Informed Consent for Vascular Access Procedures

Establishes the legal, ethical, and procedural requirements for obtaining, documenting, and maintaining informed consent for vascular access procedures, including the components of the consent discussion, requirements for emergency situations, and provisions for patients who lack decision-making capacity.

policies•Jan 2026•Patient Rights

Informed Consent for Vascular Access Procedures Policy

1. Policy Statement

It is the policy of this organization that informed consent shall be obtained, as a process and not merely a signature,1 before any vascular access procedure for which consent is required by law, regulation, or organizational policy.2 The consent process shall ensure that the patient (or their legally authorized representative) understands the nature of the proposed procedure, the associated risks and benefits, the available alternatives, and has the opportunity to ask questions and receive answers in a language they understand before granting or withholding permission.3 Documentation of the consent process shall be recorded in the patient’s health record.

2. Purpose

This policy exists to:

  • Protect patient autonomy by ensuring that every patient has the right to make informed decisions about invasive vascular access procedures performed on their body.
  • Define the required components of the informed consent discussion for vascular access procedures to ensure legal defensibility and ethical compliance.
  • Establish documentation standards that demonstrate the consent process was conducted, understood, and voluntarily agreed to.
  • Define the requirements for obtaining consent in emergency situations where the patient is unable to participate in the consent process.
  • Establish the requirements for surrogate decision-making when the patient lacks decision-making capacity.
  • Protect the organization and its clinicians from liability by ensuring that the consent process meets or exceeds all applicable legal and regulatory standards.

3. Scope

This policy applies to:

  • All clinicians who perform or order vascular access procedures requiring informed consent.
  • All vascular access procedures for which informed consent is required by organizational policy, including but not limited to: PICC insertion, central venous catheter insertion (tunneled and non-tunneled), implanted port placement and access, intraosseous device insertion, and any other invasive vascular access procedure designated by the Medical Staff as requiring formal consent.
  • Peripheral IV insertion does not typically require a separate formal written consent form, as it is generally considered part of the consent to treatment obtained at admission. However, the clinician shall still explain the procedure to the patient and obtain verbal agreement before proceeding.4 This requirement does not apply in emergent situations.
  • All clinical settings within the organization.

4. Policy Requirements

4.1.1 Informed consent is both a legal requirement and an ethical obligation rooted in the principle of patient autonomy.12 The consent process shall ensure that the patient’s decision is: informed (based on adequate disclosure of relevant information), voluntary (free from coercion, undue influence, or manipulation),5 and made by an individual with capacity (the cognitive ability to understand the information, appreciate its significance, reason about the options, and communicate a choice).6 Practices that rely on nudging, framing effects, or other persuasion techniques that bypass the patient’s deliberative process raise ethical concerns about the voluntariness of consent and shall be avoided.5 Systematic review of consent quality in emergency and elective surgical settings has identified substantial variability in compliance with established consent standards, underscoring the need for structured organizational processes and quality improvement initiatives.3 Organizational policies, consent form design, and clinician training programs should be designed to improve the overall quality of the consent process, including the readability and interactivity of consent materials.7

4.1.2 Who May Obtain Consent. Informed consent for vascular access procedures shall be obtained by the clinician who will perform the procedure, or by a designated subject matter expert who is qualified to explain the procedure, its risks, and the alternatives.8 The organization shall define, through Medical Staff bylaws or policy, which clinician categories are authorized to obtain consent for specific vascular access procedures. The ethical distinction between legitimate persuasion (sharing evidence to inform a patient’s decision) and manipulation (exploiting cognitive biases or emotional states to steer a patient toward a predetermined outcome) is critical; clinicians must ensure that the consent discussion remains firmly within the bounds of legitimate persuasion.9

4.1.3 Language and Communication. The consent discussion shall be conducted in the patient’s preferred language. When the patient’s preferred language differs from the clinician’s, qualified interpreter services (in-person or via telephone/video) shall be used.10 Family members and untrained staff shall not serve as interpreters for consent discussions. The translation and cross-cultural adaptation of consent materials introduces both linguistic and conceptual challenges that require careful validation to ensure genuine equivalence and comprehensibility.1011 Cross-cultural research documents that patient expectations regarding information disclosure and decision-making participation vary across populations and must be considered in consent process design.12 The quality of consent practices has been shown to vary significantly across clinical settings; organizational audits of consent processes are an important tool for identifying and addressing systemic gaps.13 For patients with hearing, visual, or other communication impairments, appropriate accommodations shall be provided.

