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The History and Components of Informed Consent

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Informed Consent in Predictive Genetic Testing

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Abstract

The third chapter explores the history of consent to identify the widely recognized components of consent (understanding, disclosure, and voluntariness) that represent the current model. This first part will analyze the clinical and research history of informed consent and discuss specific cases. Then, the second part will look at the emergence of the components of informed consent which are comprehension, disclosure, and voluntariness. This section will discuss the components of consent that have influenced the current model.

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Notes

  1. 1.

    Albert Jonsen, The Birth of Bioethics, 352–353; George Annas, American Bioethics: Crossing Human Rights and Health Law Boundaries, 112; Nancy Press and C. H. Browner, “Risk, Autonomy, and Responsibility: Informed Consent for Prenatal Testing,” S10.

  2. 2.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 288–289; James Childress, Who Should Decide? Paternalism in Health Care, 77.

  3. 3.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 78; Ruth Faden and Tom Beauchamp, “The Concept of Informed Consent,” 155–157.

  4. 4.

    Bonnie Steinbock, John Arras, and Alex John London, eds., Ethical Issues in Modern Medicine, 61.

  5. 5.

    Jay Katz, “Physicians and Patients: A History of Silence,” 135.

  6. 6.

    Bonnie Steinbock, John Arras, and Alex John London, eds., Ethical Issues in Modern Medicine, 61; H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 291; Robert Veatch, “Abandoning Informed Consent,” 5.

  7. 7.

    Albert Jonsen, The Birth of Bioethics, 355.

  8. 8.

    Platon Christopoulos, Matthew E. Falagas, Philippos Gourzis, and Constantinos Trompoukis, “Aspects of Informed Consent in Medical Practice in the Eastern Mediterranean Region During the 17th and 18th Centuries,” 1588–89, 1591.

  9. 9.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 42; Wouter Leclercq, Bram J. Keulers. Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1408; Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 4–5.

  10. 10.

    H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 303–304.

  11. 11.

    Tom Beauchamp, “Informed Consent,” 186–187; Willard Gaylin and Bruce Jennings, The Perversion of Autonomy, 49.

  12. 12.

    Carol Levine ed., Taking Sides: Clashing Views on Bioethical Issues, 2.

  13. 13.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 5.

  14. 14.

    Wouter Leclercq, Bram J. Keulers. Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1408.

  15. 15.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 78.

  16. 16.

    Margaret Swain, “A Brief History of Informed Consent,” 19–20.

  17. 17.

    Jerry Menikoff, Law and Bioethics: An Introduction, 155–156; Janet Dolgin and Lois Shepherd, Bioethics and the Law, 58–59; H. Tristram Engelhardt Jr., The Foundations of Bioethics, 304; Wouter Leclercq, Bram J. Keulers. Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1408.

  18. 18.

    James Childress, Who Should Decide? Paternalism in Health Care, 133.

  19. 19.

    Albert Jonsen, The Birth of Bioethics, 355; Jerry Menikoff, Law and Bioethics: An Introduction, 156.

  20. 20.

    Tom Beauchamp, “Informed Consent,” 187–188; Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 75.

  21. 21.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 144.

  22. 22.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 75.

  23. 23.

    Hana Osman, “History and Development of the Doctrine of Informed Consent,” 42.

  24. 24.

    Margaret Swain, “A Brief History of Informed Consent,” 19–20.

  25. 25.

    Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” 98–99.

  26. 26.

    Albert Jonsen, The Birth of Bioethics, 355.

  27. 27.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 44; Roberta M. Berry, “Informed Consent Law, Ethics, and Practice: From Infancy to Reflective Adolescence,” 65–66.

  28. 28.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 254; Tom Beauchamp, “Informed Consent,” 188.

  29. 29.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 144.

  30. 30.

    Hana Osman, “History and Development of the Doctrine of Informed Consent,” 42, 43; Carol Levine ed., Taking Sides: Clashing Views on Bioethical Issues, 3.

  31. 31.

