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2 Library of Congress card number For sale by the Superintendent of Documents U.S. Government Printing Office Washington, D.C

3 Making Health Care Decisions A Report on the Ethical and Legal Implications of Informed Consent in the Patient- Practitioner Relationship Volume One: Report October 1982 President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

4 President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Morris B. Abram, M.A., J.D., LL.D., Chairman, New York, N.Y. H. Thomas Ballantine, M.D., Daher B. Rahi, D.O. M.S., D.Sc. * St. Clair Shores, Michigan Harvard Medical School George R. Dunlop, M.D. University of Massachusetts Mario García-Palmieri, M.D. University of Puerto Rico Bruce K. Jacobson, M.D. * Southwestern Medical School Albert R. Jonsen, S.T.M., Ph.D. University of California, San Francisco John J. Moran, B.S. * Houston, Texas Arno G. Motulsky, M.D. University of Washington Anne A. Scitovsky, M.A. Palo Alto Medical Research Foundation Seymour Siegel, D.H.L. Jewish Theological Seminary of America, New York Lynda Smith, B.S. Colorado Springs, Colorado Kay Toma, M.D. * Bell, California Charles J. Walker, M.D. Nashville, Tennessee Carolyn A. Williams, Ph.D. University of North Carolina, Chapel Hill * Sworn in August 12, Term expired August 12, Staff Alexander M. Capron, LL.B., Executive Director Deputy Director Administrative Officer Barbara Mishkin, M.A., J.D. Anne Wilburn Assistant Directors Joanne Lynn, M.D. Alan Meisel, J.D. Alan J. Weisbard, J.D. Professional Staff Mary Ann Baily, Ph.D. Dan Brock, Ph.D. Allen Buchanan, Ph.D. Andrew Burness, M.B.A. Kathryn Kelly, M.S.W. Susan Morgan Marian Osterweis, Ph.D. Renie Schapiro, M.P.H. Daniel Wikler, Ph.D. Research Assistants Michelle Leguay Katherine Locke Ruby J. Sherrod Jeffrey Stryker Special Consultants Caroline Kaufmann, Ph.D. Louis Morris, Ph.D. Editor Linda Starke Support Staff Florence Chertok Gretchen Erhardt Ruth Morris Clara Pittman Kevin Powers Nancy Watson President s Commission Commonwealth Fellows and Student Interns Susan Formaker (1982) Kenneth Kim (1982) Eddie Lockard (1982) Stephen Massey (1982) Ruth Oratz (1981) Lisa Rovin (1982) William Thompson (1981) Mindy Werner (1982)

5 The President The White House Washington, D.C Dear Mr. President: President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC (202) October 21, 1982 On behalf of the President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of the ethical and legal implications of the requirements for informed consent, the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees informed consent as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government. We are pleased to have had an opportunity to assist in improving understanding of this important topic. Respectfully, Morris B. Abram Chairman

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7 The Honorable George Bush President United States Senate Washington, D.C Dear Mr. President: President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC (202) October 21, 1982 On behalf of the President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of the ethical and legal implications of the requirements for informed consent, the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees informed consent as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government. We are pleased to have had an opportunity to assist in improving understanding of this important topic. Respectfully, Morris B. Abram Chairman

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9 President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research Suite 555, 2000 K Street, N.W., Washington, DC (202) The Honorable Thomas P. O Neill, Jr. Speaker U.S. House of Representatives Washington, D.C October 21, 1982 Dear Mr. Speaker: On behalf of the President s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, I am pleased to transmit our Report on Making Health Care Decisions. This is one of several subjects that Public Law directs the Commission to study and regarding which we are to report to the President, the Congress, and relevant departments of government. In mandating a study of the ethical and legal implications of the requirements for informed consent, the Congress assigned us a subject that is at the heart of current concerns about the relationship between patients and health care professionals. Although our studies have shown that the public and the educators of health professionals are greatly interested in this topic, it is not one that has been primarily a matter of Federal concern. The Commission does not recommend the adoption of specific regulations on this subject by Federal departments and agencies. Indeed, while recognizing the important role that the law has played in this area, the Commission does not look to the law as the primary means of bringing about needed changes in attitudes and practices. Rather, the Commission sees informed consent as an ethical obligation that involves a process of shared decisionmaking based upon the mutual respect and participation of patients and health professionals. Only through improved communication can we establish a firm footing for the trust that patients place in those who provide their health care. There are, nonetheless, several areas in which the Federal government can play a leading role. For example, it can ensure that the hospitals it operates and the professionals it employs take the steps recommended for all health care providers in this Report. Moreover, it can lend support--especially through the Department of Health and Human Services--to initiatives to develop, evaluate, and disseminate methods of improving the interpersonal side of health care, in line with the efforts that have advanced its scientific side. The Commission believes that this Report should be of interest to members of the public and of the health care professions, as well as to officials of the Federal government. We are pleased to have had an opportunity to assist in improving understanding of this important topic. Respectfully, Morris B. Abram Chairman

