Codes of ethics
Financial conflicts of interest
Institutional Review Boards
Resources on major problems in human experiments
Cancer resources
Fred Hutchinson Cancer Research Center
Books/articles
New government actions
Lawsuit
Codes of ethics
Nuremberg Code
Directives for Human Experimentation (1949)
Belmont Report
Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979)
Declaration of Helsinki
Ethical Principles for Medical Research Involving Human Subjects
Comparison Chart 1996 to 2000.
(Requires Adobe Acrobat).
Protection Of Human Subjects -- Federal Regulations
45 CFR 46 (Rev. 1999)
Financial Relationships in Clinical Research
DRAFT Interim Guidance (2001)
National Bioethics Advisory Commission (NBAC)
Presidential board on human research ethics
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Financial conflicts of interest
The New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No. 20
Uneasy Alliance -- Clinical Investigators and the Pharmaceutical Industry
Thomas Bodenheimer
New England Journal of Medicine -- May 18, 2000 -- Vol. 342, No. 20
Is Academic Medicine for Sale?
Marcia Angell, M.D.
The New England Journal of Medicine -- September 14, 2000 -- Vol. 343, No. 11
Protecting Research Subjects -- What Must Be Done
Donna Shalala
Moore v. Regents of University of California.
California Supreme Court case saying physicians must disclose conflicts of interest that can affect patient care. One of the few cases on informed consent to arise from medical research.
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Institutional Review Boards
Journal of the American Medical Association, Dec. 9, 1998 -- Vol. 280 No. 22
Updating Protections for Human Subjects Involved in Research
Jonathan Moreno, Ph.D.; Arthur L. Caplan, Ph.D.; Paul Root Wolpe, Ph.D.; and the Members of the Project on Informed Consent, Human Research Ethics Group
Dr. Greg Koski, Director, Office for Human Research Protections, Sept. 28, 2000
Testimony to Congress
http://ohrp.osophs.dhhs.gov/references/tkoski.htm
Public Responsibility in Medicine and Research
www.primr.org/
Applied Research Ethics National Association
www.primr.org/arena.html
Community of Science
www.cos.com/
Conseil National d'Éthique en Recherche chez l'Humain
www.ncehr.medical.org/Francais/mstr_frmf.html
Department of Energy - Protection of Human Subjects Page
www.er.doe.gov/production/ober/humsubj/
FDA News and Publications
www.fda.gov/opacom/hpnews.html
FDA - IRB Operations and Clinical Investigation Requirements
www.fda.gov/oc/oha/IRB/toc.html
Online Resource for Instruction in Responsible Conduct of Research
http://rcr.ucsd.edu/
FDA Guidance on Informed Consent for Institutional Review Boards and Clinical Investigators
(1998 updates)
www.fda.gov/oc/ohrt/irbs/default.htm
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Resources on major problems in human experiments
United States Holocaust Memorial Museum
Trial of Nazi doctors for war crimes in human experimentation
Thalidomide Victims Association of Canada
Thalidomide prescribed while an experimental drug causes birth defects
Department of Energy
Human radiation experiments
Washington Post: The Body Hunters
A Washington Post series on overseas clinical trials (Dec. 2000).
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Cancer resources
American Cancer Society
1-800-ACS-2345
www.cancer.org
Cancer Information Service
1-800-4-CANCER
http://cis.nci.nih.gov/
National Cancer Institute
301-435-3848
www.nci.nih.gov/
National Comprehensive Cancer Network
www.nccn.org/
International Bone Marrow Transplant Registry
www.ibmtr.org
Cancer information
cancer.gov/cancerinformation
Fred Hutchinson Cancer Research Center
www.fhcrc.org
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Books/Articles
Gene Dreams: Wall Street, Academia, and the Rise of Biotechnology. Robert Teitelman. Basic Books, New York (1989)
Magic Bullets: The Most Exciting Adventure in the Annals of Modern Medicine: The Coming Revolution in Cancer Therapy. Grant Fjermedal. MacMillan Publishing, New York (1984)
Patient Number One: A True Story of How One CEO Took on Cancer and Big Business in the Fight of His Life. Rick Murdock and David Fisher. Crown Publishers, New York (2000)
The Golden Helix: Inside Biotech Ventures. Arthur Kornberg. University Science Books, Sausalito, Calif. (1995)
Natural Obsessions: The Search for the Oncogene. Natalie Angier. Houghton Mifflin, Boston (1988)
Natural Obsessions: Striving to Unlock the Deepest Secrets of the Cancer Cell. Natalie Angier. Houghton Mifflin, Boston (1999)
D. Christian Addicott, "Regulating Research on the Terminally Ill: A
Proposal for Heightened Safeguards," 15 Journal of Contemporary Health Law and Policy 479
(1999).
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New government actions
The May 23 hearing of the Senate Subcommittee on Public Health was canceled at the last minute due to other Senate business. It will be rescheduled at an unspecified date. The Seattle Times obtained written versions of testimony that was to have been presented, including an 11-page statement (2.9MB PDF) by the United States General Accounting Office outlining recent government actions on patient-consent and financial conflicts-of-interest in clinical trials, and expressing concern about the lack of progress in key areas.
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Lawsuit
A leading patient-advocate attorney and two Seattle law firms have filed a class-action suit against the Fred Hutchinson Cancer Research Center, claiming it violated laws overseeing ethics, human-subjects research and consumer protection when it conducted research involving cancer patients. You can read about the lawsuit at www.sskrplaw.com/gene/wright/.
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