Process consent: a model for enhancing informed consent in mental health nursing

Informed consent, essentially a legal doctrine, is designed to protect the rights of patients. However, in an area of practice such as psychiatry, informed consent imposes many problems if one considers it to be a static process. In this paper we propose that process consent, the type of consent considered essential in qualitative research projects, is not only appropriate but necessary for mental health nursing practice. This type of consent is an ongoing consensual process that involves the nurse and patient in mutual decision making and ensures that the patient is kept informed at all stages of the treatment process. We have used neuroleptic medications as an example throughout the paper and have suggested that seeking informed consent should be added to the role of the nurse in the mental health setting.     

Implied consent prior to nursing care procedures

THE AIM OF THE PAPER is to demonstrate the nurses should be wary of relying on the concept of implied consent prior to nursing care procedures. RATIONALE: The difference between a patient who implies consent and who merely complies with a procedure is almost undetectable. METHODS: An exploratory study, incorporating use of focus groups and critical incident technique to examine the way in which nurses obtain consent prior to nursing care procedures. FINDINGS: Many nurses administer care without seeking verbal or written consent, but claim that the patient's consent is implied. However, there is evidence that care is often administered in the absence of information-giving and that this perceived implied consent should more realistically be called compliance. Implied consent is consent for which information is a crucial component. There is evidence that the term implied consent signifies different things to different nurses. Furthermore, even if there is agreement about what constitutes implied consent, in practice, implied consent may be indistinguishable from compliance. Nurses who assume that they have the patient's implied consent, when in reality only have compliance, risk carrying out care procedures without the patient's consent. CONCLUSIONS: Nurses should be familiar with the principles of implied consent. They should be wary of relying on the use of implied consent prior to nursing care procedures because of the difficulty in distinguishing implied consent and compliance. Nurses should approach all aspects of care-giving with the offer of information. In order to reduce the risk of misinterpretation of a patient's implied consent, they should seek the verbal affirmation of a patient prior to a nursing care procedure. Where nurses rely on the patient's implied consent, they should do so at their own discretion and with full understanding of the meaning of the term.     

Understanding informed consent.

Understanding and facilitating the informed consent process is our duty as perioperative nurses. Acting as patient advocates, we must determine if our patients have given "informed consent" prior to surgical treatment. When we witness our patients signing consent forms, we must be sure they are competent to sign; that they have spoken with the physician and have discussed the proposed procedure (including the risks, benefits and alternative treatments) and have had their questions answered; and have read the consent form they are being asked to sign. As nurses, we must become aware of our responsibilities related to informed consent. By understanding the concept of informed consent and its legal implications, we will be able not only to the facilitate informed consent process but also to fulfill our legal responsibilities.     

The requirement for informed consent prior to nursing care procedures

AIM OF THE PAPER: The aim of this paper is to examine the extent to which there is a requirement to obtain informed consent prior to nursing care procedures. RATIONALE: The requirement for nurses to obtain consent prior to nursing care procedures is addressed in various nursing policy documents. It is important that nurses understand the legal and ethical rationale behind the principles of informed consent so that the principles are applied appropriately to the particular context of nursing care. ARGUMENT: The ethical and legal rationale behind the concept of informed consent and its relevance to nursing practice are examined. In this paper, it is argued that the function of informed consent is to protect patient autonomy and to promote meaningful decision-making. Given the potential for nursing care procedures to infringe patient autonomy, consent is clearly a relevant concept in nursing. Furthermore, in law, any touching without consent is a potential battery. Informed consent is often associated as a rigid procedure, only relevant to surgical or research procedures. Consent should be obtained prior to nursing care procedures whenever patient autonomy is at stake. However, information-giving should be determined by the needs of the patient and approached in such a way as to facilitate meaningful decision-making. Given the individual nature of infringements to patient autonomy, it is difficult to predetermine all those care procedures that require consent; any list of procedures would fail to be comprehensive. CONCLUSIONS: The principles of informed consent should underpin our approach to nursing care procedures, which should not be mechanistic but determined by the needs of individual patients.     

Teaching the informed consent process to residents

We believe the focus and emphasis of this committee on informed consent is unique, and that the development of an informed consent teaching process for residents will focus on the moral and ethical issues regarding informed consent. Even more important, we believe we will emphasize the patient care aspects of informed consent and also teach residents their responsibilities for long-term patient care with regard to patients' satisfaction and understanding of their disease process.     

