To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.
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References
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211 N.Y. 125 (1914).
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W.Shakespeare, The Tempest (Act 2, scene I, line 253), in H.Craig, ed., The Complete Works of Shakespeare (Chicago: Scott, Foresman and Company, 1961): at 1258.
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A. M.Capron, “At Last! Aye, and There's the Rub,”American Journal of Bioethics17, no. 7 (2017): 4-7.
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Department of Homeland Securityet al., “Federal Policy for the Protection of Human Subjects,”Federal Register82, no. 12 (2017): 7149-7274.
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Strictly speaking, the sections of the Common Rule are designated “__.100” and so forth, with the blank space filled in by the volume and subpart of the Code of Federal Regulations assigned to each federal agency's or department's human subject regulations. But since the Department of Health and Human Services takes the lead in this field (e.g., it houses the OHRP), its publication of the Common Rule, in volume 42, part 46 of the C.F.R., is the standard means of citing a provision of the rule.
6.
“I believe that the current model is one that is largely confrontational in its foundation. It is a model that is focused primarily on compliance… Testimony of Greg Koski, Ph.D., M.D., before the National Bioethics Advisory Commission, Sept. 12, 2000, Washington, D.C., p. 196, available at <https://bioethicsarchive.georgetown.edu/nbac/transcripts/sept00/9-00day1.pdf> (last visited Aug. 22, 2017).
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N. M.Goldfarb, “Greg Koski on Human Subjects Protection.”Journal of Clinical Research and Best Practices3, no. 9 (2007): 1-6, at 2, available at <http://www.firstclinical.com/journal/2007/0709_Koski.pdf> (last visited Aug. 22, 2017): The OPRR inspections found deficiencies in meeting operational requirements set forth in the regulations. But when you have operational deficiencies, it raises questions about whether there are deeper problems … What the government had done was to create a process that, by and large, was going through the motions without any real evidence that, in fact, it was doing much good. As Dr. Koski explained, he “never believed that more regulation was the way to go.” A “culture of compliance” was not what we wanted. We wanted to build a “culture of conscience” where people didn't do the right thing because it was required by the law, but because of their own sense of moral responsibility and personal integrity – because it was the right thing to do. We emphasized proactive approaches to prevent injury, rather than reactive approaches that would punish someone when something bad happened. Obviously, the goal was, and is, to prevent harm, not to react after harm occurs.
8.
National Research Act of 1974, Pub. Law 93-348, July 12, 1974, Title II, Part A, §§201-205 [establishment and duties of Commission], and Part B, §212(a)[IRB review required].
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See, e.g., G. O.Schaefer, E. J.Emanuel, and A.Wertheimer, “The Obligation to Participate in Biomedical Research,”Journal of the American Medical Association302, no. 1 (2009): 67-72.
10.
Jay Katz opens his pioneering examination of physician-patient communication by describing the belief of physicians since the time of Hippocrates, “‘Good’ patients follow doctor's orders without question.”J.Katz, The Silent World of Doctor and Patient (New York: Free Press, 1984): at 1.
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Id., at 16-25 and 165-206.
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Richard Nicolls, the first English Governor of the Colony of New York, oversaw the compilation of The Duke of York's Laws, drawn from the statutes of the other English colonies in America, which themselves reflected prevailing English common law on civil and criminal matters. Promulgated at Hempstead, on Long Island, March 1, 1665, the laws contained the following statement regarding punishing (as severely “as the nature of the fault may deserve”) surgeons, midwives, and physicians who depart from professional standards or intervene without their patient's consent: [No] Person or Persons…Employed about the Bed of Men women or Children at any time for preservation of Life or health as Chirurgions, Midwives, Physicians [shall] presume to Exercise or put forth any Acte…or Exercise any force violence or Cruelty upon, or to the Bodies of any whether Young or old without the advice and Counsell of the such as are Skillfull in the same Art (If such may be had,)…and Consent of the patient or patients if they be Mentis Compotes…to the prejudice or hazard of the Life or Limb of man, woman, or child. “CHIRURGIONS, MIDWIVES, PHYSICIANS” in The Duke of York's Laws, 1665-75, available at <http://www.nycourts.gov/history/legal-history-new-york/documents/charters-duke-transcript.pdf>, at 15 of 48 (last visited Aug 28, 2017).
