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research-article2015
TCNXXX10.1177/1043659615569537Journal of Transcultural NursingMarrone
Article
Informed Consent Examined Within the Context of Culturally Congruent Care: An Interprofessional Perspective
Journal of Transcultural Nursing 1–7 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1043659615569537 tcn.sagepub.com
Stephen R. Marrone, EdD, RN-BC, NEA-BC, CTN-A1,2
Abstract The process of obtaining informed consent for diverse patients poses many challenges for health care professionals as they try to balance ethical, legal, and accreditation requirements of the country within which they practice with the culture care needs of diverse consumers. Culturally competent health care organizations create a governance infrastructure that promotes equity and supports the delivery of culturally appropriate health care services that are responsive to diverse patients. The purpose of this article is to examine the concept of informed consent within the context of culturally congruent care to Saudi patients and families in an American hospital setting. The need for the provision of culturally congruent care that respects the contextual rights and dignity of patients and families while, at the same time, recognizing the legal, ethical, and moral codes of the health professions and requirements of federal, state, and regulatory agencies within the United States will be explored. Keywords legal issues, multiprofessional/interdisciplinary practice, organizational culture
Introduction Despite America’s multicultural history, the provision of culturally congruent care remains a challenge, particularly the integration of transcultural care decisions and actions into the delivery of care within the American legal structure. Informed consent is the single imperative in the delivery of safe health care (Burton Report, 2002a, 2002b). The process of obtaining informed consent and ensuring that the patient’s decision was indeed “informed” poses many dilemmas for health care professionals as they try to balance bioethical, legal, and accreditation requirements of the country within which they practice with the culture care needs of diverse patients and families (Crow, Matheson, & Steed, 2000). Ethical dilemmas encountered by Western health care practitioners caring for Saudi Arabian (Saudi) patients and families are well documented (Aboul-Enein, 2002; Al-Shahri, 2002; Alkabba, Hussein, Albar, Bahnassy, & Qadi, 2012; El Gindy, 2004; Hairon, 2007; Halligan, 2006; Johnson, 2001; Kridli, 2002; Marrone, 1999a, 1999b). However, much of the literature explores these issues within the context of expatriate health care providers caring for Saudi patients within the Kingdom of Saudi Arabia. Therefore, the purpose of this article is to examine the concept of informed consent within the context of culturally congruent care to Saudi patients in an American hospital setting. An example of a likely case scenario that depicts the ethical dilemma of obtaining informed consent for a Saudi patient in an American hospital setting is depicted in Table 1.
Behind the Veil: Communication and Decision Making in Saudi Arabia Saudi Arabia is a high-context, collectivist, Muslim culture that values interpersonal relationships and trust must develop before transactions, decisions, and meaningful communication begins. Saudi decision making is generally centralized and decision makers are typically male elders who must consider the best interests of the family. Although Saudi health care beliefs encourage active involvement of the patient in decision making, equally important, however, are the performance of roles, usually defined within the context of gender and family, and the maintenance of interpersonal harmony. In Saudi culture, the husband is respected as the head of the family and his power and influencere explicit. While wives typically have significant influence over decisions related to the home and family, in public, they characteristically interact with their husbands in a formal and deferential manner. Consequently, active involvement of Saudi women in decision making may appear passive as they will usually appear to defer to their husband’s or father’s judgment. The husband or father may answer questions directed to his wife 1
Long Island University, Brooklyn, NY, USA Columbia University, New York, NY, USA
2
Corresponding Author: Stephen R. Marrone, Harriet Rothkopf Heilbrunn School of Nursing, Long Island University, One University Plaza, Brooklyn, NY 11201 USA. Email: [email protected]
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Table 1. Case Scenario. While visiting the United States, Fatima, a 45-year-old Saudi woman developed acute chest pain and was admitted to the hospital from the emergency department. Nonsurgical treatment options were discussed and ruled out, so Fatima is scheduled for coronary artery bypass surgery on the following morning. On the evening before surgery, the cardiothoracic surgical team, male surgeon, male anesthesiologist, and female nurse practitioner (NP), arrive to meet Fatima in order to explain her surgery and anesthesia care and to obtain informed consent. Fatima’s husband, father, and mother are also present, and everyone, including Fatima, speaks fluent English, therefore, the services of an Arabic-speaking interpreter were declined. During the session, Fatima, her face completely covered by the traditional veil worn in public by Saudi women, does not make direct eye contact with the surgeon, looking only at her husband, father, mother, and the NP. Fatima’s husband answers all of the questions asked by the surgical team. The surgeon asks Fatima repeatedly “Are you listening to me? Do you hear what I am telling you?” When asked if she understands the surgical procedure, and if she agrees to the surgery and anesthesia care knowing the risks and benefits of each, Fatima says to her husband, “Inshallah,” which means “God Willing” or “As Allah Wills,” but tells the NP that she must have female nurses and anesthesiologists in the operating room with her at all times. When the surgeon offers the consent form to Fatima her husband takes it, signs his name, and gives the form to Fatima’s father who signs his name as a witness. Fatima also refuses to complete a health care proxy, once again saying “Inshallah.” The surgeon is concerned about this and the NP offers to get another consent form so that Fatima can sign. On the surgeon’s insistence, Fatima places an (X) above her husband’s name and says “Yes, Inshallah, I understand.” The surgeon and the anesthesiologist make entries in the electronic medical record stating that the patient placed an (X) on the consent form as her way of expressing that she agrees to the surgery, after the risks and benefits of the surgery and anesthesia care had been explained to her. After the preoperative visit, the NP asked Fatima, “Why did you sign the consent form with an (X)?” Fatima states that “this is the way of my people and my way of saying I agree. My husband and family know my wishes and his signature reflects my decision. Inshallah all will be well. I also wanted to have my surgery in America.” The NP documents Fatima’s response in the medical record and communicates Fatima’s wishes for an all-female nursing and anesthesia team in the operating room. According to hospital policy, barring life-saving emergency surgery, all patients must have a signed and witnessed consent for surgery and anesthesia care, and this document must be present and complete prior to transferring the patient to the operating room. Has informed consent been obtained?
