<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 2 of 13) Kelch, R. (2002). "Maintaining the public trust in clinical research." N Engl J Med 346(4): 285-7.       This is a laudatory commentary on the AAMCs report on individual conflicts of interest. (2003). Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection. Federal Register. 68: 15456-15460.       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. Angell, M. (2000). "Is Academic Medicine for Sale?" N Engl J Med 342(20): 1516-1518.       This position paper uses evidence mostly from publications to argue that conflicts of interest are so pervasive so as to compromise the integrity of much medical publication. Bekelman, J. E., Y. Li, et al. (2003). "Scope and Impact of Financial Conflicts of Interest in Biomedical Research: A Systematic Review." JAMA 289(4): 454-465.       This was a meta-analysis of the quantitative analytic literature on conflicts of interest in biomedical research from 1980 to 2002 using a variety of search techniques for materials. In 34 studies meeting all their criteria they show that about ¼ of the investigators had industry affiliations and 2/3 of academic institutions hold equity in start-ups that sponsor research. They claimed a relationship between industry sponsorship and positive conclusions. Industry sponsorship was also associated with restrictions on publication and data sharing. They concluded that conflicts of interest can have a powerful effect on biomedical research reports. Bentley, J. P. and P. G. Thacker (2004). "The influence of risk and monetary payment on the research participation decision making process." J Med Ethics 30(3): 293-298.       This study used pharmacy students' reactions to scenarios varied by risk and payment to determine the extent to which they affected decisions to participate in a clinical trial. They found that money did help enlist subjects but they were not blinded to the risks. Blumenthal, D. (2003). "Academic-Industrial Relationships in the Life Sciences." N Engl J Med 349(25): 2452-2459.       The author describes the evolving set of relationships between academic institutions and industry as it pertains to biological developments. He points out the rapid progress of biotechnology and the significant support of research by industry. He also points out the influences on scientific integrity and diminished quality of treatment of research subjects. A very important paper. Blumenthal, D. (2004). "Doctors and Drug Companies." N Engl J Med 351(18): 1885-1890.       The author describes the evolving nature of the relationships between doctors and drug companies over the 20th century and the influences that the companies have come to exert over medical practice and research. He also discusses efforts to manage these relationships. Conflicts of interest pervade. This is a very powerful statement and uncomfortable reading for physicians. Blumenthal, D., N. Causino, et al. (1996). "Relationships between Academic Institutions and Industry in the Life Sciences -- An Industry Survey." N Engl J Med 334(6): 368-374.       Despite growing acceptance of relationships between academia and industry in the life sciences, systematic, up-to-date information about their extent and the consequences for the parties involved remains scarce. They surveyed a representative sample of life-science companies in the United States to determine their relationships with academic institutions by telephone from senior executives of 210 life-science companies (69%). Ninety percent of the companies had relationships with an academic institution in 1994. Fifty-nine percent supported research, providing approximately 11.7 percent of their research-and-development funding. Over 60 percent of those companies had received patents, products, and sales as a result. The companies also reported that they often had agreements to keep the results of research secret beyond the time needed to file a patent. These relationships need greater scrutiny. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 4 Quick Links Conflicts of Interest (COI) Definitions Consequences of a COI Government Intervention Industry Sponsorship Professional Societies Clinical Practice Guidelines Other Initiatives COI in Financial Consulting Cases Bibliography Chapter 4 Download (PDF)