The most important consideration regarding the information in informed consent is

Section 3. Presentation of Issues: INFORMED CONSENT

If humans are autonomous moral agents who make decisions freely and are held morally responsible for the consequences of their actions then in order to make the decision the agent needs to have accurate information concerning the situation and not be under coercion of any form.  Hence, there is a principle of Informed Consent in both moral theory and in the legal statutes.

Functions of the principle of Informed Consent:

  1. Protects individual autonomy
  • Protects the patient�s status as a human being
  • Avoids fraud and duress
  • Encourages doctors to carefully consider their decisions
  • Fosters rational decision making by the patient.
  • Involves the public generally in medicine.
  • A Health Care Provider must reveal to the recipient of care what is in that person's best interests to know. The recipient has a right to self decision and this shapes the Health Care Provider's duty to reveal the information. This might not be the customary practice for many HCP's.  The HCP must provide all material risks. It is a material risk if a reasonable person in the recipient's condition would likely attach significance to the risk.

    READ: The Origins of Informed Consent

    Terms as declared by Spotswood W. Robinson in Canterbury vs Spence allow for two (2) exceptions:

    1. The recipient is unconscious and then there is no need for consent, particularly in an emergency situation

    2. Disclosure is contra indicated from a medical point of view because the recipient would become so ill or emotionally distraught as to:

    • a. foreclose rational decision making
    • b. complicate or hinder treatment
    • c. cause psychological damage

    However, the HCP must respond to sound medical judgment. The privilege to withhold information is carefully circumscribed . The privilege is limited and does not permit paternalism.

    So for informed consent a person must have the following:

    • Competency
    • Relevant Information
    • Freedom to make the Decision

    Concerning competency there are important considerations and issues:

    James Drane, Competency to Give an Informed Consent: A Model for Making Clinical Assessments,JAMA: Journal of the American Medical Association, August 17, 1984, Vol. 252, No. 7, pp. 925-927.

    Freedman, Benjamin.  A moral theory of informed consent. Hastings Center Report , August, 1975, pp.149-157.

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    Important questions concerning informed consent:

    • What is informed consent?
    • What are the elements of full informed consent?
    • How much information is considered "adequate"?
    • What sorts of interventions require informed consent?
    • When is it appropriate to question a patient's ability to participate in decision making?
    • What about the patient whose decision making capacity varies from day to day?
    • What should occur if the patient cannot give informed consent?
    • Is there such a thing as presumed/implied consent?

    For more on informed consent READ: https://depts.washington.edu/bhdept/ethics-medicine/bioethics-topics/detail/67

    VIDEOS:

    RIGHTS TRUTH AND CONSENT

    Informed Consent to Medical Treatment: Medical Malpractice   

    What it is and why it is important

    Clinical Trial - Informed Consent

    Informed Consent Training

    Patient's Advocate Interviews Schizophrenic Patient

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    Proxy Consent

    Kluge, Eike-Henner W.  After "Eve": whither proxy ;decision-making? Canadian Journal Association Journal, (137), October 15,1987,  p.715-720.

    What of people who may not be able to choose?

    Children and adults with deficiencies who:

    • lack knowledge
    • lack capacity to reason
    • lack ability to carry out decisions

    Can such people be interfered with and decisions made for them in order to bring about what they would choose if they were fully rational and functional?

    How do we decide what a rational person would or should do? This is a particularly difficult task when there are conflicting goods or alternatives.

    Parents and Children

    Parents are expected to make the decisions in the best interest of the children.  Parents must not be: psychotic, incompetent, depressed or negligent.  The State protects the interest of the children (citizens) from harm, even from parents.  However , 44 states have made exceptions to the laws against child abuse and neglect in the case of those parents who act out of sincere religious beliefs.

    Questions On Parental Consent:

    • Who has the authority to make decisions for children?
    • What is the basis for granting medical decision making authority to parents?
    • When can parental authority to make medical decisions for their children be challenged?
    • What if parents are unavailable and a child needs medical treatment?
    • Should children be involved in medical decisions even though their parents have final authority to make those decisions?
    • What happens when an older child disagrees with her parents about a medical treatment?
    • Under what circumstances can minors make medical decisions for themselves?

