Organ Donation,Brain Death and the Family: Valid Informed Consent

WBNS-10TV Columbus, “Columbus Man's Organs Donated despite Mom's Plea,” July 11, 2013, available at <http://www.10tv.com/content/stories/2013/07/11/columbus-new-father-dies-after-hit-skip-crash.html> (last visited April 27, 2015).

The Uniform Anatomical Gift Act stipulates that a person's decision to donate as communicated on a driver's license or through a donor registry can be revoked only by the person and not by his or her family (see National Conference of Commissioners on Uniform State Laws, UAGA, 2006, section 8). Families may not refuse to donate the organs of a decedent who had agreed to be a donor by signing a driver's license or registering in a state donor registry. The National Conference of Commissioners of Uniform State Laws, which drafted the UAGA, explained that “Section 8 is designed to state firmly the rule that a donor's autonomous decision regarding the making of an anatomical gift is to be honored and implemented and is not subject to change by others. Section 8 not only continues the policy of making lifetime donations irrevocable but also is restated to take away from families the power, right, or authority to consent to, amend, or revoke donations made by donors during their lifetimes.” See Anatomical Gift Act (2006), available at <http://www.uniformlaws.org/Act.aspx?title=Anatomical%20Gift%20Act%20%282006%29> (last visited April 27, 2015). NATCO, a professional organization for transplant professionals, published a position statement supporting the position that families should not be allowed to refuse donation when a person had signed a driver's license or was listed in a registry (First Person Consent, 2009, available at <www.natco1.org/Advocacy/files/First%20Person%20Consent.pdf> (last visited April 27, 2015)). While at one time OPOs hesitated or refused to violate a family's wishes, there has been a significant shift in the force of statements and policies advocating for taking this role away from the family.

See WBNS-10TV Columbus, supra note 1.

Siminoff L. A. Burant C. Youngner S. J. , “Death and Organ Procurement: Public Benefits and Attitudes,” Social Science and Medicine 59, no. 3 (2004): 2325–2334.

See UAGA supra note 2; National Conference of Commissioners on Uniform State Law, “Enactment Status Map,” available at <http://uniformlaws.org/Act.aspx?title=Anatomical+Gift+Act+%282006%29> (last visited April 27, 2015).

Board of Health Sciences Policy, Committee on Increasing Rates of Organ Donation, Childress J. Liverman C. , eds., Organ Donation: Opportunities for Action (Washington D.C.: National Academies Press, 2006).

OPTN/UNOS Organ Procurement Organization Committee, Report to the Board of Directors, June 23–24, Richmond, Virginia, available at <http://optn.transplant.hrsa.gov/converge/CommitteeReports/board_main_HistocompatibilityCommittee_7_2_2014_15_51.pdf> (last visited April 27, 2015).

Berg J. Appelbaum P. Parker L. Lidz C. , Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2001); Faden R. Beauchamp T. L. , A History and Theory of Informed Consent (New York: Oxford University Press, 1986).

Hall D. E. Prochazka A. V. Fink A. S. , “Informed Consent for Clinical Treatment,” Canadian Medical Association Journal 184, no. 5 (2012): 533–540.

See Hall , supra note 9.

See Berg , supra note 8.

Woien S. Rady M. Verheijde J. McGregor J. , “Organ Procurement Organizations Internet Enrollment for Organ Donation: Abandoning Informed Consent,” BMC Medical Ethics 7, no. 14 (2006): 14.

See NCCUSL, supra note 2; Iltis A. S. Rie M. Wall A. , “Organ Donation, Patients' Rights, and Medical Responsibilities at the End of Life,” Critical Care Medicine 37, no. 1 (2009): 310–315.

See Faden Beauchamp , supra note 8, at 35–36.

Bernat J. , Ethical Issues in Neurology (Philadelphia: Lippincott Williams & Wilkins, 2008): At 272.

See Iltis Rie Wall , supra note 13.

Childress J. F. Liverman C. T. , eds., Organ Donation: Opportunities for Action (Washington, D.C.: National Academies Press, 2006): At 182.

See ltis, Rie Wall , supra note 13.

See Childress Liverman supra note 17, at 88 (emphasis added).

Anecdotally, I have found that very few “ordinary” people, such as undergraduate students and friends who are not involved in health care, know what the organ donation signature on their driver's license entails.

