Ethical Principles and Practical Issues of Informed Consent
The patient’s right to choose is based on the ethical principle of autonomy, or self-determination. Pursuant to that ethical principle, informed consent refers to the right of a patient to make his or her own decisions regarding diagnosis and treatment and to do so after receiving all of the necessary information from the health care provider. Thus, informed consent includes both a decisional component and an informational component.
In the United States, the American Medical Association (AMA) has adopted standards for both of these components of informed consent, as expressed in Opinion 10.01of the AMA Code of Medical Ethics, which is titled “Fundamental Elements of the Patient-Physician Relationship” (American Medical Association, 1992). With regard to the decisional component, Opinion 10.01(2) provides that the “patient has the right to make decisions regarding the health care that is recommended by his or her physician. Accordingly, patients may accept or refuse any recommended medical treatment.” In regard to the informational component, Opinion 10.01(1) states that the “patient has the right to receive information from physicians and to discuss the benefits, risks, and costs of appropriate treatment alternatives.” These ethical principles have been accepted as standard practice in many countries around the world. In fact, the International Code of Medical Ethics of the World Medical Association (WMA) explicitly provides that “a physician shall respect a competent patient’s right to accept or refuse treatment” (World Medical Association, 2006). As discussed in Chapter SIX, in many countries research projects that use human subjects must comply with the requirements of informed consent. Moreover, some people have argued that the ethical duty of disclosure includes an obligation for health care providers to inform patients even about medical errors the providers have made (Wu and others, 1997).
The ethical principle of informed consent has also been adopted as a legal requirement in many countries. In one frequently quoted decision, a U.S. state court explained that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent, commits an assault, for which he is liable in damages” (Schloendorff v. Society of New York Hospital, 1914, p. 93). The Law of the People’s Republic of China on Medical Practitioners contains this provision: “Doctors should truthfully explain the patients’ conditions to the patients and their family members provided that attention is paid to avoid an adverse effect on the patients” (People’s Republic of China, 1999, art. 26). The point here is not to focus on the laws in particular countries but rather to recognize that in many countries informed consent has become so well accepted as a matter of ethical theory and medical practice that it has become enshrined as a legal requirement, with potentially severe consequences for a health care provider’s failure to comply.
However, practical problems exist in providing understandable information to patients and obtaining truly informed consent, even in industrialized countries with relatively well educated patients. Immigration and the movement of people across national borders mean that large numbers of patients are not fluent in the dominant language of the country in which they need to receive health care and thus face additional communication barriers that can inhibit their access to care, as discussed in Chapter TEN. For example, millions of people in the United States have limited English proficiency, and immigration is resulting in similar language barriers in other developed and developing countries as well. It is axiomatic that a patient cannot give informed consent unless that patient can obtain information and provide consent in a language that he or she understands.
In developing countries, resource limitations and educational levels pose additional problems in obtaining truly informed consent. As Yousuf and others (2007) have pointed out, overworked doctors in a developing country may lack the time and the patience to comply with all of the procedures of informed consent (p. 562). Sastry and others (2004) have noted the difficulty of implementing informed consent procedures in those parts of India where resources and staff time are limited and where educational levels are very low. These authors described the practice of informed consent for pregnant women in India as follows:
Typically, informed consent for pregnant women in most Indian hospitals and clinics is for operative procedures such as cesarean section or laparotomy. It is usual for the doctor or resident on duty to put down in his or her own handwriting the text of the consent on a patient’s case papers This is signed (or a thumbprint given) by the patient, her husband or an accompanying relative, and is generally considered to serve as legal consent; therefore, it is not interpreted as voluntary. Most often, due to time constraints, very little is explained to the patient about the procedure, risks, and benefits, or what her signature actually means. As found in other regions in India, there is a general perception by clinicians and other healthcare workers that women are “unable” to understand any of the procedures even if explained, because they are illiterate or have no medical background [Sastry and others, 2004, citations omitted].
