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[6] Kipnis K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., p. G5. [7] Negli ultimi anni, diversi autori hanno affrontato il tema dello sfruttamento nella ricerca biomedica e nei trial clinici, con particolare riferimento ai paesi in via di sviluppo ed alla ricerca sull'AIDS. Si veda, per esempio, Angell M., The ethics of clinical research in the Third World, The New England Journal of Medicine 1997, 337: 847-849; Lurie P. and Wolf S.,Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries, ibid.: 853-856; Varmus H. and Satcher D., Ethical complexities of conducting research in developing countries,ibid.: 1000-1005; Savulescu J., On the commercial exploitation of participants of research, Journal of Medical Ethics 1997, 23: 392; Resnick D., The ethics of HIV research in developing nations, Bioethics 1998, 12: 286-306; Mbidde E.,Bioethics and local circumstances, Science 1998, 279: 155; Benatar S.R., Avoiding exploitation in clinical research, Cambridge Quarterly of Healthcare Ethics 2000, 9: 562-565; Bhagat K. and Nyazema N., Ethics and HIV research in Zimbabwe, Central African Journal of Medicine 2000, 46: 105-107; Mullings A., Genetic research in the Third World (developing) countries: science or exploitation?, St. Thomas Law Review 2001, 13: 955-964; Miller F. and Brody H.,What makes clinical trials unethical?, American Journal of Bioethics 2002, 2(2): 2-10; Resnik D.B., Exploitation and the ethics of clinical trials, ibid.: 28-30; Agrawal M., Voluntariness in clinical research at the end of life, Journal of Pain Symptoms Management 2003, 25: S25-S32; e Lee S. and Kristjanson L., Human research ethics committees: issues in palliative care research, International Journal of Palliative Nursing 2003, 9: 13-18. [8] Macklin R., After Helsinki: unresolved issues in international research, Kennedy Institute of Ethics Journal 2001, 11: 17-36, pp. 23.25. [9] Resnik D.B., Exploitation in biomedical research, Theoretical Medicine and Bioethics 2003, 24: 233-259. [10] Ivi, p. 234. [11] Giovanni Paolo II, Esortazione apostolica post-sinodale Reconciliatio et paenitentia (2 Dicembre 1984), 17, in: Acta Apostolicae Sedis 1985, 77: 185-275, p. 221; citata in: Id., Lettera enciclica Veritatis splendor (6 Agosto1993), 80, in: Acta Apostolicae Sedis 1993, 85: 1133-1228, p. 1197. [12] Concilio Ecumenico Vaticano II, Costituzione pastorale sulla Chiesa nel mondo contemporaneo Gaudium et spes (7 Dicembre 1965), 27. [13] Cf. Kant I., Grundlegung zur Metaphysik der Sitten, Lipsia: Hartknoch, 1785 (Fondazione della metafisica dei costumi [trad. di F. Gonnelli], Bari: Laterza, 2a ed., 2002, p. 91). [14] Giovanni Paolo II, Veritatis splendor, 81, in: Acta Apostolicae Sedis 1993, 85, p. 1198. [15] Reeve A. (ed.), Modern Theories of Exploitation, Beverly Hills, CA: Sage Publications, 1987; Feinberg J., Harmless Wrongdoing, New York, N.Y.: Oxford University Press, 1988; Wood A., Exploitation, Social Philosophy and Policy 1995, 12: 136-150; Holmstrom N., Exploitation, Canadian Journal of Philosophy 1997, 7: 353-370; Carling A., Exploitation, in: Chadwick R. (ed.), Encyclopedia of Applied Ethics, San Diego, CA: Academic Press, 1998, vol. 2, pp. 219-232; Arneson R.,Exploitation, in: Becker L. and Becker C. (eds.), Encyclopedia of Ethics, New York, N.Y.: Routledge, 2001, vol. 1, pp. 515-517. [16] Secondo Wertheimer, sfruttare qualcuno in modo iniquo implica sempre trarre da costui un vantaggio non giusto destinato allo stesso sfruttatore: Wertheimer A., Exploitation, Princeton, NJ: Princeton University Press, 1996, p. 10. [17] Resnik D.B., Exploitation in biomedical research, op. cit., p. 240. [18] Ivi, p. 243. [19] Edwards S.D., An argument against