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vii, 278 pages ; 22 cm
  • Begley's bombshell
  • It's hard even on the good days
  • A bucket of cold water
  • Misled by mice
  • Trusting the untrustworthy
  • Jumping to conclusions
  • