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How Racial Bias Can Affect the Informed Consent Process


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By Sina Haeri, MD, MHSA, chief medical officer, Confirmed Consent 

Data has now consistently shown that racial bias in the healthcare system affects the care and treatment of minorities.

Indeed, the American Medical Association announced in late 2020 that racism is a threat to public health. This bias extends beyond our interactions with patients and can also include:

  • technology advancements
  • data analytic tools
  • therapeutics

Race & EHR Algorithms
In an article published by the New England Journal of Medicine, authors state that “embedding race into the basic data and decisions of health care, these algorithms propagate race-based medicine.” The article continues to say that “many of these race-adjusted algorithms guide decisions in ways that may direct more attention or resources to white patients than to members of racial and ethnic minorities.”  Oftentimes in health care organizations, there are certain criteria that clinicians have to complete when following electronic prompts to administer care to patients. Sometimes, these systems and criteria unknowingly are biased towards white patients.

This is common in maternal care as well. Many pregnancy risk profiles include being of the African-American race as a risk category. Many in the health care community have argued for years that this should be removed as there is great heterogeneity in this label and not all members will have elevated risk for pregnancy complications. Again this directs care and resources away from a patient who may carry extra risks due to race. 

These algorithms are common in the treatment plans across multiple settings and disciplines. Explanation of why racial or ethnic differences might exist varies greatly among algorithm developers. 

Data interpretation in these cases can be fraught with error. For example, controlling for a confounder such as black race, treats it as a dichotomous variable, not as a variable impacted by numerous variables itself (i.e. the black experience in America). Race may not always impact the treatment recommendation, but as clinicians we must ensure that every patient receives the same quality of care irrespective of race. The time is now to critically examine our established norms based on data.

Informed Consent Opportunities
Informed consent is another area susceptible to bias. Consents in a surgical facility include:

  1. the physician’s procedure consent
  2.  the facility’s consent to proceed with ordered treatment
  3. the anesthesia consent (if administered) 

Research has shown that the process of obtaining informed consent is all too frequently minimized to a signature on a form. Joint Commission standards specifically address a more thorough informed consent process than a simple sign-off.

Joint Commission’s ambulatory care program has two standards and several elements of performance related to informed consent. The elements of performance within RC.02.01.01 that refers to informed consent states:
EP 4: As needed to provide care, treatment, or services, the clinical record contains the following additional information:

  • Any informed consent

. Accredited ambulatory care organizations are expected to meet the following standard RI.01.03.01: The organization honors the patient's right to give or withhold informed consent. Related elements of performance require:

  • written policies
  • discussions on informed consent
  • documentation of informed consent when engaging in photography or media

When informed consent lapses occur, it’s often a matter of time constraints, as the information is delivered by the clinician who is already tasked with communicating:

  • the nature of the procedure
  • risks
  • benefits
  • reasonable alternatives

However, the level at which clinicians communicate and assess the patient’s understanding may be influenced by implicit or subliminal preconceived notions on:

  • socioeconomic status
  • age
  • gender 
  • language barriers
  • communicating in the patient’s preferred language

There are many ways to standardize the informed consent process for every individual regardless of race, age, gender, ethnicity, or preferred language. We used the following starting points in developing our informed consent platform:

  • closed-captioning on consent material 
  • shared decision making
  • non-English language platform to ensure that each patient receives the information via certified and documented translation, and is not impacted by the interpreter’s understanding of the spoken word at the visit
  • providing the same information each and every time, irrespective of their race, ethnicity, profession, gender, or other factor leading to bias.
  • ensuring each patient understands the value of informed refusal, which occurs when patients decline recommended treatment
  • confirming each patient had the right state of mind to give consent, and wasn’t coerced or rushed

The Joint Commission also offers training resources on informed consent. We hope you use them freely and you’re also welcome to utilize any of Confirmed Consent’s materials or reach out to me personally with questions. Let’s start sharing shamelessly in the name of communicating as clearly as possible with all patients of every race!

Sina Haeri, MD, MHSA, is chief medical officer, Confirmed Consent and chief of Maternal Fetal Medicine at Access Physicians.