Hostname: page-component-8678677fb7-dgq2d Total loading time: 0 Render date: 2026-10-10T07:59:11.304Z Has data issue: false hasContentIssue false
  • English
  • Français

Limning the Semantic Frontier of Informed Consent

Published online by Cambridge University Press:  01 January 2021

Harriet A. Washington
Get access Rights & Permissions [Opens in a new window]

Abstract

It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena.

Information

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 3: Contemporary Challenges in Informed Consent: Law, Research Practice, and Ethics , Fall 2016 , pp. 381 - 393
Copyright
Copyright © American Society of Law, Medicine and Ethics 2016

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

21 CFR 50.20, “General Requirements for Informed Consent,” available at <http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=50.20> (last visited July 14, 2016).+(last+visited+July+14,+2016).>Google Scholar
Jones, J. W., McCullough, L. B., and Richman, B. W., “Informed Consent: It's Not Just Signing a Form,” Thoracic Surg Clinics 15, no. 4 (2005): 451–460.Google Scholar
Brennan, D., “Informed Consent Forms: Are They Readable?” Southern University Illinois at Carbondale, Open SIUC Honors Theses, Paper 211 (1996).Google Scholar
Schorling, J. B. and Terry Saunders, J., “Is ‘Sugar’ the Same as Diabetes? A Community-Based Study Among Rural African-Americans,” Diabetes Care 23, no. 3 (March 2000): 330–334.CrossRefGoogle Scholar
Roter, D. L., Rude, R. E, and Comings, J., “Patient Literacy: A Barrier to Quality of Care,” Journal of General Internal Medicine 13, no. 12 (1998): 850–851.Google Scholar
Gearhart, J., “The FDA's Consent Form Language – ‘Understandable’ or Not?” September 2, 2014, available at <http://www.quorumreview.com/fdas-consent-form-language-understandable-not/> (last visited July 14, 2016).Google Scholar
Ogloff, J. R. and Otto, R. K., “Are Research Participants Truly Informed? Readability of Informed Consent Forms Used in Research,” Ethics and Behavior 1, no. 4 (1991): 239-252.CrossRefGoogle Scholar
Mann, T., “Informed Consent for Psychological Research: Do Subjects Comprehend Consent Forms and Understand Their Legal Rights?” Psychological Science 5, no. 3 (1994): 140–143.Google Scholar
See Brennan, supra note 4.Google Scholar
Longo, J. A., The Fry Graph: Validation of the College Levels,” Journal of Reading 26, no. 3 (1982): 229-234; T. M. Grunder, “Two Formulas for Determining the Readability of Subject Consent Forms,” American Psychologist 33, no. 8 (1978): 773-775 K. M. Cordasco, “Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices,” in Obtaining Informed Consent From Patients: Brief Update Review, Evidence Reports/Technology Assessments, No. 211, Agency for Healthcare Research and Quality (US), March 2013.Google Scholar
Waggoner, W. C. and Mayo, D. M., “Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms,” IRB: Ethics & Human Research 17, no. 1 (1995): 6–9.Google Scholar
Washington, H. A., “Prudence and the Pill: Testing Thalidomide in the Global South, Biopolitical Times, December 13, 2010, available at < http://www.biopoliticaltimes.org/article.php?id=5504> (last visited July 20, 2016).Google Scholar
Mann, T., “Informed Consent for Psychological Research: Do Subjects Comprehend Consent Forms and Understand Their Legal Rights?” Psychological Science 5, no. 3 (1994): 140–143.Google Scholar