4.2.1 The clinician obtaining consent shall discuss the following elements with the patient or their legally authorized representative. Evidence demonstrates that patients often have limited immediate recall of risk information disclosed during consent discussions,14 and that many written consent forms fail to adequately convey all relevant elements to patients in a comprehensible format.15 Patient comprehension of informed consent information is highly variable and is influenced by health literacy, emotional state, cognitive status, and the format of disclosure;16 structured, interactive discussions supported by plain-language materials are more effective than form-signing alone.

Description of the Procedure. A clear, jargon-free explanation of the vascular access device being proposed, where it will be placed in the body, how it will be inserted (including the use of imaging guidance such as ultrasound or fluoroscopy if applicable), and what the patient can expect to experience during the procedure (including pain management measures). Patient-reported accounts of peripheral IV insertion highlight the importance of clear clinician communication, adequate patient preparation, and responsiveness to patient discomfort and questions as core components of the procedural experience.4

Benefits of the Procedure. An explanation of why this device is being recommended, what clinical objectives it will enable (e.g., delivery of medications, nutrition, or blood products that cannot be safely administered through other means), and the anticipated duration of use.

Risks and Potential Complications. A transparent, honest discussion of the material risks associated with the proposed procedure, tailored to the specific device type.17 Risks to be discussed include, but are not limited to: infection (local and bloodstream), bleeding or hematoma, venous thrombosis (local and deep vein thrombosis), nerve injury, arterial puncture, pneumothorax or hemothorax (for central lines placed via the subclavian or internal jugular approach), catheter malposition, catheter embolization, air embolism, cardiac arrhythmia during insertion, allergic reaction to materials or medications used during the procedure, and the possibility that the procedure may not be successful and may need to be repeated or an alternative approach used. Risk disclosure shall be proportionate and accurate—neither minimized to avoid patient anxiety nor exaggerated in a manner that constitutes manipulation.9 Evidence from anesthetic practice demonstrates that patients routinely fail to recall major risks disclosed at the time of consent, even immediately after the discussion;14 this underscores the importance of iterative, comprehension-checking discussions rather than one-time disclosure.

Alternatives. A discussion of the available alternatives to the proposed procedure, including different types of vascular access devices that could be used, alternative routes of medication administration (e.g., oral, intramuscular, subcutaneous), and the option of refusing the procedure entirely. The clinician shall explain the relative advantages and disadvantages of each alternative.

Consequences of Refusal. A clear explanation of the potential consequences of declining the procedure, including the inability to deliver prescribed therapy, delays in treatment, and any increased risk to the patient’s health or life.

Questions. The patient or representative shall be given an explicit opportunity to ask questions and shall receive answers in a manner they can understand. The clinician shall assess comprehension before concluding the discussion. Validated instruments for assessing patient comprehension of consent information are available and may be used to systematically evaluate understanding.18 Applying the teach-back method—asking the patient to restate key elements of the consent discussion in their own words—is a highly effective strategy for identifying comprehension gaps and should be incorporated routinely into procedural consent discussions.19 Systematic reviews confirm that multiple modalities (teach-back, simplified language, visual aids, multimedia adjuncts) can meaningfully improve patient comprehension of informed consent.20

4.3.1 The health record shall contain documentation that demonstrates the informed consent process occurred.21 This documentation shall include, at minimum:

  • The date and time the consent discussion took place.
  • The name and credentials of the clinician who conducted the consent discussion.
  • The specific procedure for which consent is being obtained.
  • A statement that the components of the consent discussion (procedure description, benefits, risks, alternatives, consequences of refusal, and opportunity for questions) were addressed.
  • The name of the patient or legally authorized representative who participated in the discussion.
  • A statement that the patient or representative expressed understanding and voluntarily granted permission to proceed.
  • The patient’s or representative’s signature (or electronic equivalent) on the organization’s consent form, witnessed as required by policy.
  • If an interpreter was used, the name of the interpreter and the language used.
  • Where imaging guidance (ultrasound, fluoroscopy) will be used, documentation that the patient was informed of the imaging modality and its role in the procedure.22

Dynamic consent models—in which consent is personalized, iterative, and electronically managed—represent an emerging approach with particular relevance to patients undergoing repeated or longitudinal vascular access procedures.23

