the opportunity to address any misunderstandings. For example, a patient may state, “I take two pills each day.” But if asked, “When,” they might incorrectly say in the morning, when it is one pill in the morning and one at night.
  • Document in the medical record the informed consent discussion, plan and patient understanding via teach back and any educational materials provided including avideos, apps or teaching tools.
  • When using an informed consent form, it must be fully completed, with no blanks. If there is a section that is not applicable, use “N/A” or other notation to indicate the section response was not accidently or deliberately omitted.

Best Practices for Risk Managers

  • Ensure that the organization’s informed consent process is consistent with state laws, regulations and case law, federal requirements and accreditation standards.
  • Complete an assessment of the consent process including inventory of the consent forms in use for the level of health literacy and ease of understanding; current practices, such as the use of in-person or video qualified medical interpreters; and documentation of the informed consent process.
  • Consider a Consent Chain of Command if any provider has questions on what, when or who regarding informed consent, including determination of decisional capacity. (2)
  • Monitor for internal or external changes or fallouts relating to the consent process.

The informed consent process should not be taken lightly. It sets the tone for the patient-provider relationship by demonstrating the commitment to and importance of patient understanding and engagement with their treatment; improves patient adherence to the plan of care; and serves to reduce the potential liability of a claim for intentional or negligent informed consent.


  • Fay Rozovsky, “Risk Issues: Informed Consent,” webinar for AWAC Services, member company of Allied World, 2014 

Elected to the ASHRM Board for 2020-2023, Anne Huben-Kearney, RN, BSN, MPA, CPHRM, CPHQ, CPPS, DFASHRM, has extensive clinical, managerial, and administrative experience using her expertise in patient safety, risk management and quality improvement in a variety of health care settings including tertiary care institutions, community hospitals, and physician office practices and in the medical professional liability industry. She is Assistant Vice President of the Risk Management Group, AWAC Services, a member company of Allied World.

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