Hornblum, A. M., Acres of Skin: Human Experiments at Holmesburg Prison (New York: Routledge, 1999).Google Scholar
See Mann, supra note 13.Google Scholar
Rothwell, E. et al., “A Randomized Controlled Trial of an Electronic Informed Consent Process,” Journal of Empirical Research on Human Research Ethics 9, no. 5 (2014): 1–7.Google Scholar
Id.Google Scholar
Cordasco, K., “Making Health Care Safer II: An Updated Critical Analysis of the Evidence for Patient Safety Practices,” in Obtaining Informed Consent From Patients: Brief Update Review, Evidence Reports/Technology Assessments, No. 211, Agency for Healthcare Research and Quality (US), March 2013.Google Scholar
The Clopidogrel in Unstable Angina to Prevent Recurrent Events Trial Investigators, “Effects of Clopidogrel in Addition to Aspirin in Patients with Acute Coronary Syndromes without St-Segment Elevation,” New England Journal of Medicine 345, no. 7 (2001): 494–502CrossRefGoogle Scholar
Id.Google Scholar
Sleight, P., The HOPE (Heart Outcomes Prevention Evaluation) Study,” Journal of the Renin Angiotensin Aldosterone System 1, no. 1 (2000): 18–20.Google Scholar
AIDS Linked to the IntraVenous Experience (ALIVE), Johns Hopkins Bloomberg School of Public Health, available at <http://www.jhsph.edu/research/affiliated-programs/aids-linked-to-the-intravenous-experience/> (last visited July 15, 2016).+(last+visited+July+15,+2016).>Google Scholar
Bargh, J. A., Chaiken, S., and Governder, R. et al., “The Generality of the Automatic Attitude Activation Effect,” Journal of Personality and Social Psychology 62, no. 6 (1992): 893–912.Google Scholar
Id.Google Scholar
I'm indebted to Orlowski, James P. and Christensen, James A.'s paper, “The Potentially Coercive Nature of Some Clinical Research Trial Acronyms,” for some of these examples.Google Scholar
Hausleiter, J. et al., “Randomized, Double-Blind, Placebo-Controlled Trial of Oral Sirolimus for Restenosis Prevention in Patients with In-Stent Restenosis: The Oral Sirolimus to Inhibit Recurrent In-stent Stenosis (OSIRIS)Study,” Circulation 110, no. 7 (2004): 790–795.Google Scholar
Bauersachs, R. and Berkowitz, S. D. et al., “Oral Rivaroxaban for Symptomatic Venous Thromboembolism,” New England Journal of Medicine 363 (2010): 2499–2510.Google Scholar
Stanbrook, M.B., Austin, P. C., and Redelmeier, D. A., “Acronym-Named Randomized Trials in Medicine — The ART in Medicine Study,” New England Journal of Medicine 355, no. 1 (2006): 101–102.CrossRefGoogle Scholar
Cheng, T. O., “Acronyms of Clinical Trials in Cardiology—1998,” American Heart Journal 137, no. 4 (1998) 726–765.CrossRefGoogle Scholar
Orlowski, J. P. and Christensen, J. A., “The Potentially Coercive Nature of Some Clinical Research Trial Acronyms,” Chest 121, no. 6 (2002): 2023–2028.Google Scholar
Id.Google Scholar
The Office of Medical Products and Tobacco et al., “Informed Consent Information Sheet: Guidance for IRBs, Clinical Investigators, and Sponsors: Draft Guidance,” available at <http://www.fda.gov/RegulatoryInformation/Guidances/ucm404975.htm> (last visited July 15, 2016).+(last+visited+July+15,+2016).>Google Scholar
Labos, C., “The Alphabet Soup of Clinical Trial Acronyms ACRONYM: An Albeit Cool but Really Obtuse Naming Strategy for Medical Studies,” Medscape <http://www.medscape.com/viewarticle/857543> (last visited May 2016).+(last+visited+May+2016).>Google Scholar