Intensive care patients' evaluations of the informed consent process.

This study examines the informed consent process from the perspective of intensive care patients. Using the largest single-method database of patient-derived information in the United States, we systematically outlined and tested several key factors that influence patient evaluations of the intensive care unit (ICU) informed consent process. Measures of information, understanding, and decision-making involvement were found to predict overall patient satisfaction and patient loyalty intentions. Specific actions supportive of ICU informed consent, such as giving patients information on advance directives, patient's rights, and organ donation, resulted in significantly higher patient evaluation scores with large effect sizes. This research suggests that the effectiveness of the informed consent process in the ICU from the patient's perspective can be measured and evaluated and that ICU patients place a high value on the elements of the informed consent process.     

Assessing the readability statistics of national consent forms in the UK

Introduction: When obtaining consent for an invasive procedure, the patient needs to understand what is happening to them in broad terms. Best medical practice advocates that written consent is given to acknowledge patient agreement. Across the UK, the Department of Health has provided standard consent forms for obtaining consent in all situations. Potentially these written sources of information may not be comprehended by patients and thus invalidate consent. Method: Consent forms were assessed by the Flesch readability and Flesch‐Kincaid grade formulae and compared with the national reading age, the recommended level for patient medical information, three newspaper articles and a journal article. Results: The consent forms have acceptable statistics [average Flesch readability 61.1 (range 57.2–66.1) and Flesch‐Kincaid grade 7 (range 6.3–8)]. This grade, however, is above the recommended level of patient health information (Flesch‐Kincaid grade 6). When the patient statements are isolated the reading statistics worsen [average Flesch readability 52.6 (range 41–62.6) and Flesch‐Kincaid grade 9.6 (range 7.9–11.1)]. Conclusion: Consent forms should be used as adjuncts to detailed conversations, describing what a procedure involves to ensure that a patient understands, in broad terms, what is happening to them. The patient’s statement section of the form may be being written at a level above patient comprehension currently and thus could invalidate any consent given. We would advocate a documented conversation with patients to ensure they have a broad understanding of the procedure and using the consent form as an adjunct to this discussion. The patient’s statement section should be re‐written to avoid invalidating consent.     

Informed consent: An overview

Informed consent is a process, not an isolated incident. It therefore requires that health care professionals approach the process with expert knowledge, open communication, and a willingness to participate in shared decision-making. Table 2 identifies the major ethical and legal issues of informed consent. Legal precedents and professional collaboration will be necessary to further define and refine informed consent. The complexity of treatment regimens, potential system toxicities, and the chronicity of the disease process have fostered the development of a multidisciplinary team approach to the care of oncology patients. Therefore, collaboration is essential to meet the demands of the informed consent process and provide an optimal environment for the oncology nurse to intervene actively as a patient advocate.     

Informed consent: The ultimate right

Understanding the informed consent process permits the nurse to advocate for patient care safety and to promote good ethical and legal practice. This article has identified and highlighted the importance of the informed consent process. It is the ultimate right of all individuals, and the patient with a psychiatric illness is no less deserving of this ultimate right.     

Informed consent to breaking bad news

Informed consent to breaking (or waiving) bad news is an important yet neglected topic. It is distinct from informed consent to diagnosis and to treatment, and may be logically and ethically sound, provided patients are competent and that no considerable harm may be caused to others by breaking or waiving bad news to patients. This requires a differential assessment procedure in order to balance patient autonomy, benefit and justice towards others, preferably exploring patients' values, expectations and needs with them, so that an acceptable decision can be made on whether to act on their consent to breaking or waiving bad news, or to ignore it and act on informed consent by proxy. Future study should attempt to provide a detailed characterization of procedures for attaining informed consent to breaking or waiving bad news, and to test their success in establishing ethically sound health care.     

Autonomy and clinical practice. 3: Issues of patient consent

In this, the last in a three-part series considering how the concepts of autonomy, privacy and informed consent are articulated in nursing and the related literature, the authors focus on the notion of consent. Definitions of consent are considered, as are the legal elements of valid consent. Obtaining a patient's consent to treatment has several important functions. This article looks at some of these functions, such as safeguarding patient autonomy and encouraging patient participation in health care. Finally, a number of the difficulties in obtaining an informed consent from patients are considered. Some empirical studies which consider patients' understanding of the information and consent process are also discussed. From a review of the literature it appears that the issue of informed consent is very much tied up with the perceived power struggle between doctors and nurses and doctors and their patients.     

