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This guide is designed to be a resource for those conducting clinical research at UF. It includes tabs for resources, training, IRB, Safety and Ethics, NIH, Standards and Templates, and Professional Associations.
Two CITI courses offer additional HSR training that might be of interest:
Biomedical (Biomed) is generally relevant for IRB01 protocols
Social-Behavioral-Educational (SBE) is generally relevant for IRB02 protocols
Additional training that might be of interest
Covers basic healthcare ethics committee attributes
Discusses the main ethical theories and principles for healthcare ethics
Authored by Ray Moseley, PhD at the College of Medicine of the University of Florida and peer-reviewed by experts
Interactive video that educates researchers on responsible conduct of research
Become the lead characters (study PI, postdoc, grad student, and research compliance officer) in an interactive movie and make decisions about integrity in research that can have long-term consequences
Interactive video that educates clinical and social researchers on the importance of appropriately protecting research participants and avoiding research misconduct
Assume the role of one of four characters (PI, study coordinator, research assistant, and/or IRB chair) and determine the outcome of the storyline by selecting decision-making choices for each “playable” character
Free, six module ethics course funded by ORI in 2002-03. Certificates of completion are available for each module upon completion of an assessment. Module titles include: Ethical Issues in Research, Interpersonal Responsibility; Institutional Responsibility; Professional Responsibility; Animals in Research; and Human Participation in Research
Ethical Issues in Clinical Research by Bernard Lo; Lo
Call Number: UF VET MED READING ROOM General Collection -- W20.5.L795e 2010
Publication Date: 2009-06-03
This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.
The outsourcing of clinical trials to Latin America by the transnational innovative pharmaceutical industry began about twenty years ago. Using archival information and field work in Argentina, Brazil, Costa Rica, Mexico and Peru, the authors discuss the regulatory contexts and the ethical dimensions of human experimentation in the region. More than 80% of all clinical trials in the region take place in these countries, and the European Medicines Agency has defined them as priority countries in Latin America. The authors raise questions about the quality of data obtained from the trials and the violation of human rights during their implementation. Their findings are presented in this volume, the first in-depth analysis of clinical trials in the region.
Today, when many parents seem reluctant to have their children vaccinated, even with long proven medications, the Salk vaccine trial, which enrolled millions of healthy children to test an unproven medical intervention, seems nothing short of astonishing. In Selling Science, medical historian Stephen E. Mawdsley recounts the untold story of the first large clinical trial to control polio using healthy children--55,000 healthy children--revealing how this long-forgotten incident cleared the path for Salk's later trial. Mawdsley describes how, in the early 1950s, Dr. William Hammon and the National Foundation for Infantile Paralysis launched a pioneering medical experiment on a previously untried scale. Conducted on over 55,000 healthy children in Texas, Utah, Iowa, and Nebraska, this landmark study assessed the safety and effectiveness of a blood component, gamma globulin, to prevent paralytic polio. The value of the proposed experiment was questioned by many prominent health professionals as it harbored potential health risks, but as Mawdsley points out, compromise and coercion moved it forward. And though the trial returned dubious results, it was presented to the public as a triumph and used to justify a federally sanctioned mass immunization study on thousands of families between 1953 and 1954. Indeed, the concept, conduct, and outcome of the GG study were sold to health professionals, medical researchers, and the public at each stage. At a time when most Americans trusted scientists, their mutual encounter under the auspices of conquering disease was shaped by politics, marketing, and at times, deception. Drawing on oral history interviews, medical journals, newspapers, meeting minutes, and private institutional records, Selling Science sheds light on the ethics of scientific conduct, and on the power of marketing to shape public opinion about medical experimentation.