Informed consent procedures among perioperative nurses in the United Kingdom

¶ … patients with relevant information required to make an informed decision preparatory to a medical intervention is an established ethical and legal responsibility of the healthcare community. Although specific requirements vary from jurisdiction to jurisdiction, it has become well established that certain procedures must be followed in any healthcare setting in order to ensure that patients fully understand the need for a proposed treatment, as well as its implications and possible alternatives, including doing nothing at all. In some cases, healthcare professionals have a formal set of procedures they are required to follow for this purpose, which is the case with nurses practicing in the United Kingdom. The purpose of the study proposed herein is to critically assess the current and expected knowledge and application of informed consent procedures by perioperative nurses and operating department practitioners in the United Kingdom today. To accomplish this purpose, a review of the relevant secondary literature is combined with an analysis of the primary data the results from the administration of a custom questionnaire to representatives from these two groups of healthcare professionals to assess their level of understanding and awareness of their legal and ethical rights as they relate to the provision of informed consent.

TABLE of CONTENTS

CHAPTER 1: INTRODUCTION

Statement of the Problem

Purpose of Study

Importance of Study

Rationale of Study

Overview of Study

Definition of Key Terms

CHAPTER 2: REVIEW of RELATED LITERATURE

CHAPTER 3: METHODOLOGY

Description of the Study Approach

Data-gathering Method and Database of Study

Subjects

Evaluating the Role of the Perioperative Nurse in the Informed Consent Process

Informed consent is at the heart of all medical decisions. -- Joyce Robins, co-director of Patient Concern in the United Kingdom

CHAPTER 1: INTRODUCTION

Statement of the Problem

The epigram above makes it clear that clinicians in all settings have a fundamental responsibility to their patients to ensure that they understand what medical procedures are being offered, what the risks of those procedures might be, and any alternatives -- including no intervention at all -- are disclosed in full. Given its legal and ethical imperative, it is not surprising that there has been a great deal of attention paid to the issue of when, where and why informed consent must be obtained. In this regard, Wear points out that, "Clinicians often respond to ethical issues by first inquiring as to what the relevant law dictates. The instinct is a prudent one. It is not very sensible to discuss ethical options that the law prohibits, or attempt to fashion a response when the law has already provided one and insists upon it" (1999: 9). The laws and regulations concerning informed consent, though, differ significantly from place to place and time to time, making across-the-board analyses difficult or even impossible. As Wear emphasizes, "The law regarding informed consent varies across jurisdictions and countries, so in a global sense there is no single and settled sense of the law to explicate, not even on the level of basic principles and criteria" (1999: 9).

Notwithstanding the paucity of uniformity in informed consent approaches, obtaining the informed consent of patients is an expected component of clinical practice around the world (Sugarman, McCrory, Powell, Krasny, Adams, Ball & Cassell 1999). According to Sugarman and his associates, "In concert with strong theoretical justifications, an array of laws, regulations, court cases, policy statements, and professional guidelines emphasize the need for obtaining meaningful informed consent. Moreover, strong popular reactions to alleged failures to obtain consent, such as those in response to human radiation experiments conducted during the Cold War, underscore this professional, legal, and philosophical expectation" (1999: 1). The expectations and responsibilities of clinicians that are associated with informed consent counseling, then, are firmly based on ethical and legal grounds that are common to all treatment settings that emphasize the fundamental right of humans to decide for themselves what is in their best interests, even if such a decision runs contrary to evidence-based practice and the experience of the healthcare treatment team. In this regard, Wear emphasizes that, "The new ethos of patient autonomy, for its part, enjoys broad societal consensus regarding many of its basic prescriptions. Further, like the law, the new ethos seems to presume that certain needs as well as patient abilities are usually present in the same form and degree. But such univocal presumptions regarding patient abilities and needs clearly run afoul of clinical experience and its supporting empirical literature" (1999:66). Moreover, there are some powerful cross-cultural differences that can affect the informed consent counseling process in ways that may prevent patients from making the decision they would prefer as the result of coercion on the part of the counseling clinician. In this environment, identifying current levels of knowledge of informed consent requirements and procedures among perioperative nurses and operating department practitioners represents a timely and valuable enterprise, which is the purpose of this study as described further below.

