Resources: Human Subjects
Resources: UCSD and UCSF
- Lucille Pearson, Director, Human Subjects Program; X44520; lpearson@ucsd.edu
Room 202, University Center (mail code 0052); FAX: 619-534-5725
- UCSF Committee on Human Research (CHR)
Institutional Review Board (IRB) [Office of Research Affairs (ORA) Home Page; News; About the CHR; UCSF Policies and Procedures; Federal Regulations, Policies, and Reports; Helpful Hints; Guidelines; Forms; Updated 01.06.00]
- Department of Epidemiology and Biostatistics
provides a list of Web sites useful to researchers
History
- Brieger GH (1978): Human Experimentation: History. In: Encyclopedia of Bioethics, Macmillan, New York, pp. 684-692.
- Faden RR, Beauchamp TL, King NMP (1990): A History and Theory of Informed Consent. Oxford University Press.
- Fennell P (1995): Treatment without Consent: Law, Psychiatry and the Treatment of Mentally Disordered People since 1845. Routledge.
- Lederer SE (1995): Subjected to Science: Human Experimentation in America Before the Second World War. Johns Hopkins University, Baltimore.
- Rothman DJ (1995): Research, Human: Historical Aspects. In: Encyclopedia of Bioethics, Simon & Schuster Macmillan, New York, revised edition, pp. 2248-2258.
Ethics and Human Research
- Annas GJ (1998): Some Choice: Law, Medicine, and the Market. Oxford University Press.
- Beecher HK (1966): Ethics and clinical research. New Engl J Med 274: 1354-1360.
- Bibliography, National Library of Medicine: Ethical Issues
http://www.nlm.nih.gov/pubs/cbm/hum_exp.html
- Brieger GH (1978): Human Experimentation: History. In: Encyclopedia of Bioethics, Macmillan, New York, pp. 684-692.
- Brody BA (1998): The Ethics of Biomedical Research: An International Perspective. Oxford University Press.
- Emanuel EJ, Wendler D, Grady C (2000): What Makes Clinical Research Ethical? Journal of the American Medical Association 283(20): 2701-2711.
- Jones JH (1993): Bad Blood: The Tuskegee Syphilis Experiment. Free Press, New York.
- Levine RJ (1988): Ethics and Regulation of Clinical Research. 2nd Edition, Yale University Press, New Haven, CT.
- Lock S, Wells F, eds. (1997): Fraud and Misconduct in Medical Research, 2nd Edition. Login Brothers Book Company.
- National Reference Center for Bioethics Literature (Kennedy Institute of Ethics, Georgetown University)
http://bioethics.georgetown.edu
- Rivers E, Schumann SH, Simpson L, Olansky S (1953): Twenty years of followup experience in a long-range medical study. Public Health Reports 68(4): 391-395.
- Rothman DJ (1995): Research, Human: Historical Aspects. In: Encyclopedia of Bioethics, Simon & Schuster Macmillan, New York, revised edition, pp. 2248-2258.
- Sieber JE (1993): Ethical considerations in planning and conducting research on human subjects. Academic Medicine 68(9)(suppl.): S9-S13.
- Smith T (1999): Ethics in Medical Research: A Handbook of Good Practice. Cambridge University Press.
- Vanderpool HY (1996): The Ethics of Research Involving Human Subjects: Facing the 21st Century. University Publishing Group, Frederick, Maryland, 531 pp.
- Weijer C, Dickens B, Meslin EM (1997): Bioethics for clinicians: 10. Research ethics. Canadian Medical Association Journal 156(8):1153-7.
- Weisstub DN, ed. (1998): Research on Human Subjects : Ethics, Law, and Social Policy. Elsevier Science.
Guidelines for Research with Human Subjects
Regulations and Oversight
- DHHS (2000): Protection of Human Subjects, Title 45 Part 46
http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html
- FDA (2000): Institutional Review Boards, Title 21 Part 56
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr56_00.html
- FDA (2000): Protection of Human Subjects, Title 21 Part 50
http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfr50_00.html
- Levine RJ (1990): Ethics and Regulation of Clinical Research. Yale University Press.
- NIH (2000): Required education in the protection of human research participants. Notice OD-00-039, June 5, 2000
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html
- Office for Human Research Protections (OHRP)
http://ohrp.osophs.dhhs.gov
- Office for Protection from Research Risks (OPRR) (1993): Protecting Human Research Subjects: Institutional Review Board Guidebook. US Government Printing Office, Washington, DC.
http://ohrp.osophs.dhhs.gov/irb/irb_guidebook.htm
- United States Government (1997): Oversight of NIH and FDA: Bioethics and the Adequacy of Informed Consent: Hearing before the Subcommittee on Human Resources of the Committee on Government Reform and Oversight, House of Representatives, One Hundred Fifth Congress, First Session. United States Government Printing Office.
