Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patient's right to direct what happens to their body. Implicit in providing informed consent is an assessment of the patient's understanding, rendering an actual recommendation, and documentation of the process. The Joint Commission requires documentation of all the elements of informed consent "in a form, progress notes or elsewhere in the record." The following are the required elements for documentation of the informed consent discussion: (1) the nature of the procedure, (2) the risks and benefits and the procedure, (3) reasonable alternatives, (4) risks and benefits of alternatives, and (5) assessment of the patient's understanding of elements 1 through 4.
It is the obligation of the provider to make it clear that the patient is participating in the decision-making process and avoid making the patient feel forced to agree to with the provider. The provider must make a recommendation and provide their reasoning for said recommendation.
Adequacy of Informed Consent
The required standard for informed consent is determined by the state. The three acceptable legal approaches to adequate informed consent are (1) Subjective standard: What would this patient need to know and understand to make an informed decision? (2) Reasonable patient standard: What would the average patient need to know to be an informed participant in the decision? (3) Reasonable physician standard: What would a typical physician say about this procedure?
Many states use the "reasonable patient standard" because it focuses on what a typical patient would need to know to understand the decision at hand. However, it is the sole obligation of the provider to determine which approach is appropriate for a given situation.
Exceptions to Informed Consent
Several exceptions to the requirement for informed consent include (1) the patient is incapacitated, (2) life-threatening emergencies with inadequate time to obtain consent, and (3) voluntary waived consent. If the patient's ability to make decisions is questioned or unclear, an evaluation by a psychiatrist to determine competency may be requested. A situation may arise in which a patient cannot make decisions independently but has not designated a decision-maker. In this instance, the hierarchy of decision-makers, which is determined by each state's laws, must be sought to determine the next legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be appointed by the court.
Children and Informed Consent
Children (typically under 17) cannot provide informed consent. As such, parents must permit treatments or interventions. In this case, it not termed "informed consent" but "informed permission." An exception to this rule is a legally emancipated child who may provide informed consent for himself. Some, but not all, examples of an emancipated minor include minors who are (1) under 18 and married, (2) serving in the military, (3) able to prove financial independence or (4) mothers of children (married or not). Legislation regarding minors and informed consent is state-based as well. It is important to understand the state laws.
Informed Consent for Blood Transfusion
Informed consent is essential to patient autonomy. Informed consent requires a thorough understanding of transfusions and the ability to convey this information to a patient in a way that they can understand it. However, obtaining consent often has deficiencies in the explanation where benefits may not be entirely true and risks related are omitted.. It has been shown that involving experts from transfusion units in obtaining informed consent for transfusion results in patients having a better understanding of the risks and benefits. However, always involving an expert may not be the most efficient way to obtain consent, although new graduate physicians have a knowledge deficit when it comes to transfusion medicine. However, physicians that had previous transfusion medicine education displayed more understanding than those who did not. As most physicians will need to obtain informed consent for a transfusion at one point in their career, it could be argued that physicians should have enough education in regards to transfusion medicine.
The types of transfusions and their indications are:
Adverse effects of transfusions:
Obtaining informed consent in medicine is process that should include: (1) describing the proposed intervention, (2) emphasizing the patient's role in decision-making, (3) discussing alternatives to the proposed intervention, (4) discussing the risks of the proposed intervention and (5) eliciting the patient's preference (usually by signature). Discussion of all risks is paramount to informed consent in this context. Most consent includes general risks, risks specific to the procedure, risks of no treatment and alternatives to treatment. Additionally, many consent forms express that there are no guarantees that the proposed procedure will provide a cure to the problem being addressed.
Patient safety is a major focus in health care, and effective informed consent is considered a patient safety issue. The Joint Commission recently addressed the challenges to ensuring effective informed consent. The emphasis of a patient signature as an indication of understanding is being called into question. The process of informed consent is shifting to focus more on communication and less on signatures. Studies of informed consent have found that there are many barriers to obtaining effective informed consent. One major barrier is that some consent forms contain language that is at too high a reading level for many patients. Use of visual and digital communication tools is being encouraged to address some the inefficiencies in the process of obtaining consent. Patients should be actively engaged as a way to enhance communication and ensure patient safety and understanding.