Ayesha Humayun and others (2008) have noted similar problems in Pakistan with informed consent, privacy, and confidentiality. Pakistan is a Muslim country. The practice of medicine is subject to the Code of Ethics issued in 2002 by the Pakistan Medical and Dental Council (PMDC), which is a government regulatory authority. Farhat Moazam and Aamir Jafarey (2005) have identified an inherent tension in the PMDC’s Code of Ethics, which contains aspects of both the moral values of Islam and the contemporary principles of bioethics, such as autonomy, beneficence, and justice (p. 252). As stated in the PMDC’s Code of Ethics, “If secular Western bioethics can be described as rights-based, with a strong emphasis on individual rights, Islamic bioethics is based on duties and obligations (e.g., to preserve life, seek treatment), although rights (of Allah, the community, and the individual) do feature in bioethics, as does a call to virtue (Ihsan)” (Pakistan Medical and Dental Council, 2001, sec. 7.0).
The following excerpt from the article by Humayun and colleagues mentioned previously describes some of the practical limitations of obtaining informed consent in Pakistan, as well as differences between practices at public and private hospitals. Significantly, the article authors have treated informed consent as an ethical requirement for all health care professionals, even in developing countries, and they have not questioned the importance of informed consent or the applicability of that principle to every country and culture.
Excerpt from “Patients’ Perception and Actual Practice of Informed Consent, Privacy and Confidentiality in General Medical Outpatient Departments of Two Tertiary Care Hospitals of Lahore”
By Ayesha Humayun and Others
Introduction
…The concepts of privacy and confidentiality are closely related. Privacy is a broader term including physical privacy, informational privacy, protection of personal identity and the ability to make choices without interference. Confidentiality is a narrower term referring to informational privacy and the duty not to disclose any patient information without prior approval from the patient. Privacy and confidentiality are not only basic rights of the patients but also serve to further a trustful, frank and open relationship with the doctor, thus improving patient care. It has also been noted that patients often over- or underestimate their ethical rights in medicine.
While most western countries have enshrined these concepts of informed consent, privacy and confidentiality in federal or state laws and codes of ethics, such law-making is almost non-existent in Pakistan although there have been some recent efforts to create ethical guidelines for research and medical practice. Significantly, Pakistan Medical and Dental Council (PMDC), the regulatory body of medical practitioners[,] has formulated a code of ethics for all doctors, although no concrete steps have been taken to ensure their application. However, most other work on this subject focuses on research ethics and is currently limited to individual institutions or some non-governmental organizations. At the same time, cultural values in Pakistan offer a challenge to the practice of medical ethics in Pakistan. This is because crucial decision making is often done by family members or is left entirely up to the physician, and there seems to be a general acceptance of this shifting of focus from the individual to other people. Public (patient) awareness of their rights to informed consent and privacy is often low. Previous qualitative research has shown that a significant number of physicians do not think it is necessary to obtain a proper consent after providing the patients with thorough information. Furthermore, general observation points to wide differences between the quality of medical care offered at private and public hospitals. In view of these observations, this study was conducted to explore the degree to which the ethical practices of informed consent, privacy and confidentiality are observed in medical outpatient departments of public and private hospitals in Lahore, Pakistan. We follow it up with an assessment of patients’ perceptions of these practices in comparison to the assessment performed by our data collectors.
Materials and Methods
A cross-sectional study was conducted at general medical out-patient departments (OPDs) of two tertiary care hospitals of Lahore during the period March–June 2005. One hospital was from the public sector while the other was from the private sector. The sample was selected using multistage random sampling
Prior consent had been obtained from all doctors so as to be allowed to observe and evaluate any doctor-patient interaction during the study period. However, in order to minimize bias, at no point were the doctors informed of the individual patient selection. Hence they remained unaware of which patient interaction was being graded for ethical practices. This had been made clear to them while obtaining consent for their participation. In Pakistan, the nursing departments are often understaffed so that the role of nurses in the outpatient departments is limited and it is almost always the doctors who obtain informed consent from the patients regarding their examination/treatment. Therefore, nurses were not included in the study.