13.
F. G.Miller, “Consent to Clinical Research,” in F. G.Miller and A.Wertheimer, eds., The Ethics of Consent: Theory and Practice (New York: Oxford University Press, 2010).
14.
The solicitude that the law has shown for medical professionals (e.g., the higher standard of evidence required to establish actionable negligence) doubtless reflects the experience of judges and lawyers in their own profession: the occurrence of an unwanted outcome when serious and complex legal problems are being resolved does not mean that the lawyer involved failed to exercise the skill expected of a competent professional. In the practice of law an added twist arises, which is absent in medicine, where a physician's opponent is an illness or injury — namely, that in legal disputes one side wins, the other loses, yet it cannot be the case that every legal action perforce implies that one lawyer has failed to exert the necessary skill or effort on his or her client's behalf.
15.
Some twenty years later, Robert Veatch, an early, vocal proponent of using the doctrine of consent to replace medical paternalism with patient autonomy, concluded “that consent is merely a transitional concept,” which “emerged in the field as a liberal, innovative idea” but whose “time may have passed and newer, more enlightened formulations may be needed,” that would substitute a patient's exercise of active choice among alternatives for the whiff of “acquiescence” that accompanies “consent.” R. M.Veatch, “Abandoning Informed Consent,”Hastings Center Report25, no. 2 (1995): 5-12.
SeePresident's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Making Health Care Decisions, Vol. 1 (Washington, D.C.: U.S. Government Printing Office, 1982): at 44-47, quoting I. Berlin, “Two Concepts of Liberty,” in Four Essays on Liberty (Oxford: Clarendon Press, 1969): 118-138.
18.
Physicians used new or untried methods “at their peril.” Carpenter v. Blake, 60 Barb. 488 (N.Y. Sup. Ct. 1871), reversed on other ground, 50 N.Y. 696 (1872).
19.
See Hunt v. Bradshaw, 88 S.E. 2d 762 (N.C. 1955) (concurring opinion of J. Bobbitt).
20.
Katz, supra note 10, at 60. Professor Katz concludes that the ambivalence in the new doctrine of informed consent “has all the earmarks of a dream,” recalled as one first awakes, in which impossible facts are joined together. In this case, the surgeons who advised the lawyers writing the amicus brief were — unconsciously rather than deceitfully, Katz believes — trying to reconcile the increased risk that the growing powers of medicine can harm as well as hurt with the reality that it is unlikely that most patients can actually provide “intelligent consent,” as the Salgo opinion states. Id. at 63-65.
21.
Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.), cert. denied, 409 U.S. 1064 (1972); Wilkinson v. Vesey, 110 R.I. 606, 295 A.2d 676 (1972).
22.
Canterbury v. Spence, supra note 21, at 787. See generallyA. M.Capron, “Informed Consent in Catastrophic Disease Research and Treatment,”University of Pennsylvania Law Review123, no. 2 (1974): 340-438.
23.
SeeA.Meisel and L. D.Kabnick, “Informed Consent to Medical Treatment: An Analysis of Recent Legislation,”University of Pittsburgh Law Review41, no. 3 (1980): 407-564. A few states went further than restoring the medical custom standard and limited the obligation to a bare minimum disclosure of the risk of death or specified major injuries. See, e.g., Louisiana Public Health & Safety Code, Sec. 40: 1299.40 (1975).
24.
President's Commission, supra note 17, at 95.
25.
Canterbury v. Spence, supra note 21, at 789.
26.
United States v. Karl Brandt et al., Trials of the War Criminals Before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, Washington, D.C.: U.S. Government Printing Office (1949): 11374 (Aug. 19, 1947), available at <http://nuremberg.law.harvard.edu/transcripts/1-transcript-for-nmt-1-medical-case?seq=11523> (last visited Sept. 2, 2017).
27.
Leo Alexander, an American physician who was one of the expert witnesses at Nuremberg, pointed out that the defendants' criminal attitude toward their inmate-subjects interfered with being successful researchers. During research to find a vaccine for typhus, pre-vaccinated persons and nonvaccinated controls were injected with typhus rickettsia. At some point, the strain being used became avirulent in humans. “Instead of seizing upon this as a possibility to develop a live vaccine,” the experimenters were simply annoyed that the controls weren't dying, discarded the strain, “and continued testing their relatively ineffective dead vaccines against a new virulent strain.” L.Alexander, “Medical Science under Dictatorship,”New England Journal of Medicine241, no. 2 (1949): 39-43.
