Informed consent: ethical and legal implications for nursing practice

The informed consent "process" is a significant dimension of ethical and legal nursing practice. Ethical and legal nursing practices are derived through an understanding of informed consent and knowledge of related nursing responsibilities. Awareness of the historical context, ethical underpinnings, and legal requirements related to informed consent are also important. Nursing practices that speak to these facets of informed consent are in the best interest of clients and nurses.     

Nurses’ perceptions of informed consent and their related roles in Korea: An exploratory study

Background

Informed consent is based on the Western notion of autonomy that patients have the right to know about their illnesses and make decisions about their health. However, there may be difficulty in accepting informed consent in Eastern cultures based on Confucianism, such as Korea. Even though nurses have no legal binds to informed consent, they have participated in the process of obtaining informed consent as an administrative assistant in Korea and then have had moral distress.

Objectives

The purpose of this study was to investigate nurses’ perception of informed consent and their role in establishing a better process of informed consent in Korea.

Methods

This exploratory study employed in-depth interviews with nurses. Participants were 12 nurses from selected departments (orthopedics surgery, cardiac surgery, and obstetrics & gynecology) from two university hospitals in Seoul and Kwang-ju, Korea. A semi-structured interview guide was constructed from the literature and used to elicit responses.

Results

Content analysis showed that nurses perceived a lot of problems in the process of obtaining informed consent and noted the need to modify this process. Although the role of nurses was found to be insignificant in the process of obtaining informed consent, some nurses wanted to participate in the process in order to advocate for patients and to verify if patients had received the information they needed.

Conclusions

Nurses can take a proactive role in the process of informed consent, as advocator as well as witness. This may be influential in balancing patient autonomy with paternalism, changing the skewed patient–physician relationship to one of mutual respect.     

Patient advocacy: witnessing informed consent for research in acute care.

Two views exist about witnessing informed consent for research in acute care settings: nurses witness a signature, and nurses witness the informed consent itself. Nurses are obligated to fulfill legal responsibilities and ethical expectations because of their role in the clinical arena, and to serve as advocates for patients to be informed, willing research participants. This role promotes change in institutional policies to keep up with the changing face of 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.     

Applying the principles of informed consent to patient care. Legal and ethical considerations for physical therapy

This paper presents legal and ethical considerations regarding informed consent for the evaluation and treatment of patients in physical therapy practice. Therapists traditionally think of informed consent in relation to clinical research, but as the trend toward independent practice and private practice increases in physical therapy, the physical therapist must understand the process of informed consent in relation to patient care. Legal concepts of battery, self-determination, and the fiduciary relationship create a legal foundation for informed consent. The patient's moral right to self-determination and the corresponding duty of health professionals to "do no harm" create a strong moral basis for gaining a patient's informed consent. Practical suggestions are offered to physical therapists to help them assess their need for obtaining informed consent.     

Informed Consent: Ethical and Legal Considerations for Advanced Practice Nurses

The ethical principles of self-determination and autonomy govern the practice of informed consent. A patient’s right to shared decision-making and assent prior to invasive procedures, therapeutic interventions, and research projects is protected by law. Foundational nursing roles of communication, education, and patient advocacy compel advance practice nurses to formulate methods that safeguard patients’ rights. Legal implications of informed consent may vary, leaving nurse practitioners juxtaposed between judicial and ethical responsibilities. The goal of this study is to examine legal and ethical components of informed consent and to assist nurse practitioners in developing proactive practice strategies related to informed consent.     

The competency quagmire: clarification of the nursing perspective concerning the issues of competence and informed consent

Selected issues involved in informed consent and the patient's competence to give it are examined. A discussion of tests of competence reveals some of the problems encountered in using them. There are differences in medical and nursing functions and responsibilities in the informed consent process. One nursing framework, self care, is used to discuss whether informed consent should be obtained from patients when they receive specific nursing care.     

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.     

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.     

Barriers to informed consent

OBJECTIVES: To provide oncology nurses with a review of barriers that may limit the ability of adults to provide informed consent. DATA SOURCES: Published articles, research studies, and review articles pertaining to informed consent and clinical research. CONCLUSIONS: Patient-centered barriers to informed consent (such as age, education, and illness) and process-centered barriers (such as content and readability of the consent form, timing of discussion, and amount of time allotted to the process) can affect an individual's ability to provide substantial informed consent. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses must be aware and knowledgeable of the various barriers to informed consent to minimize these barriers and to improve and facilitate the informed consent process.     

Therapeutic discourse among nurses and physicians in controlled clinical trials

An ethnographic field study about the informed consent process in investigational drug trials for seriously ill persons with hepatitis C suggests that nurses and physicians referred to these trials as giving treatment, even though they involved placebos. Interview data and informed consent documents contained frequent references to the term ;treatment trial' or ;treatment'. Although these findings were unexpected and not the original focus of our study, we consider them in the light of an extensive literature on the ;therapeutic misconception' that has been described among physicians and patients with AIDS and other serious illnesses. We also suggest that certain organizational and professional characteristics of nursing and medicine reinforce this tendency to refer to the trials as treatment. Implications for further research are provided.     

