<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 1 of 11) (1953). Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10. U. S. G.P.O: 181-4. (2001). Guidance for Clinical Trials Sponsors: On the Establishment and Operation of Trial Data Monitoring Committees, Food and Drug Administration: 1-19. (2003). Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. Federal Register. 68: 15456-15460. (2004). Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. DHHS. Services, Federal Register. 69 (92): 26393-7.       This federal guideline asks IRBs and institutions to consider a variety of means to eliminate, document, disclose, and manage conflicts of interest. It is not overly prescriptive but it expects institutions to actively and effectively deal with conflicts of interest both of individual investigators and of IRB members. Conflict of interest committees distinct from IRBs are expected to be developed. Required reading for research administrators.       The Office of Public Health and Science (OPHS), Department of Health and Human Services (HHS) announces a final guidance document for Institutional Review Boards (IRBs), investigators, research institutions, and other interested parties, entitled Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. This guidance document raises points to consider in determining whether specific financial interests in research could affect the rights and welfare of human subjects, and if so, what actions could be considered to protect those subjects. This guidance applies to human subjects research conducted or supported by HHS or regulated by the Food and Drug Administration. Anand, G. (2004). Ask Before You Leap: If you're thinking of joining a clinical trial for experimental drugs, make sure to get the answers to these questions. Wall Street Journal. New York. January 26, 2004.       This brief article in the personal section of the WSJ suggests that prospective participants in a clinical trial ask a series of questions including who's in charge? Is there a well-functioning objective IRB? What are the conflicts of interest? And what's actually going to happen to me? Investigators should read this article. Annas, G. J. (2002). "Medical Privacy and Medical Research -- Judging the New Federal Regulations." N Engl J Med 346(3): 216-220.       There was a lot of worry about the degree to which the HIPAA regulations would inhibit clinical research. It is still a matter of concern but research continues unabated. Annas, G. J. (2003). "HIPAA Regulations -- A New Era of Medical-Record Privacy?" N Engl J Med 348(15): 1486-1490.      This is important in the context of impact on research. The key element is whether the research impinges on the medical chart of the subject. If it does, then all the HIPAA regulations apply. If not then only the research-related common rule applies. Capron, A. M. (1999). "Ethical and Human-Rights Issues in Research on Mental Disorders That May Affect Decision-Making Capacity." N Engl J Med 340(18): 1430-1434.       The author argues that clinical research with a therapeutic intent should have greater oversight than physiological investigation with normal controls because the risk to the subjects is greater in the former than the latter. In mental disorder investigations where informed consent is difficult to achieve, the problem is especially ethically troublesome. Cohen, J. (1999). "Research Shutdown Roils Los Angeles VA." Science 284(5411): 18-19, 21.       This is an example of the issues surrounding appropriate IRB function. Couzin, J. (2004). "HUMAN SUBJECTS RESEARCH: Pediatric Study of ADHD Drug Draws High-Level Public Review." Science 305(5687): 1088a-1089.      This brief news report succinctly reports the very serious ethical problems that arise when attempting to do research with vulnerable populations in this case children employed as control subjects. Emanuel, E. J., A. Wood, et al. (2004). "Oversight of Human Participants Research: Identifying Problems to Evaluate Reform Proposals." Ann Intern Med 141(4): 282-291.       This is a position paper on reform of the IRB system. They identify 15 current problems with the system, including 8 structural,, 5 procedural, and 2 performance-assessment. They review suggested reforms and find them not fully corrective of the problems. They then introduce their own set of potential reforms. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 2 Quick Links Research in Humans History of Rules About Research in Humans Definitions Federal Mandate Respect for Persons Beneficence Justice Common Rule IRB Mission Cases Bibliography Chapter 2 Download (PDF)