28.
United States v. Karl Brandt et al., supra note 26.
29.
To buttress his claim of universalisability, Dr. Ivy testified on June 13, 1947, that the three principles he drew from his historical study (voluntary informed consent, well-designed research justified by anticipated results, and scientifically qualified investigators minimizing suffering and injury) could also be found in “a decree of the Minister of Public Welfare of Germany in 1931 on the subject of ‘Regulations for Modern Therapy for the Performance of Scientific Experiments on Human Beings'.” Id. at 9142.
30.
Id. at 9253-9267 (June 16, 1947). Given the technical nature of the questions, the tribunal in the interest of time permitted Dr. Rose, rather than his counsel, to cross-examine the witness.
D.J.Rothman, Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (New York: Basic Books, 1991): 51-69. Rather than making a philosophical choice of progress for the group over individual welfare, Renée Fox sees physician-investigators simply failing to examine the issue. Although memories of the Nazi experiments “were still hauntingly present,” investigators in the 1950s and 60s were swept along by “the renaissance of medical research” which diverted them from “sustained brooding about the ethicality of human experimentation.” R. C.Fox, Experiment Perilous (Glencoe, IL: Free Press, 1959): at 10.
33.
Rothman, supra note 32, at 63.
34.
J. D.Moreno, “Reassessing the Influence of the Nuremberg Code on American Medical Ethics,”Journal of Contemporary Health Law & Policy13, no. 2 (1997): 347-360.
35.
H. K.Beecher, “Experimentation in Man,”Journal of the American Medical Association169, no. 5 (1959): 461-478.
36.
F. G.Miller, “Henry Beecher and Consent to Research: A Critical Re-Examination,”Perspectives in Biology and Medicine59, no. 1 (2016): 78-94.
37.
The idea that an investigator could enable a potential human research subject “to make an understanding and enlightened decision,” as the Nuremberg Code expects, is often quite impossible…for the complexities of essential medical research have reached the point where the full implications and possible hazards cannot always be known to anyone and are often communicable only to a few informed investigators and sometimes not even to them. Beecher, supra note 35, at 473.
38.
Id. at 472.
39.
United Nations General Assembly, International Covenant on Civil and Political Rights (1966): Article 7 (“No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.”), available at <http://www.ohchr.org/EN/Profession-alInterest/Pages/CCPR.aspx> (last visited Sept. 16, 2017).
40.
Council of Europe, Treaty No.164, Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (1997): Chapter V—Scientific research, available at <http://www.coe.int/en/web/conventions/full-list/-/conventions/rms/090000168007cf98> (last visited Sept. 17, 2017).
41.
Editorial, “Declaration of Helsinki,”New England Journal of Medicine271, no. 9 (1964): 473-474.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report (1978): at 3.
44.
A further set of ethical standards is in place for the pharmaceutical and medical device approval process, through the Food and Drug Administration's (FDA) inspection of the sites that conduct clinical trials, according to the agency's regulations for licensing of new drugs and devices and to the “Good Clinical Practice” standards of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
45.
As a regulatory body, the FDA's human subjects regulations have sharper and more obvious teeth; for example, drug sponsors cannot use the results of research that did not adhere to the regulations in support of their applications for a license for a new drug.
46.
It is important to note that such criticism has stimulated some beneficial change. For example, the revised Rule adds provisions that are apparently aimed at encouraging researchers to draft, and IRBs to demand, consent documents that will improve potential subjects' ability to understand what it means to enroll in a particular study. For example, in §__.116(a)(5)(i), the revised Common Rule states that the consent form must begin with “a concise and focused presentation” of “key information… organized and presented in a way that facilitates comprehension.” It goes on to say that detailed information (from providing all the required elements of consent) must not be merely a “lists of isolated facts,” but should be presented in a way that will facilitate subjects' understanding of “the reasons why one might or might not want to participate” §__.116(a)(5)(ii). Investigators — and perhaps even IRBs — may not feel enthusiastic about pursuing such a consent process, since for many clinical trials some subjects will be less inclined to enroll if they truly understand the likely benefits they will directly experience compared to those expected in an alternative therapeutic course.
