Informed Consent Patient Autonomy and Physician Beneficence within Clinical Medicine

Substantial efforts have recently been made to reform the physician-patient relationship, particularly toward replacing the `silent world of doctor and patient' with informed patient participation in medical decision-making. This 'new ethos of patient autonomy' has especially insisted on the routine provision of informed consent for all medical interventions. Stronly supported by most bioethicists and the law, as well as more popular writings and expectations, it still seems clear that informed consent has, at best, been received in a lukewarm fashion by most clinicians, many simply rejecting what they commonly refer to as the `myth of informed consent'.
The purpose of this book is to defuse this seemingly intractable controversy by offering an efficient and effective operational model of informed consent. This goal is pursued first by reviewing and evaluating, in detail, the agendas, arguments, and supporting materials of its proponents and detractors. A comprehensive review of empirical studies of informed consent is provided, as well as a detailed reflection on the common clinician experience with attempts at informed consent and the exercise of autonomy by patients.
In the end, informed consent is recast as a management tool for pursuing clinically and ethically important goods and values that any clinician should see as meriting pursuit. Concurrently, the model incorporates a flexible, anticipatory approach that recognizes that no static, generic ritual can legitimately pursue the quite variable goods and values that may be at stake with different patients in different situations. Finally, efficiency of provision is addressed by not pursuing the unattainable and ancillary. Throughout, the traditional principle of beneficence is appealed to toward articulating an operational model of informed consent as an intervention that is likely to change outcomes at the bedside for the better.

I: The Sources of a Model of Informed Consent.- One: The Legal Doctrine of Informed Consent.- I. The Goals and Sources of the Legal Doctrine of Informed Consent.- II. Elements of the Legal Doctrine.- A. Competence to Consent.- B. Disclosure.- C. Evaluation and Consent.- D. Exceptions to the Rule.- 1. The Emergency Exception.- 2. The Therapeutic Privilege Exception.- 3. The Waiver Exception.- III. Summary.- Notes.- Two: The New Ethos of Patient Autonomy.- I. Early Concerns about Patient Autonomy.- A. Concerns about Research Subjects.- B. The Influence of Extraordinary Cases.- II. A Reply from the Paternalist.- III. Patients and Physicians as Moral Strangers.- IV. Freedom in Health Care.- A. Freedom from Interference and Informed Consent.- B. Restoring Freedom.- C. Enhancing Freedom.- D. The Heterogeneity of Clinical Needs and Tasks.- V. This Is All Very Well And Good, But….- VI. Retrospect and Prospect.- Notes.- Three: The Clinical Experience of Patient Autonomy and Informed Consent.- I. Anecdotes about Patient Autonomy and Informed Consent.- II. Empirical Studies of Informed Consent.- A. Patient Understanding of Disclosed Information.- B. Other Empirical Findings.- C. Implications of the Preceding.- III. Diminished Competence.- A. Factors Ingredient in Illness.- B. Common Psychological Responses to Illness.- C. Long Term Psychological Characteristics.- D. Other Diminishing Factors.- IV. Barriers to Patient Autonomy and Informed Consent.- A. Institutional Barriers.- B. The Nature of Clinical Decision Making.- V. Summary Remarks.- Notes.- Four: The Potential Benefits of Informed Consent.- I. The Value of Patient Participation in Clinical Decision Making.- II. Goods and Values that Informed Consent Might Capture.- A. Substantial Goods and Values That Are Often At Stake.- B. Less Common but Profound Goods and Values.- III. Retrospect and Prospect.- Notes.- II: A Model of Informed Consent.- Five: Toward a Model of Informed Consent — Theoretical and Programmatic Considerations.- I. Theoretical Considerations and Commitments.- A. The Theory of Informed Consent of Faden and Beauchamp.- B. Theoretical Commitments and Biases of this Work.- 1. Ethical Theory.- 2. Rights.- 3. Respect for Patient Autonomy.- 4. The Nature of the Argument of this Work.- II. The Basic Structure of the Model Advocated in this Work.- A. The Need for a Standardized Basic Model.- B. A Heterogeneity of Needs and Possibilities.- C. Informed Consent-Event or Process?.- D. The Primacy of an Informed Consent Event in this Account.- Notes.- Six: The Informed Consent Event.- I. Stage I: The Comprehensive Disclosure.- A. The Broader Context of the Decision at Hand.- B. Diagnosis.- C. Prognosis without Treatment.- D. The Recommended Treatment with Attendant Risks and Benefits.- 1. Identifying the Potential Benefits of a Given Intervention.- 2. Identifying Risks and Potential Complications.- E. Specification of Alternative Treatments.- 1. Clear Treatment of Choice with No Alternatives.- 2. Clear Treatment of Choice with Alternatives Only from a Technical or Professional Point of View.- 3. Alternative Modalities Exist, but the Physician Could Not Conscientiously Offer Them.- 4. Alternative Therapies Exist, Have Some Merit, but the Physician Feels the Recommended Treatment has Substantial Advantages.- 5. Alternative Modalities Exist and One of Them May Well be Preferred By the Patient, but the Physician Still has a Marked Preference.- 6. No Recommendation Can be Legitimately Given, as the Alternatives are Equally Appropriate and Reasonable.- II. Stage II: The Core Disclosure.- A. The Transparency Model of Howard Brody.- B. Considerations in Offering the Core Disclosure.- III. Stage III: Assessment, Clarification and Patient Choice.- IV. Retrospect and Prospect.- Notes.- Seven: The Issue of Competence.- I. The Standard of Practice Regarding Competence: An Emerging Consensus.- II. Competence as Both Status and Capacity.- III. Triggering the Competency Assessment.- A. The “Favorability” Trigger Revisited.- B. Clinical Considerations in Responding to Such Triggers.- IV. Performing the Competency Assessment.- A. The Generic Assessment of Competency.- B. “To the Task” Assessments of Competency.- 1. The Order of Investigation in “To The Task” Testing.- 2. Negative Findings in “To The Task” Assessments of 128 Competency.- a. Patient Performance within a “To The Task” Assessment.- V. Summary Remarks.- Notes.- Eight: Exceptions to Informed Consent.- I. The Emergency Exception.- A. The Competing Value of Informed Consent.- B. The Time Factor and Treatment Refusals in an Emergency.- C. The Abbreviated Consent Option.- D. Emergency Response in the Context of Terminal or Severe Chronic Illness.- II. The Waiver Exception.- III. The Therapeutic Privilege Exception.- IV. Summary Remarks.- Nine: The Enterprise of Informed Consent.