A Critical Appraisal of Variability in Informed Consent for Vascular Access Procedures

Highlights

• Discussion of ethical and legal principles and challenges in the informed consent process.

• Discussion of minimal elements that should be included in a written informed consent document.

• Discussion about the challenges in ensuring adequate education for patients to provide informed consent and mitigation strategies.

• Discussion about informed consent practice variability stratified by device type, procedural complexity, inherent risks, and goals of therapy.

Abstract

Background: Vascular access device insertion is one of the most performed procedures in healthcare today. With different device types available to provide infusion therapy, there are many different variables to consider, including the process of obtaining informed consent from patients. This literature review aims to discuss common themes present in current evidence-based practice and point out critical areas of variability that exist.

Methods: A literature review was conducted searching Cochrane Library, Joanna Briggs Institute for Evidence-Based Practice, Cumulative Index to Nursing and Allied Health Literature, PubMed, and Google Scholar databases for recently published articles in the English language and those written in English. Articles were screened to include those that describe informed consent within the context of vascular access or other invasive procedures. There were 35 articles and 5 systematic reviews identified that met criteria for inclusion in this literature review.

Discussion: The topics of ethics, legal responsibility, who provided consent, and how education about procedures was performed demonstrated clear insight into how to improve the consent process. Some areas in current evidence lack clear direction and create variability in the informed consent procedure. These included who should obtain consent from the patient and which vascular access devices required a written consent. Who obtains consent was found to be more related to current legal precedence and not the clinician inserting the device like that found when a nonphysician clinician performed the procedure. Vascular access device related variability in requiring written versus verbal consent was found to be rooted in the degree of complexity of the procedure, need for specialized training, and the inherent risk to the patient.

Conclusion: These two areas of variability described in current clinical practice require more research and consensus agreement to standardize the practice of obtaining informed consent in vascular access device insertion.