Informed Consent

AN OVERVIEW BY ANUM AHMED

Informed consent refers to the patient’s agreement to undergo a certain medical treatment when they have understood the risks and benefits of the treatment. In many cases, informed consent is implied; for example, when you go to the doctor’s office, it is implied that you are consenting to a physical examination. However, for more invasive procedures, the patient may be required to provide documented consent. Cases where informed consent of the patient can be forgone would include emergent situations where immediate life-saving actions are critical or when the patient is mentally incapable of providing informed consent for themselves; under these conditions, there are alternative processes where a family member can legally make a substitutive decision.

In the ideal case of informed consent, the process involves four main components. First, patients must have the cognitive capacity to make the decision about their treatment--they must be mentally and emotionally competent. In order to display appropriate mental competence, a patient should be able to accurately explain the treatments, risks and benefits, and a rational reason why they want to choose a specific course of action (a concept referred to as ‘teaching-back’) after being educated about their treatment options. Secondly, the decision needs to be of the patient’s voluntary consent and should not heavily influenced by others, especially those of the medical community. There are many times when a healthcare provider imposes a “doctor knows best” mentality on the patient, even though the decision should ultimately be made by the patient.

Third, the provider is required to explain all pertinent information required to make an informed decision--and they must explain every choice a patient has for their course of action (even if an option is potentially life-threatening). While a provider may not feel the need to disclose every technical detail, they should be able to effectively communicate the potential ramifications of a treatment. Finally, the patient needs to take the information given to them by the provider and fully comprehend it--they may want extra time, help from family and friends, or outside intervention in the form of grief counseling or therapy. Even if a patient is willing to sign a consent form, it may be difficult to identify whether the patient truly has a handle on the information. It is understandably easy to get overwhelmed in these situations, and sometimes, a patient may make a decision that they would have not otherwise made if they were completely informed. It is therefore important to assess the patient’s ability to make an informed decision based on the four components listed above. After all, informed consent does not mean merely telling a patient about their options--it is about comprehension, awareness, and autonomy.

AMA J Ethics. 2016;18(9):869-886. doi: 10.1001/journalofethics.2016.18.9.peer2-1609.

Wagner, R.A. (2018, May 17). What is Informed Consent? (J.E. Keany, F. Talavera, & J. Pritchard Taylor III, Eds.). Retrieved from www.emedicinehealth.com/informed_consent/article_em.htm#what_is_informed_consen

REASONABLE PERSON VS. PROFESSIONAL STANDARD: DETERMINING THE EXTENT OF INFORMED CONSENT

LANDON ROHOWETZ

In the case titled Disclosing the risks of Dilantin to seizure clinic patients: how much to state in Case Studies in Biomedical Ethics, a group of physicians is forced to make a decision regarding what standard to use when providing information to patients about Dilantin, a commonly used seizure medication. The physicians have empirical data showing that only four out of the drug’s 16 possible risks were mentioned by more than 50% of neurologists to their patients. However, the data also show that a large majorities of patients say that they would want to know about each of the 16 side effects.1 The dilemma, therefore, lies in whether the physicians are morally required to use the professional standard and rely on judgments of disclosure of their colleagues, or whether they should use the reasonable person standard and rely on the views of reasonable people when making the information sheet.

I believe it is morally required to use the reasonable-person standard when creating the seizure medication’s information sheet because this standard respects patient autonomy more than the professional standard would. Assuming patients are reasonable and competent and that the treatment does not cause undue suffering to others, I believe that patients have the autonomy to make informed decisions regarding their own welfare. An essential element of informed consent is the disclosure of relevant information to patients. Thus, physicians should be required to disclose information that a reasonable person would want to know before making a decision for or against treatment because patients must understand the potential benefits and harms of a treatment in order to fully consent to it. In the aforementioned case, there is evidence that most (presumably reasonable) people want to know about all sixteen side effects of the drug before making a decision for or against it. Thus, the group of physicians can only assume that most patients want to know about all the side effects, and therefore they should include them on the information sheet.

