Obtaining Informed Consent for Research With Psychiatric Patients: The Controversy Continues
Tài liệu tham khảo
1973
Annas, 1977
Appelbaum, 1982, Competency to consent to research: A psychiatric overview, Arch. Gen. Psychiatry, 29, 951, 10.1001/archpsyc.1982.04290080061009
Appelbaum, P. S., and Roth, L. H.: The structure of informed consent in psychiatric research. Behav. Sci. Law, in press
Appelbaum, 1982, The therapeutic misconception: Informed consent in psychiatric research, Int. J. Law Psychiatry, 5, 319, 10.1016/0160-2527(82)90026-7
Bigelow, L. B.: Research Using as Subjects Institutionalized Chronic Schizophrenic Patients: Issues Surrounding Consent and Refusal. Talk presented at the Conference on Public Responsibility in Medicine and Research, Asilomar, California, May 9, 1983
Brady, 1982, The evolution of regulatory influences on research with human subjects
Cardon, 1976, Injuries to research subjects. A survey of investigators, N. Engl. J. Med., 295, 650, 10.1056/NEJM197609162951205
Carroll, 1980, Research as an impetus to improved treatment, Arch. Gen. Psychiatry, 37, 377, 10.1001/archpsyc.1980.01780170019001
Chalkley, 1977, Federal constraints: Earned on unearned?, Am. J. Psychiatry, 134, 911, 10.1176/ajp.134.8.911
Cooke, R. A., and Tannenbaum, A. S.: A survey of institutional review boards and research involving human subjects. In Appendix to Report and Recommendations, Institutional Review Boards. Washington, D.C., The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. DHEW Publication No. (OS) 78-0009, November 1, 1977
Court holds Maryland prison vaccine testing program constitutional. IRB, 1:10, October 1979
1981, Final regulations amending basic HHS policy for the protection of human research subjects, Federal Register, 46, 8366
1979, Belmont Report: Ethical principles and guidelines for the protection of human subjects of research, Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Federal Register, 44, 23192
1978, Protection of human subjects. Proposed regulations on research involving those institutionalized as mentally disabled, Federal Register, 43, 53950
1978, Protection of human subjects. Research involving those institutionalized as mentally infirm: Report and recommendations for public comment, Federal Register, 43, 11328
Eisenberg, 1977, The social imperatives of medical research. Impeding medical research, no less than performing it, has ethical consequences. Not to act is to act, Science, 198, 1105, 10.1126/science.337491
Fletcher, 1973, Realities of patient consent to medical research, Hastings Center Studies, 1, 39, 10.2307/3527472
Frenkel, 1977, Human experimentation: Codes of ethics, Leg. Med. Q., 1, 7
Goldiamond, 1976, Protection of human subjects and patients: A social contingency analysis of distinctions between research and practice, and its implications, Behaviorism, 4, 1
Gray, 1978, Complexities of informed consent, Am. Acad. Pol. Soc. Sci., 437, 37, 10.1177/000271627843700104
Gray, 1978, Research involving human subjects. The performance of institutional review boards is assessed in this empirical study, Science, 201, 1094, 10.1126/science.356268
Greenwald, 1982
Gruenberg, 1967, The social breakdown syndrome—Some origins, Am. J. Psychiatry, 123, 1481, 10.1176/ajp.123.12.1481
Grundner, 1981, How to make consent forms more readable, IRB, 3, 9, 10.2307/3563861
Heath, 1979, The IRB’s monitoring function: Four concepts of monitoring, IRB, 1, 1, 10.2307/3564385
Illinois lawsuits resolved by guidelines on research with mentally ill. IRB, 1:8, October 1979
Kaimowitz v. Department of Mental Health for the State of Michigan. No. 73–19434–AW (Mich. Cir. Ct., Wayne County, July 10, 1973). Mental Disability Law Reporter, 1:147, 1976
Kalman, 1982, A controlled study of satisfaction among psychobiology research patients, Am. J. Psychiatry, 139, 344, 10.1176/ajp.139.3.344
Ketai, 1981, Family influence in the recruitment of schizophrenic research subjects, Am. J. Psychiatry, 138, 351, 10.1176/ajp.138.3.351
Kocsis, 1981, The effect of psychobiological research on treatment outcome. A controlled study, Arch. Gen. Psychiatry, 33, 511, 10.1001/archpsyc.1980.01780300023002
Levine, 1981
Lidz, 1983
Lidz, 1983, The signed form—Informed consent?