    Albert Jonsen, The Birth of Bioethics, 355.

  32. 32.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 148.

  33. 33.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 135.

  34. 34.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 45.

  35. 35.

    Jay Katz, “Informed Consent- Must It Remain a Fairy Tale?” In, Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 162.

  36. 36.

    Albert Jonsen, The Birth of Bioethics, 197–198, 355.

  37. 37.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 148.

  38. 38.

    Jerry Menikoff, Law and Bioethics: An Introduction, 189.

  39. 39.

    Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286; Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” 101.

  40. 40.

    Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 133.

  41. 41.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 145, 148, 150; Carol Levine ed., Taking Sides: Clashing Views on Bioethical Issues, 3; Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286.

  42. 42.

    Jerry Menikoff, Law and Bioethics: An Introduction, 167.

  43. 43.

    Edward P. Richards, III, JD, MPH, “Consent and Informed Consent. Case Compliments of Versuslaw. Truman v. Thomas, 611 P.2d 902 (Cal.1980).”

  44. 44.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 61; Jerry Menikoff, Law and Bioethics: An Introduction, 168.

  45. 45.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 81; Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286–287.

  46. 46.

    Carol Levine ed., Taking Sides: Clashing Views on Bioethical Issues, 21.

  47. 47.

    Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286–287.

  48. 48.

    Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” 103–104.

  49. 49.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 62–63; Jerry Menikoff, Law and Bioethics: An Introduction, 186–188.

  50. 50.

    B. Sonny Bal and Theodore J. Choma, “What to Disclose? Revisiting Informed Consent,” 1346.

  51. 51.

    Albert Jonsen, The Birth of Bioethics, 355–356.

  52. 52.

    H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 330–331; Albert Jonsen, The Birth of Bioethics, 138, 149, 152, 356.

  53. 53.

    Tom Beauchamp, “Informed Consent,” 187.

  54. 54.

    Albert Jonsen, A Short History of Medical Ethics, 88–89; Albert Jonsen, The Birth of Bioethics, 130–133.

  55. 55.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 216; Michelle Byrne, “The Concept of Informed Consent in Qualitative Research,” 401.

  56. 56.

    Albert Jonsen, The Birth of Bioethics, 134–135; Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 216–219, 232.

  57. 57.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 375; Albert Jonsen, The Birth of Bioethics, 134.

  58. 58.

    Jose Miola, “The Need for Informed Consent: Lessons from the Ancient Greeks,” 152.

  59. 59.

    The Nuremberg Tribunal, “The Nuremberg Code (1947),” 433; Robert Levine, “Informed Consent: Some Challenges to the Universal Validity of the Western Model,” 143; Paul Root Wolpe and Jon F. Merz, “Hospital ERs on Front Line in Informed-Consent Debate,” 127.

  60. 60.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 411.

  61. 61.

    Albert Jonsen, The Birth of Bioethics, 134–137.

  62. 62.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 219; Tom Beauchamp, “Informed Consent,” 188.

  63. 63.

    Charles McCarthy, “The Evolving Story of Justice in Federal Research Policy,” 13.

  64. 64.

    Ulf Schmidt, “Cold War at Porton Down: Informed Consent in Britain’s Biological and Chemical Warfare Experiments,” 371–372.

  65. 65.

    Charles McCarthy, “The Evolving Story of Justice in Federal Research Policy,” 13.

  66. 66.

    David J. Rothman and Sheila M. Rothman, “The Willowbrook Hepatitis Studies,” 750–752.

  67. 67.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 428–429; Albert Jonsen, The Birth of Bioethics, 153–154.

  68. 68.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 376–377.

  69. 69.

    Albert Jonsen, The Birth of Bioethics, 141–142.

  70. 70.

    Tom Beauchamp, “Informed Consent,” 189; Barron H. Lerner, “Sins of Omission- Cancer Research without Informed Consent,” 628–629.

  71. 71.

    John D. Arras, “The Jewish Chronic Disease Hospital Case,” 744.