One might object to this argument and say that instead of using the reasonable-person standard, the group of physicians should rely on the consensus of physician colleagues and use the professional standard when deciding what to disclose on the information sheet. They may argue that physicians know the most important side effects and that the reasonable-person standard violates the principle of nonmaleficence through inclusion of side effects that are extremely rare, but upsetting to the patient, causing undue mental suffering and noncompliance. However, concern about noncompliance or fear of side effects does not justify omission of information that most patients would want to know when obtaining informed consent, which is the cornerstone of patient autonomy. Accordingly, using the professional standard for deciding what must be disclosed is not respecting patient autonomy, a principle that physicians are morally required to abide by when caring for competent patients. Therefore, using the professional standard when caring for competent patients as in this case is morally impermissible.

Veatch RM, Haddad AM, English DC. Case 17-3: Disclosing the risks of Dilantin to seizure clinic patients: how much to state. In: Case Studies in Biomedical Ethics: Decision-Making, Principles, and Cases. New York: Oxford University Press; 2010:373-374.

INFORMED CONSENT IN PREGNANT WOMEN

MEGHANA KUMAR

Most people involved in healthcare are familiar with the famous line from Billy Joel’s “We Didn’t Start the Fire” that refers to the “children of thalidomide.”1 In the 1950s and 1960s, biological mothers of these children had taken the drug thalidomide during their pregnancy to alleviate their nausea.2 Due to lack of proper research and public health education on the drug, several generations of infants were born with congenital birth defects, the hallmarks of which were limb, cardiac, and ocular anomalies. 2 The thalidomide issue is just one of the many examples of illustrating that controlled clinical research trials on pregnant women with informed consent are vital to the advancement of medicine.

However, pregnant women, “remain underrepresented in clinical research”. 3 Studies and literature reviews have cited multiple factors associated with the disparity in research related to pregnant women, but one reason that study subjects are recruited and retained is due to greater access to prenatal care for participants. 4 As a result, the population of pregnant study subjects with financial disadvantages and lack of quality prenatal care are potentially at risk of being pressured into research participation for the health of their fetus.

Are these women really giving autonomous informed consent if they are worried about the condition of their fetus? In the article “Research in Pregnant Women: The Challenges of Informed Consent”, the authors admit that pregnant women, “may be willing to take personal risks for presumed benefit to the fetus” which is added to “society’s expectation that she take part [in the study]”. This can put her under a pressure that “interferes with the ability to fully give free consent” (Helmreich et al. 580).

The presence of a potential to take advantage of underprivileged pregnant subjects coexisting with the underrepresentation of pregnant women in clinical research demands that researchers are cautious in their recruitment and retention of pregnant study subjects. Researchers must be vigilant in confirming that participants are not under significant pressure from their community or feel an obligation to the fetus’s health above their own health that would influence them to consent.

Joel, Billy. “We Didn't Start the Fire .” Columbia , July 1989
Kim, James H., and Anthony R. Scialli. “Thalidomide: The Tragedy of Birth Defects and the

Effective Treatment of Disease.” Toxicological Sciences, vol. 122, no. 1, July 2011, pp. 1–6.

3. Frew, P. M., et al. “Recruitment and Retention of Pregnant Women Into Clinical Research Trials:

An Overview of Challenges, Facilitators, and Best Practices.” Clinical Infectious Diseases, vol. 59, no. suppl 7, Dec. 2014.

4. Helmreich, Rebecca J., et al. “Research in Pregnant Women: The Challenges of Informed Consent.” Nursing for Womens Health, vol. 11, no. 6, 2007, pp. 576–585.

CAPACITY TO CONSENT

KARISHMA RAJU

As prospective physicians, we desire to make and encourage tailored healthcare plans for our patients that we will benefit their overall health. For instance, we push for dialysis for the severely fatigued, nauseous, and edematous patient with stage 5 chronic kidney disease because the alternative is crystal clear to us—death. So, when the patient declines urgent, life-saving medical intervention, what should we question?

We question if the patient is certain about accepting the alternative option of not receiving treatment. We question if the patient understands the consequences to their health that can result from not receiving treatment. We question if the patient has the capacity to accept that they need the intervention. For those where the lines are blurred as to whether they possess the capacity to thoroughly weigh the risks and benefits of consenting to medical intervention, such as patients with a complex psychiatric history, how should we approach the situation?