Purpose of Study

The overarching purpose of the proposed study is to critically assess the current and expected knowledge and application of informed consent procedures by perioperative (anesthetic) nurses and operating department practitioners (ODPs) in the UK today. To achieve this purpose, the proposed study will combine a review of the relevant secondary literature with the primary data that emerges from the administration of a custom questionnaire to approximately 300 to 350 perioperative nurses and operating room practitioners to gauge their current levels of understanding and awareness of their legal and ethical rights as they relate to the provision of informed consent. The results of this analysis may identify trends in knowledge gaps that can be used to develop educational initiatives that target these areas of deficiency among these clinicians.

Importance of Study

The importance of the proposed study relates to the fundamental right of all patients to be adequately informed concerning any treatments, procedures, and surgical interventions that are proposed by healthcare practitioners so that they can make an informed decision, a process that is a patient's legal right and an ethical responsibility of clinicians (Lea & Thomas-Lawson 2001). According to Lea and Thomas-Lawson, "Informed consent is the voluntary permission that a client, or someone acting on the client's behalf, gives to the health care provider to do something to or for that client after disclosure of adequate information to make a decision. Founded on the principles of respect for autonomy (the right to self-determination) and beneficence, the obligation of informed consent is both ethical and legal" (2001: 146). It is important to note, though, that the informed consent process involves far more than simply providing patients with a "laundry list" of medical descriptions and alternatives, but rather involves the formulation of a therapeutic alliance between clinician and patient that can provide the framework in which a truly informed decision can be made by the patient. In this regard, Lea and Thomas-Lawson add that, "The goal of actualizing client choices, including the right to accept or refuse interventions, is protected by the process of informed consent. The process is characterized by mutual participation, respect, and shared decision making between the client and healthcare provider, not merely by giving information or persuading the client" (2001: 146). Although specific requirements vary according to geographic setting, a common feature that characterizes the nurse-patient relationship in any setting is the need for nurses to understand the tenets of informed consent and recognize their legal and ethical responsibilities. In this regard, Lea and Thomas-Lawson emphasize that, "It is not surprising that the topic of informed consent and the attending principles appear in all current medical and nursing texts regardless of specialty focus (2001: 146).

Because perioperative nurses and operating department practitioners are important components of the overall healthcare team, it is important for them to thorough understand their responsibilities with regards to informed consent as well. Although some clinicians have argued that operating room practitioners "have little or no influence on direct care," Corbett emphasizes that, "This is not solely true in all operating rooms since people respond in amazing ways when given some control over what they do. The more ownership they feel, the more interest they will have, and the harder they will try and do a good job" (emphasis added) (2009: 38). Consequently, perioperative nurses and ODP are in a particularly well suited position to assist patients with informed consent counseling throughout the surgical process. In this regard, Corbett adds that, "All patients have common care needs worldwide during their preoperative, intraoperative and postoperative journey. To facilitate these needs, we have an obligation to ensure that organizational issues relating to our practice are delivered efficiently and that the educational needs of the team are identified and addressed" (2009: 38). Although the principles of informed consent have been codified and are articulated in a professional code of conduct for healthcare professionals in the UK, innovations in medicine and surgery are making the provision of "truly informed" informed consent more difficult all of the time. A good example of this can be found in a report from a practicing physician, Dr. Merrill, in the UK. Following his experience with heart surgery using innovating surgical techniques, the physician noted the problems he experienced in understanding all of his alternatives compared to a simpler earlier procedure, and finally trusted to the advice of his cardiologist to surgically intervene. In response to the experience, Dr. Merrill emphasized that, "As a physician talking to colleagues, I had the best information possible under the circumstances. But it wasn't the same as my hernia repair. The experience brought home to me the realization that the progress of medicine has made informed consent impossible -- even for me" (Merrill 1999: 190).