  72. 72.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 377–379.

  73. 73.

    Barron H. Lerner, “Sins of Omission- Cancer Research without Informed Consent,” 629.

  74. 74.

    Jose Miola, “The Need for Informed Consent: Lessons from the Ancient Greeks,” 157; Paul Root Wolpe and Jon F. Merz, “Hospital ERs on Front Line in Informed-Consent Debate,” 128.

  75. 75.

    Tom Beauchamp and LeRoy Walters eds., Contemporary Issues in Bioethics, 431.

  76. 76.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 252–253; Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 86.

  77. 77.

    Albert Jonsen, The Birth of Bioethics, 136; Nigel Cameron, The New Medicine: Life and Death After Hippocrates, 112.

  78. 78.

    Charles McCarthy, “The Evolving Story of Justice in Federal Research Policy,” 18–20; Albert Jonsen, The Birth of Bioethics, 142–143; Paul Root Wolpe and Jon F. Merz, “Hospital ERs on Front Line in Informed-Consent Debate,” 128.

  79. 79.

    Dale Whittington, “Ethical Issues with Contingent Valuation Surveys in Developing Countries: A Note on Informed Consent and Other Concerns,” 507; Kenneth Getz and Deborah Borfitz, Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials, 106.

  80. 80.

    M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2.

  81. 81.

    Jeffrey Kahn, “Informed Consent in the Context of Communities,” 918.

  82. 82.

    Charles McCarthy, “The Evolving Story of Justice in Federal Research Policy,” 21; Patricia King, “Race, Justice, and Research,” 89.

  83. 83.

    Albert Jonsen, The Birth of Bioethics, 147–148.

  84. 84.

    Albert Jonsen, The Birth of Bioethics, 147–148; Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 226.

  85. 85.

    Allan M. Brandt, “Racism and Research: The Case of the Tuskegee Syphilis Study,” 758.

  86. 86.

    Tom Beauchamp, “Informed Consent,” 189; Dale Whittington, “Ethical Issues with Contingent Valuation Surveys in Developing Countries: A Note on Informed Consent and Other Concerns,” 508.

  87. 87.

    Albert Jonsen, The Birth of Bioethics, 147–148; Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 226; Allan M. Brandt, “Racism and Research: The Case of the Tuskegee Syphilis Study,” 762.

  88. 88.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 59; Janet Dolgin and Lois Shepherd, Bioethics and the Law, 6; Robert Levine, “Informed Consent: Some Challenges to the Universal Validity of the Western Model,” 143–144.

  89. 89.

    Albert Jonsen, The Birth of Bioethics, 136, 151–157; Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 268–269.

  90. 90.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 96.

  91. 91.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 6, 439; Tom Beauchamp, Standing on Principles, 3–4.

  92. 92.

    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 765–766; Kenneth Getz and Deborah Borfitz, Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials, 103.

  93. 93.

    Benjamin Freedman, Abraham Fuks, and Charles Weijer, “In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children,” 829; Paul Root Wolpe and Jon F. Merz, “Hospital ERs on Front Line in Informed-Consent Debate,” 128; Misha Angrist, “Eyes Wide Open: The Personal Genome Project, Citizen Science and Veracity in Informed Consent,” 691.

  94. 94.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 82–83, 86.

  95. 95.

    Advisory Committee on Human Radiation Experiments, “Final Report: Executive Summary (1995),” 479; Charles McCarthy, “The Evolving Story of Justice in Federal Research Policy,” 27.

  96. 96.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 83–84.

  97. 97.

    Advisory Committee on Human Radiation Experiments, “Final Report: Executive Summary (1995),” 482; Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 226, 232–233; Albert Jonsen, The Birth of Bioethics, 139.

  98. 98.

    William J. Clinton, “In Apology for the Study Done in Tuskegee,” 402–403.

  99. 99.

    Patricia King, “Race, Justice, and Research,” 101.

  100. 100.

