reck-oned that scientific progress for the good of the entire community should take prece-dence, in particular over the protests of individual patients. In their view, provided that responsible physicians were in charge of research, the state and the public should ab-stain from meddling in their affairs.
852.1.2. The Helsinki Declaration and other texts
The Nuremberg Code was followed, almost twenty years later,
86by the Helsinki Decla-ration.
87The Declaration was produced by the World Medical Association (“WMA”).
88Despite being more detailed, the Helsinki Declaration was a toned-down adaptation of
Advisory Committee on Human Radiation Experiments, 276 JAMA 1667-71 (Nov. 27, 1996), abstract at http://jama.ama-assn.org/cgi/content/abstract/276/20/1667; Leaning, supra note 68; Perley et al., supra note 72, at 150; SPRUMONT,supra note 16, at 24.
79 See Annas (Expediency), supra note 68, at 204.
80 Article 1 of the Nuremberg Code. See the interesting opposite view on the essential character of consent expressed by H. M. Evans, Should patients be allowed to veto their participation in clinical research?, 30 J.
MED. ETHICS 198-203 (2004), at http://jme.bmjjournals.com/cgi/content/full/30/2/198.
81 See, e.g., Grodin (Historical Origins), supra note 66, at 139; Perley et al., supra note 72, at 155; Jeffrey P.
Burns, Research in Children, 31 CRIT. CAREMED 131-136, at 132 (2003). See also subsection 8.4. below.
82 Therapeutic studies aim, at least in part, to benefit the patient, while nontherapeutic studies do not intend to confer any benefit to the volunteer. See also subsection 6.1.1.3. below.
For another definition of therapeutic and nontherapeutic research, see e.g., Whitlock v. Duke University, 637 F. Supp. 1463, at 1467 (M.D.N.C. 1986), aff’d 829 F.2d 1340 (4th Cir. 1987); Grimes v. Kennedy Krieger In-stitute, 782 A.2d 807 (Md. 2001).
83 See Leaning, supra note 68; Leonard H. Glantz, The Influence of the Nuremberg Code on U.S. Statutes and Regulations, in THENAZIDOCTORS AND THE NUREMBERGCODE183, 185 (Oxford University Press 1992); Mariner, supra note 59, at 286.
84 See, e.g., Michelle D. Miller, The Informed-Consent Policy of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use: Knowledge is the Best Medi-cine, 30 CORNELLINT’LL.J. 203, 204 (1997) [hereinafter M. Miller].
85 See JONES(TUSKEGEE),supra note 78, at 95-97 (describing the attitude of the medical community in the 1930s).
86 Before the Declaration of Helsinki, in 1954, the World Medical Association had adopted five principles gov-erning medical experimentation. According to its principle 5, “It should be required that each person who submits to experimentation be informed of the nature of, the reason for, and the risk of the proposed ex-periment.” WMA, Principles for those in Research and Experimentation, (1954) at
http://www.iit.edu/departments/csep/codes/coe/World_Medical_Association_Principles_for_Those_in_Resear ch_1954.html.
87 On the history of the Declaration of Helsinki, see, for instance, Human & Fluss, supra note 72, at 4-6; Perley et al., supra note 72, at 157-59; Annas, supra note 66, at 204-5; Ummel (1990), supra note 74, at 9-10. The text of the 2002 Declaration of Helsinki [hereinafter Helsinki Declaration] is available at http://www.wma.net/e/policy/b3.htm.
88 Already in 1946, the American Medical Association had enacted three short principles. See Grodin (Historical Origins), supra note 66, at 134.
the Nuremberg Code.
89It was both made by and aimed at physicians.
90As such, it was couched in a language that still upheld the traditional superiority of physicians over patients-subjects.
91At least implicitly, the initial Helsinki Declaration endorsed self-regulation by physicians, in good part to dodge government interference.
92Hence, in its initial version of 1964,
93the Declaration imposed consent for therapeutic research only to the extent that it was “consistent with patient psychology.”
94Not until its 1975 revi-sion did it mandate prior approval of clinical trials by ethics committees*.
95The year 1966 saw the enactment of the International Covenant on Civil and Politi-cal Rights (“ICCPR”).
96Its article 7 prohibits experiments conducted without the “free consent” of the concerned persons. The Covenant is the first multilateral treaty to men-tion research.