Rationale of Study

Taken together, the foregoing issues indicate that there is an ongoing need for an assessment of knowledge levels of informed consent among perioperative nurses and operating department practitioners. Perioperative nurses and operating department practitioners, though, are frequently subjected to an enormous amount of stress in a fast-moving and hectic environment, diminishing their ability to provide the level of informed consent counseling that patients need and deserve. According to Salas, Bowers and Eden, "All individuals are susceptible to what is known as human performance limitations. Many health care workers fail to recognize that their abilities may be limited, particularly when they are fatigued, unwell, or otherwise stressed" (2001: 268). These issues are particularly pronounced among anesthesiologists, surgeons, anesthetic nurses, and surgical nurses (Salas et al. 2001). Therefore, by identifying current areas of deficiency in the understanding of informed consent requirements and responsibilities among perioperative nurses and ODPs, timely interventions can be formulated to address these issues so that they will be better prepared to provide their patients with the type of informed consent counseling they need, even during periods of stress and fatigue.

Overview of Study

This proposed study will use a five-chapter format to achieve the research purpose above stated. Chapter one will be used to introduce the issues under consideration, as well as a statement of the problem, the purpose, importance and rationale of the study. Chapter two of the proposed study delivers a critical review of the relevant and peer-reviewed literature concerning informed consent requirements and the specific legal and ethical responsibilities of healthcare providers, including nursing staff. Chapter three will be used to more fully describe the study's methodology, including a description of the study approach, the data-gathering method, the database of study consulted, and the subjects to be used in the study. Chapter four will consist of an analysis of the secondary and primary data developed during the research process and chapter five will present the study's findings, including a summary of the research and recommendations.

Definition of Key Terms

NHS: National Health Service

Operating room practitioner: According to Corbett (2009), "Operating room practitioners are a highly professional group, working behind the doors of an environment that is unfamiliar to the public. It is also new to some nursing colleagues who have never before been exposed to the three main areas of patient care: the anaesthetic room, operating room and recovery" (2009: 37).

Perioperative nurse: A perioperative nurse (or in some settings, also called an operating room nurse), is a member of the surgical team who is responsible for providing care to patients prior to, during and following the completion of their surgical procedures (Novotny, Lippman, Sanders & Fitzpatrick 2003).

CHAPTER 2: REVIEW of RELATED LITERATURE

Chapter Introduction

This chapter provides an overview of informed consent and why it is important in any healthcare setting, followed by a discussion concerning various cultural factors that should be taken into account during the informed consent counseling process. Finally, a review of the informed consent requirements for nurses and operating room practitioners in the United Kingdom is followed by a brief summary of the chapter.

Informed Consent Overview

Nurses have always been involved in obtaining informed consent from clients undergoing diagnostic tests and various interventions. Involvement of nurses in obtaining informed consent from subjects for research protocols/studies is more recent. There are no obvious differences in the legal standards for obtaining informed consent for the purpose of therapy/treatment or research; however, the character of consent provided for therapy differs from that given for research. Clients are offered therapy/treatment when there is substantial evidence that they will benefit directly; however, clients are solicited to participate in research studies that may not directly affect their well-being (Lee & Thomas-Lawson 2001).

According to Tobin, the informed consent required in order to provide any type of medical treatment, including surgery, and the process is comprised of three key components as follows:

1. Communication of necessary information which includes three essential elements: (a) the risks of the proposed treatment, (c) viable alternative treatments, and (c) likely outcomes in the absence of treatment;