research on people with intellectual disabilities, Medicine, Health Care and Philosophy 2000, 3: 69-73, p. 70. [20] Cf. Evans D. and Evans M., A Decent Proposal, op. cit., p. 17. [21] Agrawal M., Voluntariness in clinical research at the end of life, op. cit., p. S29. [22] Una discussione utile sul concetto di rischio si trova in Van Ness P.H., The concept of risk in biomedical research involving human subjects, Bioethics 2001, 15: 364-370, e nella bibliografia citata dall'Autore. [23] Berg J.W., Legal and ethical complexities of consent with cognitively impaired research subjects: proposed guidelines, Journal of Law and Medical Ethics 1996, 24: 18-35, p. 24. [24] Levine R., Balance of Harms and Benefit. Ethics and Regulation of Clinical Research, New Haven: YaleUniversity Press, 2nd ed., 1988, pp. 37-65. [25] Si veda, tra gli altri, The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioural Research, Implementing Human Research Regulation: The Adequacy and Uniformity of Federal Rules and of Their Implementations, Washington, D.C.: U.S. Government Printing Office, 1983; National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, op. cit., vol. 1. [26] Lemberger L., Early clinical evaluation in man: the buck stops here, Xenobiotica 1987, 17: 267-273; Weijer C. and Fuks A., The duty to exclude: excluding people at undue risk from research, Clinical and Investigative Medicine 1994, 17: 115-122; Elliott C., Doing harm: living organ donors, clinical research and The Tenth Man, Journal of Medical Ethics 1995, 21: 91-96; Groudine S. and Lumb P.D., At the coalface – medical ethics in practice. First, do no harm, Journal of Medical Ethics 1997, 23: 377-378; London A.J. and Kadane J.B., Placebos that harm: sham surgery controls in clinical trials, Statistical Methods in Medical Research 2002, 11: 413-427. [27] I danni psicologici includono anche l'angoscia, l'irritazione o il senso di colpa che possono nascere dalla rivelazione di informazioni imbarazzanti, e l'ansia ed il timore che conseguono alla scoperta della probabilità di sviluppare una malattia per la quale non esiste un trattamento efficace: Glass, K.C., Weijer C., Lemmens T., Palmour R.M., and Shapiro S.H., Structuring the Review of Human Genetics Protocols, Part II: Diagnostic and Screening Studies, IRB: A Review of Human Subjects Research 1997, 19(3-4): 1-13; Marteau T.M. and Croyle R.T., Psychological Responses to Genetic Testing, British Medical Journal 1998, 316: 693–696; Meiser, B., and Dunn S., Psychological Impact of Genetic Testing for Huntington’s Disease: An Update of the Literature, Journal of Neurology, Neurosurgery and Psychiatry 2000, 69: 574-578. [28] Kessel E., Estimating risks and benefits in AIDS vaccine and drug trials, AIDS Public Policy Journal 1990, 5: 186-188; Institute of Medical Ethics – Working Party on the Ethical Implications of AIDS, AIDS, ethics, and clinical trials, British Medical Journal 1992, 305: 699-701; Beloqui J., Chokevivat V., and Collins C., HIV vaccine research and human rights: examples from three countries planning efficacy trials, Health and Human Rights 1998, 3: 38-58; Leider P.A.,Domestic AIDS vaccine trials: addressing the potential for social harm to the subjects of human experiments, California Law Review 2000, 88: 1185-1232. [29] Wertz D.C. and Fletcher J.C., Privacy and disclosure in medical genetics examined in an ethics of care, Bioethics 1991, 5: 212-232; Weil J. and MacKay C.R., Howard: paternity and Pandora's box, Cambridge Quarterly of Healthcare Ethics 1993, 2: 229-237; Ross L.F., Disclosing misattributed paternity, Bioethics 1996, 10:114-130; Ritter M.M., Genetic testing and paternity, Lancet 2001, 358: 241; Lucassen A. and Parker M., Revealing false paternity: some ethical considerations, Lancet 2001, 357: 1033-1035. [30] Diamond A.L. and Laurence D.R., Compensation and drug trials, British Medical Journal 1983, 287: 675-677; Guest S., Compensation for subjects of medical research: the moral rights of patients and the power of research ethics committees, Journal of Medical Ethics 1997, 23:181-185. [31] Fitzgerald J.L. and Hamilton M., The Consequences of knowing ethical and legal liabilities in illicit drug research, Social Science and Medicine 1996, 43: 1591-1600; Id., Confidentiality, disseminated regulation and ethico-legal liabilities in research with hidden populations of illicit drug users, Addiction 1997, 92: 1099-1107; Loxley W., Hawks D., and Bevan J., Protecting the interests of participants in research into illicit drug use: two case studies, Addiction 1997, 92:1081-1085; Kinard E.M., Ethical issues in research with abused children, Child Abuse and Negligence 1985, 9: 301-311. [32] Giovanni Paolo II, Esortazione apostolica postsinodale Ecclesia in America (22 Gennaio 1999), 57, in: Acta Apostolicae Sedis 1999, 91:737-815, p. 792. A questa concezione, che vede i diritti umani profondamente radicati nella dignità di ogni individuo, si contrappone la «“interests” theory of rights» – frequentemente proposta nel contesto del dibattito sull'aborto (si veda, per esempio, Purdy L. and Tooley M., Is abortion murder?, in: Perkins R. (ed.), Abortion: Pro and Con, Cambridge, Massachusetts: Schenkman, 1974, p. 144) – secondo cui un essere può avere dei diritti solo se è in grado di avere "desideri coscienti" o "interessi". Su questo presupposto, gli embrioni e i feti umani non sono titolari di diritti umani inalienabili, neppure del diritto alla vita, allo sviluppo ed alla integrità fisica. Rifacendosi a questa teoria, Feinberg sostiene che qualcuno è danneggiato solo quando i suoi interessi sono stati contrastati, umiliati, invasi o abbattuti (Feinberg J., Harm to Others, New York: Oxford University Press, 1984, pp. 31–64). Questa definizione permetterebbe di includere un numero virtualmente illimitato di danni che i soggetti coscienti potrebbero lamentare e, invece, di escludere il danno più devastante inferto agli individui non coscienti. L'approccio "per interessi" alla fondazione dei diritti mostra tutta la sua debolezza quando è messo a confronto con la questione morale della obbligazione a riconoscere e rispettare i diritti di un altro essere. Il solo fatto che qualcuno possiede, o è capace di avere, desideri e interessi non è ovviamente una ragione sufficiente perché ciascuno di noi accondiscenda a questi desideri e protegga questi interessi. [33]Giussani L., Il senso religioso, Milano: Rizzoli, 1997, pp. 8-9. [34] Ivi, p. 14. [35] Kant I., Fondazione della metafisica dei costumi, op. cit., p. 91. Una lucida discussione intorno a questa affermazione nel contesto della teoria morale di Kant si trova in Hill T.E. Jr., Humanity as an end in itself, Ethics 1980, 91: 84-90 e in Cooper N, The Formula of the end in itself, Philosophy 1988, 63: 401-415. [36] Concilio Ecumenico Vaticano II, Gaudium et spes, 51. [37] Giovanni Paolo II, Veritatis splendor, 50, in: Acta Apostolicae Sedis 1993, 85, p. 1173. [38] Riportiamo, tra i molti, Brazier M. and Lobjoit M. (eds.), Protecting the Vulnerable: Autonomy and Consent in Health Care, New York, N.Y.: Routledge, 1991; Thomasma D.C., A communal model for presumed consent for research on the neurologically vulnerable, Accountability in Research 1996, 4: 227-239; Brody B., Research on the vulnerable sick, in: Kahn J.P., Mastrioanni A.C., and Sugarman J. (eds.), Beyond Consent: Seeking Justice in Research, New York, N.Y.: Oxford University Press, 1998, pp. 32-46; Dennis B.P., The origin and nature