<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 12 of 13) (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. Brody, B., C. Anderson, et al. (2003). "Expanding Disclosure of Conflicts of Interest: Views of Stakeholders." IRB Ethics and Human Research 25(1): 1-8. Kim, S. Y. H., R. W. Millard, et al. (2004). "Potential research participants' views regarding researcher and institutional financial conflicts of interest." J Med Ethics 30(1): 73-79.       This empirical study of the attitudes of potential research subjects towards the revelation of financial conflicts of interest and their existence gave strong evidence that subjects wanted to know. Some would be less inclined to participate in the proposed study knowing of the conflicts of interest. A very nice study. http://jme.bmjjournals.com/cgi/content/full/30/1/73 Taylor, R. and J. Giles (2005). "Cash interests taint drug advice." Nature 437(7062): 1070.       This paper and the accompanying editorial deal with groups empanelled by professional societies primarily to write "evidence based" clinical practice guidelines. A study by Materal found that substantial number of the panel members receive income or own stock in companies whose products are under consideration. The influence of these companies may be indirect in promoting drug use in the filed or to encourage use of a specific product. Better methods of developing guidelines are suggested. http://content.nejm.org/cgi/content/abstract/352/21/2202 Brody, H. and F. G. Miller (2003). "The clinician-investigator: unavoidable but manageable tension." Kennedy Institute of Ethics J 13(4): 329-46. This paper addresses the two roles of the Clinician-Investigator as scientist and caregiver. The authors indicate that research is very different from care and thus there is ethical tension in doing both (the difference position). Those that argue that the physician's role is similar in both circumstances (similarity position) are claimed to be in error because the position denies the ethical tension. A very worthwhile read. Mello, M. M., B. R. Clarridge, et al. (2005). "Academic Medical Centers' Standards for Clinical-Trial Agreements with Industry." N Engl J Med 352(21): 2202-2210.       This critical paper delineates the weaknesses of academic institutions in writing contracts that protect data and investigators from bias. This is very important reading. http://content.nejm.org/cgi/content/abstract/352/21/2202 (2003). "American Society of Clinical Oncology: Background for Update of Conflict of Interest Policy." J Clin Oncol 21(12): 2387-2393.       The new version of their conflict of interest policy that is based on complete disclosure and a number of prohibitions. A good set of rules that others could emulate. http://www.jco.org/cgi/content/full/21/12/2387 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 questionnaire study attempted to determine the impact of various levels of payment on willingness to participate in a trial. Knowledge of the characteristics of a trial and whether it would lead to behavior damaging the quality of the study. Money was an incentive. The other effects did not seem to be present. http://jme.bmjjournals.com/cgi/content/full/30/3/293 << 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)