2. Comprehension of that information by the patient; and,

3. Subsequent consent to treatment (2008: 111).

Although every patient and treatment setting is unique, these elements are common to all informed consent procedures administered by the perioperative nurse (Tobin 2008). In addition, Lachman emphasizes that, "Legally, informed consent is a requirement, unless there are extremely specific circumstances, especially if the person meets competency requirements" (2006: 37). In other words, if people are competent, they have an inalienable and fundamental right to make decisions about their medical treatment, violations of which can carry severe consequences for the healthcare provider. According to Siegel, "Medical ethics and tort law enshrine patient autonomy at the heart of the informed consent dialogue" (2008: 1694). This means that the healthcare provider must ensure that persuasion is not used as a means of coercing a patient to agree to a surgical procedure even if all evidence-based practices indicates that such intervention is needed and may spell the difference between life and death. Rather, Siegel maintains that for the perioperative nurse, "The goal of informed consent counseling is not to intervene in a patient's understanding of her own self-interest, her family's interest or the appropriate balance between them (e.g. whether to risk cardiovascular surgery that might improve quality of life but poses a threat to longevity or whether to undergo chemotherapy that might increase longevity but reduce quality of life). Instead, a professional seeks to provide the patient information about possible benefits and risks of various courses of treatment that would enable the patient to make the medical decisions that -- in her judgment -- best serve her own self-interest and the interests of others dependent upon her" (2008: 1695).

Perioperative nurses and OPDs are just human, of course, and may unknowingly and unintentionally present a compelling argument in favor of a given intervention to the point where the patient's preferences are overridden in favor of the intervention favored by the healthcare providers and the treatment team. In this regard, King and Moulton (2006) note that this tendency can be problematic in a significant percentage of cases: "Around one-third of all medical decisions should depend largely on the values and preferences of the patient, rather than the norms of physician practice. Patient preferences for information disclosure, risk taking, quality of life outcomes and tolerance of side effects differ greatly amongst the patient population, yet variations in treatment decisions often do not reflect differences in patient choice" (2006: 429). Moreover, withholding important information concerning potential alternatives, including doing nothing at all, are contrary to the tenets of informed consent. As Calloway points out, "In cases where patient lifestyle, personal preferences and values are indicative of the most appropriate treatment choice, [clinicians] are not in the best position to make treatment decisions and should not limit disclosure of alternatives" (2006: 429).

There are some sound reasons for the informed consent requirements as well that may or may not be required to be reduced to writing, but which must nevertheless be clearly communicated between practitioner and patient. In this regard, Cobb notes that, "Disclosing information relating to patient treatment enables the patient to knowingly consent to - or to reject - the treatment that the healthcare provider is proposing. The informed consent paradigm should not be solely relegated to a simple form, although written confirmation to the patient to memorialize the process is always advisable" (2005: 330). The foregoing requirements and considerations are fairly straightforward and can be used as a useful framework in which the informed consent process is applied and for what purposes, but there are some other factors involved in the patient-clinician relationship that may affect the informed consent counseling process, and these issues are discussed further below.

Emergency situations

An adult who becomes temporarily unable to consent due to, for example, being unconscious, may receive treatment necessary to preserve life. In such cases the law allows treatment to be provided without the person in the care of a nurse consent, as long as it is in the best interests of that person. Medical intervention considered being in the persons best interest, but which can be delayed until they can consent, should be carried out when consent can be given. Exceptions to this are where the person has issued an advanced directive detailing refusal of treatment.

Domain No. 2:

Obtaining consent

Obtaining consent is an ongoing process instead of a one-time affair. When a person is told about proposed treatment and care, it is important that the information is given in a sensitive and understandable way. The person should be given enough time to consider the information and the opportunity to ask questions if they wish to. Nurses should not assume that the person in their care has sufficient knowledge, even about basic treatment, for them to make a choice. The code supports involving people in the care giving processes. It clearly states: "You must uphold people's rights to be fully involved in decisions about their care." It is essential that they are given sufficient information to enable them to determine whether or not to accept or decline treatment and care. This right is supported in the code where it states: "You must respect and support people's rights to accept or decline treatment and care." If a person feels the information they have received is insufficient, they could make a complaint to the NMC or take legal action. Most legal action is in the form of an allegation of negligence. It is therefore essential that nurses ensure that they: "…share with people, in a way they can understand, the information they want or need to know about their health." In exceptional cases, for example, where consent was obtained by deception or where not enough information was given, this could result in an allegation of battery (or civil assault in Scotland); however, only in the most extreme cases is criminal law likely to be involved.

Domain No. 3:

Who should obtain consent?

