Hostname: page-component-745bb68f8f-grxwn Total loading time: 0 Render date: 2025-01-11T23:03:03.221Z Has data issue: false hasContentIssue false
  • English
  • Français

Personalized Disclosure by Information-on-Demand: Attending to Patients' Needs in the Informed Consent Process

Published online by Cambridge University Press:  01 January 2021

Gil Siegal ,
Richard J. Bonnie  and
Paul S. Appelbaum
Get access Rights & Permissions [Opens in a new window]

Extract

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.

However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully.

Type
Independent
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 2 , Summer 2012 , pp. 359 - 367
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

For a general overview of informed consent theory and practices, see Berg, J. W. Appelbaum, P. S. Lidz, C. W. Parker, L. S., Informed Consent: Legal Theory and Clinical Practice (New York: Oxford University Press, 2001); Faden, R. R. Beauchamp, T. L. King, N. M. P., eds., A History and Theory of Informed Consent (New York: Oxford University Press, 1986).Google Scholar
Canterbury v. Spence, 464 F.2d 772, 781 (D.C. Cir. 1972). But see Boozang, K. M., “The Therapeutic Placebo: The Case for Patient Deception,” Florida Law Review 54, (2002): 687–746.Google Scholar
Levinson, W. Roter, D. L. Mullooly, J. P. Dull, V. T. Frankel, R. M., “Physician-Patient Communication – The Relationship with Malpractice Claims among Primary Care Physicians and Surgeons,” JAMA 277, no. 7 (1997): 553–559.CrossRefGoogle Scholar
Kutner, M. Greenberg, E. Jin, Y. Paulsen, C., “The Health Literacy of America's Adults: Results from the 2003 National Assessment of Adult Literacy,” Washington, D.C., National Center for Education Statistics, U.S. Department of Education, 2006; Williams, M.V. Parker, R. M. Baker, D. W. Parikh, N. S. Pitkin, K. Coates, W. C. Nurss, J. R., “Inadequate Functional Health Literacy among Patients at Two Public Hospitals,” JAMA 274, no. 21 (1995): 1677–1682; Peters, E. Vastfjall, D. Slovic, P. Mertz, C. K. Mazzocco, K. Dickert, S., “Numeracy and Decision Making,” Psychological Sciences 17, no. 3 (2006): 407–413.Google Scholar
Powers, B. J. Trinh, J. V. Bosworth, H. B., “Can This Patient Read and Understand Written Health Information?” JAMA 304, no. 1 (2010): 76–84; Hall, M. A. Schneider, C. E., “How Should Physicians Involve Patients in Medical Decisions?” JAMA 283, no. 18 (2000): 2390–2391; Meisel, A. Roth, L. H., “Toward an Informed Discussion of Informed Consent: A Review and Critique of the Empirical Studies,” Arizona Law Review 25 (1983): 265–346.CrossRefGoogle Scholar
McNeil, B. Pauker, S. Sox, H. Jr. Tversky, A., “On the Elicitation of Preferences for Alternative Therapies,” New England Journal of Medicine 306, no. 21 (1982): 1259–1262.CrossRefGoogle Scholar
Epstein, R. M. Peters, E., “Beyond Information: Exploring Patients' Preferences,” JAMA 302, no. 2 (2009): 195–197; Siegal, G. Siegal, N. Bonnie, R. J., “An Account of Collective Action Problems in Public Health,” American Journal of Public Health 99, no. 12 (2009): 1583–1587.CrossRefGoogle Scholar
Rothberg, M. B. Sivalingam, S. K. Ashraf, J. Visintainer, P. Joelson, J. Kleppel, R. et al. , “Patients' and Cardiologists' Perceptions of the benefits of Percutaneous Coronary Intervention for Stable Coronary Disease,” Annals of Internal Medicine 153, no. 1 (2010): 307–313.CrossRefGoogle Scholar
Barr, J. K. Steinberg, M. K., “A Physician Role Typology: Colleague and Client Dependence in an HMO,” Social Science & Medicine 20, no. 3 (1985): 253–261.CrossRefGoogle Scholar
For a tabulation of states' informed consent laws, see King, J. S. Moulton, B. W., “Rethinking Informed Consent: The Case for Shared Medical Decision-Making,” American Journal of Law & Medicine 32, no. 4 (2006): 429–501, at 493–501.CrossRefGoogle Scholar