    Andrew Thompson and Norman J. Temple eds., Ethics, Medical Research, and Medicine: Commercialism versus Environmentalism and Social Justice, 158–160.

  101. 101.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 233–235; Kenneth Getz and Deborah Borfitz, Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials, 144.

  102. 102.

    Paul Farmer and Nicole Gastineau Campos, “New Malaise: Bioethics and Human Rights in the Global Era,” 294.

  103. 103.

    Alex John London, “Children and “Minimal Risk” Research: The Kennedy-Krieger Lead Paint Study,” 811–812; David Buchanan and Franklin G. Miller, “Justice in Research on Human Subjects,” 386–387.

  104. 104.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 233–235.

  105. 105.

    Alex John London, “Children and “Minimal Risk” Research: The Kennedy-Krieger Lead Paint Study,” 813.

  106. 106.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 65–66, 68.

  107. 107.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 58, 376, 382.

  108. 108.

    Laura Weiss Roberts, “Informed Consent and the Capacity for Voluntarism,” 708–709.

  109. 109.

    Susan Marr, “Protect Your Practice: Informed Consent,” 180.

  110. 110.

    Tom Beauchamp, “Informed Consent,” 185–186; The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 767; Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 84; Bernard Gert, Charles Culver, and K. Clouser, Bioethics: A Systematic Approach, 213; Debbie Schachter, Sukirtha Tharmalingam, and Irwin Kleinman, “Informed Consent and Stimulant Medication: Adolescents’ and Parents’ Ability to Understand Information about Benefits and Risks of Stimulant Medication for the Treatment of Attention-Deficient/Hyperactivity Disorder,” 139; Jeffrey Carlisle and Ann T. Neulicht, “The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors,” 25; James Childress, Who Should Decide? Paternalism in Health Care, 134.

  111. 111.

    Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 34.

  112. 112.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 67.

  113. 113.

    Albert Jonsen, The Birth of Bioethics, 131–132, 199; Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 74–75.

  114. 114.

    Jerry Menikoff, Law and Bioethics: An Introduction, 306; Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286.

  115. 115.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 218–219; Franklin Miller and Alan Wertheimer, The Ethics of Consent, 387; Nigel Cameron, The New Medicine, 85.

  116. 116.

    Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 31.

  117. 117.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 378–379.

  118. 118.

    Tom Beauchamp, “Informed Consent,” 190; Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 133–134; Susan Marr, “Protect Your Practice: Informed Consent,” 180.

  119. 119.

    Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 30–31.

  120. 120.

    Albert Jonsen, The Birth of Bioethics, 152–153, 199–200.

  121. 121.

    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 59; Tom Beauchamp, Standing on Principles, 7, 9.

  122. 122.

    Tom Beauchamp, “Informed Consent,” 190.

  123. 123.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 77.

  124. 124.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 89.

  125. 125.

    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 233–235.

  126. 126.

    Jay Katz, “Physicians and Patients: A History of Silence,” 136, 138.

  127. 127.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 70; Clare M. Delany, “Respecting Patient Autonomy and Obtaining Their Informed Consent: Ethical Theory- Missing in Action,” 198–199; Howard Brody, Ethical Decisions in Medicine, 199; Bruce Jennings, “Autonomy,” 77.

  128. 128.

    John O. Beahrs and Thomas G. Gutheil, “Informed Consent in Psychotherapy,” 4–5; Dan Brock, “Patient Competence and Surrogate Decision-Making,” 133; Onora O’Neill, Autonomy and Trust in Bioethics, 28; John Williams, “Consent,” 11; Willard Gaylin and Bruce Jennings, The Perversion of Autonomy, 4; M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 1, 3.

  129. 129.

    Robert Veatch, “Abandoning Informed Consent,” 7, 9.

  130. 130.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 58.

  131. 131.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 16, 24.

  132. 132.

    Roberta M. Berry, “Informed Consent Law, Ethics, and Practice: From Infancy to Reflective Adolescence,” 70; Janet L. Dolgin, “The Legal Development of the Informed Consent Doctrine: Past and Present,” 97.