Lipsett, 1982, On the nature and ethics of phase 1 clinical trials of cancer chemotherapies, J.A.M.A., 248, 941, 10.1001/jama.1982.03330080023022
Lubasch, A. H.: Court is told to hold a trial in the death of drug test subject. New York Times, September 14, 1982, p. 7, col. 1
Macklin, 1981, “Due” and “undue” inducements: On paying money to research subjects, IRB, 3, 1, 10.2307/3564136
McCabe, 1977, Human rights and interviews, Arch. Gen. Psychiatry, 34, 1369, 10.1001/archpsyc.1977.01770230111011
McCrae, 1982, Are stress questionnaires stressful?, IRB, 4, 1, 10.2307/3564375
Meisel, 1983, Toward an informed discussion of informed consent: A review of the empirical studies, Ariz. Law Rev., 25, 265
Meisel, 1977, Toward a model of the legal doctrine of informed consent, Am. J. Psychiatry, 134, 285, 10.1176/ajp.134.3.285
Murphy, 1975, Total institutions and the possibility of consent to organic therapies, Human Rights, 5, 25
Ostfeld, 1980, Older research subjects: Not homogeneous, not especially vulnerable, IRB, 2, 7, 10.2307/3563997
Park, 1967, Effects of informed consent on research patients and study results, J. Nerv Ment. Dis., 145, 349, 10.1097/00005053-196711000-00001
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Compensating for Research Injuries. The Ethical and Legal Implications of Programs to Redress Injured Subjects. Volume One: Report. Govt. Print. Off. (No. 040-000-00455-6). Washington, D.C., Supt. of Docs., June 1982
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Protecting Human Subjects. The Adequacy and Uniformity of Federal Rules and Their Implementation. Govt. Print. Off. (No. 040-000-00452-1). Washington, D.C., Supt. of Docs., December 1981, p. 73
President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research: Second Biennial Report on the Implementing Human Research Regulation. The Adequacy and Uniformity of Federal Rules and of their Implementation. Washington, D.C., Govt. Print. Off, 1983
Prisoner loses suit claiming coercion to participate in research. IRB, 1:8, August/September 1979
Pryce, 1978, Clinical research upon mentally ill subjects who cannot give informed consent, B. J. Psychiatry, 133, 366, 10.1192/bjp.133.4.366
Public response critical of HEW regulations on mentally disabled. IRB, 1:8, April 1979
1970, Legal therapy for the doctor-patient relationship, Yale Law J., 79, 1533, 10.2307/795271
Riecken, 1982, Informed consent to biomedical research in Veterans Administration hospitals, J.A.M.A., 248, 344, 10.1001/jama.1982.03330030050025
Robbins, W.: Dioxin tests conducted on 70 Philadelphia inmates, now unknown, in 60 s. New York Times, July 17, 1983, p. 10, col. 1
Robertson, 1982, Taking consent seriously: IRB intervention in the consent process, IRB, 4, 1, 10.2307/3564226
Roth, 1982, Competency to decide about treatment or research. An overview of some empirical data, Int. J. Law Psychiatry, 5, 29, 10.1016/0160-2527(82)90013-9
Rothman, 1982, A new look at Tuskegee and Willowbrook, The Hastings Center Report, 12, 5, 10.2307/3561798
Sacks, 1974, Recovery from delusions. Three phases documented by patient’s interpretation of research procedures, Arch. Gen. Psychiatry, 30, 117, 10.1001/archpsyc.1974.01760070093015
Shah, S. A.: Personal communication, 1980
Siris, 1979, Intrapsychic structural effects of psychiatric research, Am. J. Psychiatry, 136, 1567, 10.1176/ajp.136.12.1567
Stanley, 1981, Preliminary findings on psychiatric patients as research participants: A population at risk?, Am. J. Psychiatry, 138, 669, 10.1176/ajp.138.5.669
1978, A statement of principles of ethical conduct for neuropsychopharmacologic research in human subjects
X-rays beamed on prisoners to test sterility by radiation. New York Times, February 29, 1976, p. 37, col. 1