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A letter report issued by the General Accounting Office with an abstract that begins "Clinical research is critical for the development of strategies for the prevention, diagnosis, prognosis, treatment, and cure of diseases. Clinical research has been defined as patient-oriented research, epidemiologic and behavioral studies, and outcomes research and health services research. The National Institutes of Health (NIH) is the principal federal agency that funds clinical research supporting individual clinical investigators, clinical trials, general and specialized clinical research centers, and clinical research training. For many years, there have been concerns that clinical research proposals are viewed less favorably than basic research during the peer review process at NIH and that clinical research has not received its fair share of NIH funding. In November 2000, the Clinical Research Enhancement Act was enacted to address some of these concerns. NIH reports that it has increased its financial support of clinical research and that spending on clinical research has kept pace with total NIH research spending. NIH has taken some steps to improve its peer review of clinical research applications. The Center for Scientific Review recently added two new peer review study sections for the review of clinical research applications--one for clinical cardiovascular science and other for clinical oncology. NIH has increased its support of general clinical research centers, as required by the act, although the program has grown more slowly than NIH's overall estimated expenditures on clinical research. NIH has established the four clinical research career enhancement award programs mandated by the act. Three of these programs have been implemented, and they support new and midcareer clinical investigators and institutional clinical research teaching programs. The fourth program is designed to support graduate training in clinical investigation. NIH has initiated a new extramural loan repayment program specifically for clinical investigators as required by the act. This program was launched in December 2001. NIH received 456 applications by the February 2002 deadline. Twenty-one of NIH's institutes plan to fund 396 loan repayment contracts, for a total of $20.2 million, by the end of fiscal year 2002."

There are just five black African clinical research scientists with a strong publication record in South Africa -- part of an ageing, shrinking and grossly under-funded academic cadre that creates the ongoing knowledge so vital to handle our debilitating epidemics. That is according to Professor Bongani Mayosi, Head of the Department of Medicine at the University of Cape Town (UCT), and Chief Specialist at Groote Schuur Hospital. Mayosi helped convene a workshop of the country's top health science educators to brainstorm curricular mechanisms to address the overall paucity and advise government. Speaking during the 15 July workshop, aimed at increasing both the quality and quantity of PhDs in the clinical sciences at South African and African medical schools, Mayosi said that while the principle of centralised funding of academic health complexes had finally been accepted by the Minister of Health,1 clinical research funding remained an alarmingly low government priority.

What is clinical research? The growth of clinical research in the UK since the Second World War is examined, including the 1953 Cohen Report and the subsequent creation of the Medical Research Council's Clinical Research Board. Lord Walton of Detchant, as Chairman, guided the discussion on the inter-relationships between the MRC, the NHS, the Royal Colleges, other professional bodies and other funding organizations. Among other issues were the changes imposed by Government policy over the period, the influence of the early clinical research fellowships, growth of clinical career structures, planning of the Clinical Research Centre at Northwick Park, the tropical research units, and the effects of the Rothschild and Dainton reports on funding for clinical research and the role of the Chief Scientist. Participants include: Sir Douglas Black, Sir John Gray, Sir Raymond Hoffenberg, Dr Sheila Howarth, Professor Peter Lachmann, Sir Patrick Nairne, Professor Sir Stanley Peart and Dr Peter Williams. Introduction by Dr David Gordon, vi, 74pp, 2 tables, subject and name index.

In this study, professional impact is defined as the academic literature that is cited in the literature that is used by professions in order to pursue skilled activities that are specific to their expertise. Specifically, we are focusing on the clinical guidelines that are used in the many health and medical professions that are issued by government bodies at national and international levels to ensure a certain quality level and to make results comparable at the national level.To date, more than 50.000 references have been identified in about 500 Swedish clinical guidelines issued by the above mentioned governmental bodies in Sweden. Of these, 73 % of the references have been matched to a PubMed id.The goal of this project is to develop a conceptual and theoretical contribution to the development of indicators for measuring the impact of research outside of the specifically academic literature. ; Impact i Kliniska Riktlinjer

"Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies"--

FrontMatter -- Contents -- Preface -- Acknowledgments -- Reviewers -- Summary -- 1 Introduction -- 2 The Necessity and Challenges of Clinical Research Involving Children -- 3 Regulatory Framework for Protecting Child Participants in Research -- 4 Defining, Interpreting, and Applying Concepts of Risk and Benefit in Clinical Research Involving Children -- 5 Understanding and Agreeing to Children's Participation in Clinical Research -- 6 Payments Related to Children's Participation in Clinical Research -- 7 Regulatory Compliance, Accreditation, and Quality Improvement -- 8 Responsible Research Involving Children -- References -- Appendices -- A Study Origins and Activities -- B State Regulation of Medical Research with Children and Adolescents: An Overview and Analysis -- C Health Care Privacy and Conflict-of-Interest Regulations Relevant to Protection of Human Participants in Research -- D Glossary, Acronyms, and Laws and Regulations -- E Committee Biographical Statements -- Index.

Front Matter -- Preface -- Contents -- Introduction: Privacy Issues in Research -- The Potential-and the Threat-of Genetic Information -- Can We-and Should We-Ensure Genetic Privacy? -- Handling Genetic Data in the Laboratory -- Institutional Safeguards -- What, If Anything, Should the Federal Government Do? -- APPENDIX A Program and Discussion Questions -- APPENDIX B Agenda -- APPENDIX C A Comment by Frederick R. Anderson -- APPENDIX D Participant Biographies.

Annotation The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone-members of institutional review boards, scientists, philosophers, lawyers-addressing the ethical issues involved. Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions ... The book] is sophisticated but readable ... and] should be on every IRB administrator's desk and in every medical ethics library.-Norman Fost, M.D., The New England Journal of Medicine Levine ... is one of the foremost historians of contemporary clinical science ... His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history.-Daniel M. Fox, Bulletin of the History of Medicine You will be charmed by the book's] elegance and lucidity and ... persuaded of its relevance to doctors in any country.-Alex Paton, British Medical Journal Should be of wide interest to those keen to see advances in medical research brought into general medical practice.-Gilbert Omenn, Issues in Science and Technology

In our era, biobanks ensure preservation of specimens' quality in short or long time storage. For each type of material and for each kind of organism, there is a specific preservation protocol. Actually, the efforts of single scientists or Institutions are not sufficient for research, especially in rare diseases field.The building of network that join together biobanks, research institutes, universities, pharmaceutical companies and patients' associations answers to research's needs. The creation of national and international networks had greatly contributed to share samples and their related information. In this review, we describe the European situation and how different associations and Institutions are joined together in wide networks. We marked the efforts and the ways needed to link and to harmonize Institutions placed in different countries and subjected to different national laws in lacks of unified legislation. We reviewed primary, biobank needs and principal preservation technics and protocols.Our observations had marked the importance of building wide networks. We would concluded noting the importance to extend actual networks including other national or foreign institutions. The networks should be organized to provide flexibility for facilitating its growth.