See Childress Liverman , supra note 17, at 112 (emphasis added).

Beauchamp T. L. , “Informed Consent: Its History, Meaning, and Present Challenges,” Cambridge Quarterly of Healthcare Ethics 20, no. 4 (2011): 515–523.

Beauchamp T. Childress J. , Principles of Biomedical Ethics (New York: Oxford University Press, 2009): At Chap. 4.

See Faden Beauchamp , supra note 8, at 33 n.2.

See Hall , supra note 9.

For a discussion of different types of consent, see Whitney S. N. McGuire A. L. McCullough L. G. , “A Typology of Shared Decision Making, Informed Consent, and Simple Consent,” Annals of Internal Medicine 140, no. 1 (2004): 54–60. For a discussion of varying degrees of capacity required for consent, see Drane J. F. , “Competency to Give an Informed Consent. A Model for Making Clinical Assessments,” JAMA 252, no. 7 (1984): 925–927.

Engelhardt H. T. Jr. , The Foundations of Bioethics (New York: Oxford University Press, 1996).

Schloendorff v. Society of New York Hospital , 211 N.Y. 125, 105 N.E. 92 (1914).

See Berg , supra note 8.

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

Nair-Collins M. , “Brain Death, Paternalism, and the Language of ‘Death,”’ Kennedy Institute of Ethics Journal 23, no. 1 (2013): 53–104.

See Farragher R. Laffey J. , “Maternal Brain Death and Somatic Support,” Neurocritical Care 3, no. 2 (2005): 99–106; Dillon W. Lee R. Tronolone M. , “Life Support and Maternal Brain Death during Pregnancy,” JAMA 248, no. 9 (1982): 1089–1091; Field D. Gates E. Creasy R. Jonsen A. Laros A. , “Maternal Brain Death during Pregnancy: Medical and Ethical Issues,” JAMA 260, no. 6 (1988): 816–820; Bernstein I. Watson M. Simmons G. Catalano P. Davis G. Collins R. , “Maternal Brain Death and Prolonged Fetal Survival,” Obstetrics & Gynecology 74, no. 3 pt. 2 (1989): 434–437; Nuutinen L. Alahuta S. Heikkinen J. , “Nutrition during Ten-Week Life Support with Successful Fetal Outcome in a Case with Fatal Maternal Brain Damage,” Journal of Parenteral and Enteral Nutrition 13, no. 4 (1989): 432–435.

Organ Donation: Saying Goodbye before Organ Donation Surgery, 2008, Experiences of Donor Families, available at <http://www.healthtalkonline.org/Organ_donation_and_transplant/organ_donation/Topic/4113> (last visited April 27, 2015); Sque M. Long T. Payne S. Allardyce D. , “Why Relatives Do Not Donate Organs for Transplants” ‘Sacrifice’ or ‘Gift of Life’?” Journal of Advanced Nursing 61, no. 2 (2008): 134–144.

See Youngner S. J. , “Some Must Die,” in Youngner S. J. Fox R. O'Connell L. J. , eds., Organ Transplantation: Meanings and Realities (Madison: University of Wisconsin, 1996): At 50; Lock M. , “Living Cadavers and the Calculation of Death,” Body and Society 10, no. 2–3 (2004): 135–152.

For example, see Holtkamp S. , Wrapped in Mourning: The Gift of Life and Organ Donor Family Trauma (London: Brunner Routledge, 2001): 6–7, 20–27, 32–51, 60–69.

See Woien , supra note 12.

Carolina Donor Services, “Frequently Asked Questions,” available at <http://carolinadonorservices.org/frequently-asked-questions> (last visited April 27, 2015).

Vincent A. Logan L. , “Consent for Organ Donation,” British Journal of Anesthesia 108, S1 (2012): i80–i87; Long T. Sque M. Addington-Hall J. , “What Does a Diagnosis of Brain Death Mean to Family Members Approached about Organ Donation? A Review of the Literature,” Progress in Transplantation 18, no. 2 (2008): 118–125; Pearson I. Y. Baseley P. Spencer-Plane T. Chapman J. R. Robertson P. , “A Survey of Families of Brain Dead Patients: Their Experiences, Attitudes to Organ Donation and Transplantation,” Anaesthesia and Intensive Care 23, no. 1 (1995): 88–95; Siminoff L. A. Mercer M. B. Arnold R. , “Families Understanding of Brain Death,” Progress in Transplantation 13, no. 3 (2003): 218–224; see Siminoff , supra note 4.