Ethical approval for the study was obtained from the review committee of the Center for Health Research, Lahore. The study was conducted in compliance with the “Ethical Principles for Medical Research involving Human Subjects” of [the] Helsinki Declaration. Patient names were not recorded to assure confidentiality. Verbal consent was obtained from all subjects and documented in the presence of a witness
Results
We enrolled and followed 93 patients in each of the two hospitals
…Observance of ethical practices was inadequate or improper in most instances. The practice of informed consent in the private hospital was much better compared to the public hospital (p: < 0.0001). No informed consent was taken at all in 90.3% cases in the public hospital compared to 53.3% of the patients in the private hospital. Similarly, confidentiality was adequately practised more often in the private hospital than in the public hospital (p: < 0.0001). On the other hand, the differences in the provision of privacy were not statistically significant
…Compared to the public hospital, more patients in the private hospital believed that the ethical principles had been well observed by the doctors interacting with them (p: < 0.0003)
Discussion
The present study was designed with a purpose to assess the actual practice of informed consent, privacy and confidentiality by the doctors through direct observation of the entire process of patient care provided in outpatient departments (OPDs) of public and private hospitals, and correlate these ethical practices with patient perception of doctors’ ethical practices. Our results show that the doctors took proper informed consent from very few patients coming to these hospitals. One of reasons behind such practice is that the cultural trends in Pakistan still tend to accept the paternalistic model of medical care. This is in line with the Asian culture as a whole, where the decision-making is often left purely to the doctors or other family members. Studies from Kashmir and Japan reflect similar practices wherein patients are willing to accept what doctors choose for them, while doctors are satisfied with their role of a decision-maker. For example in a study by…[Yousuf] RM et al, 65% [of] physicians in Kashmir and 35% [of] physicians in Malaysia said they would listen to the family’s request to withhold information from the patient. A study from Hong Kong also shows the patients and physicians to be more willing to accept the role of families in crucial decisions regarding medical care. Even in countries like Lithuania and South Africa, the practices of doctors often do not meet the moral and legal requirements for medical ethics, although the observance of ethics is better than what our study has found in Pakistan.
While the situation in US was not much different till the 1960s, the current medical practice in US lays significant focus on the concepts of informed consent and shared decision-making. This differs substantially from the trends in Asia and experts have gone to the extent of calling it a “cultural artifact” in that reliance on this concept is not universal. Even in US, there is often a clash between these ethical standards and the moral intuitions of many physicians.
Improper consent of some form was taken from a large number of patients at the private hospital but just a few from public hospital. No informed consent was taken from an alarming proportion of patients (90%) at the public hospital. Even in the private hospital more than half the patients were denied their right to informed consent. On the whole, the practice of informed consent was better at the private hospital but still far from the ideal. Several reasons may account for the differences. Firstly, doctors at private hospitals are better paid than their colleagues in the public sector, something that may translate into better performance at work and greater care for the patients. Secondly, doctors in the private sector are often employed on contracts that need regular renewal. Doctors’ work is regularly monitored and assessed, and this renewal is often linked to patient satisfaction with care. Hence doctors in the private sector are more likely to respect the patients’ fundamental rights related to their medical management. On the other hand, jobs in the public sector are secure and more or less permanent in nature. At the same time, there is little or no accountability of the doctors since there is usually no effort to elicit patients’ opinion about the care provided to them. The results of our study are in line with those from a study conducted in a public sector hospital in Karachi that concluded that the current practice of informed consent was below the internationally acceptable standards. Even though that study commented only on preoperative informed consent, it is pertinent to note that the trend of both our studies is similar. Another study from a private hospital in Karachi also reported that the number of patients complaining of lack of privacy was greater than in the west.