or daughter. However, the female patient and family members may interject information if clarification is needed. Family members are also expected to act as a patient advocate (Lawrence & Rozmus, 2001). When it is necessary for a Saudi woman to communicate directly with a male health professional, they often speak to the point and try to avoid eye contact. For women, direct eye contact is limited to other women or family members, although erudite Saudis generally respect direct eye contact as a sign of honesty and integrity (Al-Shahri, 2002; Johnson, 2001; Kulwicki & Ballout, 2013; Zogby, 2002). Muslims must refrain from “predicting the future,” for the future is Allah’s will; therefore, it is common for a Saudi man or woman to say “Inshallah,” meaning as Allah wills, rather than saying “yes” or “no” to direct questions (Al-Shahri, 2002). Health care professionals of the same gender as the patient are a very important aspect of the plan of care for Saudi patients, especially Saudi women. Traditionally, a Saudi woman may not sign an operative consent form; two male family members must sign for her. If no male family members are available, four women may sign. In contrast to the traditional worldview, the contemporary and legal viewpoint supports women’s rights and privileges to making completely independent decisions. Contemporary Saudi principles support women’s rights and privileges to make independent decisions. Nevertheless, many Saudi women will entrust the signing of consents on their behalf to male family members (El Gindy, 2004; Johnson, 2001; Kridli, 2002; Kulwicki & Ballout, 2013; Lawrence & Rozmus, 2001).
Informed Consent Informed consent is a legal doctrine and the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment (Appelbaum, 2007; Jones & Richman, 2007). The underpinnings of informed consent originate from the legal and ethical right the patient has to direct what happens to them and from the ethical duty of the physician to actively involve patients in their health care (Childers, Lipsett, & Pawlik, 2009). The goal of which is a fully informed patient who can participate in treatment choices, including nontreatment, about his or her care (De Bord, 2014; Showalter, 2014). The antecedents of informed consent in the clinical setting can be traced to the principles of ethics for research with human subjects developed in response human experimentation performed without consent during and since World War II (Annas & Grodin, 1992). The Nuremberg Code, written in 1946, states that the voluntary consent of human subjects is absolutely essential and that experiments should be conducted in a manner such to avoid all unnecessary physical and mental suffering and injury (Showalter, 2014). In 1954, the Declaration of Helsinki outlined the physician–patient relationship during medical experimentation and makes the distinction between medical research in which the aim is diagnostic or therapeutic for a patient and medical research. These guidelines, which continue to emphasize informed consent and disclosure of risks and benefits, have
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Marrone been revised throughout the years, but remain the foundation of federal regulations governing the protection of human subjects in research. The Belmont Report (1979) expanded previous works and distinguished between biomedical and behavioral research and the practice of clinical medical practice. The report underscores the basic ethical principles of respect for persons, beneficence, and justice includes the following requirements: informed consent, disclosure, competency, voluntariness, risks and benefits, and selection of subjects. The Belmont Report provides the basis of the biomedical, legal, and ethical underpinnings of informed consent in the clinical setting.
the patient himself or herself signed the consent form, and nothing more. The witness’ signature does not indicate that all of the elements of informed consent have been discussed. This is a controversial area, however, when nurses serve as the witness during the informed consent process. Most states have legislation that determines the required standard for informed consent. Best practice requires that the informed consent process meets both the professional obligation to provide the best care and alternatives and respects the patient’s right to be an active participant in the decision. The law describes the following three approaches: reasonable physician standard, reasonable patient (person) standard, and the subjective standard (De Bord, 2014).
Informed Consent in Health Care
Reasonable Physician Standard
The practice of obtaining informed consent originates from the legal and ethical right the patient has to direct what happens to his or her body and from the ethical duty of the physician to involve the patient in health care decisions. According to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1984), the core values underlying informed consent include serving the patient’s well-being, the intrinsic value and implications for the patient’s self-determination, active participation on the part of the patient, and freedom from outside or undue interference. A Patient’s Bill of Rights was originally adopted by the American Hospital Association (AHA) in 1973. To more clearly outline what hospitalized patients can expect regarding their care, in 2001, the AHA changed the titled to The Patient Care Partnership which articulates that patients should expect (a) high quality hospital care, (b) involvement in their care, (c) discussion of the benefits and risks of each treatment option, (d) reasonable expectations regarding treatment options and effects related to long term quality of life, (e) the right to consent or refuse treatment, and (f) consent in writing to treatments and confirm understanding and agreement to what is planned (AHA, 2003). Health care organizations typically require that the patient, or legal guardian, sign a consent form for surgery, anesthesia care, and other invasive procedures. Informed consent is more than simply getting a patient to sign a written consent form; therefore, it is important to remember that the mere signing of a consent form does not ethically or morally meet the requirements of informed consent (American Medical Association, 2001). The signed consent should reflect the outcome of a dialogue between the patient and the physician (Jones, McCullough, & Richman, 2005). But who determines if informed consent has been obtained? Most interpretations of informed consent support that it is the patient’s signature that drives the impression of informed consent, not the physician’s. In addition, the role of the witness is sometimes confusing. The witness is a person who signs the consent form indicating that he or she observed that
What would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. Most research supports that physician disclosure of information related to informed consent is less than adequate for true informed consent. This standard is generally considered inconsistent with the goals of informed consent since the focus is on the physician rather than on what the patient needs to know. This standard however may be perfectly acceptable in cultures in which the paternalistic approach to medicine and health care are the accepted norm.
