Enterprise Risk Management (ERM) Legal & Regulatory

Clarifying Informed Consent

Informed consent can be a confusing concept. In addition to different components of consent to understand, there are regulatory, state and federal mandates that apply. The following discusses elements of informed consent along with guidelines to consider when establishing, implementing and improving the informed consent process.

Having clear processes and well-written consent forms are just the beginning of the communication necessary for informed consent. Providers must ensure patients completely understand the treatments and procedures. Common barriers include literacy challenges, educational issues, language barriers, lack of communication tools, as well as difficulty determining who has the right to consent.

Simple and Informed Consent

The two types of consent are simple and informed.  A simple consent applies to common treatments or procedures with minimal risks, such as withdrawing blood, treating the flu or getting an MRI. Informed consent applies to more invasive procedures that carry more risk, such as surgery, complicated medical plans or research treatments.

Common law indicates that every competent adult has the fundamental right of self-determination. The Patient Self Determination Act is a federal law and compliance is mandatory. Those who can’t consent for themselves would include a minor patient or an adult patient who has been deemed incompetent to make medical decisions. When these situations occur, each patient has the right to be represented by another person who has the capacity to make medical decisions. Best practices are that this should not be the treating provider.

Informed consent is a conversation when the risks, benefits and alternatives of medical care and treatment are discussed with a patient and/or his/her representative. All procedures require consent, but not all are required to be “informed consent.” Informed consent is a process in which a medical provider gives patients and/or their representative enough information to decide whether or not to go forward with care, treatments or medical procedures. If health care providers find themselves in a position where a patient is declaring that he/she did not consent to a medical procedure or treatment, the medical record will be examined to determine what conversations took place with the treating physician. Even battery could be alleged and, if litigation ensures, the courts determine validity. Scenarios such as these underline why accurate documentation is vital.

Informed Consent Basics

  1. Outline the risks, benefits, alternative treatment available
  2. Involve the patient in decision making
  3. Communicate at a level the patient can understand
  4. Contain enough information for the patient to make an informed decision
  5. Explain refusal of care and the risks associated
  6. Include the Informed consent in the medical record
  7. Obtain a language interpreter if patient requires one; family alone is not acceptable

Requirements for Achieving Consent

  1. Electronic records complete
  2. Technologies must communicate
  3. The Joint Commission guidelines followed
  4. CMS requirements included
  5. Organizational processes in place
  6. Providers should not delegate to other staff members
  7. Progress notes and documentation must be complete
  8. Processes followed by provider and staff
  9. Staff and provider educated about informed consent

Federal and Regulatory Guidelines

The Joint Commission (TJC) has requirements surrounding the informed consent process and safe care. Specifically, The Joint Commission states:

“To establish a mutual understanding between the patient and the licensed independent practitioner or other licenses practitioners with privileges about the care, treatment and services that the patient will receive. Informed consent is not merely a signed document. It is a process that considers patient needs and preferences, compliance with the law and regulations and patient education. Using the informed consent process helps the patient to participate fully in decisions about his or her care, treatment and services.” Standard RI.01.03.01 (2017)

TJC requires that the informed consent process complies with hospital policy. This includes documentation, who can give consent, as well as exceptions. It also requires that discussions with the patient include the nature of the treatment and services to be considered, potential benefits, risks, and side effects; as well as reasonable medical goals. Additionally, the hospital’s medical staff bylaws should address the procedures that require informed consent.

Centers for Medicare and Medicaid Services (CMS) requires that consent include the name of the hospital where treatment will take place; name of specific procedure to be performed; statement that the procedure/treatment has been explained appropriately as it relates to the risks, benefits, and alternatives; and signature of the patient or his/her representative, along with the date and time.

CMS further indicates that a “well designed consent form” includes the name of practitioner, date, time and signatures of the patient and/or representative plus a statement if other practitioners will be performing certain aspects of care.

Tips for Leaders:

  1. Compare your consent policy to CMS guidelines, as well as TJC using this two-page online tool.
  2. Interview patients to be certain they are satisfied with the informed consent discussion with their providers.
  3. Add your consent form as part of your surgical safety checklist or other applicable safety checklists you may have implemented and review each one to three years.
  4. Audit documentation to ascertain if any providers demonstrate patterns of non-compliance.
  5. Consider automation to help alleviate potential errors of scanning paper copies into the wrong chart.
  6. Provide education and training for providers and staff.
  7. Make sure there is shared decision making between the provider and patient (and/or personal representative).

Whether you are reviewing your organizational consent guidelines or implementing something new, careful attention should be placed on regulatory and federal components. In the end, the most important aspect is that patients understand the care and treatment received and that the risks and benefits were acknowledged, accepted and documented.


  1. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter07-17.pdf
  2. http://www.strategiesfornursemanagers.com/ce_detail/72818.cfm#
  3. https://www.ncbi.nlm.nih.gov/pubmed/10141946
  4. https://www.jointcommission.org/assets/1/23/Quick_Safety_Issue_Twenty-One_February_2016.pdf
  5. Elwyn G, et al. Shared decision making: A model for clinical practice. Journal of General Internal Medicine. Oct. 2012; 27 (10):1361–1367 (accessed Jan. 15, 2016). 6. Bilimoria KY, et al. Development and evaluation of the
  6. https://www.jointcommission.org/assets/1/6/2009_CLASRelatedStandardsHAP.pdf

Leigh Ann Yates, AIC, MBA, CPHRM, FASHRM, is a senior healthcare consultant at Hallmark Financial Services in Dallas, Texas.

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