See OrganDonor.gov, quoted in Nair-Collins, supra note 31.

See Nair-Collins , supra note 31.

UNOS, “Theological Perspectives,” available at <http://www.unos.org/donation/index.php?topic=fact_sheet_9> (last visited April 28, 2015) quoted in Nair-Collins, supra note 31.

See Nair-Collins , supra note 31.

See, for example, Shewmon D. , “The Brain and Somatic Integration: Insights into the Standard Rationale for Equating ‘Brain Death’ with Death,” Journal of Medicine and Philosophy 26, no. 5 (2001): 457–478; Shewmon D. , “Brain Death: Can It Be Resuscitated?” Issues in Law and Medicine 25, no. 1 (2009): 3–14; Bernat J. , “Refinements in the Definition and Criterion of Death,” in Youngner S. Arnold R. Schapiro R. , eds., The Definition of Death: Contemporary Controversies (Baltimore: Johns Hopkins University Press, 1999): At 83–92; Halevy A. Brody B. , “Brain Death: Reconciling Definitions, Criteria, and Tests,” Annals of Internal Medicine 119, no. 6 (1993): 519–525; Brody B. , “How Much of the Brain Must be Dead?” in Youngner S. Arnold R. Schapiro R. , eds., The Definition of Death: Contemporary Controversies (Baltimore: Johns Hopkins University Press, 1999): At 71–82.

Taylor R. , “Reexamining the Definition and Criterion of Death,” Seminars in Neurology 17, no. 3 (1997): 265–270; Shah S. Truog R. Miller F. , “Death and Legal Fictions,” Journal of Medical Ethics 37, no. 12 (2011): 719–722; Shah S. Miller F. , “Can We Handle the Truth? Legal Fictions in the Determination of Death,” American Journal of Law and Medicine 36, no. 4 (2010): 540–585.

Youngner S. Arnold S. , “Philosophical Debates about the Definition of Death: Who Cares?” Journal of Medicine and Philosophy 26, no. 5 (2001): 527–537; Youngner S. , “Defining Death: A Superficial and Fragile Consensus,” Archives of Neurology 49, no. 5 (1992): 570–572.

For a discussion of the nature of these conflicts, see Nair-Collins , supra note 31.

Some reject the general definitions-criteria-test framework developed by Capron A. Kass L. R. , “A Statutory Definition of the Standards for Determing Human Death,” University of Pennsylvania Law Review 121, no. 1 (1972): 87–118 and Bernat J. L. Culver C. M. Gert B. , “On the Definition and Criterion of Death,” Annals of Internal Medicine 94, no. 3 (1981): 389–94. For further discussion of this, see Nair-Collins , supra note 31.

See, e.g., Veatch R. , “The Impending Collapse of the Whole-Brain Definition of Death,” Hastings Center Report 23, no. 4 (1993): 18–24; Veatch R. , “The Death of Whole-Brain Death: The Plague of the Disaggregators, Somaticists, and Mentalists,” Journal of Medicine and Philosophy 30, no. 4 (2005): 353–378.

Bernat J. , “The Whole-Brain Concept of Death Remains Optimum Public Policy,” Journal of Law, Medicine & Ethics 34, no. 1 (2006): 35–43.

Uniform Determination of Death Act (1980, at 5), available at <http://www.uniformlaws.org/shared/docs/determinationofdeath/udda80.pdf> (last visited April 28, 2015).

As set forth in President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Defining Death: Medical, Legal, and Ethical Problems in Medicine and Biomedical and Behavioral Research (Washington, D.C.: Government Printing Office, 1981a); President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Biobehavioral Research, “Guidelines for the Determination of Death. Report of the Medical Consultants on the Diagnosis of Death to the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research,” JAMA 246, no. 19 (1981b): 2184–2186; Wijdicks E. , “Determining brain death in adults,” Neurology 45, no. 19 (1995): 1003–1011; and Wijdicks E. , “Quality Standard Subcommittee of American Academy of Neurology: Practice Parameters for Determining Brain Death in Adults,” American Academy of Neurology 45, no. 5 (1995): 1012–1014.