Reasonable Patient (Person) Standard What would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand and is the most widely used standard across the United States.
Subjective Standard What would this patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice since it requires tailoring information to each patient. How much information is adequate? The Canterbury v. Spence case (1972) was one of the landmark cases establishing the standard of disclosure, known as the reasonable person standard, which requires that physicians provide patients and/or legal guardians with information that a “reasonable” person would find relative to making a choice. Prior to this, physicians often provided patients with the information which the physician’s peer group considered relevant for patients to make decisions about their care. The reasonable person standard is the standard commonly used today. State legislation typically determines the required standard for informed consent and most states support the reasonable patient (person) standard. This standard meets both
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the professional obligation to provide the best care and respects the patient as a person with the right to a voice in health care decisions. Therefore, it is consistent with the Principles of Medical Ethics of the American Medical Association (2001), which states that physicians shall be dedicated to providing competent medical care, respect the rights of patients, and respect the law. Interestingly, once again, we see the Western view of patients as participatory members in health care decisions, which is not a universally accepted expectation.
Informed Consent by Proxy Informed consent by proxy is a legal term for transferring a patient’s consent for medical procedures to another person (Showalter, 2104). Consent by proxy generally applies when a patient lacks capacity to actively engage in the informed consent process or if the patient willingly delegates this decision to another competent individual. In Saudi culture, in general, family members often make treatment decisions on behalf of their family members. It is acceptable for a competent patient to waive consent or designate another competent individual to make treatment decisions for them and for the physician to seek consent from a family member in lieu of the patient provided the patient consents to this arrangement, is assured that any questions about their health care and treatments are answered to their satisfaction. The informed consent process, dialogue, outcomes in this case must be clearly documented in the medical record and communicated among the health care team (Appelbaum, 2007; Childers et al., 2009; Giger, Davidhizar, & Fordham, 2006; Showalter, 2014). In order for the patient’s consent to be valid, the patient must be deemed competent to make the imminent decision at hand and consent must be given voluntarily. In most cases, patient capacity to actively participate in the informed consent process and make their own decisions is evident. As there are different standards of decision-making capacity, health care providers seeking informed consent should make certain that patients have the ability to understand their clinical situation and the risks associated with the treatment decision(s) under discussion (Appelbaum, 2007; Childers et al., 2009).
Informed Consent Documentation Essential elements for documenting informed consent include (a) a clear description of the planned procedure and its associated risks and benefits; (b) discussion of the particulars related to alternative therapies that are deemed appropriate to the individual patient, including the option of no treatment; (c) dialogue regarding the risks and benefits of each treatment option, including the option of no treatment; (d) documentation that the patient or surrogate decision maker was given an opportunity to ask questions and that questions were answered and understood sufficiently; and (e) agreement to the treatment as evidenced by the signatures
of the patient or surrogate decision maker, health care provider(s), and witness (Anderson & Weane, 2007; Childers et al., 2009). Furthermore, best practice supports that the provider’s response(s) to the patient’s questions and/or concerns should be documented and that the medical record reflects the presence of all individuals who were involved in the informed consent process. The signed consent form reflects the culmination of the requisite dialogue to ensure the patient’s active and informed participation in their treatment decisions. Although the patient’s signature on a consent form may satisfy legal requirements, it does not necessarily reflect that the patient understands the goal of care, the proposed treatments and options, or whether the plan is aligned with their values and beliefs (Childers et al., 2009; Jones & Richman, 2007; Showalter, 2014; White, 2002).
Informed Consent: Nursing Responsibilities During the informed consent process, nurses are typically expected to witness the patient’s signature. A critical aspect of the nurse’s patient advocacy role is to ensure that health care interventions do not proceed unless the patient fully understands the relevant details. If this does not occur, the nurse must notify the physician that informed consent has not been obtained, in spite of the patient’s signature on the consent form, and that additional information and explanation are necessary (White, 2002). The American Nurses Association’s “Code of Ethics for Nurses” (2001) states that the nurse’s primary commitment is to the patient, whether an individual, family, or community; practices with compassion and respect for the inherent dignity, worth, and uniqueness of every individual; and advocates for the health, safety, and rights of the patient. It may therefore be concluded that nurses must advocate on behalf of culturally sensitive approaches to clinical care and policy development, and to assess and document their care related to ascertaining the culturally driven patient’s need to know regarding informed consent. The International Council of Nurses’ “Position Statement on Nurses and Human Rights” (2011) emphasizes nurses’ obligations to safeguard people’s rights and ensure that patients receive appropriate information prior to consenting to treatment or procedures (United Nations—International Bill of Human Rights, 1996; United Nations—Universal Declaration of Human Rights, 1948). Likewise, the nurse should initiate appropriate actions, such as consulting with the responsible health care practitioner, to seek resolution if the tenets of informed consent have not been duly processed and implemented. Consensus of the critical attributes related to the nurse’s role in informed consent include the responsibilities of advocacy, respect, safeguarding human rights, collaboration, and seeking clarification. The nurse would also be expected to
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Marrone collaborate with other members of the health care team, particularly the surgeon, if patients are unclear about any pertinent information related to the intended therapy and/or procedure, and to review the entries made by other members of the health care team in the medical record. By doing so the nurse recognizes and respects the patient as unique, treats the patient with dignity, advocates for the health, safety, and rights of each patient, and collaborates with other members of the health care team to ensure that the patient is truly informed.