Informed Consent
- Appelbaum PS (1987): Informed Consent: Legal Theory and Clinical Practice. Oxford University Press.
- Bartone JC (1994): Consumer Reference Book and Index about Informed Consent. Abbe Pub Assn of Washington DC.
- Braun WO (1988): Jurisprudence and Informed Consent: Index of Modern Information. Abbe Pub Assn of Washington DC.
- Getz K (Allen W, ed.) (1999): Informed Consent: A Consumer's Guide to the Risks and Benefits of Volunteering for a Clinical Trial. CenterWatch.
- Glantz LH, Grodin MA, eds. (1994): Children as Research Subjects: Science, Ethics and Law. Oxford University Press.
- Grundner TMM (1986): Informed Consent: A Tutorial. National Health Publishing.
- Kahn JP, Mastroianni AC,Sugarman J, eds. (1998): Beyond Consent: Seeking Justice in Research. Oxford University Press.
- Keyes WN (1995): Life, Death, and the Law: A SourceBook on Autonomy and Responsibility in Medical Ethics. Charles C Thomas Publisher, Limited.
- Mazur DJ (1998): Medical Risk and the Right to an Informed Consent in Clinical Care and Clinical Research. American College of Physician Executives.
- McLean SAM (1989): A Patient's Right To Know: Information Disclosure, the Doctor and the Law. Ashgate Publishing Company.
- Norris D (1996): Glossary of Lay Language Synonyms for Common Terms Used in Informed Consent Documents for Clinical Studies: A Handbook for Clinical Researchers. Plexus Publishing.
- Robison WL, Pritchard MS, eds. (1979): Medical Responsibility: Paternalism, Informed Consent, and Euthanasia. Humana Press.
- Rozovsky FA (1998): Consent to Treatment: A Practical Guide. Aspen Publishers, Inc.
- Switankowsky IS (1998): A New Paradigm for Informed Consent. University Press of America.
- Tomes JP (1993): Informed Consent: A Guide for the Healthcare Professional. Healthcare Financial Management Educational Foundation.
- Wear S (Engelhardt HT, Wildes KW, eds.) (1998): Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care. Georgetown University Press.
Competence and Informed Consent
- Grisso T, Appelbaum PS (1998): Assessing Competence to Consent to Treatment: A Guide for Physicians and Other Health Professionals. Oxford University Press.
- Grisso T, Appelbaum PS (1998): MacArthur Competence Assessment Tool for Treatment. Professional Resource Exchange.
- Grubb A, ed. (1994): Decision-Making and Problems of Incompetence. Wiley, John & Sons.
- Lidz CW, Meisel A, Roth LH (1997): Informed Consent: A Study of Decision-Making in Psychiatry. Guilford P.
- Melton GB, Saks MJ, Koocher GP, eds. (1983): Children's Competence to Consent. Perseus Books.
- National Bioethics Advisory Commission (NBAC) report (1998): Research Involving Persons with Mental Disorders That May Affect Decisionmaking Capacity
- Oldham JM, Haimowitz S, Delano SJ (1999): Protection of persons with mental disorders from research risk: A response to the report of the National Bioethics Advisory Commission. Archives of General Psychiatry 56: 688-696 (plus commentaries and reply, 697-704).
- White BC (1994): Competence to Consent. Georgetown University Press.
Other
- Chapman AR (1997): Health Care and Information Ethics: Protecting Fundamental Human Rights. Sheed & Ward.
- Hellman S, Hellman DS (1991): Of mice but not men: Problems of the randomized clinical trial. New Eng J Med 324: 1585-1589.
- McLean S (1999): Old Law, New Medicine: Medical Ethics and Human Rights. Rivers Oram Press.
- Shimm DS, Buchanan AD, Spece RG, Jr., eds. (1996): Conflicts of Interest in Clinical Practice and Research. Oxford University Press.
- Research Subjects Protection Programs, University of Washington
http://eduserv.hscer.washington.edu/bioethics/resource
U of W School of Medicine Bioethics Resources Index [Mail to: The Bioethics Education Project; c/o The Department of Medical History and Ethics; Box 357120; University of Washington School of Medicine; Seattle, WA 98195; Fax: (206) 685-7515]
- University of Minnesota: Research Subjects Protection Programs
http://www.research.umn.edu/subjects/index.html
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