According to the esteemed psychiatrist Dr. CW Van Staden, “the clinical assessment of a particular patient’s capacity to give informed consent in a case of mental disorder is better informed by the consideration of conditions necessary to give informed consent than by making inferences from general features implied by a specific diagnosis”.1 Regardless of diagnosis, if the patient holds the capability to communicate and comprehend what they are consenting to, the patient should be permitted independence towards providing informed consent.

Additionally, to give independent and informed consent, the patient’s mental disorder must not prevent them from understanding the significance of the medical intervention. For instance, a patient with severe narcissistic personality disorder (who is under the misconception that their body is incapable of being in a weakened state of disease) who is suffering from an aortic dissection may not be able to accept the need for surgery. Therefore, this particular patient would lack the capacity to provide informed consent. However, if a manic bipolar patient with the same lethal condition were able to coherently accept the fact that without surgery, he or she would most likely expire within the next week and chose to decline the procedure with coherent reasons, healthcare providers would have no choice but to accept this decision.

Van Staden, C. W. "Incapacity to give informed consent owing to mental disorder." J Med Ethics, no. 29, 6 June 2002, pp. 41-43. Accessed 22 Aug. 2018.

IMPROVING PATIENT INFORMED CONSENT IN SURGERY

BRANDI JUNGELS

It is a physician’s responsibility to provide patients with the information they need to make important decisions regarding their healthcare and treatment. This process, known as informed consent, is critical to all areas of medicine including complicated fields such as cardiac surgery. Patients need to be aware of the possible risks and benefits before undergoing such an invasive procedure, but this data can often be difficult to relay. According to an article by Villanueva et al., published in the Patient Education and Counseling Journal, “various factors such as time constraints, use of medical jargon, patients’ health literacy and patients’ retention of information can affect the fulfillment of an adequate informed consent”.1 Addressing these barriers to informed consent will help patients undergoing surgery feel more in control and satisfied with their healthcare.

Since informed consent is so necessary in complicated cases, a great deal of research has been dedicated to exploring the most effective ways to convey information to patients. An article by Villanueva and colleagues compiled results from studies that investigated patient recall and comprehension after use of an intervention method, such as using illustrations or a video, compared to the traditional verbal method of giving information.1 Their goal was to see what could be done for patients before a surgery that would help them remember and understand the procedure better. Their research concluded that “The use of additional text, illustrations, and multimedia tools provide additional benefits to standard consent techniques…[with] interactive multimedia interventions [appearing] to be the most promising to enhance preoperative patient education.” 1 Giving patients information through a variety of means, not just verbally, and incorporating interactive media will help patients understand and remember more about their upcoming procedure.

Part of being a physician is making medicine understandable to the variety of patients that require care. It is especially important for patients undergoing invasive surgery to understand the procedure, including all the possible risks and outcomes, and remember the information even if they are scheduled to have the surgery months in advance. One way physicians can make medical procedures more comprehendible is through the use of visual and auditory aids such as illustrations and video. Patients who are able to understand their treatment will be better equipped to make informed decisions, which leads them to better health outcomes.

Villanueva, Claudia, et al. “Improving informed consent in cardiac surgery by enhancing preoperative education.” Patient Education and Counseling, 2018. Science Direct, doi: https://doi.org/10.1016/j.pec.2018.06.008.

END-OF-LIFE DECISIONS IN THE GERIATRIC POPULATION AND INFORMED CONSENT

RACHANA KOMBATHULA

For many, conversations about death and end of life are painful and uncomfortable--something to be avoided for as long as possible. When our healthcare system is analyzed in detail, we see that “American culture reflects a paradox: the more openly we discuss death and its inevitability, the more money we spend to postpone and deny it.”1 Due to possible ambiguity of autonomy and welfare, it is necessary to scrutinize the factors of informed consent in geriatric populations.

According to a Symposium of Consent and Confidentiality, consent must include respect for persons. This respect has 2 dimensions: respect for autonomy and concern for welfare. As medical professionals, informed consent allows us to align our own objectives for welfare with the patient’s wishes. For the geriatric population, the most common complication of informed consent is that of autonomy. Many elderly patients who suffer from dementia or other mentally-impairing illnesses may not have the cognitive capacity to fully comprehend or appreciate the benefits and consequences of starting, continuing, or withholding medical procedures. Therefore, they may lack the information necessary to provide truly informed consent. Though family members may give consent in lieu of the patient, their values may not align with those of the patient, creating an ethical dilemma.