  133. 133.

    Tom L. Beauchamp, “Informed Consent: Its History, Meaning, and Present Challenges,” 515; Barron H. Lerner, “Beyond Informed Consent: Did Cancer Patients Challenge Their Physicians in the Post-World War II Era?” 508–509.

  134. 134.

    Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 66–67; Jay Katz, “Informed Consent- Must It Remain a Fairy Tale?” 159.

  135. 135.

    Albert Jonsen, The Birth of Bioethics, 354.

  136. 136.

    Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 34, 38.

  137. 137.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 20; Robert Veatch, “Abandoning Informed Consent,” 6; Jeffrey Carlisle and Ann T. Neulicht, “The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors,” 28; Onora O’Neill, Autonomy and Trust in Bioethics, 2, 8,11; George Annas, American Bioethics: Crossing Human Rights and Health Law Boundaries, 95; Tom Beauchamp, “Informed Consent: Its History and Meaning,” 59–60.

  138. 138.

    Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care, 33.

  139. 139.

    Edmund Pellegrino, “Benefit and Harm,” 102.

  140. 140.

    Robert Veatch, “Abandoning Informed Consent,” 7, 9.

  141. 141.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 70–71.

  142. 142.

    Donald Evans, “Autonomy and Individual Responsibility,” 119.

  143. 143.

    Jay Katz, “Physicians and Patients: A History of Silence,” 137.

  144. 144.

    Alan Goldman, “The Refutation of Medical Paternalism,” 68.

  145. 145.

    Susan Marr, “Protect Your Practice: Informed Consent,” 180.

  146. 146.

    Jay Katz, “Physicians and Patients: A History of Silence,” 137–138.

  147. 147.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 305; Willard Gaylin and Bruce Jennings, The Perversion of Autonomy, 4.

  148. 148.

    Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 12.

  149. 149.

    Leon Eisenberg, “The Social Imperatives of Medical Research,” 454.

  150. 150.

    Jay Katz, “Physicians and Patients: A History of Silence,” 136.

  151. 151.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 70.

  152. 152.

    Terrence Ackerman, “Why Doctors Should Intervene,” 75.

  153. 153.

    E. H. Morreim, Balancing Act: The New Medical Ethics of Medicine’s New Economics, 134–135; Roberta M. Berry, “Informed Consent Law, Ethics, and Practice: From Infancy to Reflective Adolescence,” 69–70.

  154. 154.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 69, 102–103.

  155. 155.

    Jay Katz, “Physicians and Patients: A History of Silence,” 138.

  156. 156.

    Wouter Leclercq, Bram J. Keulers, Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1406.

  157. 157.

    Debbie Schachter, Sukirtha Tharmalingam, and Irwin Kleinman, “Informed Consent and Stimulant Medication: Adolescents’ and Parents’ Ability to Understand Information about Benefits and Risks of Stimulant Medication for the Treatment of Attention-Deficient/Hyperactivity Disorder,” 139.

  158. 158.

    Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 10–11; M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2.

  159. 159.

    Hana Osman, “History and Development of the Doctrine of Informed Consent,” 45.

  160. 160.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 100–101; Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 34–35.

  161. 161.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 85–87; Dan Brock, “Patient Competence and Surrogate Decision-Making,” 130; Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 10–11, 43, 51; H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 306.

  162. 162.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 85–87; Dan Brock, “Patient Competence and Surrogate Decision-Making,” 130.

  163. 163.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 85–87.

  164. 164.

    James Childress, Who Should Decide? Paternalism in Health Care, 78; Wouter Leclercq, Bram J. Keulers. Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1410.

  165. 165.

    Donald Evans, “Autonomy and Individual Responsibility,” 119; Jason Karlawish, “Research on Cognitively Impaired Adults,” 599, 602.

  166. 166.

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    M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2.

  170. 170.

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    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 66.

