Minimizing Risk in Clinical Research
Authors: Daniel D. Federman
Journal: Annals of Internal Medicine (2003)

Editorials1 July 2003Minimizing Risk in Clinical ResearchDaniel D. Federman, MDDaniel D. Federman, MDFrom Harvard Medical School, Boston, MA 02115.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-139-1-200307010-00015 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail The randomized clinical trial, the gold standard of modern clinical investigation, is a remarkable social construction. Its overall goal is the scientific demonstration that a new drug or device produces a health benefit that justifies its risk. Ultimately, the therapeutic fruits of all biomedical advance have to be submitted to this scrutiny before they can enter clinical use.Normal volunteers and patients are by far the most important participants in the process. Since many of these are in the group receiving the placebo, and since many trials fail, many sick and well participants have little likelihood of benefiting in the ...References1. Ethical and policy issues in research involving human participants. Vol 1. Bethesda: National Bioethics Advisory Commission; 2001. Google Scholar2. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. Washington, DC: U.S. Government Printing Office; 1979. Google Scholar3. Levine RJ. Institutional review boards: a crisis in confidence [Editorial]. Ann Intern Med. 2001;134:161-3. [PMID: 11177321] LinkGoogle Scholar4. Faden RR, Beauchamp TL. A History and Theory of Informed Consent. New York: Oxford Univ Pr; 1986. Google Scholar5. Institute of Medicine. Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: National Academy Pr; 2003. Google Scholar6. Mello MM, Studdert DM, Brennan TA. The rise of litigation in human subjects research. Ann Intern Med. 2003;139:40-5. LinkGoogle Scholar7. Humphreys K, Trafton J, Wagner TH. The cost of institutional review board procedures in multicenter observational research [Letter]. Ann Intern Med. 2003;139:77. LinkGoogle Scholar8. Institute of Medicine. To Err Is Human. Washington, DC: National Academy Pr; 2000. Google Scholar Author, Article, and Disclosure InformationAuthors: Daniel D. Federman, MDAffiliations: From Harvard Medical School, Boston, MA 02115.Disclosures: None disclosed.Corresponding Author: Daniel D. Federman, MD, Harvard Medical School, 25 Shattuck Street, Boston, MA 02115. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoThe Rise of Litigation in Human Subjects Research Michelle M. Mello , David M. Studdert , and Troyen A. Brennan Metrics Cited byIs informed consent related to success in exercise and diet intervention as evaluated at 12 months? DR's EXTRA studyEvaluation of informed consent in health research: a questionnaire surveyClinical trials in the out-of-hospital setting: Rationale and strategies for successful implementationEvaluation of informed consent: a pilot study 1 July 2003Volume 139, Issue 1Page: 71-72KeywordsClinical trialsConflicts of interestGene transferInstitutional review boardsLegislationResearch designRisk managementSafetyScientists ePublished: 1 July 2003 Issue Published: 1 July 2003 Copyright & PermissionsCopyright © 2003 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...