Bogardus, S. T. Holmboe, E. Jekel, J. F., “Perils, Pitfalls and Possibilities in Talking about Medical Risk,” JAMA 281, no. 11 (1999): 1037–1041.CrossRefGoogle Scholar
Schuck, P. H., “Rethinking Informed Consent,” Yale Law Journal 103, no. 3 (1994): 899–959; Manson, N. C. O'Neill, O., Rethinking Informed Consent in Bioethics (Cambridge, U.K.: Cambridge University Press, 2007): At 27.CrossRefGoogle Scholar
Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 122 (Tenn. 1999).CrossRefGoogle Scholar
For example, Wilson-Toby v. Bushkin, 72 A.D. 3d 810, 898 N.Y.S.2d 633 (2010). (Although consent forms advised the plaintif generally that cosmetic breast surgery would result in permanent scarring, the court ruled that “consent forms signed by the plaintif ‘do not establish, as a matter of law, that the scarring that the plaintif actually experienced as a result of the procedure was, in its nature and in its extent, consistent with the type of scarring that, prior to the procedure, the plaintif had been told to consider as being among the reasonably foreseeable risks of the proposed procedure, or that a reasonable, fully informed person in the plaintif's position would have undergone the procedure despite the existence of such risk.’” [citation omitted]).Google Scholar
Appelbaum, P. S., “Assessment of Patients' Competence to Consent to Treatment,” New England Journal of Medicine 357, no. 18 (2007): 1834–1840.CrossRefGoogle Scholar
Tversky, A. Kahneman, D., “The Framing of Decisions and the Psychology of Choice,” Science 211, no. 4481 (1981): 453–458.CrossRefGoogle Scholar
Smith, S. K. Trevena, L. Simpson, J. M. Barratt, A. Nutbeam, D. McCaffery, K. J., “A Decision Aid to Support Informed Choices about Bowel Cancer Screening among Adults with Low Education: Randomized Controlled Trial,” BMJ (October 26, 2010): 341 (“Providing balanced, evidence based information about the benefits and harms of screening for bowel cancer may reduce participation in screening among adults with low education”).CrossRefGoogle Scholar
Halpern, S. D. Shaked, A. Hasz, R. D. Caplan, A. L., “Informing Candidates for Solid-Organ Transplantation about Donor Risk Factors,” New England Journal of Medicine 358, no. 26 (2008): 2832–2837. (“This policy should outline specific aspects of transplantation that should be disclosed during the consent process…to allow patients to make a dichotomous choice to accept or decline all nonstandard organs as a group, and eliminate the practice of organ-specific consent. In particular, we believe UNOS should abandon its current recommendation that patients be notified when organs are offered from donors with behavioral risk factors.” These phrases support the need to refrain from providing ‘all’ information.CrossRefGoogle Scholar
Sage, W. M., “Unfinished Business: How Litigation Relates to Health Care Regulation,” Journal of Health Politics, Policy and Law 28, nos. 2–3 (2003): 387–419; LaBine, S. J. LaBine, G., “Determinations of Negligence and the Hindsight Bias,” Law and Human Behavior 20, no. 5 (1996): 501–516.CrossRefGoogle Scholar
Losanoff, J. E. Litwinczuk, K. M. Ranella, M. J. Basson, M. D., “Elective Inguinal Hernia Repair: A Unified Informed Consent, or Who Wants to Know What?” American Surgeon 75, no. 4 (2009): 296–300.CrossRefGoogle Scholar
Hall, A., “What the Navajo Culture Teaches about Informed Consent,” HEC Forum 14, no. 3 (2002): 241–246; Carrese, J. A. Rhodes, L. A., “Western Bioethics on the Navajo Reservation. benefit or Harm?” JAMA 274, no. 10 (1995): 826–929.CrossRefGoogle Scholar
Ormond, K. E. Banuvar, S. Daly, A. Iris, M. Minogue, J. Elias, S., “Information Preferences of High Literacy Pregnant Women Regarding Informed Consent Models for Genetic Carrier Screening,” Patient Education and Counseling 75, no. 2 (2009): 244–250.CrossRefGoogle Scholar
