The ethical foundation of informed consent in clinical research

OBJECTIVES: To provide a foundation for understanding the ethical concept of informed consent with particular emphasis on the characteristics and principles that make it a moral imperative. DATA SOURCES: Government reports, published articles, and book chapters from the ethics literature. CONCLUSIONS: Informed consent is central to the conduct of cancer clinical trials and good patient care. It is a thoughtful, collaborative process whereby an individual gives autonomous authorization and the decision of the individual is respected by the health professionals. IMPLICATIONS FOR NURSING PRACTICE: Understanding the theory and practice of informed consent is an essential aspect of the nurses role. There are many challenges to this process in the oncology setting because of the severity of the diseases and the complexity of the research, and nurses must be prepared to assure that informed decision-making takes place.     

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.     

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.     

Oncology patients in critical care: ethical dilemmas

Although ICU care encompasses many important ethical dilemmas, the care of oncology patients in ICU can be particularly troublesome. This article explores some of the common ethical issues related to oncology patients in critical care: informed consent, allocation of resources, and no code policies.     

Genetic testing and informed consent

OBJECTIVES: To discuss unique issues related to cancer predisposition genetic testing and informed consent. DATA SOURCES: Published professional articles, review articles, research articles, clinical practice, position statements, websites, and textbooks. CONCLUSIONS: The discovery of germline mutations that confer a predisposition for the development of cancer will continue. The provision of adequate information is central to the process of genetic counseling and testing so that individuals may give informed consent and make choices appropriate to their own specific circumstances. IMPLICATIONS FOR NURSING PRACTICE: The use of genetic information for the management of cancer will impact the practice of all oncology nurses in the coming years. Knowledge of genes that predispose for cancer and standards that delineate essential components of quality care during the informed consent process is vital.     

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.     

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.     

Human Subjects Protection and Federal Regulations of Clinical Trials

ObjectivesTo explore the federal regulations governing clinical trials and human subject protection, the importance of research participant's informed consent, and the role the oncology clinical research nurse has within the clinical trial setting.Data SourcesPeer-reviewed journal articles, internet, book chapters, white papers.ConclusionFederal regulations mandate the conduct of a clinical research trial, human research participant protection, and the informed consent process.Implications for Nursing PracticeThe oncology nurse supports the autonomy and safe conduct of the human research participant during a clinical research trial and provides education and support through the informed consent process.     

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 and patients with cancer: role of the nurse as advocate

Informed consent is an ongoing process, and oncology nurses are important advocates to identify information gaps and patient concerns during this process. This article discusses the rights of research participants from a regulatory perspective. Two case scenarios are presented and discussed to describe how nurses can ensure that patients are truly informed and understand the clinical trial process.     

Moral Justification of Phase 1 Oncology Trials

ABSTRACT

This article attempts to answer the following normative questions: Can one consider the design of Phase 1 trials ethically appropriate due to the unfavorable ratio of risks and benefits? What are some ethical safeguards for Phase 1 oncology research? A comparative review of literature contributed to the consolidation of the proposed ethical framework for Phase 1 oncology trials. This framework gives a special attention to issues of therapeutic misconception and vulnerability. The benefits and dangers associated with the enrollment in trials are described as well as the absence of alternatives, treatment-specific optimism, and vagueness in factual presentation during the informed consent process. The notion of therapeutic misconception is contrasted with optimism despite realism that stems from psychological, cultural, and religious factors and not necessarily from the lack of information. Close attention is given to the possible ways in which the inherent uncertainty and resulting cognitive biases may affect the informed consent process and the definition of therapeutic misconception. The article ends with recommendations for an ethical way of enrolling palliative patients in early stages of oncology research, giving special attention to provision of adequate consent, protection of vulnerability, and avoidance of therapeutic misconception.     

Involvement and (potential) influence of care providers in the enlistment phase of the informed consent process: the case of AIDS clinical trials

This article draws on ethnographic field data collected during an investigation of the informed consent process and AIDS clinical trials. It describes the involvement of care providers (physicians, nurse practitioners, physician assistants) during the enlistment, or recruitment, phase of the informed consent process. It shows that sometimes care providers are involved in the receipt, evaluation and distribution of information on clinical trials through their interactions with research professionals and patients. It suggests that the involvement of care providers has the potential to influence the informed consent process. Some of the ethical and practice considerations of this are discussed.     

Negotiating the informed-consent process in developing countries: a comparison of Swaziland and Pakistan

Protecting the rights of research participants when conducting studies within an international context presents many challenges. The purpose of this article was to compare and contrast the process of obtaining informed consent in two very different countries - Swaziland and Pakistan. Major aspects of the informed-consent process presented included identification of gatekeepers, seeking permission from officials, negotiating with these officials and Institutional Review Board (IRB) committees in regard to the type of data to be collected, and explaining informed consent to participants in the field. Data for this article is based upon qualitative research of collaboration between nurses and healers in Swaziland and from a variety of studies completed in Pakistan. These studies demonstrate the inadequacy and complexity of applying western-based concepts of informed consent to developing countries.     

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 in the intensive care unit: ensuring understanding in a complex environment

PURPOSE OF REVIEW: Informed consent in the intensive care unit continues to receive marked attention. As greater numbers of patients enter into the intensive care unit with devastating illness, patients and families are faced with more complex medical problems and decisions regarding therapy. Furthermore, research investigations of critical illness add a level of complexity to informed consent and decision making that mandates a careful approach. RECENT FINDINGS: Publications in the past year evidence the potential obstacles for appropriate informed consent. Physicians demonstrate variability in interpretation for the need for informed consent and frequently lack formal training in communicating informed consent. Critical care researchers must communicate the goals and benefits of trial participation carefully, avoiding the demonstrably common pitfall of therapeutic misconception. Excellent consensus statements now exist to guide the researcher in pursuing critical care research, creating informed consent documentation, and recognizing the appropriate setting for waiver of consent. As expected, extended discussion is the most effective tool for improving the quality of informed consent. SUMMARY: Quality of informed consent for the critically ill improves as attention is paid to standardizing indications and formalizing training for physicians. In research, conflicts of interest should be recognized and used to guide the investigator's dialogue on research benefits and risks. Patient safety must be maintained as the primary priority; however, waiver of consent may be considered in situations in which the benefit to medical knowledge far exceeds patient risk.     

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.     

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.     

Doing research on the ethics of doing research

In the previous issue of Critical Care Chenaud and colleagues found that most intensive care unit patients who had given informed consent for their participation in a clinical trial could not recall either the purpose of the trial or its related risks several days later. These findings should remind us that informed consent is a process, not an event, but they should not be interpreted to mean that recall is, of itself, a useful criterion for evaluating either the validity or the quality of the informed consent process. On an entirely separate note, the decision of the authors not to obtain informed consent for this study itself raises interesting questions about the ethics of doing research on the ethics of doing research.     

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.