Lifting the Veil Has informed consent been obtained? Let us explore these questions using the 8-element framework set forth by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1984).
Serving the Patient’s Well-Being This element is satisfied. Fatima required the urgent surgery and anesthesia care and chose to have her surgery in the United States rather than return home to Saudi Arabia.
Absence of Objective Medical Criteria Within the Boundaries of Health Care This element is satisfied. This element requires that other treatment options be explained to the patient during the consent process. During the initial assessment, nonsurgical treatments for Fatima had been discussed and ruled out.
was made by Fatima’s husband and father. However, Fatima’s dialogue with the nurse and placement of the (X) on the consent form are evidence that she agreed. Her behavior was culturally driven to support the public view that the husband is the family decision maker. Educated Saudi women such as Fatima often choose between the traditional worldview or the modern, Western view of decision making and selfdetermination. Fatima chose to publicly respect the more traditional view while at the same time made her decision and request (for female staff) known.
Active Participation This element is satisfied. Fatima actively participated in the decision-making process although her behavior may appear to be passive and nonparticipatory based on Western cultural norms.
Capacity This element is satisfied. Fatima possessed the mental and emotional capacity to delegate her decision for surgery to her husband so that her husband could sign the consent. Her agreement, however, is reflected by the (X) on the consent form.
External Limitations
This element is satisfied. This element includes the patient’s choice among different treatment options. In spite of Fatima’s limited options, she chose to have surgery in the United States.
This element is satisfied. Fatima’s decision to have surgery and to permit her husband to sign the consent was not contrary to public interest and was not the outcome of defective or mistaken decision making preventing self-determination. The key difference observed in this scenario is the process by which consent was obtained and signed, but the outcome remained the same: Fatima was informed, actively participated in the decision, and agreed to the treatment plan.
Respect for Self-Determination
Interpretation
This element is satisfied. Self-determination, also referred to as autonomy, is the ability to make one’s own decisions. Although Fatima’s husband and father verbally answered the questions during the preoperative interview, Fatima was able to make her decision and preferences known. This is evidenced by her placing an (X) on the consent form and, more importantly, the dialogue entered in the medical record by the surgeon, anesthesiologist, and NP, as well as her requesting a predominantly female operating room team.
Dialogue with Fatima indicates that she is informed of the risks and benefits of surgery and anesthesia and her behavior during the preoperative interview and teaching session were culturally and contextually appropriate. The (X) on the consent is sufficient to support that Fatima was informed about her surgery and documentation in the medical record by the surgical team supports that the (X) was the patient’s way of expressing agreement for the surgery. Fatima’s husband’s and father’s signatures on the consent are consistent with Saudi culture and acceptable since both can attest that the patient herself signed the (X). The husband’s and father’s signatures on the consent form combined entries in the medical record are legally sufficient and culturally acceptable to support that Fatima was informed about and agreed to the surgery and anesthesia care.
Patient’s Reasonable Subjective Preferences
Freedom From Interference This element is satisfied. In the context of informed consent, interference refers to the influence of another on the person consenting for a procedure. It might appear that the decision
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Implications for Research, Education, Practice, and Policy Development Culturally competent health care organizations advance and sustain a governance infrastructure that promotes equity through policy, practices, education, research, and allocated resources that support the delivery of culturally appropriate health care services and provide effective, equitable, understandable, and respectful quality care and services that are responsive to diverse cultural health beliefs, values, and practices that are integrated into the patient-centered, interprofessional plan of care (Institute of Medicine, 2001, 2002; Marrone, 2012; Office of Minority Health, 2013). In addition, American health care professionals must engage in global dialogue for the development of an International Interprofessional Code of Ethics that addresses the essential elements of ethical, moral, and legal decision making. Best practices related to the informed consent process supports that the provider and the patient achieve a collaborative understanding of the patient’s best interests and transparency and disclosure related to the informed consent process. Therefore, culturally competent health care organizations must establish culturally and linguistically appropriate goals, policies, and management accountability, and integrate them throughout the organizations’ planning and operations, partner with the community to design, implement, and evaluate policies, practices, and services to ensure cultural and linguistic relevance, and create culturally sensitive conflict– resolution processes (Office of Minority Health, 2013). It is imperative that health care organizations work closely with local (state), regional, and national legal and risk management constituents to ensure that programs, practices, and policies are conducted in accordance with applicable law and accreditation standards and are consistent with the mission, vision, and values of the organization. National health care systems must develop, implement, and evaluate strategic goals and standard operating procedures that protect and preserve the legal, ethical, and financial integrity of health care organizations and the national health care infrastructure in general while at the same time being responsive to the diverse needs of patients and families that may access the health care system. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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research-article2015
TCNXXX10.1177/1043659615569537Journal of Transcultural NursingMarrone
Article
Informed Consent Examined Within the Context of Culturally Congruent Care: An Interprofessional Perspective
Journal of Transcultural Nursing 1–7 © The Author(s) 2015 Reprints and permissions: sagepub.com/journalsPermissions.nav DOI: 10.1177/1043659615569537 tcn.sagepub.com
Stephen R. Marrone, EdD, RN-BC, NEA-BC, CTN-A1,2