of informed consent: experiences among vulnerable groups, Journal of Professional Nursing 1999, 15: 281-287; Udo, S., Protecting the vulnerable: testing times for clinical research ethics, Social Science and Medicine 2000, 51: 969-977; Nicholson R., Who is vulnerable in clinical research?, Bulletin of Medical Ethics 2002 (181): 19-24; Steinbock B., Arras J.D., and London A.J., Ethical Issues in Modern Medicine, Boston, MA: McGraw-Hill, 2003; e Eckstein S. (ed.), Manual for Research Ethics Committees, Cambridge, UK – New York, N.Y.: Cambridge University Press, 6th ed., 2003. [39] Kipnis K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., pp. G7-G12. [40] Si veda, per esempio, National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, op. cit., vol. 1, pp. 90-91. [41] Grant V.J., Consent in paediatrics: a complex teaching assignment,Journal of Medical Ethics 1991, 17:199-204; Dorn L.D., Susman E.J., and Fletcher J.C., Informed consent in children and adolescents: age, maturation and psychological state, Journal of Adolescent Health 1995, 16: 185-190; Cohen D., Flament M., Taieb O., Thompson C., and Basquin M.,Electroconvulsive therapy in adolescence, European Journal of Child and Adolescent Psychiatry 2000, 9: 1-6; Dickey S.B., Kiefner J., and Beidler S.M., Consent and confidentiality issues among school-age children and adolescents, Journal of School Nursing 2002, 18: 179-186. [42] Freedman R.I., Ethical challenges in the conduct of research involving persons with mental retardation, Mental Retardation 2001, 39: 130-41. [43] Keyserlingk E.W., Glass K., Kogan S., and Gauthier S., Proposed guidelines for the participation of persons with dementia as research subjects, Perspectives in Biology and Medicine 1995, 38:319-361; Karlawish J.H. and Casarett D.,Addressing the ethical challenges of clinical trials that involve patients with dementia,Journal of Geriatric Psychiatry and Neurology 2001, 14: 222-228. [44] Bruera E., Miller L., McCallion J., Macmillan K., Krefting L., and Hanson J., Cognitive failure in patients with terminal cancer: a prospective study,Journal of Pain Symptomatology Management 1992, 7: 192-195; Appelbaum P.S., Grisso T., Frank E., O'Donnell S., and Kupfer D.J., Competence of depressed patients for consent to research,American Journal of Psychiatry 1999, 156: 1380-1384; Carpenter W.T. Jr, Gold J.M., Lahti A.C., Queern C.A., Conley R.R., Bartko J.J., Kovnick J., and Appelbaum P.S., Decisional capacity for informed consent in schizophrenia research,Archives of General Psychiatry 2000, 57: 533-538; Kim S.Y., Cox C., and Caine E.D., Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research, American Journal of Psychiatry. 2002, 159: 797-802; Kim S.Y., Karlawish J.H., and Caine E.D., Current state of research on decision-making competence of cognitively impaired elderly persons, American Journal of Geriatric Psychiatry 2002, 10: 151-165. [45] Ashcroft R.E., Chadwick D.W., Clark S.R., Edwards R.., Frith L., and Hutton J.L., Implications of socio-cultural contexts for the ethics of clinical trials, Health Technology Assessment 1997, 1(9): 1-65. [46] Smithline H.A., Mader T.J., and Crenshaw B.J., Do patients with acute medical conditions have the capacity to give informed consent for emergency medicine research?,Academic Emergency Medicine 1999, 6: 776-780. [47] Trout M.E.,Should research in prisons be barred?, Journal of Legal Medicine 1974, 2: 2-10; DeRiemer T.A., Human research in Connecticut prisons, Connecticut Medicine 1975, 39: 387-391; White L.P., Biomedical experimentation on prisoners, Western Journal of Medicine 1976, 124: 514-516; Somerville M.A., Criminality, confinement, psychiatric care and consent: a dilemma augmenting combination, Legal