Informed Consent

1. Informed Consent
Lena Haygood (R) RT

2. With Informed Consent....
……It’s Not About the Form
….It’s more than a signature on a piece of
paper!

3. What is Informed Consent ?
• The process of communication between a patient
and physician that results in the patient’s
authorization of agreement to undergo a specific
medical intervention
(American Medical Association)
• Failure to obtain informed consent renders any
physician liable for negligence or battery and
constitutes medical malpractice.

4. Why Do We Need Informed Consent?
The Short Answer:
• It’s the ethical thing to do
• It’s a safety and quality of care issue
• It’s the law
• Regulatory Requirement
• Hospital Policy

5. Why Do We Need Informed Consent?
The Slightly Longer Answer:
• Greater patient safety and satisfaction
• Attainment of higher ethical standards and
organizational morale
• Closer adherence to legal requirements and
reduced risk of litigation
• Increased levels of institutional quality (e.g.
compliance with accreditation standards)
• Potential time and money savings related to
reduced litigation

6. Who is Responsible for Informed Consent?
The clinician has core responsibility…but…a team
approach is required with contributions from:
• Entire clinical staff
(clinician, nurse, technologist)
• Administrative and clinical leadership
• Legal counsel

7. When is Informed Consent Required?
In most institutions, for:
• Surgery
• Anesthesia
• Other invasive or complex medical or radiologic
procedures

8. What is considered an invasive procedure?
• Any penetration of the skin, use of radiation for
treatment, or comparable invasive procedure
involving interference with the body tissues.
• Also can be any other procedure that entails
substantial risk to the patient.
– Angiographic procedures
– Anything with scalpels, needles
– Injection of diagnostic substances into body cavities,
internal organs, etc.

9. What’s Needed for Informed Consent?
• The diagnosis, if known
• The nature and purpose of a proposed treatment or
procedure
• The risk and benefits of proposed treatment or
procedures
• Alternatives (regardless of costs or extent covered
by insurance)
• The risk and benefits of alternatives
• The risks and benefits of not receiving treatments or
undergoing procedures

10. Who Can Consent?
• Patient, if adult and competent
– Impaired due to injury, ETOH or medications of drugs
• Healthcare Power of Attorney or legal guardian
• In the absence of a legally authorized
representative, a “statutory surrogate” may give
consent.

11. Statutory Surrogates
Statutory Surrogates Include, in order of priority, the following:
1. Patient's spouse, unless legally separated.
2. Adult child of the patient. If more than one child, consent of a
majority who are reasonably available
3. Parent of the patient.
4. If the patient is unmarried, the patient's domestic partner if no
other person has assumed any financial responsibility for the
patient.
5. Brother or sister of patient.
6. A close friend of patient who is familiar with the patient's health
care views and desires and is willing to become involved in
the patient's healthcare and to act in the patient's best
interest.

12. • The sad part is that, many studies reveal that
physicians often fail to observe the practice and the
spirit of informed consent.

13. Why Do We Need to Improve Informed
Consents?
Even after signing a consent form, many patients still
do not understand basic information about the risks
and benefits of their proposed treatment options.

14. What are the Potential Consequences of
Lack of True Informed Consent
• Increased chance of a patient safety incident or
medical error
• Increased chance for malpractice cases
• Violation of professional and ethical obligations to
clinicians to communicate clearly

15. What Can We Do to Improve Our Informed
Consent?
• Simplify our language
• Allow time for questions
• Make sure the patient understands
• Plan for language assistance in advance of
appointment
• Train support staff

16. Use of Interpreter
• Information must be verbally provided to patient in
their native language; consent must be written in
English.
• If patient/family refuses hospital interpreter and
chooses to use a friend or family member; if must
be noted in the medical record.
• If translation services are used the interpreter
should sign as a “witness” and specify their name,
title, date and time.

17. Signing and Witnessing the Consent
• The patient (or the patient’s health care decision
maker) should sign the consent along with two
persons should witness the patient’s signature.
These witnesses are attesting to the fact that the
patient signed the form only and need not witness
the full consent discussion between the patien and
the physician.

18. Misc.
• The identify and professional status of individuals
responsible for authorizing and performing
procedures or treatments must be on consent.
• Discussion…..