Abstract The process of obtaining informed consent for diverse patients poses many challenges for health care professionals as they try to balance ethical, legal, and accreditation requirements of the country within which they practice with the culture care needs of diverse consumers. Culturally competent health care organizations create a governance infrastructure that promotes equity and supports the delivery of culturally appropriate health care services that are responsive to diverse patients. The purpose of this article is to examine the concept of informed consent within the context of culturally congruent care to Saudi patients and families in an American hospital setting. The need for the provision of culturally congruent care that respects the contextual rights and dignity of patients and families while, at the same time, recognizing the legal, ethical, and moral codes of the health professions and requirements of federal, state, and regulatory agencies within the United States will be explored. Keywords legal issues, multiprofessional/interdisciplinary practice, organizational culture
Introduction Despite America’s multicultural history, the provision of culturally congruent care remains a challenge, particularly the integration of transcultural care decisions and actions into the delivery of care within the American legal structure. Informed consent is the single imperative in the delivery of safe health care (Burton Report, 2002a, 2002b). The process of obtaining informed consent and ensuring that the patient’s decision was indeed “informed” poses many dilemmas for health care professionals as they try to balance bioethical, legal, and accreditation requirements of the country within which they practice with the culture care needs of diverse patients and families (Crow, Matheson, & Steed, 2000). Ethical dilemmas encountered by Western health care practitioners caring for Saudi Arabian (Saudi) patients and families are well documented (Aboul-Enein, 2002; Al-Shahri, 2002; Alkabba, Hussein, Albar, Bahnassy, & Qadi, 2012; El Gindy, 2004; Hairon, 2007; Halligan, 2006; Johnson, 2001; Kridli, 2002; Marrone, 1999a, 1999b). However, much of the literature explores these issues within the context of expatriate health care providers caring for Saudi patients within the Kingdom of Saudi Arabia. Therefore, the purpose of this article is to examine the concept of informed consent within the context of culturally congruent care to Saudi patients in an American hospital setting. An example of a likely case scenario that depicts the ethical dilemma of obtaining informed consent for a Saudi patient in an American hospital setting is depicted in Table 1.
Behind the Veil: Communication and Decision Making in Saudi Arabia Saudi Arabia is a high-context, collectivist, Muslim culture that values interpersonal relationships and trust must develop before transactions, decisions, and meaningful communication begins. Saudi decision making is generally centralized and decision makers are typically male elders who must consider the best interests of the family. Although Saudi health care beliefs encourage active involvement of the patient in decision making, equally important, however, are the performance of roles, usually defined within the context of gender and family, and the maintenance of interpersonal harmony. In Saudi culture, the husband is respected as the head of the family and his power and influencere explicit. While wives typically have significant influence over decisions related to the home and family, in public, they characteristically interact with their husbands in a formal and deferential manner. Consequently, active involvement of Saudi women in decision making may appear passive as they will usually appear to defer to their husband’s or father’s judgment. The husband or father may answer questions directed to his wife 1
Long Island University, Brooklyn, NY, USA Columbia University, New York, NY, USA
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Corresponding Author: Stephen R. Marrone, Harriet Rothkopf Heilbrunn School of Nursing, Long Island University, One University Plaza, Brooklyn, NY 11201 USA. Email: [email protected]
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Journal of Transcultural Nursing
Table 1. Case Scenario. While visiting the United States, Fatima, a 45-year-old Saudi woman developed acute chest pain and was admitted to the hospital from the emergency department. Nonsurgical treatment options were discussed and ruled out, so Fatima is scheduled for coronary artery bypass surgery on the following morning. On the evening before surgery, the cardiothoracic surgical team, male surgeon, male anesthesiologist, and female nurse practitioner (NP), arrive to meet Fatima in order to explain her surgery and anesthesia care and to obtain informed consent. Fatima’s husband, father, and mother are also present, and everyone, including Fatima, speaks fluent English, therefore, the services of an Arabic-speaking interpreter were declined. During the session, Fatima, her face completely covered by the traditional veil worn in public by Saudi women, does not make direct eye contact with the surgeon, looking only at her husband, father, mother, and the NP. Fatima’s husband answers all of the questions asked by the surgical team. The surgeon asks Fatima repeatedly “Are you listening to me? Do you hear what I am telling you?” When asked if she understands the surgical procedure, and if she agrees to the surgery and anesthesia care knowing the risks and benefits of each, Fatima says to her husband, “Inshallah,” which means “God Willing” or “As Allah Wills,” but tells the NP that she must have female nurses and anesthesiologists in the operating room with her at all times. When the surgeon offers the consent form to Fatima her husband takes it, signs his name, and gives the form to Fatima’s father who signs his name as a witness. Fatima also refuses to complete a health care proxy, once again saying “Inshallah.” The surgeon is concerned about this and the NP offers to get another consent form so that Fatima can sign. On the surgeon’s insistence, Fatima places an (X) above her husband’s name and says “Yes, Inshallah, I understand.” The surgeon and the anesthesiologist make entries in the electronic medical record stating that the patient placed an (X) on the consent form as her way of expressing that she agrees to the surgery, after the risks and benefits of the surgery and anesthesia care had been explained to her. After the preoperative visit, the NP asked Fatima, “Why did you sign the consent form with an (X)?” Fatima states that “this is the way of my people and my way of saying I agree. My husband and family know my wishes and his signature reflects my decision. Inshallah all will be well. I also wanted to have my surgery in America.” The NP documents Fatima’s response in the medical record and communicates Fatima’s wishes for an all-female nursing and anesthesia team in the operating room. According to hospital policy, barring life-saving emergency surgery, all patients must have a signed and witnessed consent for surgery and anesthesia care, and this document must be present and complete prior to transferring the patient to the operating room. Has informed consent been obtained?