    Answers: http://depts.washington.edu/bioethx/topics/parent.html

    History of the Massachusetts Religious Exemption Law

    http://www.masskids.org/dbre/dbre_6.html

    Cases of Childhood Deaths Due to Parental Religious Objections to Necessary Medical Care

    READ: http://www.masskids.org/jcl/jcl_6appendix.html?FACTNet

    Religious Freedom: http://www.freedomforum.org/packages/first/curricula/educationforfreedom/L06main.htm

    Victims of Religion Based Medical Neglect

    http://www.childrenshealthcare.org/victims.htm

    Listing of Religious Groups that Promote Faith Healing and Cases:

    READ: http://www.religioustolerance.org/medical2.htm

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    Pregnancy and Autonomy : Conflict of Rights? Woman vs fetus?

    Can a pregnant woman be forced to stop doing something or forced to do something without her consent?  Can the woman be coerced based upon concern for the welfare or the fetus or developing child within her?  What are the possible relationships of the pregnant woman to the fetus?

    • a. the fetus is not a person therefore there is no conflict
    • b. the fetus will develop into a person ( potential) and there is a conflict

    There are those who maintain that actions have consequences and the pregnant woman accepts those consequences.  The issue is just how far can a state go in prescribing the behavior of a pregnant woman? Should we establish a basic minimum or an obtainable ideal as the limit?

    King, Patricia. (1986). Should mom be constrained in the best interests of the fetus? Nova Law Review, 13(2), pp. 343-348.  

    READ: Summary and Critique of " Should mom be constrained in the best interests of the fetus?"

    READ: South Carolina- Cornelia Whinter Case: http://www.aclu.org/news/w071596a.html

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    Questions:

    • What accounts for the rising awareness of maternal-fetal conflict?
    • What happens when medical therapy is indicated for one patient, yet contraindicated for the other?
    • When does a fetus or a newborn become a person?
    • People have rights. Does a fetus have rights?
    • What if maternal decisions seem to be based on unusual beliefs?
    • What about obtaining court orders to force pregnant women to comply?

    Answers at: http://depts.washington.edu/bioethx/topics/matern.html

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    PRENATAL RIGHTS: http://dmoz.org/Society/Issues/Human_Rights_and_Liberties/Prenatal_Rights/

    • ACLU Reproductive Freedom: What's Wrong with Fetal Rights - A look at fetal protection statutes and wrongful death actions on behalf of fetuses.
    • The Controversy Over Fetal Rights - A select bibliography from the University of Arizona Library.
    • Fetal Abuse - The rash of women being charged criminally, or having their babies taken away from them, because they took drugs while pregnant focuses attention on the notion that unborn babies deserve the same legal protections as children.
    • Fetal Rights Institute - The Fetal Rights Institute is dedicated to the extension of human rights to the unborn through lawful, non-violent means.
    • Fetal Rights: Unborn Victim - The Center for Reproductive Law and Policy (CRLP) is a non-profit organization dedicated to promoting women�s equality worldwide by guaranteeing reproductive rights as human rights.
    • Maternal-Fetal Conflict - Examines the rising awareness of maternal-fetal conflict from an athical perspective in the medical profession.
    • Rights of the Unborn Under International Law - Discusses the basis for claims that the unborn have rights. Site created by Priests For Life.
    • Setback For Fetal Rights - Article republished from the Chicago Tribune of May 27, 1999 covers a Wisconsin alcohol case.
    • Fetuses Gain Legal Status - Bush administration allows states to call fetus 'unborn child' in order to give mothers prenatal care coverage enrolling them in the State Children's Health Insurance Program. (February 1, 2002)
    • ABC News.com : The Fetal Rights Debate - A look at fetal abuse cases, including drug abuse cases and acts of violence. (June 25, 2001)
    • Fetal victim's rights : Causing a miscarriage an act of murder?  Christian Science Monitor http://www.csmonitor.com/durable/2000/02/15/fp3s1-csm.shtml

    Decision-making capacity is often referred to by the legal term competency. It is one of the most important components of informed consent. Decision-making capacity is not black and white. You may have the capacity to make some decisions, but not others.
    The 4 main ethical principles, that is beneficence, nonmaleficence, autonomy, and justice, are defined and explained. Informed consent, truth-telling, and confidentiality spring from the principle of autonomy, and each of them is discussed.
    Description of Clinical Investigation. ... .
    Risks and Discomforts. ... .
    Benefits. ... .
    Alternative Procedures or Treatments. ... .
    Confidentiality. ... .
    Compensation and Medical Treatment in Event of Injury. ... .
    Contacts. ... .
    Voluntary Participation..
    Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.