The nurse proposing to perform a procedure should obtain consent, although there may be some situations where this may be delegated to another. When choosing to delegate the nurse must: "… establish that anyone you delegate to is able to carry out your instructions" and "… confirm that the outcome of any delegated task meets required standards." Usually the individual performing a procedure should be the person to obtain consent. In certain circumstances, nurses may seek consent on behalf of colleagues if they have been specially trained for that specific area of practice. There may be occasions where nurses, although caring for the person, are not responsible for either obtaining consent or performing the procedure. In these cases the nurse is often best placed to know and to judge what information the person requires in order to make a decision. Nurses are reminded of the importance of communication within the team and are advised that any concerns regarding a persons understanding of a procedure should be communicated appropriately. Such difficulties in understanding could be as a result of language differences. Interpreters may be required to assist in such cases. The Code on these two points specifically states: "You must keep your colleagues informed when you are sharing the care of others" and "You must make arrangements to meet peoples language and communication needs."

Domain No. 4:

Forms of consent

A person in the care of a nurse may demonstrate their consent in a number of ways. If they agree to treatment and care, they may do so verbally, in writing or by implying (by co-operating) that they agree. Equally they may withdraw or refuse consent in the same way. Verbal consent, or consent by implication, will be enough evidence in most cases. Written consent should be obtained if the treatment or care is risky, lengthy or complex. This written consent stands as a record that discussions have taken place and of the person's choice. If a person refuses treatment, making a written record of this is just as important. A record of the discussions and decisions should be made.

Domain No. 5:

When consent is refused

Legally, a competent adult can either give or refuse consent to treatment, even if that refusal may result in harm or death to him or herself. Nurses must respect their refusal just as much as they would their consent. It is important that the person is fully informed and, when necessary, other members of the health care team are involved. A record of refusal to consent, as with consent itself, must be made. The law and professional bodies recognise the power of advanced directives or living wills. These are documents made in advance of a particular condition arising and show the persons treatment choices, including the decision not to accept further treatment in certain circumstances. Although not necessarily legally binding, they can provide very useful information about the wishes of a person who is now unable to make a decision.

Domain No. 6:

Consent of people under 16

If the person is under the age of 16 (a minor), nurses must be aware of local protocols and legislation that affect their care or treatment. Consent of people under 16 is very complex, so local, legal or membership organisation advice may need to be sought. Children under the age of 16 are generally considered to lack the capacity to consent or to refuse treatment. The right to do so remains with the parents, or those with parental responsibility, unless the child is considered to have significant understanding and intelligence to make up his or her own mind about it. Children of 16 or 17 are presumed to be able to consent for themselves, although it is considered good practice to involve the parents. Parents or those with parental responsibility may override the refusal of a child of any age up to 18 years. In exceptional circumstances, it may be necessary to seek an order from the court. Child minders, teachers and other adults caring for the child cannot normally give consent. The Age of Legal Capacity (Scotland) Act 1991 sets out the current position on the legal capacity of children, including giving or withholding consent to treatment. The law is broadly similar to that in England and Wales; however, one important difference is that parents consent cannot override a refusal of consent by a competent child. In Scotland a child under the age of 16 has the legal capacity to consent to his or her own treatment where, according to the Act…"in the opinion of the qualified medical practitioner attending to him/her, he/she is capable of understanding the nature and possible consequences of the procedure or treatment."

Source: Excerpted from the Code at http://www.nmc-uk.org/Nurses-and-midwives/Advice-by-topic/a/Advice/Consent/

There are also requirements set forth in the Code concerning obtaining consent from patients who are mentally incapacitated or who are detained pursuant to relevant mental health acts, but these domains were omitted from the foregoing domain listings and will not be included in the custom questionnaire based on the wider applicability of the other domains to the most common issues that are encountered in modern surgery services.

Chapter Summary

This chapter provided a review of the juried and scholarly literature to develop an overview of informed consent and its importance, a discussion of the cultural factors that may influence the informed consent counseling process and a review of the informed consent requirements for nurses and operating room practitioners in the United Kingdom today. The proposed study methodology is more fully described in chapter three below.