or daughter. However, the female patient and family members may interject information if clarification is needed. Family members are also expected to act as a patient advocate (Lawrence & Rozmus, 2001). When it is necessary for a Saudi woman to communicate directly with a male health professional, they often speak to the point and try to avoid eye contact. For women, direct eye contact is limited to other women or family members, although erudite Saudis generally respect direct eye contact as a sign of honesty and integrity (Al-Shahri, 2002; Johnson, 2001; Kulwicki & Ballout, 2013; Zogby, 2002). Muslims must refrain from “predicting the future,” for the future is Allah’s will; therefore, it is common for a Saudi man or woman to say “Inshallah,” meaning as Allah wills, rather than saying “yes” or “no” to direct questions (Al-Shahri, 2002). Health care professionals of the same gender as the patient are a very important aspect of the plan of care for Saudi patients, especially Saudi women. Traditionally, a Saudi woman may not sign an operative consent form; two male family members must sign for her. If no male family members are available, four women may sign. In contrast to the traditional worldview, the contemporary and legal viewpoint supports women’s rights and privileges to making completely independent decisions. Contemporary Saudi principles support women’s rights and privileges to make independent decisions. Nevertheless, many Saudi women will entrust the signing of consents on their behalf to male family members (El Gindy, 2004; Johnson, 2001; Kridli, 2002; Kulwicki & Ballout, 2013; Lawrence & Rozmus, 2001).
Informed Consent Informed consent is a legal doctrine and the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment (Appelbaum, 2007; Jones & Richman, 2007). The underpinnings of informed consent originate from the legal and ethical right the patient has to direct what happens to them and from the ethical duty of the physician to actively involve patients in their health care (Childers, Lipsett, & Pawlik, 2009). The goal of which is a fully informed patient who can participate in treatment choices, including nontreatment, about his or her care (De Bord, 2014; Showalter, 2014). The antecedents of informed consent in the clinical setting can be traced to the principles of ethics for research with human subjects developed in response human experimentation performed without consent during and since World War II (Annas & Grodin, 1992). The Nuremberg Code, written in 1946, states that the voluntary consent of human subjects is absolutely essential and that experiments should be conducted in a manner such to avoid all unnecessary physical and mental suffering and injury (Showalter, 2014). In 1954, the Declaration of Helsinki outlined the physician–patient relationship during medical experimentation and makes the distinction between medical research in which the aim is diagnostic or therapeutic for a patient and medical research. These guidelines, which continue to emphasize informed consent and disclosure of risks and benefits, have
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Marrone been revised throughout the years, but remain the foundation of federal regulations governing the protection of human subjects in research. The Belmont Report (1979) expanded previous works and distinguished between biomedical and behavioral research and the practice of clinical medical practice. The report underscores the basic ethical principles of respect for persons, beneficence, and justice includes the following requirements: informed consent, disclosure, competency, voluntariness, risks and benefits, and selection of subjects. The Belmont Report provides the basis of the biomedical, legal, and ethical underpinnings of informed consent in the clinical setting.
the patient himself or herself signed the consent form, and nothing more. The witness’ signature does not indicate that all of the elements of informed consent have been discussed. This is a controversial area, however, when nurses serve as the witness during the informed consent process. Most states have legislation that determines the required standard for informed consent. Best practice requires that the informed consent process meets both the professional obligation to provide the best care and alternatives and respects the patient’s right to be an active participant in the decision. The law describes the following three approaches: reasonable physician standard, reasonable patient (person) standard, and the subjective standard (De Bord, 2014).
Informed Consent in Health Care
Reasonable Physician Standard
The practice of obtaining informed consent originates from the legal and ethical right the patient has to direct what happens to his or her body and from the ethical duty of the physician to involve the patient in health care decisions. According to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1984), the core values underlying informed consent include serving the patient’s well-being, the intrinsic value and implications for the patient’s self-determination, active participation on the part of the patient, and freedom from outside or undue interference. A Patient’s Bill of Rights was originally adopted by the American Hospital Association (AHA) in 1973. To more clearly outline what hospitalized patients can expect regarding their care, in 2001, the AHA changed the titled to The Patient Care Partnership which articulates that patients should expect (a) high quality hospital care, (b) involvement in their care, (c) discussion of the benefits and risks of each treatment option, (d) reasonable expectations regarding treatment options and effects related to long term quality of life, (e) the right to consent or refuse treatment, and (f) consent in writing to treatments and confirm understanding and agreement to what is planned (AHA, 2003). Health care organizations typically require that the patient, or legal guardian, sign a consent form for surgery, anesthesia care, and other invasive procedures. Informed consent is more than simply getting a patient to sign a written consent form; therefore, it is important to remember that the mere signing of a consent form does not ethically or morally meet the requirements of informed consent (American Medical Association, 2001). The signed consent should reflect the outcome of a dialogue between the patient and the physician (Jones, McCullough, & Richman, 2005). But who determines if informed consent has been obtained? Most interpretations of informed consent support that it is the patient’s signature that drives the impression of informed consent, not the physician’s. In addition, the role of the witness is sometimes confusing. The witness is a person who signs the consent form indicating that he or she observed that
What would a typical physician say about this intervention? This standard allows the physician to determine what information is appropriate to disclose. Most research supports that physician disclosure of information related to informed consent is less than adequate for true informed consent. This standard is generally considered inconsistent with the goals of informed consent since the focus is on the physician rather than on what the patient needs to know. This standard however may be perfectly acceptable in cultures in which the paternalistic approach to medicine and health care are the accepted norm.