97Despite these initial good intentions, it was not until end of the 1960s that the re-search community began to truly adhere to the chief ethical tenet of informed consent.
98It certainly did not help that both the Nuremberg Code and the Helsinki Declaration
89 “The spirit of the Nuremberg Code was not, and perhaps could not be, taken seriously. Its language was too uncompromising and too inhospitable to the advancement of science that subsequent codes reintroduced by giving physicians-scientists considerable discretion in pursuing their objectives.” Katz, supra note 71, at 236.
See also Grimes, 782 A.2d at 850.
90 See Mariner, supra note 59, at 289.
91 See Katz, supra note 71, at 231, 234 and 237.
92 See also Weindling, supra note 63. The same is true for most other guidelines adopted throughout the Western World following the Helsinki Declaration. For Switzerland, see Sprumont’s comments regarding the 1970 and 1981 guidelines of the Swiss Academy of Medical Sciences (“SAMS”). SPRUMONT,supra note 16, at 185.
93 The initial text of the Declaration is reproduced in the book THENAZIDOCTORS AND THE NUREMBERGCODE, supra note 59, at p.331-33.
94 Under the 1964 Declaration, consent was imperative only for nontherapeutic experiments. But, even for these experiments, this key principle was mentioned only toward the end of the Declaration (at section III, point 3a.). See Katz, supra note 71, at 234; also Leaning, supra note 68.
Even in the 2000 version, informed consent is only mentioned fairly late in paragraphs 20 and 22. See also M. Miller, supra note 84, at 217.
95 Ethical committees nowadays are entrusted with the task of reviewing critically clinical trial protocols before the corresponding trials can begin. See subsection 7.1.
See paragraph I.1. of the 1975 Helsinki Declaration (revised at Tokyo). See also Perley et al., supra note 72, at 159.
The United States first introduced this requirement for FDA-regulated clinical trials in 1971. See, e.g., OIG, HHS, FDA Oversight of Clinical Investigators (June 2000), at 11, at
http://oig.hhs.gov/oei/reports/oei-05-99-00350.pdf [hereinafter OIG (FDA Oversight)]. According to Spru-mont, it was in 1953 that the American NIH first established this obligation for its own trials. See SPRUMONT, supra note 16, at 95 and 115 (mentioning two different dates).
In Switzerland, as of October 1992, only three cantons had fixed this obligation in their legislation. Id. at 219.See also Ummel (1990), supra note 74, at 22.
Other European countries were also late in implementing this provision of the Helsinki Declaration. For France, see, for instance, CCNE N°2, supra note 57, at 5; CCNE, Recommandations sur les Comités locaux, Rapport, [Recommendation on local committees, Report] N°13 (Nov. 7, 1988), at http://www.ccne-ethique.fr/francais/pdf/avis013.pdf [hereinafter CCNE N°13].
96 The Covenant entered into force on March 23, 1976; text at
http://www.unhchr.ch/html/menu3/b/a_ccpr.htm. For Switzerland, it entered into force in September 1992.
97 See Perley et al., supra note 72, at 153. See, in Europe, Article 3 of the Convention for the Protection of Human Rights and Fundamental Freedoms, at http://www.echr.coe.int/NR/rdonlyres/D5CC24A7-DC13-4318-B457-5C9014916D7A/0/EnglishAnglais.pdf (prohibiting torture and inhuman or degrading treatments).
98 See Faden, supra note 78, at 1667-71.
lack binding legal standing.
99Only few commentators contend that these texts are mandatory as part of public international law or customary law.
100For most legal authors, they are recommendations that need to be implemented in national legislations to be enforceable.
101Even the ICCPR is not self-executing.
102The last quarter of the 20
thcentury witnessed a multiplication of bioethical initia-tives.
103Famous sets of rules include the CIOMS
104International Ethical Guidelines for Biomedical Research Involving Human Subjects, first enacted in 1982.
105The WHO promulgated its own set of Good Clinical Practices in 1995.
106In 1997, the Council of
99 “The rules that they [the Nuremberg Code and the Helsinki Declaration] set out are tenuous, unaccompa-nied by any real controls, traditional sanctions, or other means of enforcement. Moreover, as a series of general statements, they are ambiguous with respect to both the principles themselves and their practical application.” Perley et al., supra note 72, at 160. See also Annas (Dilemma), supra note 70, at 7-9.
