Informed Consent

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Informed Consent and the Clinician-Patient Relationship:

Informed Consent and the Clinician-Patient Relationship Elizabeth Dugger Carey

Informed Consent and Clinician-Patient Relationship:

Informed Consent and Clinician-Patient Relationship “Informed consent is a legal procedure to ensure that a patient, client, and research participants are aware of all the potential risks and cost involved in a treatment or procedure. The elements of informed consent include informing the client of the nature of the treatment, possible alternative treatments, and the potential risks and benefits of the treatment.” Cherry, K (2012)

Informed Consent and Clinician-Patient Relationship:

Informed Consent and Clinician-Patient Relationship The clinician-client relationship refers to the relationship that is built between a health care professional and a patient after several interactions. This relationship develops slowly over time; its structure depends on the client's needs and the goals of the nurse and patient . Trust is one of the most important components of a clinician-client relationship. A strong foundation of trust promotes comfort, security and honesty

Informed Consent and Clinician-Patient Relationship:

Informed Consent and Clinician-Patient Relationship Considerations If at any time the level of trust is broken, it is difficult to re-establish it. For this reason, it is important that clinicians continue to foster a relationship based on trust.

Informed Consent and Clinician-Patient Relationship:

Informed Consent and Clinician-Patient Relationship Benefits Most patients find themselves in a vulnerable position when dealing with clinicians . Trust in this relationship is important in ensuring that clients remain calm and comfortable in this vulnerable state

Informed Consent and Clinician-Patient Relationship:

Informed Consent and Clinician-Patient Relationship Bidirectional Trust is bidirectional in the clinician-client relationship. Not only must the client trust that the clinician will provide quality care based on his unique needs, but also the clinician must trust that the client will provide honest information.

History of Informed Consent and Clinician-Patient relationship :

History of Informed Consent and Clinician-Patient relationship Earliest Informed Consent: focused on the rights of those who participated in medical research gradually put attention on informed consent as a right of the patient for any and all medical treatment

History of Informed Consent and Clinician-Patient relationship :

History of Informed Consent and Clinician-Patient relationship Regulation: Varies from state to state Not a feral bill or law for definition First formal discussions began in 1947

History of Informed Consent and Clinician-Patient relationship :

History of Informed Consent and Clinician-Patient relationship Nuremberg Code: Patient must have legal capacity to give consent Patient should be able to exercise free power of choice Patient should have sufficient knowledge and comprehension to make an enlightened decision

History of Informed Consent and Clinician–Patient relationship:

History of Informed Consent and Clinician–Patient relationship Ethics in Medical Research Involving Humans: Adopted in June 1964 Beginning of present day Informed Consent 1962 Consumer Bill of Rights The right to be informed, safety, to choose and to be heard 1970 manufacturers must include risk inserts to contraceptives 1966 fair Packaging and Labeling Act requires all consumer products to be informatively labeled

History of Informed Consent and Clinician Patient relationship:

History of Informed Consent and Clinician Patient relationship The Department of Health and Human Services and the Food and Drug Administration 1981-concept of consent in research was further defined An explanation and purpose of the research Foreseeable risks or discomforts Any benefits Disclosure of alternative courses of treatment

Appropriate Informed Consent:

Appropriate Informed Consent Primary Goal Patient have an opportunity to be an informed participant in his health care decisions

Appropriate Informed Consent:

Appropriate Informed Consent Elements of an Informed Consent Nature of the decision/treatment/procedure Reasonable alternatives to the proposed treatment Relevant risks, benefits and uncertainties related to each proposed procedure/treatment Assessment of patient understanding Acceptance of the intervention by the patient

Appropriate Informed Consent:

Appropriate Informed Consent What is considered adequate information? Reasonable clinician standard Reasonable patient standard Subjective standard

Appropriate Informed Consent:

Appropriate Informed Consent Which treatments/procedures require signed informed consent? Determined by institution Examples surgery anesthesia or most invasive procedures

Appropriate Informed Consent:

Appropriate Informed Consent When is it appropriate to question a patient’s ability to participate in decision making Assess patient’s ability to understand his/her situation Assess patient understanding of the risks associated with the decision at hand Patient can communicate a decision based on understanding of subjects discussed

Appropriate Informed Consent:

Appropriate Informed Consent What about the patient whose decision making capacity varies from day to day? In and out of coherent state due to medications and type of treatment or injury Inform the patient during a lucid state Even if you must temporarily lighten or stop medications

Appropriate Informed Consent:

Appropriate Informed Consent What if the patient can not give informed consent Advanced directive including a surrogate Specific hierarchy defined by the state of practice If surrogate is not available, clinicians are expected to act in the best interest of the patient

Appropriate Informed Consent:

Appropriate Informed Consent Is there an implied consent? Emergency situations when patient is unable to express his/her wishes Presence in a hospital etc. does NOT represent implied consent

PowerPoint Presentation:

Cherry, K (2012). What is Informed Consent?. www.about.com . Retrieved from www.about.com/orthopedics/informed_consent Katz, J. (1984). The Silent World of Doctor and Patient. New York, NY: Free Press Shuster PhD, E. (1997). Fifty Year Later: The significance of the Nuremberg Code. The New England Journal of Medicine, 337 , 1436-1440 Murray, P. M. (1990). The History of Informed Consent. The Iowa Orthopedic Journal, 10, 104-109 Bellum, W (2012). Informed Consent. American Medical Association. Retrieved from www.ama-assn.org/ama/ References

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