Reasonable Patient (Person) Standard What would the average patient need to know in order to be an informed participant in the decision? This standard focuses on considering what a patient would need to know in order to understand the decision at hand and is the most widely used standard across the United States.
Subjective Standard What would this patient need to know and understand in order to make an informed decision? This standard is the most challenging to incorporate into practice since it requires tailoring information to each patient. How much information is adequate? The Canterbury v. Spence case (1972) was one of the landmark cases establishing the standard of disclosure, known as the reasonable person standard, which requires that physicians provide patients and/or legal guardians with information that a “reasonable” person would find relative to making a choice. Prior to this, physicians often provided patients with the information which the physician’s peer group considered relevant for patients to make decisions about their care. The reasonable person standard is the standard commonly used today. State legislation typically determines the required standard for informed consent and most states support the reasonable patient (person) standard. This standard meets both
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the professional obligation to provide the best care and respects the patient as a person with the right to a voice in health care decisions. Therefore, it is consistent with the Principles of Medical Ethics of the American Medical Association (2001), which states that physicians shall be dedicated to providing competent medical care, respect the rights of patients, and respect the law. Interestingly, once again, we see the Western view of patients as participatory members in health care decisions, which is not a universally accepted expectation.
Informed Consent by Proxy Informed consent by proxy is a legal term for transferring a patient’s consent for medical procedures to another person (Showalter, 2104). Consent by proxy generally applies when a patient lacks capacity to actively engage in the informed consent process or if the patient willingly delegates this decision to another competent individual. In Saudi culture, in general, family members often make treatment decisions on behalf of their family members. It is acceptable for a competent patient to waive consent or designate another competent individual to make treatment decisions for them and for the physician to seek consent from a family member in lieu of the patient provided the patient consents to this arrangement, is assured that any questions about their health care and treatments are answered to their satisfaction. The informed consent process, dialogue, outcomes in this case must be clearly documented in the medical record and communicated among the health care team (Appelbaum, 2007; Childers et al., 2009; Giger, Davidhizar, & Fordham, 2006; Showalter, 2014). In order for the patient’s consent to be valid, the patient must be deemed competent to make the imminent decision at hand and consent must be given voluntarily. In most cases, patient capacity to actively participate in the informed consent process and make their own decisions is evident. As there are different standards of decision-making capacity, health care providers seeking informed consent should make certain that patients have the ability to understand their clinical situation and the risks associated with the treatment decision(s) under discussion (Appelbaum, 2007; Childers et al., 2009).
Informed Consent Documentation Essential elements for documenting informed consent include (a) a clear description of the planned procedure and its associated risks and benefits; (b) discussion of the particulars related to alternative therapies that are deemed appropriate to the individual patient, including the option of no treatment; (c) dialogue regarding the risks and benefits of each treatment option, including the option of no treatment; (d) documentation that the patient or surrogate decision maker was given an opportunity to ask questions and that questions were answered and understood sufficiently; and (e) agreement to the treatment as evidenced by the signatures
of the patient or surrogate decision maker, health care provider(s), and witness (Anderson & Weane, 2007; Childers et al., 2009). Furthermore, best practice supports that the provider’s response(s) to the patient’s questions and/or concerns should be documented and that the medical record reflects the presence of all individuals who were involved in the informed consent process. The signed consent form reflects the culmination of the requisite dialogue to ensure the patient’s active and informed participation in their treatment decisions. Although the patient’s signature on a consent form may satisfy legal requirements, it does not necessarily reflect that the patient understands the goal of care, the proposed treatments and options, or whether the plan is aligned with their values and beliefs (Childers et al., 2009; Jones & Richman, 2007; Showalter, 2014; White, 2002).
Informed Consent: Nursing Responsibilities During the informed consent process, nurses are typically expected to witness the patient’s signature. A critical aspect of the nurse’s patient advocacy role is to ensure that health care interventions do not proceed unless the patient fully understands the relevant details. If this does not occur, the nurse must notify the physician that informed consent has not been obtained, in spite of the patient’s signature on the consent form, and that additional information and explanation are necessary (White, 2002). The American Nurses Association’s “Code of Ethics for Nurses” (2001) states that the nurse’s primary commitment is to the patient, whether an individual, family, or community; practices with compassion and respect for the inherent dignity, worth, and uniqueness of every individual; and advocates for the health, safety, and rights of the patient. It may therefore be concluded that nurses must advocate on behalf of culturally sensitive approaches to clinical care and policy development, and to assess and document their care related to ascertaining the culturally driven patient’s need to know regarding informed consent. The International Council of Nurses’ “Position Statement on Nurses and Human Rights” (2011) emphasizes nurses’ obligations to safeguard people’s rights and ensure that patients receive appropriate information prior to consenting to treatment or procedures (United Nations—International Bill of Human Rights, 1996; United Nations—Universal Declaration of Human Rights, 1948). Likewise, the nurse should initiate appropriate actions, such as consulting with the responsible health care practitioner, to seek resolution if the tenets of informed consent have not been duly processed and implemented. Consensus of the critical attributes related to the nurse’s role in informed consent include the responsibilities of advocacy, respect, safeguarding human rights, collaboration, and seeking clarification. The nurse would also be expected to
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Marrone collaborate with other members of the health care team, particularly the surgeon, if patients are unclear about any pertinent information related to the intended therapy and/or procedure, and to review the entries made by other members of the health care team in the medical record. By doing so the nurse recognizes and respects the patient as unique, treats the patient with dignity, advocates for the health, safety, and rights of each patient, and collaborates with other members of the health care team to ensure that the patient is truly informed.