See Halevy Brody , supra note 44.

Id., at 520; citing Schrader H. Krogness K. Aakvaag A. Sortland O. Purvis K. , “Changes of Pituitary Hormones in Brain Death,” Acta Neurochirirgica 52, no. 3 (1980): 239–248; Mollaret P. Goulon M. , “Le Coma Depasse,” Revue Neurologique 101 (1959): 3–15; Grenvik A. Powner D. Snyder J. Jastremski M. Babcok R. Loughhead M. , “Cessation of Therapy in Terminal Illness and Brain Death,” Critical Care Medicine 6, no. 4 (1978): 284–291; Outwater K. J. Rockoff M. A. , “Diabetes Insipidus Accompanying Brain Death in Children,” Neurology 34, no. 9 (1984): 1243–1246; Fiser D. Jimenez J. F. Wrape V. Woody R. , “Diabetes Insipidus in Children with Brain Death,” Critical Care Medicine 15, no. 6 (1987): 551–553; Hohenegger M. Vermes M. Mauritz W. Redl G. Sporn P. Eiselsberg P. , “Serum Vasopressin (avp) Levels in Polyuric Brain-Dead Organ Donors,” European Archives of Psychiatry and Neurological Sciences 239, no. 4 (1990): 267–269; Arita K. Uozumi T. Oki S. Ohtani M. Taguchi H. Morio M. , “[Hypothalamic Pituitary Function in Brain Death Patients – from Blook Pituitary Hormones and Hypothalamic Hormones],” No Shinkei Geka 16, no. 10 (1988): 1163–1171.

See Halevy Brody , supra note 44, at 521, citing Rodin E. Tahir S. Austin D. Andaya L. , “Brainstem Death,” Clinical Electroeacephalogy 16, no. 2 (1985): 63–71; Deliyannakis I. Ioannou F. Davaroukas A. , “Brainstem Death with Persistence of Bioelectric Activity of the Cerebral Hemispheres,” Clinical Electroeacephalogy 6, no. 2 (1975): 75–79; Grigg M. Kelly M. Celesia G. , “Electroencephalographic Activity after Brain Death,” Archives in Neurology 44, no. 9 (1987): 948–954.

See Halevy Brody supra note 44, at 521, Barelli A. Della Corte F. Calimici R. Sandroni C. Proietti R. Magalini S. , “Do Brainstem Auditory Evoked Potentials Detect the Actual Cessation of Cerebral Functions in Brain Dead Patients?” Critical Care Medicine 18, no. 3 (1990): 322–323; Ferbert A. Buchner H. Ringelstein E. Hacke W. , “Isolated Brainstem Death,” Electroencephalogy Clinical Neruophysiology 65 (1986): 157–60.

Bernat J. , “How Much of the Brain Must Die in Brain Death?” Journal of Clinical Ethics 3, no. 1 (1992): 21–26.

See Bernat supra note 44, at 86.

See Brody , supra note 44, at 74.

United States President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, 1981a and 1981b, supra note 52.

See Nair-Collins , supra note 31.

Shewmon D. , “Chronic “Brain Death:” Meta-Analysis and Conceptual Consequences,” Neurology 51, no. 6 (1998): 1538–1545; Shewmon D. , “Somatic Pathophysiological Equivalence and Implications for the Integrative-Unity Rationale,” Spinal Cord 37, no. 5 (1999): 313–324.

See Brody , supra note 44, at 75; Verheijde J. Rady M. McGregor J. , “Brain Death, States of Impaired Consciousness, and Physician-Assisted Death for End-of-Life Organ Donation,” Medicine, Health Care and Philosophy 12, no. 4 (2009): 409–421.