Nordrum, A., “Why Do Prescription Drugs Have Such Weird Names? Blame Branding Consultants and the FDA,” International Business Times, June 24, 2015, available at http://www.ibtimes.com/why-do-prescription-drugs-have-such-weird-names-blame-branding-consultants-fda-1981819 (last visited July 20, 2016).Google Scholar
“How Drugs Are Named,” UCB, December 9, 2011, available at <http://www.ucb.com/rd/info-centre/drug-naming> (last visited July 15, 2016).+(last+visited+July+15,+2016).>Google Scholar
See Nordrum, supra note 34.Google Scholar
Id.Google Scholar
See supra note 28.Google Scholar
See Cheng, supra note 29.Google Scholar
Strunk, William Jr., The Elements of Style (Project Gutenberg EBook of 1920 edition; Harcourt, Brace and Company New York): at Chapter V, available at <http://www.gutenberg.org/files/37134/37134-h/37134-h.htm> (last visited July 22, 2016).+(last+visited+July+22,+2016).>Google Scholar
Peterson, B. T., Clancy, S. J., Champion, K., and McLarty, J. W., “Improving Readability of Consent Forms: What the Computers May Not Tell You,” IRB: A Review of Human Subjects Research 14, no. 6 (1992): 6–8.CrossRefGoogle Scholar
“Burking in Baltimore,” Baltimore Sun, December 13, 1886; B. Jensen, “Blood Money,” Baltimore City Paper, 1998; J. Jasper, “Body Snatching” Baltimore Afro-American, September 4, 1954, available at <https://news.google.com/newspapers?nid=2211&dat=19540904&id=kZwlAAAAIBAJ&sjid=pfUFAAAAIBAJ&pg=2262,815382&hl=en> (last visied July 20, 2016); L. Rosner, The Anatomy Murders: Being the True and Spectacular History of Edinburgh's Notorious Burke and Hare and of the Man of Science Who Abetted Them in the Commission of Their Most Heinous Crimes (Philidelphia:University of Pennsylvania Press, 2009).+(last+visied+July+20,+2016);+L.+Rosner,+The+Anatomy+Murders:+Being+the+True+and+Spectacular+History+of+Edinburgh's+Notorious+Burke+and+Hare+and+of+the+Man+of+Science+Who+Abetted+Them+in+the+Commission+of+Their+Most+Heinous+Crimes+(Philidelphia:University+of+Pennsylvania+Press,+2009).>Google Scholar
Washington, H. A., Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present, (New York: Doubleday, 2007)Google Scholar
Washington, H. A., “Henrietta Lacks, Unsung Hero,” Emerge Magazine, October 1995; Washington, H. A., Deadly Monopolies: The Shocking Corporate Takeover of Life Itself—and the Consequences for Your Health and Our Medical Future (New York: Doubleday, 2011): 46–56.Google Scholar
Kolata, G., “Johns Hopkins Admits Fault in Fatal Experiment,” New York Times, July 17, 2001.Google Scholar
Ericka Grimes V. Kennedy Krieger Institute, Inc., Myron Higgins, a minor, etc., et al., v. Kennedy Krieger Institute, Inc., Court of Appeals of Maryland, Nos. 128, 129, Sept. Term, 2000, Decided: August 16, 2001, available at <http://case-law.findlaw.com/md-court-of-appeals/1236870.html#sthash.M0Rdr5BO.dpuf> (last visited July 15, 2016).+(last+visited+July+15,+2016).>Google Scholar
CBS, “Baltimore Ranked One of the Poorest Cities in America,” February 18, 2015.Google Scholar
Rosenwald, M. S. and Fletcher, M. A., “Why Couldn't 130 Million Transform One of Baltimore's Poorest Places?” Baltimore Sun, May 2, 2016.Google Scholar
Haraway, D., “Situated Knowledges: The Science Question in Feminism and the Privilege of Partial Perspective,” Feminist Studies 14, no. 3 (1988): 575–599.Google Scholar