Similarly, the Hippocratic Oath, pledged by doctors, is not legally binding. There are different versions of the Hippocratic oath; various examples can be found at
http://classics.mit.edu/Hippocrates/hippooath.html, http://www.montchoisi.ch/radiologie/Serment.html, at http://www.indiana.edu/~ancmed/oath.htm.
100 Sprumont holds the view that the Nuremberg Code is mandatory: “il [the Code] constitue en droit interna-tional l’expression du jus cogens, à savoir d’un droit impératif auquel les Etats ne peuvent déroger.” See Do-minique Sprumont, Les principaux modèles de réglementation de la recherche impliquant des êtres humains, 1 RSDS [Revue Suisse de droit de la santé] 39, at 40-41 (Sept. 2003) [hereinafter Sprumont (RSDS)]. See also Perley et al., supra note 72, at 152. See Annas (Dilemma), supra note 70, at 8.
101 There are a few exceptions. For instance, the Court of Appeals of Maryland held that the Code is “part of international common law and may be applied, in both civil and criminal cases, by state, federal and munici-pal courts in the United States.” Grimes, 782 A.2d at 835.
A Ohio District Court observed that “[t]he Nuremberg Code is part of the law of humanity. It may be applied in both civil and criminal cases by the federal courts in the United States.” In Re Cincinnati, 874 F. Supp. at 821.See also Annas (Dilemma), supra note 70, at 9; paragraph 9 Helsinki Declaration (stating: “No national ethical, legal or regulatory requirements should be allowed to reduce or eliminate any of the protections for human subjects set forth in this Declaration.”).
102 See Abdullahi v. Pfizer, 2002 U.S. Dist. LEXIS 17436 (S.D.N.Y. 2002).
103 “In December 1999, a 20-page, small-print publication identified 62 intergovernmental and nongovernmen-tal international agencies that had produced guidelines on a wide variety of bioethical topics and 29 miscel-laneous international texts produced by ad hoc tribunals, congresses, and the like, beginning with the 1947 Nuremberg Code.” Bernard M. Dickens, The Challenge of Equivalent Protection, in ETHICAL AND POLICY ISSUES ININTERNATIONAL RESEARCH: CLINICAL TRIALS IN DEVELOPING COUNTRIES, VOLUMEII, COMMISSIONED PAPERS AND STAFF ANALYSIS, at A-15, (National Bioethics Advisory Commission, May 2001), at
http://www.georgetown.edu/research/nrcbl/nbac/clinical/Vol2.pdf.
On the origin of the bioethics discourse, see for instance Gary S. Belkin & Allan M. Brandt, Bioethics: Using its Historical and Social Context, 39 (3) INT ANESTHESIOL CLIN. 1-11 (Summer 2001). See also SPRUMONT, su-pra note 16, at 66-67.
For a criticism of both rigid codes and blind adherence to them, see Henry K. Beecher, Consent in clinical ex-perimentation: myth and reality, 195 JAMA 34 (Jan. 3, 1966) [hereinafter Beecher (Myth)]; Henry K.
Beecher, Some guiding principles for clinical investigation, 95 JAMA 1135 [hereinafter Beecher (Guiding)].
104 “The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949.” CIOMS, What is CIOMS?, at http://www.cioms.ch/frame_what_is_cioms.htm.
105 The CIOMS Guidelines were revised in 1993 and 2002; they are mainly oriented toward research in develop-ing countries. See CIOMS, International Ethical Guidelines for Biomedical Research Involvdevelop-ing Human Sub-jects (2002), at http://www.cioms.ch/guidelines_nov_2002_blurb.htm [hereinafter CIOMS 2002 Guidelines].
See also Christian Byk, Les règles Internationales d’Ethique pour la Recherche Biomédicale impliquant des Sujets Humains, 4(4) INTERN. J. OF BIOETH. 299-302 (1993) (on the 1993 revision of the CIOMS guidelines);
Perley et al., supra note 72, at 160-65.
106 See WHO, Guidelines for good clinical practice (GCP) for trials on pharmaceutical products, TRS850-Annex 3, (1995) at http://www.who.int/medicines/library/par/ggcp/GCPGuidePharmatrials.pdf. See also Juhana Idänpään-Heikkilä, Harmonisation globale, Directives de l’OMS pour de bonnes pratiques clini-ques, 39(2) CMS 223-29 (1995).