<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 10 of 11) IRBs (2003). "American Society of Clinical Oncology Policy Statement: Oversight of Clinical Research." Journal of Clinical Oncology 21(12): 1-10. Cutcliffe, J. R. and P. Ramcharan (2002). "Leveling the Playing Field? Exploring the Merits of the Ethics-as-Process Approach for Judging Qualitative Research Proposals." Qual Health Res 12(7): 1000-1010.      Qualitative research involving in depth interviews is associated with a continuing interaction of interviewer and interviewee, an ability of the interviewer to subtly or not so subtly coerce (see the movie, Capote) and for the subject to feel locked in to continue. IRBs have no, they say, been kind to qualitative research. They discuss the concepts of implementation of "consent as a process." http://qhr.sagepub.com/cgi/reprint/12/7/1000 Whittle, A., S. Shah, et al. (2004). "Institutional Review Board Practices Regarding Assent in Pediatric Research." Pediatrics 113(6): 1747-1752.      This telephone survey of IRB chairpersons queried about the process of assent. They found great variability in the presence of criteria (age cutoff). They also varied on payment to the children and/or to the parents. It may have had some influence in getting IRBs to more effectively defer their rules for research with children. http://pediatrics.aappublications.org/cgi/content/full/113/6/1747 Motil, K., J. Allen, et al. (2004). "When a research subject calls with a complaint, what will the IRB do?" IRB Ethics and Human Research 26(1): 9-13.      The authors describe the process by which the Baylor College of Medicine IRB deals with research subject complaints. It is based on a carefully orchestrated inquiry mechanism that is designed to get objective information and result in justice. Edwards, S. J. L., R. Ashcroft, et al. (2004). "Research Ethics Committees: Differences and Moral Judgement." Bioethics 18(5): 408-427.      This paper deals with the inconsistencies between research ethics committees and includes that it is inappropriate to try to make them all behave identically. They argue that different committees may have different ideas of justice, that there is no single moral standard for such committees, and third that committees have different processes. TO this I add that calculation of risk and benefit is not an exact science. http://www.blackwell-synergy.com/doi/abs/10.1111/j.1467-8519.2004.00407.x Coffey, M. J. and L. Ross (2004). "Human Subject Protections in Genetic Research." Genetic Testing 8(2): 209-213.      This paper considers the Certificate of Confidentiality, a tool available to researchers to keep personal health-related informed from those who might seek primary data from a study. They also reflect on how after documentation of other protective instruments is missing from research reports. http://www.liebertonline.com/doi/abs/10.1089/gte.2004.8.209 Ray, W. A. and C. M. Stein (2006). "Reform of Drug Regulation -- Beyond an Independent Drug-Safety Board." N Engl J Med 354(2): 194-201.       This paper thoroughly reviews the weakness of our drug regulation system and suggests adding new and expansive elements to it. The foci are on complete information before and after a trial and processes to monitor drugs past release even to the point of requiring additional studies. What's ironic to me is that if both sponsors and the FDA were more honest and effective in the first place, their horrible examples could have been prevented. http://content.nejm.org/cgi/content/extract/354/2/194 << 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)