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    Debbie Schachter, Sukirtha Tharmalingam, and Irwin Kleinman, “Informed Consent and Stimulant Medication: Adolescents’ and Parents’ Ability to Understand Information about Benefits and Risks of Stimulant Medication for the Treatment of Attention-Deficient/Hyperactivity Disorder,” 140.

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    Dan Brock, “Patient Competence and Surrogate Decision-Making,” 129.

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    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 768.

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    H.C. Howard, Y. Joly, D. Avard, et al., “Informed Consent in the Context of Pharmacogenomic Research: Ethical Considerations,” 160.

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    Edwin G. Belzer Jr., Lynn McIntryre, Catherine Simpson, et al., “A Method to Increase Informed Consent in School Health Research,” 316.

  181. 181.

    Bill Rogers, “Lawsuit a Reminder to be Certain of Informed Consent,” 42.

  182. 182.

    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 768.

  183. 183.

    Robert M. Arnold and Charles W. Lidz, “Informed Consent: Clinical Aspects of Consent in Health Care,” 9–10.

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    Jay Katz, “Physicians and Patients: A History of Silence,” 136–137; Tom Beauchamp, “Informed Consent,” 205; Onora O’Neill, Autonomy and Trust in Bioethics, 17–18.

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    Robert M. Arnold and Charles W. Lidz, “Informed Consent: Clinical Aspects of Consent in Health Care,” 4.

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    Franklin Miller and Alan Wertheimer, The Ethics of Consent, 377–378.

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    Jerry Menikoff, Law and Bioethics: An Introduction, 186–187; B Sonny Bal and Theodore J. Choma, “What to Disclose? Revisiting Informed Consent,” 1346.

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    Gregory Pence, Medical Ethics: Accounts of the Cases that Shaped and Define Medical Ethics, 233–235.

  202. 202.

    Albert Jonsen, The Birth of Bioethics, 357–358.

  203. 203.

    Wouter Leclercq, Bram J. Keulers, Marc R. M. Scheltinga, et al., “A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions,” 1408.

  204. 204.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 121.

  205. 205.

    Bernard Lo, Resolving Ethical Dilemmas, 22; Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 146.

  206. 206.

    Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 133–134.

  207. 207.

    James Childress, Who Should Decide? Paternalism in Health Care, 134–135; Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 146.

  208. 208.

    Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 134.

  209. 209.

    Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286.

  210. 210.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 146; Bernard Lo, Resolving Ethical Dilemmas, 22.

  211. 211.

    Benjamin Freedman, “Offering Truth: Once Ethical Approach to the Uninformed Cancer Patient,” 113.

  212. 212.

    Bernard Lo, Resolving Ethical Dilemmas, 22.

  213. 213.

    James Childress, Who Should Decide? Paternalism in Health Care, 134–135.

  214. 214.

    Jay Katz, “Physicians and Patients: A History of Silence,” 138.

  215. 215.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 298.

  216. 216.

    Jeffrey Carlisle and Ann T. Neulicht, “The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors,” 26.

  217. 217.

    John O. Beahrs and Thomas G. Gutheil, “Informed Consent in Psychotherapy,” 8.

  218. 218.

    Robert M. Arnold and Charles W. Lidz, “Informed Consent: Clinical Aspects of Consent in Health Care,” 4; Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 133; Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 146; Bernard Gert, Charles Culver, and K. Clouser, Bioethics: A Systematic Approach, 202.

  219. 219.

    M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2.

  220. 220.

    Linda Farber Post, Jeffrey Blustein, Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 41; Bernard Gert, Charles Culver, and K. Clouser, Bioethics: A Systematic Approach, 214–215.

  221. 221.

    H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 299.

  222. 222.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 81; Bernard Gert, Charles Culver, and K. Clouser, Bioethics: A Systematic Approach, 210.

  223. 223.

    Regine Kollek, “Article 6: Consent,” 132–133.

  224. 224.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 84–85; H.C. Howard, Y. Joly, D. Avard, et al., “Informed Consent in the Context of Pharmacogenomic Research: Ethical Considerations,” 157.

