This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
World Medical Association, World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects.
Committee on Assessing the System for Protecting Human Research Subjects. Preserving Public Trust: Accreditation and Human Research Participant Protection Programs. Washington, DC: National Academy Press, 2001.
Lo B, Wolf LE. Ethical issues in clinical research: an issue for all internists. Am J Med 2000; 109:82–85.
Steinbrook R. Protecting research subjects—the crisis at Johns Hopkins. N Engl J Med 2002;346:716–20.
Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346:1425–30.
National Bioethics Advisory Commission. Ethical and Policy Issues in Research Involving Human Participants. Bethesda, MD: National Bioethics Advisory Commission, 2001.
McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting G. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003;290:360–366.
Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med 2002;346:1405–1408.
Tully S. The Party’s Over. Fortune June 26, 2000: 156.
Committee on Assessing the System for Protecting Human Research Subjects. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academies Press, 2002.
Moses H, Martin JB. Academic relationships with industry: a new model for biomedical research. JAMA 2001;285:933–935.
Friedman LS, Richter ED. Relationship between conflicts of interest and research results. J Gen Intern Med 2004;19:51–56.
Bekelman JE, Li Y, Gross CP. Scope and impact of financial conflicts of interest in biomedical research: a systematic review. JAMA 2003;289:454–465.
Van Kolfschooten F. Can you believe what you read? Nature 2002;416:360–363.
Rennie D, Flanagin A. Publication bias; the triumph of hope over experience. JAMA 1991;267:411–412.
Rennie D, Flanagin A. Conflicts of interest in the publication of science. JAMA 1991;266:266–267.
Rennie D, Flanagin A. Thyroid storm. JAMA 1997;277:1238–1243.
Rennie D, Flanagin A, Yank V. The contributions of authors. Jama 2000;284:89–91.
Chopra SS. Industry Funding of Clinical Trials: Benefit or Bias? JAMA 2003;290:113–114.
Dong BJ, W.W. H, Gambertoglio JG, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA 1997;277:1205–1213.
Kahn JO, Cherng DW, Mayer K, Murray H, S. L. Evaluation of HIV-immunogen, an immunologic modifier, administered to patients infected with HIV having 300 to 549 × 106/L CD4 cell counts. JAMA 2000;284:2193–2202.
Schulman KA, Seils DM, Timbie JW, et al. A national survey of provisions in clinical-trial agreements between medical schools and industry sponsors. N Engl J Med 2002;347:1335–1341.
DeAngelis CD, Fontanarosa PB, Flanagin A. Reporting financial conflicts of interest and relationships between investigators and research sponsors. JAMA 2001;286:89–91.
Association of American Medical Colleges, Protecting subjects, preserving trust, promoting progress: policy and guidelines for the oversight of individual financial interests in human subjects research.
King NMP. Defining and Describing Benefit Appropriately in Clinical Trials. Journal of Law, Medicine, and Ethics 2000;28:332–343.
Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet 2001;358:1772–7.
Joffe S, Weeks JC. Views of American clinical oncologists about the purpose of clinical trials. J Natl Cancer Inst 2002;94:1847–53.
Peppercorn JM, Weeks JC, Cook EF, Joffe S. Comparison of outcomes in cancer patients treated within and outside clinical trials: conceptual framework and structured review. Lancet 2004;363:263–270.
Churchill LR, Nelson DK, Henderson GE, et al. Assessing benefits in clinical research: why diversity in benefit assessment can be risk. IRB 2003;3:1–8.
Kodish E, M. E, Noll RB, et al. Communication of randomization in childhood leukemia trials. JAMA 2004;291:494–496.
RAC Informed Consent Working Group. NIH Guidance on Informed Consent For Gene Transfer Research. NIH Office of Biotechnological Activities. Updated Accessed March 2004
Horng S, Emanuel E, Wilfond B, Rackoff J, Martz K, Grady C. Descriptions of benefits and risks in consent forms for phase 1 oncology trials. N Engl J Med 2002;347:2134–2140.
Agre P, Campbell FA, Goldman BD, et al. Improving informed consent: the medium is not the message. IRB 2003;25:11–19.
Federman DD, Hanna KE, Rodriguez LL, ed. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, D.D.: National Academies Press, 2002.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2007 Springer Science+Business Media, LLC
About this chapter
Cite this chapter
Lo, B., Garan, N. (2007). Historical Perspective and Evolving Concerns for Human Research. In: Leong, S.P.L. (eds) Cancer Clinical Trials: Proactive Strategies. Cancer Treatment and Research, vol 132. Springer, Boston, MA. https://doi.org/10.1007/978-0-387-33225-3_1
Download citation
DOI: https://doi.org/10.1007/978-0-387-33225-3_1
Publisher Name: Springer, Boston, MA
Print ISBN: 978-0-387-33224-6
Online ISBN: 978-0-387-33225-3
eBook Packages: MedicineMedicine (R0)