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TitleA History and Theory of Informed Consent.pdf
TagsCrime & Justice Morality Natural And Legal Rights Autonomy Informed Consent
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Table of Contents
	1. Foundations in Moral Theory
		Principles, Rules, and Rights
		Three Principles
		Balancing Moral Principles and Rights
	2. Foundations in Legal Theory
		Moral Principles and Legal Rights
		Common Law and the Legal Doctrine
		Constitutional Law and the Right to Privacy
	3. Pronouncement and Practice in Clinical Medicine
		Problems of Historical Interpretation
		Codes and Treatises from Hippocrates to the AMA
		American Medical Practices in the Nineteenth and Early Twentieth Centuries
		The Arrival of Informed Consent
		Conclusion: Everything's Changed, and Nothing's Changed
	4. Consent and the Courts: The Emergence of the Legal Doctrine
		Reading Law
		Consent Before the Twentieth Century
		The Early Twentieth-Century Cases: The Birth of Basic Consent
		1957–1972: Consent Becomes Informed
		1972–Present: Informed Consent Flourishes
	5. The Development of Consent Requirements in Research Ethics
		Consent in the Biomedical Sciences
		Consent in the Behavioral Sciences
	6. The Evolution of Federal Policy Governing Human Research
		Early Federal Recognition—Two DHEW Agencies from 1962–1974
		Later Federal Developments: Two Commissions and New Regulations from 1974–1983
	7. The Concept of Autonomy
		Autonomy and Informed Consent
		Three Conditions of Autonomous Action
		Is Authenticity a Necessary Condition?
	8. The Concepts of Informed Consent and Competence
		Two Concepts of Informed Consent
		Competence to Consent: The Gatekeeping Concept
	9. Understanding
		Understanding and Authorizing
		Criteria of Substantial Understanding
		Standards of Understanding and Disclosure
		Communication and the Understanding of Information
	10. Coercion, Manipulation, and Persuasion
Document Text Contents
Page 2

A History and Theory
of Informed Consent

Page 204


worth less than others; in extreme instances, as in Nazi maltreatment,
they were viewed as utterly worthless except as instrumental to the ends
of the investigator. Widespread contemporary concern about the fate of
subjects of research was prompted in part by recognition that derelicts,
prisoners, prisoners of war, and those of "inferior races" or inferior
social status had been treated and still were being treated in some cases
as somehow deficient in their humanity and rights.

The history of moral outrage over these events and our subsequent
change of moral outlook is not traceable to a single misgiving about the
use of subjects or to a basis in the abuse of any single moral principle
such as respect for autonomy. Apprehension about exploitation, for
example, encompassed uneasiness about coercion, deception, and the
imposition of pain and suffering. Nor can any single event be cited as
"the cause" of this revolution in perspective, despite the extraordinary
impact of each of the cases explored in this chapter.

Nazi Germany is now easy—probably too easy—to dismiss as distant,
unrepresentative, and even otherworldly; but Milgram's research, Wil-
lowbrook, Tuskegee, and the Jewish Chronic Disease Hospital still serve
for many today as models of moral failure that are not easily dismissible
as distanced aberrations. Tuskegee continues to serve as a particularly
striking example of negligence, insensitivity, and the dangers of harmful
intrusions that are unmonitored by policies protective of subjects. The
Jewish Chronic Disease Hospital case, too, is an historically instructive
example of how a single case can inform and even transform the research
community. At the hearings on this case many distinguished investiga-
tors testified that Dr. Southam's conduct was not significantly different
from prevalent customs in the biomedical research community. Much
the same observation was made when Milgram's research was first criti-
cized in social psychology. It is almost unimaginable that even ten years
later an appeal to customary practice could have been credibly submit-
ted. Indeed, by 1977, even Milgram was acknowledging that "many
regard informed consent as the cornerstone of ethical practice in exper-
imentation with human subjects."124

More than Nuremberg, which had no such immediate impact, in the
later years these cases stimulated discussion and altered viewpoints
across the landscape of American research and biomedical ethics. These
changing viewpoints were given their most forceful expression in federal
regulatory activity, a subject to which we now turn in Chapter 6.


1. Criticisms in Congress and at NIH are discussed in Chapter 6. For criticism in
the popular press, see, for example, J. Lear, "Do We Need New Rules for Experi-
ments on People?" Saturday Review (February 5, 1966): 61-70; J. Lear, "Experi-
ments on People—The Growing Debate," Saturday Review (July 2, 1966): 41-43;

Page 205


and W. Goodman, "Doctors Must Experiment on Humans—But What are the
Patient's Rights?" New York Times Magazine (July 2, 1965): 12-13, 29-33.