Informed consent may be waived in emergency situations if there is no time to obtain consent or if the patient is unable to communicate and no surrogate decision maker is available. Also, not every procedure requires explicit informed consent. For example taking a patient's blood pressure is a part of many medical treatments. However, a discussion regarding the risks and benefits of using a sphygmomanometer usually is not required.
Clinical Significance in Human Clinical Studies
Informed consent is mandatory for all clinical trials involving human beings. The consent process must respect the patient's ability to make decisions and adhere the individual hospital rules for clinical studies. Adherence to ethical standards in study design and execution is usually monitored by an Institutional Review Board (IRB). The IRB was established in the United States in 1974 by the National Research Act which called for regulation in human research that was prompted by questionable research tactics used in the Tuskegee syphillis experiments and others. Ethical and safe research standards have been an area of federal and presidential interest since then, with the development of many organizations and task forces since 1974 dedicated to this topic alone. Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
An IRB may waive informed consent if certain conditions are met. Paramount to this is that there be 'minimal risk' to the research participants. One example of minimal risk research is the assessment of interventions that normally occur in emergency situations. Examples of this include studying medications used for intubations in the emergency room or conducting a retrospective chart review.
Shared Decision Making
Informed consent is a collaborative process allowing patients and healthcare providers to make decisions together when more than one reasonable alternative exists, accounting for the patient’s unique preferences and priorities and the best scientific evidence available.
It is most appropriate in weighing the benefits and harms of invasive procedures, computed tomography (CT), and post-ED disposition including the use of thrombolytics for acute ischemic stroke, lumbar puncture to rule out subarachnoid hemorrhage, and CT for minor pediatric head injuries.
Shared decision-making (SDM) challenges in Emergency Medicine include patient, provider, system and evidence level limitations. Examples include: (1) if patients are capable of or willing to engage in decision making (2) if providers feel it provides more or less medico-legal protection, (3) if the Emergency Department is overwhelmed and time is of the essence to make decisions, and (4) if the facility lacks well-validated risk prediction tools to guide decision making.
As mentioned previously, there is a deficit in providing necessary information to patients when obtaining informed consent. Providers should be educated on common procedures and interventions from experts and should be able to relay this information to patients as well as other members of the healthcare team. Members of the healthcare team, such as nurses and patient care assistants, should also be educated about all potential adverse reactions so that they are able to identify them and notify a provider so that any immediate intervention that is needed can be performed in a timely manner. Members of the healthcare team involved with the care of a patient should also be informed about procedures and interventions as they may be used as witnesses in obtaining informed consent. They would be able to evaluate whether all necessary information was given to the patient and provide any information the provider obtaining informed consent may have forgotten.