Concern for welfare, as defined in the essay Consent and End of Life Decisions, is based on health, freedom from pain, mobility, shelter and other aspects of daily living.2 Many geriatric patients fear that as they grow older, medical interventions will be employed to prolong life simply because they are available, but not with the intention of improving quality of life or welfare. This difference in perspectives of concern for welfare between physicians and their geriatric patients further complicates informed consent, as it implies that though medical conditions may be understood by both parties, the decisions regarding treatments may differ between physician and patient.

Currently, the only way to resolve the majority of issues with end of life decisions and informed consent is by starting to plan for a comfortable death well in advance. Though it may seem ominous and perhaps premature, it is quite important to initiate advanced care planning for geriatric patients to maximize their autonomy and welfare. It is crucial to discuss and document end of life wishes first with the patient, and then with involved family and friends to explore all options. Benefits of advanced care planning may include higher quality of remaining life, reduced medical expenses, peace of mind for patient, physician, and family, and preserved informed consent.

Annas, G.J., & Miller, F.H. (n.d.). The empire of death: how culture and economics affect informed consent in the U.S., the U.K., and Japan. American Journal of Law and Medicine, 20(357).
Harris, J. (2003). Consent and end of life decisions. Journal of Medical Ethics, 29(1), 20-15. doi:10.1136/jme.29.1.10

CASE EVALUATION OF HENRIETTA LACKS: LACK OF INFORMED CONSENT PRESENT IN DISENFRANCHISED COMMUNITIES

SHAFAA MANSOOR

When something benefits the common good, it should provide benefit for all. There seems to be no limit on the amount of good that can come from scientific advances and breakthroughs. Unfortunately, human bias and selfishness can get in the way of making scientific discoveries equally applicable to all of the members with some members being aided preferentially while others go without. As physicians, it is part of our responsibility to address these inequities as best we are able. In the case of Henrietta Lacks, the physicians caring for her had an obligation to provide informed consent was ignored, resulting in what is arguably one of the most controversial health advances to have spread, regenerated, and taken over the world – HeLa cells.

Henrietta Lacks, a young African American woman was admitted to the Johns Hopkins Hospital on January 29th, 1951 for vaginal bleeding. She was examined and diagnosed with malignant cervical cancer and began to receive therapy immediately. Despite this, Henrietta passed away in late October of that year at age 31 leaving behind her husband and five children. However, neither she nor her family were informed that some of her cancer cells recovered from a biopsy were sent to a lab and became the first cells to be “immortal” – they could withstand laboratory conditions unlike previous cervical cell samples and replicate continuously in culture. Henrietta Lack’s cells would go on to be used to investigate the effects of drugs, toxins, hormones, and radiation in humans and would also be utilized in the development of the polio vaccine.

If Henrietta was given the choice to have her cells taken and used as they were, would she have said yes? There is no way of knowing because rather than giving the woman behind many scientific breakthroughs any sort of choice in the matter, she was treated simply a research subject without any respect for her autonomy. Though it took time and advocacy from her family, Henrietta Lacks was finally recognized for her immense contribution to modern science. When considering informed consent through the lens of this case, it quickly becomes apparent why informed consent is necessary, especially when dealing with patients from communities are at most risk for having theirs rights violated. Racism and socioeconomic barriers are structurally inherent into our society whether we encounter it daily or not. As physicians, it is our responsibility to use our privilege to play a role in protecting disenfranchised communities that are too often overlooked or mistreated. We are advocates for human life and ultimately, we have a duty to educate and inform as much as possible.

Butanis, B. (2017, April 12). The Immortal Life of Henrietta Lacks | Johns Hopkins Medicine. Retrieved from http://www.hopkinsmedicine.org/henriettalacks/immortal-life-of-henrietta-lacks.html

Nisbet, M. C., & Fahy, D. (2013). Bioethics in popular science: evaluating the media impact of The Immortal Life of Henrietta Lacks on the biobank debate. BMC medical ethics, 14(1), 10.