Medicine Quarterly 1981-1983, 5-7: 147-159; Dudley H.A.,Research ethics committees and military defence, Journal of the Royal College of Physicians (London) 1994, 28: 237-241; Regehr C., Edwardh M., and Bradford J., Research ethics and forensic patients, Canadian Journal of Psychiatry 2000, 45: 892-898 [si vedano anche i commenti a questa articolo apparsi sulla stessa rivista, 2002, 47: 384-386]. [48] Hewlett S., Consent to clinical research: adequately voluntary or substantially influenced?, Journal of Medical Ethics 1996, 22: 232-237; Harrell J.S., Bradley C., Dennis J., Frauman A.C., and Criswell E.S., School-based research: problems of access and consent, Journal of Pediatric Nursing 2000, 15: 14-21; Rothstein M.A., Ethical guidelines for medical research on workers, Journal of Occupational and Environmental Medicine 2000, 42: 1166-1171; Hayman R.M., Taylor B.J., Peart N.S., Galland B.C., and Sayers R.M., Participation in research: informed consent, motivation and influence,Journal of Paediatric and Children Health 2001, 37: 51-54; Pentz R.D., Flamm A.L., Sugarman J., Cohen M., Daniel Ayers G., Herbst R., and Abbruzzese J.L., Study of the media's potential influence on prospective research participants' understanding of and motivations for participation in a high-profile phase I trial, Journal of Clinical Oncology 2002, 20: 3785-3791. [49] Silverman H.J., Ethical considerations of ensuring an informed and autonomous consent in research involving the critically ill. American Journal of Respiratory Critical Care Medicine, 1996, 154: 582-586; Casarett D., Beyond vulnerability: the ethics of end-of-life research, Journal of Pain Symptoms Management 1999, 18: 143-145; Schutta K.M. and Burnett C.B., Factors that influence a patient's decision to participate in a phase I cancer clinical trial, Oncology Nursing Forum 2000, 27: 1435-1438; Ellis P.M., Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature, Annals of Oncology 2000, 11: 939-945; Bosk C.L., Obtaining voluntary consent for research in desperately ill patients, Medical Care 2002, 40(9 Suppl.): V64-V68; Casarett D.J., Knebel A., and Helmers K.,Ethical challenges of palliative care research, Journal of Pain Symptom Management 2003, 25: S3-S5; Karlawish J.H.T.,Conducting research that involves subjects at the end of life who are unable to give consent, ibid.: S14-S24. [50] Quanto lo sfruttamento della vulnerabilità economica, qualora associata alla vulnerabilità sociale, potesse risultare facile e pervasivo fu messo in luce chiaramente dallo scandalo dello studio sulla sifilide a Tuskegee(U.S. Department of Health, Education and Welfare, Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel, Washington, D.C.: U.S. Government Printing Office, 1973; Jones J.H., Bad Blood: The Tuskegee Syphilis Experiment, New York: Free Press, 2nd ed., 1993; Pence G., Classic Cases in Medical Ethics, New York: McGrow-Hill, 2nd ed., 1995, pp. 225-252). Lo studio, iniziato nel 1932, si protrasse per 40 anni, coinvolgendo 600 uomini afro-americani che abitavano nel Macon Country (Alabama), dei quali 399 erano affetti da sifilide e 201 erano sani. I ricercatori sfruttarono l'elevato grado di vulnerabilità dei soggetti – dovuto a indigenza, ignoranza e discriminazione razziale – senza fornire loro alcuna informazione sullo studio in atto e senza richiedere il consenso ad esso. Gli uomini ricevettero, come compenso per la partecipazione alla ricerca, l'accesso a cure mediche non legate alla malattia, alcuni pasti ed i mezzi di trasporto gratuiti, e, nelle fasi più avanzate dello studio, un contributo di 50 dollari per la sepoltura al fine di incoraggiare il consenso all'autopsia. La remunerazione per la partecipazione ad una ricerca è una pratica