‘Sign Here’ — The Language and Convention of Informed Consent
By: Talia Rajasekar and Alejandro Quezada
Several words in the English language function both as nouns and as verbs: shelter, answer, notice, and practice, to name a few. However, the prominent usage of the word tends to be unequally distributed between parts of speech. For instance, “consent” as a noun can easily become a distant institution, relegated to a bullet point in HR workshops and healthcare training. Only the “verbification” of this word, however, captures the act of giving and receiving such an important pillar of ethics. This act of giving and receiving consent is a different beast entirely, a fact to which professionals such as surgeon Dr. Atul Gawande attests to in a collection of essays detailing the emotional and mental toll of the industry [1]:
“No one said I could die from this.”
“It’s my last hope.”
“Are you saying I’m going to die?”
Dr. Gawande — a general and endocrine surgeon at Brigham and Women’s Hospital in Boston — explains the risks of spinal surgery to a near-paralytic patient, whom he has dubbed Lazaroff. A surgery that was previously planned, already outlined, and scheduled for the next day [1].
The previously offered lines of dialogue were lifted verbatim from Gawande’s discussion with Lazaroff. Though they certainly bespeak a sense of fear on the part of the patient, it is critical to recognize that he is not alone in these fears. Such hesitation can be confounded by several factors, including confusing terminology, pre-existing conditions, and apprehension on the part of the healthcare provider.
This issue of professionals’ apartment misgivings rings especially true in the case of Gawande’s patient, since Gawande and his team had their own reservations about the procedure. The surgery, even if successful, could have only prolonged the patient’s life by a few months, and with the procedure came a high risk for a number of complications, including a stroke or heart attack. Though Gawande expressed these to Lazaroff and his son in great detail, pain — being an often powerful breeder of hope — nudged Lazaroff to sign the “informed consent form” in the hours before his surgery [1].
Lazaroff died in the week following his otherwise successful operation. Hellenistic philosophers might regret this loss of life but declare that, ultimately, no guilt falls on any party, since all precautions were in place and no information was hidden. However, recent investigation into informed consent and autonomy has yielded critical insights into emotional overwhelm and informational overload [2]. While this absolutely does not mean to insinuate that this shift in burden must fall from the patient to the physician, it certainly raises important questions about how technically dense information is delivered to emotionally and mentally fraught patients. In a patient perspective study by Burns et al., though 80 percent of patients were satisfied with the information provided by their team concerning their treatment plan, over half of those surveyed could not accurately identify even one complication from these procedures [3].
This issue of informed consent extends beyond the confines of an operating room and into everyday care. For example, the clinical trial setting comes to mind. These research studies are a vital component of healthcare development, providing an avenue for promising new treatments and interventions to be tested extensively for efficacy and safety prior to being approved for wider use. Because of this, heavy emphasis must be placed on ensuring that patients understand all crucial information pertaining to these studies.
The treatments being tested in these trials are, by definition, experimental in nature, and carry with them both known and unknown risks and side effects that must be properly explained to a patient prior to their enrollment. It is not uncommon for patients to turn to these studies as a last resort of treatment, often due to exhausting other existing options or due to factors such as lack of insurance or accessibility, which is why it is crucial that they be properly informed of a trial’s nature before deciding to participate. This can often prove to be challenging, as there may be instances where patients neglect these risks due to a sense of urgency to begin receiving treatment, or where the patient’s ability to understand these details is impaired due to age or disability. The issue is both evident and prevalent across this field; a systematic review of informed consent literature found that 69.6% of participants fully understood their study’s purpose, and only 54.9% could recall at least one risk associated with the treatment [3].
Considering these factors, ensuring that proper consent is executed may appear to be an impossible task. However, several measures can be taken to reduce the risk of ill-informed patients signing up for studies. When possible, providing patients with informational documents prior to the official consenting process can prove to be highly beneficial, as this allows patients, their families, and primary physicians to review trial details before officially beginning the enrollment process [4].
Having family members who typically care for the patients present during the consenting process can allow for additional questions and discussions regarding the clinical trial to arise, ensuring a better understanding for both parties. Similarly, having a legal representative or impartial witness present when applicable can provide additional reassurance to patients that proper consenting procedures are being carried out [4].
As a fundamental tenet of biomedical ethics and the Belmont Report, informed consent continues to be a standard to which all healthcare professionals must adhere. Though this ethical authority disavows the excuses made by a lack of education and expectations put forth by the medical team, the act of asking and receiving requires mental and medical gymnastics that balance patient overwhelm and education. Perhaps once this balance is practiced, consent can be remembered more as a verb than as a noun, rooted in the patient more than it is custom.
Talia is a third year Molecular, Cell, and Developmental Biology major and current THINQ fellow.
Alejandro is a UCLA Alum and current THINQ fellow.
Sources:
- Gawande, A. (2003). Complications: A surgeon’s notes on an imperfect science. Picador.
- Bester, J. (2016). The limits of informed consent for an overwhelmed patient: Clinicians’ role in protecting patients and preventing overwhelm. AMA Journal of Ethics, 18(9), 869–886. https://doi.org/10.1001/journalofethics.2016.18.9.peer2-1609.
- Burns, P., Keogh, I., & Timon, C. (2005). Informed consent: A patients’ perspective. The Journal of Laryngology and Otology, 119(1), 19–22. https://doi.org/10.1258/0022215053222860.
- Pietrzykowski, T., Smilowska, K. (2021). The reality of informed consent: empirical studies on patient comprehension — systematic review. Trials, 22, 57. https://doi.org/10.1186/s13063-020-04969-w
