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The Helsinki Declaration is a very important document regarding the protection of patients’ rights in clinical trials and one of the fundamental sources of operational principles for every ethics committee. Although they have been updated, the international guidelines for ethics committees continually fail to address certain issues pertaining to the protection of patients’ rights in clinical trials. These issues include, most significantly, the method of electing ethics committees (a free, secret ballot should be preferred to direct appointment), the avoidance of conflict of interest during the election of ethics committee members, and the necessary insurance coverage for the participants of clinical trials. Polish law should, on the other hand, be developed in such way as to not limit the effectiveness of ethics committees in protecting patients’ rights in clinical trials. The ideal solution would be to draft a uniform law concerning not only clinical trials, but all medical experiments. The opinions of experts who have been reviewing medical research projects for several years may prove to be especially valuable in this setting.

The practice of clinical medicine is inextricably linked with the need for moral values and ethical principles. The study of medical ethics is, therefore, rightly assuming an increasingly significant place in undergraduate and postgraduate medical courses and in allied health curricula. Making Sense of Medical Ethics offers a no-nonsense introduction to the principles of medical ethics, as applied to the everyday care of patients, the development of novel therapies and the undertaking of pioneering basic medical research. Written from a practical rather than a philosophical perspective, the authors call upon their extensive experience of clinical practice, research and teaching to illustrate how ethical principles can be applied in different "real-life" situations. Making Sense of Medical Ethics encourages readers to understand the principles of medical ethics as they apply to clinical practice; explore and evaluate common misconceptions; consider the ethics underlying any medical decision; and as a result, to realize that a good appreciation of medical ethics will help them to practice more effectively in the future.

The UK Medical Research Council, in order to further its mission of maintaining and improving human health, supports a substantial number of clinical trials on a wide variety of medical questions; some of these trials involve the use of placebos as controls or to maintain blinding. Before providing support, proposed trials are carefully reviewed to assess scientific quality, and to determine whether a placebo is required and is ethical — in addition to ethics review by independent Research Ethics Committees. Some questions such as the choice of placebos in trials in developing countries, in surgical trials and those involving alternative medicine require consideration of additional, specific issues. Involvement of consumers in MRC work has been increasing and includes the establishment of a Consumer Liaison Group; members of this group comment on patient information leaflets for clinical trials, helping to improve patient understanding of trials and ensuring topics like placebo use are explained clearly. Views differ on the value of placebos in clinical care and on their mechanism of action; continuing research is helping to clarify the issues.

The author relates conditions for conducting clinical trials in Russia, current experiences of ethics committees, areas where conflicts of interest can occur regarding publishing the results of clinical trials in medical journals and the state of medical journalism in Russia today.

Clinical trials are required in order to develop new treatments and improve both patient life expectancy and quality of life. In this respect the last 10 years proved their efficiency. However clinical research shows one of the most difficult dilemmas from an ethical point of view. Patients included in clinical trials are submitted to known and unknown risks and hazards, but rarely benefit from the results. This is even more evident when clinical trials use children who are terminally ill. The core consideration becomes how far should we go with research when considering the child best interest.

This textbook develops the issue of ethics to a philosophical level complex enough to be applicable to students of philosophy and applied ethics courses. It is the first book to address clinical problems from a classical perspective. This title available in eBook format. Click here for more information . Visit our eBookstore at: www.ebookstore.tandf.co.uk.

A broad critical review of national policies on biomedical research - human, epidemiologic, clinical trials, genetic, reproductive, etc.

As the_number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled. Includes a manual for investigators, research nurses and study coordinators with minimal experience or who are new to clinical research An easy-to-read and open text design using ‘sidebars’ of examples and information boxes related to the main text Includes a list of Frequently Asked Questions and Glossary Duke Clinical Research Institute is the world’s largest academic clinical research organisation and is well known and respected within the clinical research community.

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested.

Comprehensive in scope and research, this book will be a crucial resource for researchers in the medical sciences, as well as teachers and students alike.