<< Previous Section | < Previous Page | Next Page > | Next Section >> Bibliography (page 2 of 2) Dominguez, R. A., D. J. Feaster, et al. (2005). "Searching for an efficient institutional review board review model: Interrelationship of trainee-investigators, funding, and initial approval." Journal of Laboratory and Clinical Medicine 145(2): 65.      These authors studied the IRB review process at their own institution to determine factors leading to delay in approval. They found that the presence of a trainee and the absence of external funding both were associated with delayed approval and suggested an educational intervention. http://www.journals.elsevierhealth.com/periodicals/ymlc/ article/PIIS002221430400349X/abstract Judy Illes, et al. (2004). "Discovery and disclosure of incidental findings in neuroimaging research." Journal of Magnetic Resonance Imaging 20(5): 743-747.      This preliminary study identified the serious problem of incidental findings in brain imaging research. The findings may be quite important yet professional reading of the studies may be substantially delayed. Experimental designs should address the importance of a timely review of studies and reporting of coincidental findings. Fisher, C. and S. Kornetsky (2005). "SACHRP recommendations for review of children's research requiring DHHS secretary's approval." IRB 27(3): 8-10.      These recommendations of SACHRAP, the Secretary's Advisory Committee on Human Research Protection, deal with the Federal 46.407 provisions to have control review of protocols that have more than minimal risk in pediatric research subjects. Jones, A. M. and B. Bamford (2004). "The other face of research governance." BMJ 329(7460): 280-281.      Two descriptions of what happened when a protocol deviation was discovered and the research ethics office was notified. Was the response overkill or not? http://bmj.bmjjournals.com/cgi/content/full/329/7460/280 Bhutta, Z. (2002). "Ethics in international health research: a perspective from the developing world." Bulletin of the World Health Organization 80(2): 114-20. http://www.who.int/bulletin/archives/80(2)114.pdf This is an analysis of international research involving developing countries. He focuses on the elements that require discussion in the developing countries, including "standard of care" and prior agreements. The author also argues for more training in bioethics in developing countries and more focus on the public health measures that will do the most good for the population. Korenman, S. and L. Shaker-Irwin (2003). Research Subject Advocacy--A New Way to Enhance Integrity in Clinical Research. Endocrine Society News. 1: 6-7.       The National Center for Research Resources provided General Clinical Research Centers funding to recruit and hire individuals to be Research Subject Advocates. The job description was somewhat vague. In this paper the authors describe their response to the charge to advocate for subjects and to oversee their research activities in a constructive manner. This describes how UCLA did it up to the date of the paper. This role has continued to evolve to include much more education, protocol monitoring, and face to face relationships with subjects and the research team. Neill, K. (2003). "Research Subject Advocate: A New Protector of Research Participants." Accountability in Research 10(2): 159-74.       In October 2001 General Clinical Research Centers were funded to recruit Research Subject Advocates,(RSAs). They rapidly developed their job descriptions in such a way as to help participants in clinical research throughout the experience. This paper describes the early days of the program. Steinbrook, R. (2002). "Improving Protection for Research Subjects." N Engl J Med 346(18): 1425-1430.       A professional examination of the frailties of the clinical research process with attention to IRBs DSMBs and other vehicles for accountability. This is one of a series of activities in various journals addressing the "crisis" in the process of clinical research identified by the serious failures occurring at Penn, John Hopkins, Rochester and other major research institutions. Vincent, C. (2003). "Understanding and Responding to Adverse Events." N Engl J Med 348(11): 1051-1056.       In this essay the author focuses attention on the process of dealing with serious adverse events both as how to analyze them constructive to improve future performance and to support the participants, their families and the research team under these stressful conditions. He discusses system weaknesses as well as individual errors in the setting not of blame but of fostering improvement. Owning up to problem, truth-telling, and support are very important but prompt and through attentions to harms done is essential to reestablishing confidence in the research team may also be seriously affected by a serious adverse event and should have an opportunity for expression and counseling if appropriate. This paper will really help the team to deal with a serious adverse event. Marshall, E. (2000). "BIOMEDICAL ETHICS:Penn Report, Agency Heads Home In on Clinical Research." Science 288(5471): 1558-1559.       This report describes the response of Penn to the egregious problems in their clinical esearch activities revealed by the Jesse Gelsinger case. They are planing to use outside monitors for studies in which the institution has an interest. Furthermore their gene therapy institute would no longer do clinical trials. Both Penn and various Federal agencies indicated plans to more monitoring of clinical research. << Previous Section | < Previous Page | Next Page > | Next Section >> Chapter 6 Quick Links Monitor Research Cases Bibliography Chapter 5 Download (PDF)