Clinical Research: Safety & Ethics

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.        

This book represents the first comprehensive, gold standard reader on research integrity in the biomedical sciences. Now more than ever, the responsible conduct of research (RCR) has become critically important as new technologies affect research practices in both positive and negative ways. Since learning to do science and practicing it brings researchers into contact with a vast array of ethical issues, it is critical to know the standards and how they are evolving. Indeed, research integrity requires scientists at all levels to operate ethically in a system that supports ethical practice.   This unique, foundational text covers all the relevant areas -- subject protection, research misconduct and conflict of interest as well as newly quantified concerns about research bias and non-reproducibility, as well as other unique issues. Developed by renowned experts, this compelling title discusses the full range of practices and policies that should support research that is honestly produced and disseminated. It also specifically incorporates topics noted by the National Institutes of Health as essential and required for training in RCR. Getting to Good - Research Integrity in the Biomedical Sciences is a major contribution to the literature on bioethics and will serve as an invaluable resource for all researchers, students, administrators and professionals interested in research ethics and integrity.

Since the early 2000s, the field of Responsible Conduct of Research has become widely recognized as essential to scientific education, investigation, and training. At present, research institutions with public funding are expected to have some minimal training and education in RCR for their graduate students, fellows and trainees. These institutions also are expected to have a system in place for investigating and reporting misconduct in research or violations of regulations in research with human subjects, or in their applications to federal agencies for funding. Public scrutiny of the conduct of scientific researchers remains high. Media reports of misconduct scandals, biased research, violations of human research ethics rules, and moral controversies in research occur on a weekly basis.Since the 2009 publication of the 2nd edition of Shamoo and Resnik's Responsible Conduct of Research, there has been a vast expansion in the information, knowledge, methods, and diagnosis of problems related to RCR and the multitude of ethical issues of human subject protections. With the climate surrounding research conduct always shifting, developments in the field make an updated edition a necessity. All chapters have been revised and reflect the most current RCR landscape. New or further-developed topics include social responsibility and misconduct in social sciences, climate-change research, authorship, and peer review. Updates include new information on research involving human subjects or "vulnerable" biological subjects, as well as genetic research. Just like in previous editions, all chapters contain recent case studies and legal examples of various subjects.