4.3.2 Consent Form. The organization shall maintain a standardized Informed Consent Form for vascular access procedures that includes all required elements and is approved by Legal Counsel and the Medical Staff Office. Consent forms shall be written at or below a 6th-grade reading level to maximize comprehension across the patient population.24 Systematic analysis of informed consent models across clinical domains provides design principles for consent materials, including plain language, logical flow, and appropriate use of visual elements.25 Several technology-assisted and multimedia modalities have demonstrated effectiveness in improving patient understanding and satisfaction with the consent process:

  • Self-directed and multimedia digital consent: Self-directed multimedia consent processes can improve comprehension and autonomy in the consent workflow.26
  • Digital and electronic consent platforms: Digital consent tools that support documentation and shared decision-making have shown promise in elective and procedural settings.27
  • Video-based consent adjuncts: Digital video consent approaches have been validated in bariatric surgery28 and other elective procedure settings, demonstrating improved patient comprehension compared to verbal-only consent.
  • Multimedia presentations: Multimedia consent presentations improve patient understanding of surgical risks and post-procedure expectations.29
  • Video decision aids: Video decision aids improve informed decision-making in patients facing complex or high-stakes procedures, including those with advanced illness.30
  • Three-dimensional virtual reality simulations: Immersive 3D VR models of invasive procedures have demonstrated improved patient comprehension of procedure anatomy and risks in randomized trials.31
  • Educational consent videos: Standardized educational consent videos have been shown to be equivalent to or better than standard verbal consent in terms of patient comprehension.32
  • Digital decision-support tools: A systematic review of digital tools in the informed consent process found broadly positive effects on comprehension, satisfaction, and decision quality.33
  • Procedure-specific multimedia adjuncts: Multimedia tools designed for specific procedures (e.g., Mohs surgery) have improved patient understanding of procedural steps and potential complications.34

When multimedia or digital adjuncts are used, they supplement but do not replace the direct clinician–patient consent discussion. Photographic or image-based documentation of procedural sites may complement the written consent record in selected clinical contexts.35

4.3.3 Timing. Consent shall be obtained sufficiently in advance of the procedure to allow the patient adequate time for deliberation.36 Standardized visual aids and consent tools presented at a structured pre-procedure visit have been associated with improved provider and patient satisfaction with the consent process.36 Consent obtained while the patient is in a state of acute distress, under the influence of sedating medications, or immediately before being transported to the procedure area raises concerns about voluntariness and capacity and should be avoided when possible. For surrogate-authorized procedures, particular attention shall be paid to the timing and pacing of the consent discussion, as surrogates must simultaneously process clinical information, make decisions on behalf of a loved one, and manage their own emotional responses.37

4.4 Emergency Situations

4.4.1 In emergency situations where a vascular access procedure is immediately necessary to preserve the patient’s life or prevent serious harm, and the patient is unable to participate in the consent process (e.g., unconscious, incapacitated), and a legally authorized representative is not available within the timeframe required for treatment, the procedure may proceed without formal written consent under the emergency exception to informed consent.38 The process of obtaining consent in acute and trauma settings raises unique challenges in terms of capacity assessment, decisional urgency, and information comprehension that require tailored approaches distinct from those used in elective settings.38

4.4.2 Emergency Documentation. When the emergency exception is invoked, the health record shall document: the nature of the emergency, the specific threat to the patient’s life or health that necessitated immediate intervention, the attempts made to contact a legally authorized representative, the clinical rationale for proceeding without consent, and the names of the clinicians involved in the decision.

4.4.3 As soon as the emergency has stabilized, the treating team shall inform the patient (if they have regained capacity) or their legally authorized representative of the procedure performed and the circumstances, and shall obtain retroactive consent or document the discussion.

4.5 Patients Lacking Decision-Making Capacity

4.5.1 When a patient lacks decision-making capacity (as assessed by the treating physician or a qualified designee),6 consent shall be obtained from the patient’s legally authorized representative, as defined by applicable state law. The hierarchy of surrogate decision-makers shall follow the organization’s Surrogate Decision-Making Policy, which reflects state-specific legal requirements. Frailty is a recognized factor that may impair a patient’s ability to fully process and retain consent-relevant information, and its presence shall be considered in the capacity assessment process;39 however, frailty or advanced age alone does not establish incapacity, and clinicians shall not assume decisional incompetence without formal evaluation.40

4.5.2 The surrogate decision-maker shall receive the same informed consent discussion as would be provided to the patient, and their authorization shall be documented in the same manner. The surrogate’s role is to apply a substituted-judgment standard (i.e., to make the decision the patient would make if able) or, where the patient’s wishes are unknown, a best-interests standard.4142 Patients with dementia or Alzheimer’s disease may retain meaningful comprehension of written and verbal information at early stages of cognitive decline, and clinicians shall not presume incapacity on the basis of a diagnosis alone.4344 Specialized capacity assessment instruments and approaches are available for evaluating consent-relevant comprehension in patients with cognitive impairments or other conditions affecting decisional capacity.45