|||Slim K,Bazin JE, From informed consent to shared decision-making in surgery. Journal of visceral surgery. 2019 May 14; [PubMed PMID: 31101549]|
|||Edwards S, Review of a medical illustration department's data processing system to confirm general data protection regulation (GDPR) compliance. Journal of visual communication in medicine. 2019 May 15; [PubMed PMID: 31088229]|
|||Williams CM,Nester C,Morrison SC, International approaches to paediatric podiatry curricula: It's the same, but different. Journal of foot and ankle research. 2019; [PubMed PMID: 31086569]|
|||Boskey ER,Johnson JA,Harrison C,Marron JM,Abecassis L,Scobie-Carroll A,Willard J,Diamond DA,Taghinia AH,Ganor O, Ethical Issues Considered When Establishing a Pediatrics Gender Surgery Center. Pediatrics. 2019 May 13; [PubMed PMID: 31085738]|
|||Xu J,Prince AER, Shared decision-making in vascular surgery. Journal of vascular surgery. 2019 May 5; [PubMed PMID: 31068265]|
|||Krüger M, [On the judgment by the Federal Court of Justice on living organ donors]. Der Chirurg; Zeitschrift fur alle Gebiete der operativen Medizen. 2019 May 8; [PubMed PMID: 31069415]|
|||Friedman M,Arja W,Batra R,Daniel S,Hoehn D,Paniz AM,Selegean S,Slova D,Srivastava S,Vergara N, Informed consent for blood transfusion: what do medicine residents tell? What do patients understand? American journal of clinical pathology. 2012 Oct; [PubMed PMID: 23010711]|
|||Furumaki H,Fujihara H,Yamada C,Watanabe H,Shibata H,Kaneko M,Nagai S,Ishizuka K,Tsuzuki M,Adachi M,Takeshita A, Involvement of transfusion unit staff in the informed consent process. Transfusion and apheresis science : official journal of the World Apheresis Association : official journal of the European Society for Haemapheresis. 2016 Feb; [PubMed PMID: 26878975]|
|||O'Brien KL,Champeaux AL,Sundell ZE,Short MW,Roth BJ, Transfusion medicine knowledge in Postgraduate Year 1 residents. Transfusion. 2010 Aug; [PubMed PMID: 20345564]|
|||Hébert PC,Wells G,Blajchman MA,Marshall J,Martin C,Pagliarello G,Tweeddale M,Schweitzer I,Yetisir E, A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. The New England journal of medicine. 1999 Feb 11 [PubMed PMID: 9971864]|
|||Carson JL,Stanworth SJ,Alexander JH,Roubinian N,Fergusson DA,Triulzi DJ,Goodman SG,Rao SV,Doree C,Hebert PC, Clinical trials evaluating red blood cell transfusion thresholds: An updated systematic review and with additional focus on patients with cardiovascular disease. American heart journal. 2018 Jun [PubMed PMID: 29898855]|
|||Docherty AB,O'Donnell R,Brunskill S,Trivella M,Doree C,Holst L,Parker M,Gregersen M,Pinheiro de Almeida J,Walsh TS,Stanworth SJ, Effect of restrictive versus liberal transfusion strategies on outcomes in patients with cardiovascular disease in a non-cardiac surgery setting: systematic review and meta-analysis. BMJ (Clinical research ed.). 2016 Mar 29 [PubMed PMID: 27026510]|
|||Carson JL,Terrin ML,Noveck H,Sanders DW,Chaitman BR,Rhoads GG,Nemo G,Dragert K,Beaupre L,Hildebrand K,Macaulay W,Lewis C,Cook DR,Dobbin G,Zakriya KJ,Apple FS,Horney RA,Magaziner J, Liberal or restrictive transfusion in high-risk patients after hip surgery. The New England journal of medicine. 2011 Dec 29 [PubMed PMID: 22168590]|
|||Sharma S,Sharma P,Tyler LN, Transfusion of blood and blood products: indications and complications. American family physician. 2011 Mar 15 [PubMed PMID: 21404983]|
|||Taylor RW,O'Brien J,Trottier SJ,Manganaro L,Cytron M,Lesko MF,Arnzen K,Cappadoro C,Fu M,Plisco MS,Sadaka FG,Veremakis C, Red blood cell transfusions and nosocomial infections in critically ill patients. Critical care medicine. 2006 Sep [PubMed PMID: 16849995]|
|||Pesut B,Thorne S,Stager ML,Schiller CJ,Penney C,Hoffman C,Greig M,Roussel J, Medical Assistance in Dying: A Review of Canadian Nursing Regulatory Documents. Policy, politics [PubMed PMID: 31060478]|
|||Hewins W,Zienius K,Rogers JL,Kerrigan S,Bernstein M,Grant R, The Effects of Brain Tumours upon Medical Decision-Making Capacity. Current oncology reports. 2019 May 2; [PubMed PMID: 31049786]|