Medical informed consent: general considerations for physicians

Medical informed consent is essential to the physician's ability to diagnose and treat patients as well as the patient's right to accept or reject clinical evaluation, treatment, or both. Medical informed consent should be an exchange of ideas that buttresses the patient-physician relationship. The consent process should be the foundation of the fiduciary relationship between a patient and a physician. Physicians must recognize that informed medical choice is an educational process and has the potential to affect the patient-physician alliance to their mutual benefit. Physicians must give patients equality in the covenant by educating them to make informed choices. When physicians and patients take medical informed consent seriously, the patient-physician relationship becomes a true partnership with shared decision-making authority and responsibility for outcomes. Physicians need to understand informed medical consent from an ethical foundation, as codified by statutory law in many states, and from a generalized common-law perspective requiring medical practice consistent with the standard of care. It is fundamental to the patient-physician relationship that each partner understands and accepts the degree of autonomy the patient desires in the decision-making process.     

Informed consent prior to nursing care procedures

It is largely undisputed that nurses should obtain consent prior to nursing care procedures. This article reports on a qualitative study examining the way in which nurses obtain such informed consent. Data were collected through focus group discussion and by using a critical incident technique in order to explore the way in which nurses approach consent prior to nursing care procedures. Qualified nurses in two teaching hospitals in England participated in the study. An analysis of the data provides evidence that consent was often not obtained by those who participated in the study and that refusals of care were often ignored. In addition, participants were often uncertain how to proceed with care when the patient was unable to consent. Consent prior to nursing care procedures is an essential but undeveloped concept, for which a new ethos is required.     

Informed consent procedures in patients with an acute inability to provide informed consent: Policy and practice in the CENTER-TBI study

PurposeEnrolling traumatic brain injury (TBI) patients with an inability to provide informed consent in research is challenging. Alternatives to patient consent are not sufficiently embedded in European and national legislation, which allows procedural variation and bias. We aimed to quantify variations in informed consent policy and practice.MethodsVariation was explored in the CENTER-TBI study. Policies were reported by using a questionnaire and national legislation. Data on used informed consent procedures were available for 4498 patients from 57 centres across 17 European countries.ResultsVariation in the use of informed consent procedures was found between and within EU member states. Proxy informed consent (N = 1377;64%) was the most frequently used type of consent in the ICU, followed by patient informed consent (N = 426;20%) and deferred consent (N = 334;16%). Deferred consent was only actively used in 15 centres (26%), although it was considered valid in 47 centres (82%).ConclusionsAlternatives to patient consent are essential for TBI research. While there seems to be concordance amongst national legislations, there is regional variability in institutional practices with respect to the use of different informed consent procedures. Variation could be caused by several reasons, including inconsistencies in clear legislation or knowledge of such legislation amongst researchers.     

Malpractice litigation for uninformed consent. Implications for physical therapists

Although physicians generally are expected to secure their patients' informed consent to medical treatment, an emerging body of legal opinion holds that in certain situations nurses and allied health care professionals may be found similarly responsible. Failure of a health care provider to protect a patient's right of informed consent might result in a lawsuit alleging that serious harm was sustained needlessly because the patient plaintiff was not informed of certain significant risks of or consequences that resulted from treatment. As a professional group that puts patients at risk of harm during treatment, physical therapists need to know about their legal duty to facilitate a patient's awareness of and consent to treatment. This article discusses the nature of that duty and how a patient plaintiff might try to prove negligence against a physical therapist who allegedly fails to secure a valid statement of informed consent. The article also provides recommendations so that physical therapists might protect themselves from malpractice suits alleging "uninformed" consent.     

ICU research: the impact of invasiveness on informed consent

Purpose

Studies into the preferences of patients and relatives regarding informed consent for intensive care unit (ICU) research are ongoing. We investigated the impact of a study’s invasiveness on the choice of who should give consent and on the modalities of informed consent.

Methods

At ICU discharge, randomized pairs of patients and relatives were asked to answer a questionnaire about informed consent for research. One group received a vignette of a noninvasive study; the other, of an invasive study. Each study comprised two scenarios, featuring either a conscious or unconscious patient. Multivariate models assessed independent factors related to their preferences.