Lifting the Veil Has informed consent been obtained? Let us explore these questions using the 8-element framework set forth by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1984).
Serving the Patient’s Well-Being This element is satisfied. Fatima required the urgent surgery and anesthesia care and chose to have her surgery in the United States rather than return home to Saudi Arabia.
Absence of Objective Medical Criteria Within the Boundaries of Health Care This element is satisfied. This element requires that other treatment options be explained to the patient during the consent process. During the initial assessment, nonsurgical treatments for Fatima had been discussed and ruled out.
was made by Fatima’s husband and father. However, Fatima’s dialogue with the nurse and placement of the (X) on the consent form are evidence that she agreed. Her behavior was culturally driven to support the public view that the husband is the family decision maker. Educated Saudi women such as Fatima often choose between the traditional worldview or the modern, Western view of decision making and selfdetermination. Fatima chose to publicly respect the more traditional view while at the same time made her decision and request (for female staff) known.
Active Participation This element is satisfied. Fatima actively participated in the decision-making process although her behavior may appear to be passive and nonparticipatory based on Western cultural norms.
Capacity This element is satisfied. Fatima possessed the mental and emotional capacity to delegate her decision for surgery to her husband so that her husband could sign the consent. Her agreement, however, is reflected by the (X) on the consent form.
External Limitations
This element is satisfied. This element includes the patient’s choice among different treatment options. In spite of Fatima’s limited options, she chose to have surgery in the United States.
This element is satisfied. Fatima’s decision to have surgery and to permit her husband to sign the consent was not contrary to public interest and was not the outcome of defective or mistaken decision making preventing self-determination. The key difference observed in this scenario is the process by which consent was obtained and signed, but the outcome remained the same: Fatima was informed, actively participated in the decision, and agreed to the treatment plan.
Respect for Self-Determination
Interpretation
This element is satisfied. Self-determination, also referred to as autonomy, is the ability to make one’s own decisions. Although Fatima’s husband and father verbally answered the questions during the preoperative interview, Fatima was able to make her decision and preferences known. This is evidenced by her placing an (X) on the consent form and, more importantly, the dialogue entered in the medical record by the surgeon, anesthesiologist, and NP, as well as her requesting a predominantly female operating room team.
Dialogue with Fatima indicates that she is informed of the risks and benefits of surgery and anesthesia and her behavior during the preoperative interview and teaching session were culturally and contextually appropriate. The (X) on the consent is sufficient to support that Fatima was informed about her surgery and documentation in the medical record by the surgical team supports that the (X) was the patient’s way of expressing agreement for the surgery. Fatima’s husband’s and father’s signatures on the consent are consistent with Saudi culture and acceptable since both can attest that the patient herself signed the (X). The husband’s and father’s signatures on the consent form combined entries in the medical record are legally sufficient and culturally acceptable to support that Fatima was informed about and agreed to the surgery and anesthesia care.
Patient’s Reasonable Subjective Preferences
Freedom From Interference This element is satisfied. In the context of informed consent, interference refers to the influence of another on the person consenting for a procedure. It might appear that the decision
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Implications for Research, Education, Practice, and Policy Development Culturally competent health care organizations advance and sustain a governance infrastructure that promotes equity through policy, practices, education, research, and allocated resources that support the delivery of culturally appropriate health care services and provide effective, equitable, understandable, and respectful quality care and services that are responsive to diverse cultural health beliefs, values, and practices that are integrated into the patient-centered, interprofessional plan of care (Institute of Medicine, 2001, 2002; Marrone, 2012; Office of Minority Health, 2013). In addition, American health care professionals must engage in global dialogue for the development of an International Interprofessional Code of Ethics that addresses the essential elements of ethical, moral, and legal decision making. Best practices related to the informed consent process supports that the provider and the patient achieve a collaborative understanding of the patient’s best interests and transparency and disclosure related to the informed consent process. Therefore, culturally competent health care organizations must establish culturally and linguistically appropriate goals, policies, and management accountability, and integrate them throughout the organizations’ planning and operations, partner with the community to design, implement, and evaluate policies, practices, and services to ensure cultural and linguistic relevance, and create culturally sensitive conflict– resolution processes (Office of Minority Health, 2013). It is imperative that health care organizations work closely with local (state), regional, and national legal and risk management constituents to ensure that programs, practices, and policies are conducted in accordance with applicable law and accreditation standards and are consistent with the mission, vision, and values of the organization. National health care systems must develop, implement, and evaluate strategic goals and standard operating procedures that protect and preserve the legal, ethical, and financial integrity of health care organizations and the national health care infrastructure in general while at the same time being responsive to the diverse needs of patients and families that may access the health care system. Declaration of Conflicting Interests The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding The author(s) received no financial support for the research, authorship, and/or publication of this article.
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