47.
Miller, supra note 36, at 90-91.
48.
For example, one leading voice for research ethics has recently enthused over the “unprecedented opportunities to answer important clinical research questions…available through the analysis of massive amounts of data (“big” data) in commercial, health care, research, and government databases, in social media and mobile devices, and in growing collections of biologic specimens and clinical and genomic data.” C.Grady, “The Changing Face of Informed Consent,”New England Journal of Medicine376, no. 9 (2017): 856-859, at 856.
49.
H.Jonas, “Philosophical Reflections on Experimenting with Human Subjects,”Daedalus98, no. 2 (1969): 219-257, at 245.
50.
See, e.g., R. R.Faden, N. E.Kass, S. N.Goodmanet al., “An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics,”Hastings Center Report43, no. S1 (2013): S16–S27; R. E. McKinney Jr., L. M. Beskow, D. E. Ford et al., “Use of Altered Informed Consent in Pragmatic Clinical Research,” Clinical Trials 12, no. 5 (2015): 494-502.
51.
Capron, supra note 3, at 5-6.
52.
National Research Act of 1974, Pub. Law 93-348, July 12, 1974, Title II, Part B, §212(a).
53.
The possibility is not a mere hypothetical, having been championed for example by Henry Beecher in the report he prepared for Harvard Medical School, when it wanted an alternative to the Nuremberg Code, which the Department of the Army had begun including in its contracts for research with human subjects around 1960. “The inescapable responsibility for determining what investigations may be done on a particular patient must rest with the investigator or physician concerned, bearing in mind that present-day specialization in medicine and complexity of procedures proposed or undertaken are frequenty beyond the grasp of the subjects involved.” H. K.Beecher, “Tentative Statement Outlining the Philosophy and Ethical Principles Governing the Conduct of Research on Human Beings at the Harvard Medical School,” (unpublished manuscript; undated) in J.Katz, Experimentation with Human Beings (New York: Russell Sage Foundation, 1972): 315, at 316.
54.
C.Grady, L.Eckstein, B.Berkmanet al., “Broad Consent for Research with Biological Samples: Workshop Conclusions,”American Journal of Bioethics15, no. 9 (2015): 34-42.
55.
See, e.g., D.Grande, N.Mitra, A.Shah, F.Wan, and D. A.Asch, “The Importance of Purpose: Moving beyond Consent in the Societal Use of Personal Health Information,”Annals of Internal Medicine161, no. 12 (2014): 855-862.
56.
Yet, as Christine Grady has noted, “In survey after survey… people report that they prefer to be asked and given a choice about research even if there is little risk to them.” Grady, supra note 48, at 857 (citations omitted).
57.
President's Commission, supra note 17, at 108. A smaller majority of physicians hold the same view.
58.
The preamble to the new Common Rule indicates that federal officials have taken notice of the public's cynical view about the purpose informed consent typically serves. In revising §__.116 to underline and beef up several general points about consent (by numbering them, instead of treating such considerations in a single, short introduction and then emphasizing the elements of consent by enumerating them separately), the drafters were sensitive to the complaint that long and complex consent forms serve mostly as “sales documents or means to protect against institutional liability.” Department of Homeland Security et al., supra note 4, at 7212.
59.
See note 22, supra, and accompanying text.
60.
T. L.Beauchamp and J. F.Childress, Principles of Biomedical Ethics, Seventh Edition (New York: Oxford University Press, 2013): at 332.
61.
A. M.Capron, “The Real Problem Is Consent for Treatment, Not Consent for Research,”American Journal of Bioethics13, no. 12 (2013): 27-29.
62.
Beauchamp and Childress, supra note 60, at 332.
63.
See note 11, supra, and accompanying text.
64.
Jonas, supra note 49, at 239.
65.
See, e.g., K. A.Getz, “Charting a Course for the Patient Centricity Movement,”Clinical Researcher29, no. 2 (2015): 36-40; Patient-Centered Outcomes Research Institute, “Engagement” (2017), available at <https://www.pcori.org/engagement> (last visited Nov. 20, 2017).