4.5.3 Pediatric Patients. When the patient is a minor, consent shall be obtained from the parent or legal guardian. Depending on the patient’s age and developmental maturity, assent from the minor patient shall also be sought, as children’s developing capacity for autonomous judgment merits recognition within the consent process.4647 Evidence from pediatric cardiac surgery demonstrates that children can meaningfully participate in pre-procedural consent discussions when given developmentally appropriate information and multidisciplinary support.48

4.5.4 Assent from Incapacitated Patients. Even when consent is provided by a surrogate, the treating clinician shall, to the extent possible, explain the procedure to the patient and seek their assent (agreement) before proceeding. A scoping review of assent operationalization in pre-adolescent populations provides criteria for meaningful assent that are directly translatable to clinical care settings.49

4.5.5 Specialty Populations. Patients in perinatal and neonatal settings present unique informed consent challenges, including emergent delivery scenarios, rapidly changing clinical status, and the dual-patient relationship (mother and neonate); consent practices in these settings shall be governed by specialty-specific guidance.50

4.6.1 A patient with decision-making capacity has the right to refuse any vascular access procedure, even if refusal may result in adverse clinical outcomes. The refusal shall be respected.

4.6.2 When a patient refuses a recommended vascular access procedure, the clinician shall: ensure the patient understands the potential consequences of refusal, explore the patient’s concerns and address them to the extent possible, document the refusal, the information provided to the patient about consequences, and the patient’s stated understanding, offer alternative approaches if available, and notify the ordering provider.

5. Compliance

5.1 Monitoring. Compliance shall be monitored through retrospective chart audits of consent documentation completeness for all procedures requiring formal written consent (conducted quarterly by Quality/Risk Management), review of patient complaints or grievances related to the consent process, tracking of emergency consent exception utilization, and concurrent observation of consent discussions by Clinical Education or Quality staff during audit periods.

5.2 Key Performance Indicators.

  • Informed consent documentation completion rate for applicable vascular access procedures (target: 100%).
  • Percentage of consent forms containing all required elements (target: 100%).
  • Patient complaints related to the consent process (target: zero).
  • Emergency consent exception utilization rate with complete documentation (target: 100% documentation for all exceptions invoked).

5.3 Enforcement. Performing an elective vascular access procedure requiring formal consent without documented informed consent is a serious policy violation. Violations shall be reported to Risk Management and the Chief Medical Officer and may result in restriction of procedural privileges, mandatory re-education, and progressive disciplinary action.

6. Exceptions

6.1 The only exception to the requirement for written informed consent is the emergency exception defined in Section 4.4, which is itself subject to rigorous documentation requirements.

6.2 Procedures for which separate written consent is not required (e.g., routine peripheral IV insertion) remain subject to the requirement for verbal explanation and patient agreement as described in Section 3.

  • SOP-VA-110: Informed Consent Procedure for Vascular Access
  • SOP-VA-111: Emergency Consent Exception Documentation Procedure
  • POL-009: Patient Education in Infusion Therapy
  • POL-001: Foundations of Clinical Practice and Specialized Population Management
  • Informed Consent Form for Vascular Access Procedures (FORM-VA-CONSENT-001)
  • Organizational Informed Consent Policy (General)
  • Organizational Surrogate Decision-Making Policy
  • Organizational Interpreter Services Policy
  • Applicable State Informed Consent Statutes
  • Joint Commission Patient Rights Standards (RI.01.02.01, RI.01.03.01)
  • CMS Conditions of Participation: Patient Rights

8. References

9. Revision History

VersionDateAuthor(s)Description of Change
1.02026-02-01D. Woo, M. Stern, I.M. WrightInitial policy creation and approval
1.12026-02-23D. Woo, M. Stern, I.M. WrightAdded comprehensive reference citations (50 sources)
———Scheduled review date: 2027-02-01 or upon change in applicable consent law, whichever occurs first

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  2. The Joint Commission. Quick Safety Issue 21: Informed Consent—More Than Getting a Signature. April 2022. https://www.jointcommission.org/resources/news-and-multimedia/newsletters/newsletters/quick-safety/quick-safety-issue-21-informed-consent/ ↩︎ ↩︎

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