A federal judge recently struck down a key provision of Texas' new law requiring doctors to show pregnant women images from the sonogram and to play the sounds of the fetal heartbeat before an abortion, ruling that the measure violates the free speech rights of both doctors and patients. See Associated Press, “Texas: Judge Halts and Abortion Requirement,” New York Times, available at <http://www.nytimes.com/2011/08/31/us/31brfs-JUDGEHALTSAN_BRF.html?_r=1&ref=health> (last visited March 8, 2012). (last visited March 8, 2012).' href=https://scholar.google.com/scholar?q=23+A+federal+judge+recently+struck+down+a+key+provision+of+Texas'+new+law+requiring+doctors+to+show+pregnant+women+images+from+the+sonogram+and+to+play+the+sounds+of+the+fetal+heartbeat+before+an+abortion,+ruling+that+the+measure+violates+the+free+speech+rights+of+both+doctors+and+patients.+See+Associated+Press,+“Texas:+Judge+Halts+and+Abortion+Requirement,”+New+York+Times,+available+at++(last+visited+March+8,+2012).>Google Scholar
O'Connor, A. M. Wennberg, J. E. Legare, F. Llewellyn-Thomas, H. A. Moulton, B. W. Sepucha, K. R. Sodano, A. G. King, J. S., “Toward The ‘Tipping Point’: Decision Aids and Informed Patient Choice,” Health Affairs 26, no. 3 (2007): 716–725.Google Scholar
Hall, D .E. Hanusa, B. H. Switzer, G. E. Fine, M. J. Arnold, R. M., “The Impact of iMedConsent on Patient Decision-Making Regarding Cholecystectomy and Inguinal Herniorrhaphy,” Journal of Surgical Research (2011), available at <http://www.sciencedirect.com/science/article/pii/S0022480411004331> (last visited April 2, 2012); Franklin, D., “Uninformed Consent: Tech Solutions for Faulty Permissions in Health Care,” Scientific American, March 15, 2011, available at <http://www.scientificamerican.com/article.cfm?id=uninformed-consent-mar-11> (last visited March 8, 2012).+(last+visited+April+2,+2012);+Franklin,+D.,+“Uninformed+Consent:+Tech+Solutions+for+Faulty+Permissions+in+Health+Care,”+Scientific+American,+March+15,+2011,+available+at++(last+visited+March+8,+2012).>Google Scholar
Fagerlin, A. Ubel, P. A. Smith, D. M. Zikmund-Fisher, B. J., “Making Numbers Matter: Present and Future Research in Risk Communication,” American Journal of Health Behavior 31, no. 4, Supp. 1 (2007): S47–S56.CrossRefGoogle Scholar
Tang, H. Ng, J. H. K., “Googling for a Diagnosis – Use of Google as a Diagnostic Aid: Internet Based Study,” BMJ 333, no. 7579 (2006): 1143–1145; Hartzband, P. Groopman, J., “Untangling the Web – Patients, Doctors, and the Internet,” New England Journal of Medicine 362, no. 12 (2010): 1063–1066; Siegal, G., “Electronic Medical Tourism and the Medical WWW,” in Cohen, I. G., ed., Globalization of Health Care (New York: Oxford University Press, in press).CrossRefGoogle Scholar
See Hall, et al. , supra note 25: “… at the same time that the IC process appears to empower patient participation, it may over-whelm some patients with more information than they want. Fully 85% of patients arrived in the clinic wanting to know as many details as possible about their health status, but after the clinic visit, only 25% continued to report this preference. At the same time, the proportion of patients preferring as few details as possible increased from 0% to 36%. These preliminary findings may warrant reconsidering the amount of detail disclosed in the iMed documents and the IC process.”Google Scholar
Siegal, G. Bonnie, R. J., “Closing the Organ Gap,” Journal of Law, Medicine & Ethics 34, no. 4 (2006): 415–423. Seventy percent of people forced to state their position vis-à-vis organ donation in mandated choice pilot programs in Texas and Virginia chose not to be a donor.CrossRefGoogle Scholar