Main Menu

Ophthalmology

Infectious Diseases

Palliative care

Law & Medicine down arrow

 

 

Introduction

Basic Principles

Informational Duty

Material Risk

Causation

Experimental Rx

Withdrawing Consent

Language

Refusal

Emergencies

Personal Information

Therapetic Privilege

Proof

Summary

References

 

 

 

Bioethics

 

Home > Disclaimer > Law & Medicine

 

Law & Medicine

 

 

Informed Consent

Summary

 

Informed Consent Gap:

There may be an " Informed consent gap" between these legal requirements and what actually happens.

Factors that can be barriers to adequate informed consent:

  • Physician communication (disclosure)
    • Very stressful situation, the patients/parents can become very upset and HCPs often feel reluctant to add to their stress and unhappiness.
    • Therapeutic privilege invoked – HCP may perceive that it is inappropriate to discuss material risks because HCP feels that the parents/patient won’t be able to cope with the information and may forgo life saving therapy.
    • Time consuming. HCP may not have sufficient time to discuss details accurately
  • Patient/parent understanding (comprehension/retention)
    • Emotional distress makes it very difficult or impossible to absorb new information.
    • Information itself:
      • Nature: Technical – outside usual experience and difficult to understand.
      • Quantity: large amount of information given at the same time
    • Language barriers

 

Informed Consent Requirements:

Having said all of this, consent must meet certain requirements before it is an effective defense to an action for negligence or battery:

Consent must be:

  • Given voluntarily with no coercion
  • Given by a patient who has capacity
  • Referable to the treatment and to the person who is to administer the treatment
  • Given by a patient who is informed.

 

Timing:

  • The discussion must take place at the right time to give the patient an opportunity to think about the therapy.
    • not immediately before the procedure or too many weeks before when the patient might have forgotten the discussion.

 

Content:

Information that the physician must disclose:

The prognosis if the patient remains untreated.
Goals of treatment.

Alternative means of achieving these goals

  • Is any other effective treatment available?
Success and failure rates of the different treatment methods.
Known side effects or material risks of the different treatment methods together with likelihood of  these side effects occurring:
  • Information that a reasonable person in the patients position would attach importance to.
  • The more serious the consequence and the higher the risk – then the more likely it is that a patient would wish to know about those risks.
  • Contributing factors to the risk.
Limits of relevant knowledge.
HCP should answer all of the patient's questions and ask the patient if they have any other questions (and those other questions should also be answered.)
The HCP`s recommendation about whether or not the treatment  should be given.
Any conflict of interest should be disclosed.
  • The doctor has a fiduciary duty to disclose personal interests unrelated to the patient's health, whether research or economic, that may affect his medical judgment.

 

 

 

 

Back to top

Next