Informed Consent

Lena Haygood (R) RT

With Informed Consent....

……It’s Not About the Form

….It’s more than a signature on a piece of paper!

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.

Why Do We Need Informed Consent?The Short Answer:

It’s the ethical thing to doIt’s a safety and quality of care issueIt’s the lawRegulatory RequirementHospital Policy

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

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 leadershipLegal counsel

When is Informed Consent Required?In most institutions, for:

SurgeryAnesthesiaOther invasive or complex medical or radiologic procedures

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 proceduresAnything with scalpels, needlesInjection of diagnostic substances into body cavities, internal organs, etc.

What’s Needed for Informed Consent?The diagnosis, if knownThe nature and purpose of a proposed treatment or procedureThe risk and benefits of proposed treatment or proceduresAlternatives (regardless of costs or extent covered by insurance)The risk and benefits of alternativesThe risks and benefits of not receiving treatments or undergoing procedures

Who Can Consent?Patient, if adult and competent

Impaired due to injury, ETOH or medications of drugs

Healthcare Power of Attorney or legal guardianIn the absence of a legally authorized representative, a “statutory surrogate” may give consent.

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.

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

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.

What are the Potential Consequences of Lack of True Informed ConsentIncreased chance of a patient safety incident or medical errorIncreased chance for malpractice casesViolation of professional and ethical obligations to clinicians to communicate clearly

What Can We Do to Improve Our Informed Consent?Simplify our languageAllow time for questionsMake sure the patient understandsPlan for language assistance in advance of appointmentTrain support staff

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.

Signing and Witnessing the ConsentThe 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.

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

Discussion…..