  225. 225.

    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 767–768.

  226. 226.

    Laura Weiss Roberts, “Informed Consent and the Capacity for Voluntarism,” 707–709.

  227. 227.

    Janet Dolgin and Lois Shepherd, Bioethics and the Law, 411.

  228. 228.

    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 84–85.

  229. 229.

    Ruth R. Faden and Tom L., Beauchamp, A History and Theory of Informed Consent, 35–39.

  230. 230.

    Amy A. Ernst and Susan Fish, “Exception from Informed Consent: Viewpoint of Institutional Review Boards—Balancing Risks to Subjects, Community Consultation, and Future Directions,” 1050.

  231. 231.

    John Williams, “Consent,” 12; Spottswood W. Robinson, “United States Court of Appeals Canterbury v. Spence,” 134–135.

  232. 232.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 145–146; Hana Osman, “History and Development of the Doctrine of Informed Consent,” 46.

  233. 233.

    Susan Marr, “Protect Your Practice: Informed Consent,” 180.

  234. 234.

    Nancy Press and C. H. Browner, “Risk, Autonomy, and Responsibility: Informed Consent for Prenatal Testing,” S12.

  235. 235.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 316.

  236. 236.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 69–70.

  237. 237.

    Ulrike Felt, Milena D. Bister, Michael Strassnig, et al., “Refusing the Information Paradigm: Informed Consent, Medical Research, and Patient Participation,” 92.

  238. 238.

    Lewis Vaughn, Bioethics: Principles, Issues, and Cases, 144.

  239. 239.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 192.

  240. 240.

    H. Tristram, Engelhardt Jr., The Foundations of Bioethics, 300; Jeffrey Carlisle and Ann T. Neulicht, “The Necessity of Professional Disclosure and Informed Consent for Rehabilitation Counselors,” 25–26.

  241. 241.

    Tom L. Beauchamp, “Informed Consent: Its History, Meaning, and Present Challenges,” 518.

  242. 242.

    Robert Levine, “Informed Consent: Some Challenges to the Universal Validity of the Western Model,” 144.

  243. 243.

    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 299.

  244. 244.

    Albert Jonsen, The Birth of Bioethics, 130–132; Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 78

  245. 245.

    Jerry Menikoff, Law and Bioethics: An Introduction, 306; Alfred Tauber, Patient Autonomy and the Ethics of Responsibility, 75; Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 286.

  246. 246.

    John Kilner, Rebecca Pentz, and Frank Young, eds., Genetic Ethics, 33.

  247. 247.

    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 3.

  248. 248.

    M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2.

  249. 249.

    Albert Jonsen, The Birth of Bioethics, 356.

  250. 250.

    Tom Beauchamp and James Childress, Principles of Biomedical Ethics, 96, 428–430; Albert Jonsen, The Birth of Bioethics, 143, 154–155, 356.

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    Paul Ramsey, The Patient as Person: Explorations in Medical Ethics, 12–13.

  252. 252.

    Richard McCormick, “Proxy Consent in the Experimentation Situation,” 12–13.

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    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 84.

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    Tom Beauchamp, “Informed Consent,” 199.

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    World Medical Association, “Declaration of Helsinki (1996) Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects,” 435.

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    M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 3.

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    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 305–306.

  259. 259.

    Alan Goldman, “The Refutation of Medical Paternalism,” 65; Tom Beauchamp, “Informed Consent,” in, Robert Veatch, Medical Ethics, 200–201.

  260. 260.

    Laura Weiss Roberts, “Informed Consent and the Capacity for Voluntarism,” 709.

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    Debra Pinals and Paul Applebaum, “The History and Current Status of Competence and Informed Consent in Psychiatric Research,” 84.

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    Albert Jonsen, The Birth of Bioethics, 151–152.

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    G. Whitney, “Reproduction Technology for a New Eugenics,” 179.

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    Debora Spar, The Baby Business: How Money, Science, and Politics Drive the Commerce of Conception, 101.