Informed consent: a study of the OR consenting process in New Zealand

The outcome of the informed consenting process should be that patients are knowledgeable about their future procedure, but there is no guarantee that signing the informed consent form means that patients have understood the information that their health care providers have given to them. To evaluate the informed consenting process in an OR direct admissions department of a city hospital in New Zealand, we interviewed 18 surgical patients. We transcribed the audiotaped interviews and analyzed the data using a general inductive approach derived from Grounded Theory. Our analysis indicated that educational information was not always based on patients' previous knowledge or understanding, although most patients understood the surgical consenting process to be complete after they met with the physician and signed the form. Our study highlights that although patients spoke with their physicians and nurses, there was still a lack of understanding. Perioperative nurses are in a prime position to reinforce informed consent. They should actively support the consenting process and be proactive in collaborating with patients and physicians to ultimately ensure that the patient has every opportunity to make an informed decision.     

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.     

Consent and assessment of capacity to decide or refuse treatment

Consent protects the right of patients to decide what happens to them. Before any medical intervention, adults must give valid consent, which must be voluntary, informed and given free of undue influence. When consent is being obtained, patients must be informed about the intervention, why it is being done and its risks; information they are given must be recorded. Every effort should be made to explain the issues in terms that the patient can understand and by providing support and aids to communicate. Consent can be expressed, where patients say they consent or put it in writing, or implied, where a healthcare professional infers from their behaviour that they consent. While different types of consent are valid, some are evidence of stronger proof in court that valid consent has been given. Competent adults have the right to refuse treatment, regardless of the reasons they give for refusal and even if the refusal will result in death; clinicians must respect their decision. In some circumstances-such as when an unconscious person is admitted as an emergency-healthcare professionals can make decisions on behalf of patients, and must do so in patients' best interests.     

Informed consent and the elderly. An ethical challenge for critical care nursing

Nursing ethics was long reticent about ethical challenges that elderly patients pose for critical care nursing. One of these, the legal doctrine of informed consent, has important implications for critical care nursing ethics. Deriving from the principle of respect for persons and intended to preserve their autonomy, informed consent represents both a duty and an ideal for care givers to implement in the process of ethical decision making. All too often the ideal is lost, however, and the doctrine reduced to a sterile and bureaucratic procedure. When elderly patients are unable to give an adequately informed consent, advance directives can enable them to express their wishes by prior choosing. If they become cognitively impaired, however, it is much more difficult to determine what, if any, preferences such a patient might express if able to do so. Medical empowerment of the elderly, a laudable social goal, can be as contradictory as informed consent itself and many elderly patients may opt out of their own decision making. The resultant moral distress of such a complex process is still another ethical challenge that faces the critical care nurse. Because nursing holds a position of moral centrality among the health care professions, critical care nurses cannot avoid the prospect that issues like those identified in this article will continue to challenge and confront them in the coming decade. By turning to colleagues in nursing as well as other professions, nurses can best strengthen and consolidate their vital role as mediators of meaning and morality in life-and-death situations.     

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.     

The meaning of autonomy in Chinese culture: obtaining informed consent for operation

The purpose of gaining the patient's informed consent is ethical, lying in respect for his or her autonomy, and such consent forms the foundation for the performance of clinical medical treatment. In order to respect the patient's autonomy, for example, during decisions about operations, doctors have the obligation to clearly explain that patient's medical condition to him/her. A thorough briefing should be given prior to the obtaining of the patients' consent. In fulfillment of their duties as medical professionals, both doctors and nurses should be involved in clinically informing patients as well as in obtaining their signature for operation and anesthesia. Although informing patients about their physical state is not the responsibility of nurses, it remains absolutely necessary for nurses to understand how people in Asian cultures understand autonomy. This paper begins with a discussion of autonomy in ethics, and then outlines the differences between the Eastern and Western concepts of autonomy, before discussing the obtaining of the signature of consent, a process performed by the nursing staff during clinical treatment, and resulting in the provision of such signatures by patients with the legal capacity to provide them.     

The quality of parental consent for research with children: a prospective repeated measure self-report survey

BACKGROUND: Researchers have ethical and legal responsibilities to ensure that individuals give informed consent to participate in research. The few studies of parental consent for paediatric research suggest there may be inadequate competence, information, understanding, or voluntariness for valid consent to occur. OBJECTIVES: To determine parents' level of understanding of the research study requirements and satisfaction with the informed consent process. PARTICIPANTS: English literate parents of children actively involved in research studies. METHODS: A repeated measures self-report survey was conducted to measure parent understanding (actual and perceived) of the study consented for and satisfaction with the informed consent process. Relationships between parents understanding of the research and their satisfaction with the consent process were explored and changes in parent understanding or satisfaction over time were described. RESULTS: Questionnaires from 109 parents were returned, representing 25 different studies. Parents demonstrated a high level of knowledge of information essential for informed consent, such as the purpose, benefits, and participant rights. Nervousness or inability to concentrate, and reading ease of the information sheet were found to relate to parents' knowledge and their perceptions of the adequacy of the consent. Parents overall reported high satisfaction with the consent process. CONCLUSIONS: These findings support and extend previous research on parental consent for research with children. They suggest areas where further research is indicated, including: the value and use of information and consent documents given to parents, the views and concerns of parents for whom English is not their first language, and further exploration of the concerns of the few dissatisfied parents. Current practices of obtaining informed consent for research lack supporting research evidence and may not be ethically justifiable.