Similarly, the principle of confidentiality (informational privacy) was also inadequately practised in our study. This is not surprising since even a study in a country like Canada, has shown that quite a few of the family physicians do not fully understand their obligations towards patient confidentiality. Furthermore, the practice of confidentiality was more inadequate/unsatisfactory in the public sector hospital than the private one. While the reasons cited above may also contribute to this difference as well, there are others factors that must also be explored. Significant patient burden at general OPDs of public hospitals often makes it impossible for the doctors to follow the full protocol of informed consent and confidentiality. Usually the OPDs are in the form of big rooms in which on one side the patients are waiting (a part of their total waiting time in and outside the OPD room) while on the other, there are some examination tables (with or without a screen). In the center of the room, many doctors are interviewing and examining multiple patients and/or writing medical prescriptions. 2 to 4 patients are dealt with simultaneously. Seldom if ever are the attendants requested to leave the room while the patient is being interviewed or examined. Hence the patient and his/her problems are discussed in front of all present in the room. Such practice may prevent the patients in revealing their complete history and list of symptoms.
Provision of privacy during physical examinations was also inadequate in both hospitals. However, privacy-related practices were still somewhat better than the practices of informed consent and informational privacy. The private hospital again showed better ethical practices than the public hospital although in this case the difference was not statistically significant. This may be because in both settings, doctors have no choice but to carry out these examinations behind a screen, especially examinations requiring significant exposure
Our study shows that compared to the public hospital, more patients in the private hospital believed that ethical practices were well observed by doctors interacting with them. This is fairly in line with the assessment of our data collectors where principles of informed consent, informational privacy and physical privacy were more often applied in the private hospitals as discussed earlier. We compared whether the patients’ perception of these ethical practices matched correctly with the assessment of our data collectors. In 38/93 instances in the public hospital and 24/93 in the private hospital, patients’ perception differed with the assessment of our trained data collector. This is a significant number, and again shows that many patients are unaware of, or misunderstand[,] their ethical rights. Once again, the discordance is higher in the public hospital and this may be directly related to the lower socioeconomic status of these patients compared to those in the private hospital.
It is noteworthy, that there are also some other reasons for inadequate ethical practices in Pakistan. For example, although innovative ethical curricula have been shown to improve the confidence and practice of doctors with regards to medical ethics, PMDC does not include education in bioethics as a major component of the medical curriculum. It follows, that very few medical colleges in Pakistan impart formal training in bioethics. Such education is also largely omitted from postgraduate training programs. Lack of applied ethical training is also perceived in other countries like Germany and even US, which has always championed the cause of bioethics. This lack of Pakistani education in ethics means that trainees can only learn from the practices of their consultants, most of whom belong to the era when a paternalistic approach towards the patients was in vogue. This leads to a vicious cycle where every subsequent generation of doctors believes in paternalism. Even doctors who favor practices like informed consent, often abandon these practices since they believe that most of their patients are uneducated and would not be able to decide what is best for them. It is true though, that often the patients do not want to take any decision and want the doctor to decide each and every thing for them. Furthermore, the lack of accountability and legal recourse means that doctors who do not respect patient ethics are never taken to task in this country.
However, regardless of the excuses provided for the lack of medical ethics, it should be kept in mind that the principles of informed consent, confidentiality and physical privacy must always be applied in medical practice.
Conclusion
Adherence to principles of ethics in medical practice is inadequate in Pakistan. Formal training in bioethics should be incorporated in undergraduate and postgraduate medical training so that the healthcare providers understand the concept, process and application of medical ethics. Local languages should be utilized in written and verbal consent. Forms for written consent should be easy to understand for even the less educated patients. Every patient should be interviewed and examined in a separate room to ensure informational and physical privacy and the number of medical staff should complement the patient load at any hospital. Sincere attempts need to be made at legalizing the value and processes of medical ethics and public health programs should aim at making the patients aware of their legal rights to informed consent, confidentiality and privacy.
Source: Excerpted from “Patients’ Perception and Actual Practice of Informed Consent, Privacy and Confidentiality in General Medical Outpatient Departments of Two Tertiary Care Hospitals of Lahore,” by A. Humayun and others, 2008. BMC Medical Ethics, 9(14), doi: 10.1186/1472-6939-9-14 (citations, references, tables, and some text omitted). Copyright 2008 by Humayun et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited
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