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    Tom Beauchamp and LeRoy Walters, eds., Contemporary Issues in Bioethics, 511–512.

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    Stephen Jay Gould, “Carrie Buck’s Daughter,” 529.

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    Philip Reilly, “Eugenic Sterilization in the United States,” 517–520, 522–524.

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    Albert Jonsen, “A History of Bioethics as Discipline and Discourse,” 7; M. Sara Rosenthal, “Informed Consent in the Nuclear Medicine Setting,” 2; Ruth Macklin, “The Inner Workings of an Ethics Committee: Latest Battle over Jehovah’s Witnesses,” 233.

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  270. 270.

    Willard Gaylin and Bruce Jennings, The Perversion of Autonomy, 144, 149–150.

  271. 271.

    Tom Beauchamp, “Informed Consent,” 200–201.

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    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 309.

  273. 273.

    Council for International Organizations of Medical Sciences (CIOMS) in collaboration with The World Health Organization (WHO), “International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993),” 438.

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    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 309.

  275. 275.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 68.

  276. 276.

    Tom Beauchamp, “Informed Consent,” 200–201.

  277. 277.

    Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 68.

  278. 278.

    Maria Patrao Neves, “Respect for Human Vulnerability and Personal Integrity,” 162; Tom Beauchamp and LeRoy Walters, eds., Contemporary Issues in Bioethics, 511; Cara Dunne and Catherine Warren, “Lethal Autonomy: The Malfunction of the Informed Consent Mechanism within the Context of Prenatal Diagnosis of Genetic Variants,” 165–166; Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 42.

  279. 279.

    James Childress, Who Should Decide? Paternalism in Health Care, 78; Jessica W. Berg, Paul S. Applebaum, Charles W. Lidz, and Lisa S. Parker, Informed Consent: Legal Theory and Clinical Practice, 68.

  280. 280.

    Dan Brock, “Patient Competence and Surrogate Decision-Making,” 128; Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 9.

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    Linda Farber Post, Jeffrey Blustein, and Nancy Neveloff Dubler, Handbook for Health Care Ethics Committees, 42.

  282. 282.

    Dan Brock, “Patient Competence and Surrogate Decision-Making,” 128; Thomas Grisso and Paul S. Applebaum, Assessing Competence to Consent to Treatment, 9.

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    Neil Sharpe and Ronald Carter, Genetic Testing: Care, Consent, and Liability, 131.

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    Council for International Organizations of Medical Sciences (CIOMS) in collaboration with The World Health Organization (WHO), “International Ethical Guidelines for Biomedical Research Involving Human Subjects (1993),” 438.

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    The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” 768.

  286. 286.

    Jonathan Moreno, “Convenient and Captive Populations,” 111.

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    Ruth Macklin, “Justice in International Research,” 134.

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    Jeffrey Kahn, “Informed Consent in the Context of Communities,” 919; Laura Weiss Roberts, “Informed Consent and the Capacity for Voluntarism,” 705–706; Amy A. Ernst and Susan Fish, “Exception from Informed Consent: Viewpoint of Institutional Review Boards—Balancing Risks to Subjects, Community Consultation, and Future Directions,” 1052.

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    James Ross, Elizabeth Sundberg, and Katherine Flint, “Informed Consent in School Health Research: Why, How, and Making it Easy,” 172.

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    Tom Beauchamp, “Informed Consent,” 201–202.

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    Neil C. Manson and Onora O’Neill, Rethinking Informed Consent in Bioethics, 82.

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    Tom Beauchamp and James Childress, Principles of Biomedical Ethics 96; Albert Jonsen, The Birth of Bioethics, 147.

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    H. Tristram Engelhardt Jr., The Foundations of Bioethics, 330–331.

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    Jessica Minor

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Minor, J. (2015). The History and Components of Informed Consent. In: Informed Consent in Predictive Genetic Testing. Springer, Cham. https://doi.org/10.1007/978-3-319-17416-7_3

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