The process of obtaining informed patient consent

Obtaining patients' consent for procedures and operations is not simply a question of getting them to sign a form. It is a process that enables health professionals to explain to patients what is going to be done to them. It should inform them of the risks and benefits of any proposed procedures, and of any alternatives that might be available. It demonstrates respect for patient autonomy and should help to prevent legal action against health professionals.     

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.     

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.     

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.     

Improving understanding of the informed consent process and document

OBJECTIVES: To review theoretical perspectives relating to the communication of informed consent and to describe research efforts and strategies to enhance the informed consent process and document. DATA SOURCES: Research studies review articles, education and communication models, and NCI National Working Group on Informed Consent Recommendations. CONCLUSIONS: Information communicated during the informed consent process is difficult to understand, raising ethical concerns about whether informed decision-making has taken place. Empirical research focuses on the nature of patient-provider interactions and the effectiveness of various delivery systems, a need exists to overcome conceptual and methodologic limitations. IMPLICATIONS FOR NURSING PRACTICE: Nurses must ensure that patients understand informed consent information. Several communication strategies are posited.     

The decannulation process in children

Decannulation in children is a difficult process because of associated morbidity and psychological factors. In a collaborative effort, physicians and nurses play a vital role in determining a child's readiness and in preparing the family. The actual process that the physician will use to decannulate a child depends on the reason for which the child was tracheostomized. This article discusses the assessment necessary to determine readiness for decannulation, the preparation of the child and the family, and the variations in the actual methodology.     

The legal framework for informed consent.

Touching a patient without consent can leave the nurse open to action for battery. Consent must be informed and not given under duress. Consent can be written, verbal or implied. Patients should be advised if the risk of complications is other than minimal.     

National efforts to improve the informed consent process

OBJECTIVES: To inform oncology nurses about several national efforts to improve the informed consent document and process. DATA SOURCES: A federally funded grant program to stimulate research of informed consent, an initiative from the National Cancer Institute to improve informed consent documents in cancer clinical trials, and a model consent document developed by the National Action Plan on Breast Cancer. CONCLUSIONS: These initiatives assist investigators and institutional review boards in presenting relevant and understandable information to potential clinical trial participants. IMPLICATIONS FOR NURSING PRACTICE: These national efforts will raise awareness of providing potential research participants with clear information to assist them in making an educated, informed decision.     

Informed consent.

Patients have a right to informed consent and a right to forego treatments, procedures, or surgery if they feel uninformed or have changed their minds.