comune ma poco discussa. Per una riflessione critica sulla questione si veda Dickert N. and Grady C., What's the price of a research subject: approaches to payment for research participation, The New England Journal of Medicine 1999, 341: 198-203 e Anderson J.A. and Weijer C., The research subject as wage earner, Theoretical Medicine and Bioethics 2002, 23: 359-376. [51] Jayasuriya D.C., Law, ethics, and biomedical research involving human subjects in developing countries, Journal of Clinical Research and Drug Development 1989, 3: 83-88; Beauchamp T., Jennings B., Kinney E., and Levine R.,Pharmaceutical research involving the homeless, Journal of Medicine and Philosophy 2002, 27: 547-564. [52] Weijer C., Protecting communities in research: philosophical and pragmatic challenges, Cambridge Quarterly of Healthcare Ethics 1999, 8: 501–513. [53] National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants, op. cit., vol. 1, p. 90. Several aspects of social vulnerability are discussed in: Weisstub D.N., Arboleda-Florez J., and Tomossy G.F., Establishing the boundaries of ethically permissible research with special populations, Health and Law in Canada 1996, 17: 45-63; Dennis B.P., The origin and nature of informed consent: experiences among vulnerable groups, Journal of Professional Nursing 1999, 15: 281-287; Dyregrov K, Dyregrov A, Raundalen M., Refugee families' experience of research participation, Journal of Trauma Stress 2000, 13: 413-426. [54] Strong C., Ethical conflicts between mother and fetus in obstetrics, Clinical Perinatology 1987, 14: 313-328; Meyer K.C., Forced medical treatment in pregnancy: resolving the conflicting rights of mother and fetus, Medical Staff Counseling 1990, 4: 53-58; Mattingly S.S., The maternal-fetal dyad. Exploring the two-patient obstetric model, Hastings Center Report 1992, 22(1): 13-18; Pinkerton J.V. and Finnerty J.J., Resolving the clinical and ethical dilemma involved in fetal-maternal conflicts,American Journal of Obstetrics and Gynecology 1996, 175: 289-295; Chervenak F.A. and McCullough L.B., The fetus as a patient: an essential ethical concept for maternal-fetal medicine, Journal of Maternal and Fetal Medicine 1996, 5: 115-119; Flagler E., Baylis F., and Rodgers S., Bioethics for clinicians: 12. Ethical dilemmas that arise in the care of pregnant women: rethinking "maternal-fetal conflicts", Canadian Medical Association Journal 1997, 156: 1729-1732; Fasouliotis S.J. and Schenker J.G., Maternal-fetal conflict, European Journal of Obstetrics, Gynecology and Reproductive Biology 2000, 89: 101-107. [55] Kipnis K., Vulnerability in research subjects: a bioethical taxonomy, op. cit., pp. G1-G2. [56] Krugman S., Experiments at the Willowbrook State School,Lancet 1971, I: 966-967; Id., The Willowbrook hepatitis studies revisited: ethical aspects, Review of Infective Diseases 1986, 8: 157-62. [57] Faden R.R., Beauchamp T.L., and King N.M.P., A Historyand Theory of Informed Consent, New York – Oxford: OxfordUniversity Press, 1986, pp. 161-167; MacKlin R., Mortal Choices, New York: Pantheon, 1987, pp. 167-194. [58] Benedek, T.G., The Tuskegee study of syphilis: analysis of moral versus methodological aspects, Journal of Chronic Diseases 1978, 31: 35-50; King P.A., Edgar H., and Caplan A.L., Twenty years after. The legacy of the Tuskegee Syphilis Study, Hastings Center Report 1992, 22(6): 29-38; Corbie-Smith G., The continuing legacy of the Tuskegee Syphilis Study: considerations for clinical investigation, American Journal of Medical Sciences 1999, 317: 5-8; White R.M., Unraveling the Tuskegee Study of Untreated Syphilis,Archives of Internal Medicine 2000, 160: 585-598; Id., The Tuskegee syphilis study, Hastings Center Report 2002, 32(6): 4-5. |