2. On historical developments leading to the use of this phrase, see Judith P. Swa-
zey, "Protecting the 'Animal of Necessity': Limits to Inquiry in Clinical Investiga-
tion," Daedalus 107 (1978): 129-45, and Irving Ladimer, "Human Experimentation:
Medico-legal Aspects," New England Journal of Medicine 257 (July 4, 1957): 18-24.

3. The first known "code" of research ethics is sometimes said to be that of the
American investigator William Beaumont (1785-1853), who established rough
guidelines for responsibility in experimentation. His 1833 rules form the oldest
known American document on research ethics, and perhaps the oldest code tailored
for experimentation to be found anywhere. One of its provisions states that the vol-
untary consent of the subject is necessary; a second specifies that the project must be
abandoned if the subject becomes dissatisfied. See Henry K. Beecher, Research and
the Individual: Human Studies (Boston: Little, Brown and Co., 1970), 219. Beau-
mont's treatment of his famous subject, Alexis St. Martin, did not, however, always
live up to the high-minded language of his code. See Jesse S. Myer, Life and Letters
of Dr. William Beaumont, 3rd ed.—repaginated (St. Louis: C. V. Mosby, 1981).

4. But see Percival, Chapter I, Section XII: "It is for the public good, and in an
especial degree advantageous to the poor . . . that new remedies and new methods . . .
should be devised. But in the accomplishment of this salutary purpose, the gentlemen
of the faculty should be scrupulously and conscientiously governed by sound reason."
This passage does have implications for the researcher-subject relationship. Thomas
Percival, Medical Ethics; or a Code of Institutes and Precepts, Adapted to the Profes-
sional Conduct of Physicians and Surgeons (Manchester: S. Russell, 1803), 31. The
more readily available edition is Chauncey D. Leake, ed., Percival's Medical Ethics
(Huntington, NY: Robert E. Krieger Publishing Co., 1975), 76.

5. Useful brief accounts of various historical developments earlier than those that
we consider are found in A.C. Ivy, "The History and Ethics of the Use of Human
Subjects in Medical Experiments," Science 108 (July 2, 1948): 1-5; Beecher,
Research and the Individual, 5-15, and Experimentation in Man (Springfield, IL:
Charles C Thomas, 1959), 6-8 [This book was issued after publication in the Journal
of the American Medical Association 169 (January 1959): 461-78]; Donald E. Konold,
A History of American Medical Ethics 1847-1912 (Madison, WI: State Historical Soci-
ety, 1962), Chapter 3; Gert H. Brieger, "Human Experimentation: History," in War-
ren T. Reich, ed., Encyclopedia of Bioethics, 4 vols. (New York: Free Press, 1978),
2:684-92, and "Some Aspects of Human Experimentation in the History of Nutri-
tion," in National Research Council, Use of Human Subjects in Safety Evaluation of
Food Chemicals: Proceedings of a Conference (Washington, D.C.: National Academy
of Sciences, 1967), 207-15; Joseph V. Brady and Albert R. Jonsen, "The Evolution
of Regulatory Influences on Research with Human Subjects," in Robert Greenwald,
Mary Kay Ryan, and James E. Mulvihill, eds., Human Subjects Research (New York:
Plenum Press, 1982), 3-5; Charles R. McCarthy, "Research Policy, Biomedical," in
Reich, Encyclopedia of Bioethics, 4: 1492-98; Susan Eyrich Lederer, "'The Right and
Wrong of Making Experiments on Human Beings': Udo J. Wile and Syphilis," Bulletin
of the History of Medicine 58 (1984): 380-97, esp. 396; and Stanley J. Reiser,
"Human Experimentation and the Convergence of Medical Research and Patient
Care," Annals of the American Academy of Political and Social Science 437 (May
1978): 8-18.

