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.     

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 choice and consent for cervical spine manipulation

Informed consent is essential in ethical health care practice. Information and advice regarding choices is a precondition of informed consent. Autonomy, truthfulness and ethical decision making are all relevant to the informed choice and consent process. The purpose of this paper is firstly to discuss these topics. Following this, a case of informed choice and consent for cervical spine manipulation is examined. This case illustrates ethical problems that can arise in the informed choice and consent process. The moral reasoning in the case is clarified with the assistance of an ethical grid. The conclusion is that autonomy, a patient's right to self determination, is paramount in the informed choice and consent process. Autonomy enhancing informed consent requires more than a mechanical recitation of procedures, hazards and options. In order to uphold a patient's right to self determination, patients need to be included in the decision making process by allowing them to make treatment choices based on accurate information and advice from the physiotherapist.     

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.     

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.     

护理实践中落实患者知情同意权的问题与困惑

本文概述了落实患者知情同意权的意义,分析了护士在落实患者知情同意权过程中存在的问题与困惑,提出了有待进一步探讨的问题。     

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.     

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.     

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.     

Bioethics and informed consent in American health care delivery

Bioethics is a multi-dimensional discipline. The traditional aspect being medical ethics, a branch of Western philosophy which, since the time of Hippocrates, has sought to formulate rules of proper conduct for physicians. Ethics and informed consent are interrelated issues. Consent is the central issue on which hangs most of the ethical problems in human experimentation. The informed consent of the human patient is the ultimate protection from the hazards of research and therapy in medicine, the basic premise of this being that every human being has the right to determine what shall be done to his own body. The patient must have full prognosis, complications, sequelae, discomforts, costs, inconveniences, risks and expectations. Medically and ethically what should the patient be told? There appears to be no obvious format, but the patient should be told enough to allow him to make a rational decision. This paper contains an analysis of the reactions of just a few American nurses to this dilemma. The nurse who attempts to use only her scientific training to determine ethical conduct is in a quandary because seldom is there empirical evidence available to support her decision, no matter what it is.     

《护理学基础》教材中增加尊重患者同意权内容建议

知情同意权是由“知情权”和“同意权”两部分构成的一个整体。尊重患者的知情同意权是医务人员必须遵守的临床伦理法则,体现了对患者生命价值和人格尊严的尊重,也是防范医疗纠纷的重要内容。为了让护生在专业课程的学习过程逐渐培养尊重患者知情同意权的意识,在《护理学基础》教材的相关内容中,不仅要体现对患者“知情权”的尊重,也应强调尊重患者的“同意权”。     

抑郁症发作期患者就诊与住院知情同意状况的调查与分析

目的探讨抑郁症发作期患者就诊与住院知情同意状况,寻找既方便患者就诊和住院,又可避免因患者知情同意问题引起医疗纠纷的方法。方法对符合CCMD-3的抑郁发作期患者进行知情同意状况调查。结果患者对就诊知情者87例(52.41%),不知情者79例(47.59%);同意就诊者70例(42.17%),不同意就诊者96例(57.83%)。患者对住院知情者65例(39.16%),不知情者101例(60.84%);同意住院者53例(31.93%),不同意住院者113例(68.07%)。结论保证监护人对患者就诊和住院治疗的知情同意权是减少医疗纠纷的关键。     

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.     

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.     

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.     

Informed consent in physical medicine and rehabilitation. The physician/patient relationship--the doctor as a fiduciary

This article reviews the principle of informed consent and the ethical and legal bases upon which it rests. The process of obtaining an appropriate informed consent is explored, and the elements that make a consent valid are delineated. The principles of substitute decision-making and the special rules applied to circumstances such as emergency, therapeutic privilege, refusal of consent, and medical necessity are discussed. The concept of the relationship between physician and patient as a fiduciary relationship is explored as the fundamental basis for the modern doctrine of informed 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.     

Emergency Medical Service Providers' Attitudes andExperiences Regarding Enrolling Patients in Clinical Research Trials

Objective: The purpose of this study was to evaluate Emergency Medical Services (EMS) providers' attitudes andexperiences about enrolling patients in clinical research trials utilizing the federal rules for exception from informed consent. We hypothesized that Emergency Medical Technicians (EMTs) would have varied attitudes about research using an exception from informed consent which could have an impact on the research. Methods andsetting: Since January 2007, the EMS system has been participating in a randomized, multi-center interventional trial in which out-of-hospital providers enroll critically injured trauma patients using exception from informed consent.A voluntary, anonymous, written survey was administered to EMS providers during an in-service. The survey included demographics andLikert-type questions about their experiences with andattitudes towards research in general, andresearch using an exception from informed consent for an out-of-hospital clinical trial. Results: The response rate was 79.3% (844/1067). Most respondents, 93.3%, agreed that “research in EMS care is important.” However, 38.5% also agreed that individual EMTs/paramedics should maintain the personal right of refusal to enroll patients in EMS trials. Fifty-four percent of respondents agreed with the statement that “the right of research subjects to make their own choices is more important than the interests of the general community.” In response to statements about the current study, 11.3% agreed that “the study is unethical because the patient cannot consent” and69.2% responded that they would personally be willing to be enrolled in the study before they were able to give consent if they were seriously injured. Those who had not enrolled a patient into the study (681 respondents) were asked their reasons: 76.8% had not encountered an eligible patient or did not work for an agency that carried the fluid; 4.3% did not have time; 4.1% forgot and1.1% stated that they were opposed to enrolling patients in studies without their consent. Conclusion: The majority of EMS personnel in one community support EMS research andthis specific out-of-hospital clinical trial being conducted under an exception from informed consent. Potential barriers to enrollment were identified. Further study in other systems is warranted to better understand EMS provider perspectives about exception from informed consent research.