See, for example, Falk V. Taggart D. , “NICE Guidance for Off-Pump CABG: Turn Of the Pump” Heart 97, no. 21: 1731–1733.; Hannan E. Wu C. Smith C. Higgins R. Carlson R. Culliford A. Gold J. Jones R. , “Off-Pump versus On-Pump Coronary Artery Bypass Graft Surgery: Differences in Short-Term Outcomes and in Long-Term Mortality and Need for Subsequent Revascularization,” Circulation 116, no. 10 (2007): 1145–1152; Takagi H. Tanabashi T. Kawai N. Kato T. Umemoto T. , “Off-Pump Coronary Artery Bypass Sacrifices Graft Patency: Meta-Analysis of Randomized Trials,” Journal of Thoracic Cardiovascular Surgery 133, no. 1 (2007): e2–e3; Hueb W. Lopes N. Pepeira A. Hueb A. Soares P. Favarato D. Ramires J. A. , “Five-Year Follow-Up of a Randomized Comparison between Off-Pump and On-Pump Stable Multi-vessel Coronary Artery Bypass Grafting: The MASS III Trial,” Circulation 122, no. 11 Supp. (2010): S48–S52.

Rivkees S. , “Pediatric Graves' Disease: Controversies in Management,” Hormone Research in Pediatrics 74, no. 5 (2010): 305–311. Grave's disease is hyperthyroidism caused by the immune system releasing antibodies that the body recognizes as thyroid stimulating hormone (TSH) and hence the body responds by making the thyroid work harder.

Id., at 309.

Bosworth T. , “Experts Disagree on Role of Transplant in Myeloma,” Clinical Oncology News , 2013, available at <http://www.clinicaloncology.com/ViewArticle.aspx?d=Hematologic+Malignancies&d_id=149&i=August2013&i_id=988&a_id=23817> (last visited July 16, 2014; login required).

On concerns about validity of testing used to establish death using neurological criteria, see Verheijde supra note 63; Joffe A. , “The Neurological Determination of Death: What Does It Really Mean?” Issues in Law and Medicine 23, no. 2 (2007): 119–140; Karakatsanis K. G. , “‘Brain Death”’ Should it Be Reconsidered?” Spinal Cord 46, no. 6 (2008): 396–401. On concerns about equating brain death with death, see Shewmon A. , “‘Brainstem Death,’ ‘Brain Death’ and Death: A Critical Re-Evaluation of the Purported Equivalence,” Issues in Law and Medicine 14, no. 2 (1998): 125–145.

See Holtkamp , supra note 35, at 23; citing Hill D. Munglani R. Sapsford D. , “Haemodynamic Responses to Surgery in Brain-Dead Organ Donors,” Anaesthesia 49, no. 9 (1994): 835–836; Pennefather S. Dark J. Bullock R. , “Hemodynamic Responses to Surgery in Brain-Dead Organ Donors,” Anaesthesia 48, no. 12 (1993): 1034–1038; Wetzel R. Setzer N. Stiff J. Rogers M. , “Hemodynamic Responses in Brain Dead Organ Donor Patients,” Anesthesia & Analgesia 64, no. 2 (1985): 125–128; McCullagh P. , ed., Brain Dead, Brain Absent, Brain Donors: Human Subjects or Human Objects (Hoboken: Wiley, 1993): At 46.

See Wetzel , supra note 70, at 127.

See Holtkamp , supra note 35, at 24.

See, e.g., Whyte K. Selinger E. Caplan A. Sadowski J. , “Nudge, Nudge or Shove, Shove – The Right Way for Nudges to Increase the Supply of Donated Cadaver Organs,” American Journal of Bioethics 12, no. 2 (2012): 32–39; Shaw D. Elger B. , “Persuading Bereaved Familities to Permit Organ Donation,” Intensive Care Medicine 40, no. 1 (2014): 96–98.

There are other standards for determining what ought to be disclosed. These include the professional standard and the subjective standard. The professional standard would not require disclosure because, since most physicians do not disclose the controversy, the professional standard is non-disclosure. This approach suffers from a serious weakness, namely that it allows physicians to withhold information that patients might reasonably want simply because the vast majority of physicians choose not to disclose it. The subjective standard would require disclosure for any patient who would want the information. The subjective standard requires clinicians to be able to determine what every individual would care to know.

See Woein , supra note 12, at 5.

Chouhan P. Draper H. , “Modified Mandated Choice for Organ Procurement,” Journal of Medical Ethics 29, no. 3 (2003): 157–162; Shaw Elger , supra note 73.