Results

A total of 185 patients (40 %) and 125 relatives (68 %) responded. The invasiveness of a study had no impact on which people were chosen to give consent. This increased the desire to get more than one person to give consent and decreased the acceptance of deferred or two-step consent. Up to 31 % of both patients and relatives chose people other than the patient himself to give consent, even when the patient was conscious. A range of 3 to 17 % of the respondents reported that they would accept a waiving of consent. Younger respondents and individuals feeling coerced into study participation wanted to be the decision makers.

Conclusions

Study invasiveness had no impact on patients’ and relatives’ preferences about who should give consent. Many patients and relatives were reluctant to give consent alone. Deferred and two-step consent were less acceptable for the invasive study. Further work should investigate whether sharing the burden of informed consent with a second person facilitates participation in ICU research.     

The nurse's role in the informed consent process

OBJECTIVES: To review the informed consent process in relation to oncology nursing roles and responsibilities, patient comprehension, cultural sensitivity, and qualitative methodologies. DATA SOURCES: Scientific and review articles, regulatory documents, and texts relating to informed consent. CONCLUSIONS: Nursing is involved in almost every aspect of the informed consent process. To be effective, nurses must be knowledgeable about fundamental concepts associated with informed consent and corresponding responsibilities and willing to address the complexities of the informed consent process. IMPLICATIONS FOR NURSING PRACTICE: Situations related to informed consent provide challenges and opportunities for professional growth. Keeping abreast of the evolving standards and concepts of informed consent enhances the essential roles that nurses play in clinically based research.     

The child patient and consent to treatment: legal overview

The giving of consent by the patient before medical treatment is a central tenet of medical law. Although it may be fairly clear when an adult patient has given consent, the situation can be less clear, and more complex, when a child patient is involved. This article seeks to explore the legal issues and concepts that arise when treating a minor, and to show how the courts and legal process may become involved.     

Research on informed consent: investigator-developed versus focus group-developed consent documents, a VA cooperative study

In the Department of Veterans Affairs Cooperative Study (VACSP) #470, A Randomized, Multicenter, Controlled Trial of Multi-Modal Therapy in Veterans with Gulf War Illnesses, a substudy was designed with the primary objective of comparing the utility of an informed consent document developed by a focus group of Gulf War veterans (focus group-developed) to an informed consent document developed by the standard process involving the study investigators (investigator-developed). In December 1998 a focus group of five Gulf War veterans convened at the coordinating center and developed a consent document during three sessions. The focus group used the investigator-developed consent document as a "starting point" and then modified it by consensus agreement. They also reviewed and modified the substudy's assessment questionnaire. Utility will be evaluated in 1092 veterans participating in the parent study, VACSP #470, by directly comparing selected patient-centered outcomes between those receiving the focus group-developed consent document versus those receiving the investigator-developed document. The primary outcomes to be evaluated over a 1-year follow-up period include measures of the informed consent process, such as patient recall, expectations about risks and benefits of participation, and understanding about the voluntariness of consent. Secondary outcomes will assess the impact of the substudy on the parent study with respect to recruitment and adherence. VACSP #470 was initiated in May 1999 in 20 sites that were randomly allocated to use either the focus group-developed or investigator-developed consent document. Sites are unaware of the type of consent document assigned. This article focuses on the rationale and design of the informed consent substudy and also discusses potential ethical issues.     

Informed consent in theory and practice: legal and medical perspectives on the informed consent doctrine and a proposed reconceptualization

The theoretical, legal, and medical doctrines of informed consent are analyzed. The elements of informed consent include disclosure of information, competency, understanding, voluntariness, and decision-making. The doctrine is ground in deference to individual autonomy and recognition that the exercise of self-determination in matters of health is a liberty interest honored by our history and traditions. The exceptions to informed consent including emergency, incompetency, therapeutic privilege, and waiver are especially important in critically ill patients and reflect a balancing of autonomy values and society's interest in the promotion of health. Legal decisions inevitably are based on atypical physician-patient encounters and focus on a particular problem or procedure rather than on overall medical care. In addition, they often reflect an artificial view of the doctor-patient relationship. Medical decision-making is a complex, evolving pursuit of a diagnosis and proper treatment regimen. Moreover, patients are not always interested in the role assigned to them by law. A reconceptualization of informed consent doctrines utilizing sliding scale standards based on variables pertinent to each individual patient is suggested.