Informed Consent for Bone Marrow Procedures
Informed consent for bone marrow procedures must include a clear description of the procedure's purpose, expected benefits, material risks (including false-negative results and procedure-specific complications), alternative treatment options, and the risks of not proceeding with the procedure, all delivered through a shared decision-making process that allows adequate time for patient questions and comprehension. 1, 2
Core Elements Required in Bone Marrow Informed Consent
Essential Information Components
The informed consent discussion must cover seven fundamental elements 1:
- Patient capacity/competence - Verify the patient has decision-making ability for this specific procedure 1
- Voluntariness - Ensure the decision is uncoerced and autonomous 1
- Disclosure of material information - Provide comprehensive details about risks, benefits, and alternatives 1
- Recommendation of a plan - Present a clear treatment recommendation based on patient values 2
- Understanding - Confirm patient comprehension of the information provided 1
- Decision - Allow the patient to make an informed choice 1
- Authorization - Obtain formal consent, preferably written for invasive procedures 1
Specific Procedural Information
Purpose and rationale - Explain why the bone marrow procedure is being performed, including the diagnosis being investigated or treated and how this procedure will guide management 1, 3
Procedure description - Provide a clear explanation in lay terms of what the bone marrow aspiration, biopsy, or transplantation entails 1, 4
Expected benefits - Detail the anticipated outcomes and how the procedure will help the patient's condition 1, 3
Material risks and complications - Disclose common and serious risks including 1:
- Bleeding and infection at the procedure site
- Pain and discomfort during and after the procedure
- Damage to nerves and blood vessels
- Anesthesia-related complications
- False-negative results (for diagnostic procedures)
- Procedure failure
- For bone marrow transplantation specifically: graft-versus-host disease, organ toxicity, and mortality risk 5, 3
Alternative treatment options - Present other reasonable approaches with their respective benefits and risks, explicitly stating that "different people make different choices" 1, 2
Risks of not proceeding - Clearly explain potential consequences of declining the procedure, particularly if this carries risk of irreversible outcomes 1, 2
Process and Documentation Requirements
Timing and Delivery
Adequate time for consideration - The consent form should be provided well before the procedure (ideally not hours before), allowing patients time to read, process, and formulate questions 6
Physician responsibility - Obtaining informed consent is a non-delegable duty that must be performed by the physician, not relegated to staff 1
Oral explanation required - Written consent forms alone are insufficient; the physician must explain the information verbally and engage in dialogue with the patient 6
Shared Decision-Making Approach
Assess decision-making preferences - Explicitly ask patients how they prefer to make decisions: shared responsibility, patient-led after receiving information, or physician-led recommendations based on patient values 2
Elicit patient values - Ask what makes the patient's life worth living and what functional limitations they would accept 2
Synthesize recommendation - Connect the patient's stated values to the proposed treatment in a clear recommendation 2
Balanced presentation - Present advantages and disadvantages of each option without steering toward a particular choice 2
Documentation Standards
Written documentation - Record the informed consent discussion in the medical record, including 1, 2:
- Information provided about the condition and treatment options
- Patient's understanding and questions asked
- Patient's decision and signature
- Name of clinician obtaining consent
- Confirmation that the patient had opportunity to ask questions
Ongoing consent - Document continued assent throughout treatment phases, particularly for procedures like bone marrow transplantation that occur over extended periods 1
Special Considerations
Language and Comprehension
Language barriers - Use qualified interpreters when needed; do not rely on family members 1
Health literacy - Tailor explanations to the patient's educational level and verify comprehension through teach-back methods 1
Cognitive impairment - For patients with cognitive limitations, assess decision-specific capacity and involve appropriate legal representatives when necessary 1
Patient-Specific Risk Factors
Individualized risk discussion - Address patient-specific risks based on comorbidities (e.g., increased bleeding risk in patients on anticoagulation, infection risk in immunocompromised patients) 1
Genetic and infectious disease testing - For bone marrow donation/banking, inform patients that testing will be performed and how they will be notified of abnormal results 1
Emotional and Psychological Aspects
Emotional impact - Acknowledge that information may cause anxiety while also providing relief through understanding 6
Trust and motivation - Research shows patients are often motivated by trust in their physician and belief in the procedure's curative potential 5
Retention of information - Patients typically retain major points about the procedure but may have difficulty recalling specific complications, necessitating written materials for reference 5
Common Pitfalls to Avoid
Consent as mere formality - Avoid treating consent as a checkbox exercise; it must be a genuine communication process 7, 6
Inadequate time allocation - Do not obtain consent immediately before the procedure when patients are anxious and unable to process information adequately 6
Delegation to non-physicians - Never delegate the consent discussion to nursing or administrative staff 1
Omission of "no treatment" risks - Always discuss what happens if the patient declines the procedure, particularly when delay carries significant consequences 1, 2
Failure to assess understanding - Do not assume patients understand because they signed a form; actively verify comprehension 1