For further discussion regarding brain death doubts, see DuBois J. M. , “The Ethics of Creating and Responding to Doubts about Death Criteria,” Journal of Medicine and Philosophy 35, no. 3 (2010): 365–380. For a critique of this view, see Potts M. Verheijde J. L. Rady M. Y. Evans D. W. , “The Ethics of Limiting Informed Debate: Censorship of Selected Medical Publications in the Interest of Organ Transplant,” Journal of Medicine and Philosophy 38, no. 6 (2013): 625–638.

See Choie E.-K. Fredland V. Zachodni C. Lammers J. E. Bledsoe P. Helft P. R. , “Brain Death Revisited: The Case for a National Standard,” Journal of Law, Medicine and Ethics 36, no. 4 (2008): 824–836; Truog R. , “Brain Death – Too Flawed to Endure, Too Ingrained to Abandon,” Journal of Law, Medicine & Ethics 35, no. 2 (2007): 273–281; Joffe A. Anton N. Duff J. Decaen A. , “A Survey of American Neurologists about Brain Death: Understanding the Conceptual Basis and Diagnostic Tests for Brain Death,” Annals of Intensive Care 2, no. 4 (2012); Greer D. Varelas P. Haque S. Wijdicks E. , “Variability of Brain Death Determination Guidelines in Leading Us Neurologic Institutions,” Neurology 70, no. 4 (2008): 284–289.

See Lock , supra note 34.

See Youngner S. J. Landefeld C. S. Coulton C. J. Juknialis B. W. Leary M. , “‘Brain Death’ and Organ Retrieval. A Cross-Sectional Survey of Knowledge and Concepts among Health Professionals,” Journal of the American Medical Association 261, no. 15 (1989): 2205–2210.

See Holtkamp , supra note 35, at 45 and 64.

Id., at 7.

DuBois J. M. Waterman A. Iltis A. S. , “Is Rapid Organ Recovery a Good Idea? An Exploratory Study of the Public's Knowledge and Attitude,” American Journal of Transplantation 9, no. 10 (2009): 2392–2399.

See <http://www.readability-score.com/> (last visited April 28, 2015).

Rodrigue J. Cornell D. Howerd R. , “The Instability of Organ Donation Decisions by Next-of-Kin and Factors that Predict it,” American Journal of Transplant 8, no. 12 (2008): 2661–2667; Bellali T. Papadatou D. , “Parental Grief Following the Brain Death of a Child: Does Consent or Refusal to Organ Donation Affect Their Grief?” Death Studies 30, no. 10 (2006): 883–917; Burroughs T. E. Hong B. A. Kappel D. F. Freedman B. K. , “The Stability of Family Decisions to Consent or Refuse Organ Donation: Would You Do It Again?” Psychosomatic Medicine 60, no. 2 (1998): 156–162.

Truog R. , “Consent for Organ Donation – Balancing Conflicting Ethical Obligations,” New England Journal of Medicine 358, no. 12 (2008): 1209–1210.

See Truog , supra note 86.

Citing Zink S. Wertlieb S. , “A Study of the Presumptive Approach to Consent for Organ Donation: A New Solution to an Old Problem,” Critical Care Nurse 26, no. 2 (2006): 129–136.

See Truog , supra note 86.

See Oregon Health Plan, available at <http://www.oregon.gov/OHA/healthplan/Pages/index.aspx> (last visited April 28, 2015); Thorne J. I. , “Oregon Plan Approach,” in Strosber M. A. Wiener J. M. Baker R. Fein A. I. D. , eds., Rationing America's Medical Care: The Oregon Plan and Beyond (Washington, D. C.: Brookings Institution, 1992): At 24–36; Bodenheimer T. B. , “The Oregon Health Plan – Lessons for the Nation, First of Two Parts,” New England Journal of Medicine 337, no. 9 (1997): 651–655.

DuBois J. M. Anderson E. , “Attitudes toward Death Criteria and Organ Donation among Healthcare Personnel and the General Public,” Progress in Transplantation 16, no. 1 (2006): 65–73.

45CFR46.116.a.4

45CFR46.116.a.8

See Faden Beauchamp , supra note 8 at 258–261; For further discussion of manipulation, see Engelhardt, supra note 27, p. 308–309; see Beauchamp and Childress, supra note 23, at 133–135.

O'Neill O. , “Some Limits of Informed Consent,” Journal of Medical Ethics 29, no. 1 (2003): 4–7.

See DuBois , supra note 83.