CHAPTER 3: METHODOLOGY

Description of the Study Approach

The study proposed herein will use a mixed methodology to achieve the research purpose of critically assessing the current and expected knowledge and application of informed consent procedures by perioperative (anesthetic) nurses and operating department practitioners (ODPs) in the UK today. The first part of the mixed methodology will consist of a review of the secondary juried and scholarly literature concerning informed consent in general, and its applicability to perioperative nurse and ODP practice in the UK. The second part of the mixed methodology will consist of a qualitative and quantitative questionnaire to critically assess the current and expected knowledge and application of informed consent procedures by perioperative (anesthetic) nurses and operating department practitioners (ODPs) in the UK. The used of a mixed methodology to collect both primary and secondary data is highly congruent with the guidance provided by Dennis and Harris who emphasize, "Primary data are information that is being collected for the first time in order to address a specific research problem. This means that it is likely to be directly relevant to the research, unlike secondary data, which may be out of date or collected for a totally different purpose. Ideally, an effective research project should incorporate both primary and secondary data" (2002: 39).

The questionnaire to be used in the proposed study will be divided into three sections, with the first section used to collect relevant demographic data. The second section is used to measure the respondents' knowledge levels in the six domains of the Code described in Table 1 above. The final section of the custom questionnaire will consist of an open-ended comment section where respondents will be encouraged to share any empirical observations, personal experiences or insights they may have concerning informed consent counseling and the processes that are involved.

Data-gathering Method and Database of Study

The research will be conducted in four National Health Service (NHS) hospitals in a particular geographical location.

Subjects

The proposed study's subjects will consist of between 300 and 350 anesthetic nurses and ODPs who are currently practicing in the four hospitals described above.

Instrument

Table 2

Proforma Perioperative Nurse/Operating Room Practitioner Informed Consent Questionnaire

Section One -- Fill-in-the-Blank & Multiple Choice Questions

Position Title:

( Operating Room Practitioner

( Perioperative/Anesthetic Nurse

Age (years):

Sex:

( Male

( Female

Years in current position

( < 1 year

( > 1 year < 3 years

( > 3 years < 6 years

( >6 years < 10 years

( > 10 years

Section Two: Likert-Scaled Questions

Domain

Statement

Strongly

Agree

Agree

NA

Disagree

Strongly Disagree

Domain No. 1: Emergency situations

Adults who are unable to consent due to temporary conditions such as being unconscious cannot receive the medical treatment that necessary to preserve life.

The law does not allow treatment without informed consent to be provided to the person who is in the care of a nurse, even if it is in the best interests of that person.

Medical interventions that are in the patient's best interests but which are not life-threatening can be addressed while the person is treated for any life-threatening condition.

Domain No. 2: Obtaining consent

Once I obtain an informed consent, I'm finished with the process.

Patients shouldn't be bothered with their surgical intervention planning process.

Patients should be given just enough information to make the decision the treatment team prefers.

Domain No. 3:

Who should obtain consent?

Providing informed consent counseling and obtaining informed consent is solely the responsibility of the treating physician.

The responsibility to provide informed consent counseling and obtain informed consent from a patient cannot be delegated under any circumstances.

If nurses or OPDs are worried that a patient does not completely understand a surgical procedure, they should keep their concerns to themselves.

Domain No. 4:

Forms of consent

Informed consent can only be expressed in writing.

Once informed consent is provided, it cannot be withdrawn or changed.

Written consent should only be obtained if the treatment or care is risky, lengthy or complex

It is not important to memorialize a patient's refusal for treatment.

Domain No. 5:

When consent is refused

Competent adults can refuse medical interventions, even if that refusal could result in harm or death.

A patient's refusal to treatment does not carry the same weight as an informed consent to treatment.

Domain No. 6:

Consent of people under 16

Anyone under the age of 18 years must have a parent or legal guardian's informed consent.

Parents can override any informed consent decision of their children up to the age of 21 years.

Adults other than parents and legal guardians can normally provide informed consent.

Section Three: Open-Ended Comments

In the section below, please provide any additional observations, personal experiences, thoughts or insights you may have concerning the informed consent counseling process and nurse/operating department practitioner responsibilities.