PubMed · 11917564
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Graham Scott. Code breaker.. https://pubmed.ncbi.nlm.nih.gov/11917564/
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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.
BACKGROUND: The use of the randomized consent design (commonly known as the Zelen design) is a controversial issue in randomized controlled trials. In the Zelen design, participants are randomly allocated prior to seeking consent. Those participants allocated to the intervention group are then approached and offered the intervention, which they can decline or accept. Zelen first proposed the design in 1979. It has been used infrequently since this time, although there are some notable exceptions in nursing, midwifery and some medical specialities. AIM: This paper describes the Zelen design, including the two forms used (the single and double consent versions) and discusses the advantages and disadvantages of using such a design. METHODS: An explanation of the differences between the Zelen design and a conventional randomized controlled trial is presented. In a conventional design, detailed knowledge of the alternative interventions is given to the prospective participant. The participant gives consent and is allocated to one of the groups. In a Zelen design, participants are randomly allocated and then approached and offered the group to which they were allocated. The Zelen design is used firstly, to reduce disappointment bias in the conventional consent-randomization process, and secondly, to remove subjective bias in the recruitment process. There are concerns relating to the use of the Zelen design, including ethical concerns relating to the timing of random allocation and consent and the collection of clinical data. CONCLUSION: It is hoped that by presenting issues pertaining to the Zelen design, other nursing and midwifery researchers may be prompted to consider its use when designing clinical research. The Zelen design is controversial, and debate about its merits and shortcomings is useful. This paper contributes to the ongoing debate.