Washington, H. A., Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present (New York: Doubleday, 2007); J. Walter Fisher, “Physicians and Slavery in the Antebellum Southern Medical Journal,” Journal of the History of Medicine and Allied Sciences XXIII (January 1968): 45; “Surgery and the Negro Physician: Some Parallels in Background,” National Medical Association Journal XLIII (May 1951): 145-52; T. L. Savitt, Medicine and Slavery: The Diseases and Health Care of Blacks in Antebellum Virginia, (Champaign University of Illinois Press, 1981); also, W. Fisher, “The Use of Blacks for Medical Experimentation and Demonstration in the Old South,” Journal of Southern History 48, no. 3 (1982): 331-348; W. Weyers, The Abuse of Man: An Illustrated History of Dubious Medical Experimentation (New York: Ardor Scribendi, 2007); W. U. Eckart, Medizin und Kolonialimperialismus: Deutschland 1884–1945 (Paderborn: Schöningh, 1997); W. M. Byrd and L. A. Clayton, An American Health Dilemma: Race, Medicine, and Health Care in the United States, 1900-2000 (Boston: Routledge, 2000).Google Scholar
See Washington, supra note 43, at 263–299.Google Scholar
Enquselassie, F., Nokes, J., and Cutts, F., “Communities’ Confidentiality Should Be Maintained and Community Consent Sought,” BMJ 312, no. 7022 (1996): 54-55; R. Crawshaw, M. J. Garland, B. Hines, and C. Lobitz, “Oregon Health Decisions: An Experiment with Informed Community Consent,” JAMA 254, no. 22 (1985): 3213-3216; J. Cassell and A. Young, “Why We Should Not Seek Individual Informed Consent for Participation in Health Services Research,” Journal of Medical Ethics 28, no. 5 (2002): 313-317; C. Blohm, J. Simon, “Group Consent in Population Based Research,” Journal de International Bioethique 19, no. 3 (2008): 49-67, 123.Google Scholar
Katz, J., “Blurring the Lines: Research, Therapy, and IRBs,” The Hastings Center Report 27, no. 1 (1997): 9-11, available at <http://www.jstor.org/stable/3528019> (last visited July 15, 2016).Google Scholar
Natanson, C., Kern, S. J., and Lurie, P. et al., “Cell-Free Hemoglobin-Based Blood Substitutes and Risk of Myocardial Infarction and Risk of Myocardial Infarction and Death: A Meta-Analysis,” JAMA 299, no. 19 (2008): 2304–2312.Google Scholar
See Katz, supra note 53.Google Scholar
Waggoner, W. C. and Mayo, D. M., “Who Understands? A Survey of 25 Words or Phrases Commonly Used in Proposed Clinical Research Consent Forms,” IRB: A Review of Human Subjects Research 17, no. 1 (1995): 6–9.CrossRefGoogle Scholar
Kunen mused that “[t]here is no greater example of the power of an adjective to modify a noun than the use of the word ‘legal’ before the word ‘ethics’.”Google Scholar
Nuremberg Military Tribunal s, 1949-1953, Vol. 2 of Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law, No. 10., Nuremberg, October 1946-April1949, Washington, D.C.: GPO, available at <https://www.loc.gov/rr/frd/Military_Law/pdf/NT_war-criminals_Vol-II.pdf> (last accessed July 20, 2016.)+(last+accessed+July+20,+2016.)>Google Scholar
Washington, H. A., Medical Apartheid: The Dark History of Experimentation from Colonial Times to the Present (New York: Doubleday, 2007).Google Scholar
Advisory Committee on Human Radiation Experiments, Final Report of the Advisory Committee on Human Radiation Experiments (Washington, D.C.: U.S. Government Printing Office, 1995): 734.Google Scholar
Elliott, C., “Whatever Happened to Human Experimentation?” Hastings Center Report 46 (2016): 1–4.Google Scholar
Orwell, G., “Appendix: The Principles of Newspeak,” in Nineteen Eighty-Four, Project Gutenberg of Australia eBook No. 0100021.txt, 2001, available at <http://gutenberg.net.au/ebooks01/0100021.txt> (last visited July 15, 2016).Google Scholar