10 Table of Contents Volume One: Report Introduction 1 Summary of Conclusions and Recommendations 2 The Commission s Process 6 The Report 10 Part I: Values 13 Chapter 1: Informed Consent as Active, Shared Decisionmaking 15 Legal Background 18 Development of the Law 18 The Influence of the Litigation Process 23 Law, Ethics, and Medical Practice 29 The Context of Consent 31 Historical Development 31 Contemporary Trends 32 The Commission s View 36 Chapter 2: The Values Underlying Informed Consent 41 Serving the Patient s Well-Being 42 Absence of Objective Medical Criteria 42 Patient s Reasonable Subjective Preferences 43 The Boundaries of Health Care 43 Respecting Self-Determination 44 Intrinsic Value of Self-Determination 45 Freedom from interference 45 Creative self-agency 46 Implications of Self-Determination 47 External limitations 47 The absence of contemporaneous choice 49 Active participation 50 Part II: Goals and Realities 53 Chapter 3: Decisionmaking Capacity and Voluntariness 55 Capacity to Make Particular Decisions 55

11 Importance of Capacity 56 Elements of Capacity 57 Standards for Assessing Capacity 60 Voluntariness in Decisionmaking 63 Forced Treatment 63 Coerced Treatment 65 Manipulation 66 Chapter 4: The Communication Process 69 The Nature and Scope of Disclosure 70 Current Medical Status 74 Treatment Alternatives and the Professional s Recommendation 76 Treatment information in practice 78 The Role of Uncertainty 85 Types of uncertainty 86 Attitudes toward uncertainty 87 Mode of Presentation and Barriers to Effective Communication 89 Justifications for Less Than Full Disclosure 93 Attitudes toward less than full disclosure 96 Effects of disclosure and nondisclosure 99 The Relationship of Ethical and Legal Standards 102 The Development of Legal Rules 102 Attitudes toward the Law 104 The Use of Consent Forms 105 Part III: Means 113 Chapter 5: Practical Innovations 115 Preparing the Patient for Effective Participation 115 Developing Other Sources of Information for Patients 120 Pharmacists and Pamphlets for Patients on Medication 121 Opening Medical Libraries to the Public 123 Involvement of Family in the Process 126 Chapter 6: Professional Outlook and Behavior 129 Selection Criteria for Medical School 130 Current Standards 131 Changes in Criteria and Process 132 Combined Degrees and Early Admission 134 Innovations in Medical Education 135 Frequently Cited Problems 136 Curricular Innovations 139 Postgraduate Training 144 Examinations 144

12 Innovations in Nursing Education 145 Changes in Skills and Responsibilities 146 Relationship to Medicine 148 Chapter 7: Legal Reforms and Their Limitations 151 The Law as a Means of Improvement 151 Enhancing Self-Determination of the Formerly Competent 155 Instruction Directives 156 Proxy Directives 158 Statutory Developments 160 Requisites for a valid directive 160 Legal effect of directives 161 Proxy s characteristics and authority 162 Administrative aspects 164 Part IV: Decisionmaking Incapacity 167 Chapter 8: Who Is Incapacitated and How Is It To Be Determined? 169 Identification of Incapacity 169 Assessments of Incapacity 172 Policies and Procedures 173 Chapter 9: Substantive and Procedural Principles of Decisionmaking for Incapacitated Patients 177 Substantive Principles 177 Substituted Judgment 178 Best Interests 179 The Standard for Surrogate Decisionmaking 180 Procedures for Surrogate Decisionmaking 181 The Selection of a Surrogate 181 Emergencies 182 Nonemergency situations 182 Review Procedures 184 Judicial review 185 Institutional review 187 Addendum 189 Index 193

13 Tables Figures Table 1. Public and Physicians Views on Initiation of Discussion and Explanation of Treatment 79 Table 2. Frequency With Which Physicians Report They Withhold Information 97 Table 3. Nature of Consent Obtained for Various Procedures 108 Table 4. Selected Elective Courses Offered in Medical Schools, and Table 5. Graduates Reports on Adequacy of Time Devoted to Instruction in Selected Topics During Medical School 142 Figure 1. Discussion of Uncertainty in Medical Care 88 Figure 2. Conditions Under Which Public Feels Physician Can Justifiably Withhold Information 98 Figure 3. The Legal Doctrine of Informed Consent: Public and Physician Views 105 Figure 4. The Best Disclosure Standard: Public and Physician Views 106 Figure 5. The Purpose and Effect of Consent Forms: Public and Physician Views 109 Volumes Two and Three: Appendices, which contain studies prepared for the Commission and material submitted for its consideration, are available from the Superintendent of Documents.

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