The earliest "scientific use" of human experimental subjects, as opposed to fortui-
tous or random observations, generally took the form of auto-experimentation by
investigators, sometimes with high risk. Such auto-experimentation included, for
example, self-inoculation with gonorrheal pus, intravenous injection of castor oil, the

Page 408


Shelp, Earl, 21n
Shipley, W.E., 144n
Sidgwick, Henry, 75, 106n
Siegler, Mark 102n, 272n, 296n, 376n
Sigerist, Henry, 63-64, 103n
Simonaitis, Joseph E., 109n
Simpson, R.H., 335n
Singer, Marcus, 21n
Singer, Peter, 21n
Singer, Richard, 374n, 381n
Skinner v. Oklahoma, 48n
Slater v. Baker and Stapleton, 116, 146n,

Slote, Michael A., 21n
Slovic, Paul, 45n, 334n, 335n
Smidovich, V., 152-53, 189
Smith, Austin, 226n
Smith, Herbert Winston, 144n, 147n
Smith, M. Brewster, 179, 185, 197n,198n
Smith, Mary J., 374n
Somerville, Margaret, 294n
Southam, Chester M., 161-62
Sox, H.C., 335n
Stanley v. Georgia, 48n
Stansfleld, Martha P., 294n
Starr, Paul, 107n
Statutes. See Law; Legislation
Sterberg, R.J., 272n
Stewart, William H., 208, 228n
Stone, Alan, 296n
Strull, William M., 113n
Stuart, R.B., 336n
Stump, W., 45n
Stump v. Sparkman, 149n
Subjective standard of causation, 34-45,

Subjective standard of disclosure, 30, 33-

34, 46n, 47n, 136-37, 305-6, 308
Superintendent of Belchertown State

School v. Saikewicz, 41, 49n
Swazey, Judith P., 188n, 193n, 231n

Therapeutic privilege, 35, 37-38, 43,
135, 145n, 148n, 156, 205, 207,
213, 364. See also Withholding

Thompson, William C., 236-37, 269n,
321-22, 335n, 379n

Thomson, Judith Jarvis, 21 n
Threats, 76, 85, 239, 256, 339-44, 349,

356-57, 360, 371, 375n, 380n
Tolman, Edward C., 270n
Torcia, Charles, 269n
Tort, defined, 23
Trammell, Richard, 2In
Tribe, Laurence, 48n
Trogun v. Fruchtman, 44n
Truman v. Thomas, 44n, 46n, 138-39
Trust, 43, 62, 69, 75, 84, 87, 94, 279,

Truthfulness, 55, 57, 60, 66, 68-69, 74-

Tuskegee syphilis experiments, 165-67,

194n, 195n
Tversky, Amos, 319-20, 334n, 335n
Twombly v. Leach, 144n

United States v. Karl Brandt, 153, 191n,
192n, 296n

Veatch, Robert M., 102n, 103n, 110n,
111n, 232n

Veith, Ilza, 103n
VeresaefF, V., 153. See also Smidovich, V.
Vinacke, W. Edgar, 171-72, 176, 196n,

Voluntariness, 292, 294n, 295n

in law, 38-39
relationship to autonomy, 255-57
in research subjects, 180-83, 210,


Taub, Harvey A., 336n
Taylor, Shelley, 381n
Taylor, Telford, 191n
Tearoom-trade research, 172, 177-78,

197n. See also Deception; Privacy
Tedeschi, James T., 349, 374, 377n
Temin, Peter, 226n
Terry, Luther, 208
Thalidomide, 203
Theory of liability

defined, 24
for informed consent, 26-30

Waddington, Ivan, 102n

as informed consent exception, 38-39
Walker v. Pierce, 149n
Wall v. Brim, 44n
Wallace, R. Jay, 248
Waltz, Jon R., 45n, 47n, 136, 148n, 277,

295n, 331n
Warner, Richard, 346, 376n
Warren, Samuel, 48n
Warwick, Donald, 197n, 377n, 378n
Weintraub, M., 336n

Page 409


Welborn, Mary C., 103n, 377n
Wells v. World's Dispensary Medical

Association, 118
Wertheimer, Alan P., 375n
West, Candace, 332n
Whalen v. Roe, 40, 49n
White, W.D., 143n
Wichita Jury Study, 172-74, 196n
Wiggins, R.A., 381n
Wikler, Daniel, 297n
Wilbur, D.L., 109n
Wilkinson v. Vesey, 32, 45n, 46n, 47n,

91, 132, 137, 296n
Williams, Thomas Franklin, 107n
Willowbrook, 163-64, 194n,

Wilson v. Scott, 48n

Winslade, William, 296n, 376n
Wisconsin v. Voder, 48n
Withholding information, 144n, 168, 170,

364, 366. See also Therapeutic

World Medical Association (WMA), 156-

Young, J.H., 226n
Youngner, Stuart, 263, 272n

Ze Barth v. Swedish Hospital Medical
Center, 45n

Zimbardo, Philip G., 197n
Zimmerman, David, 375n

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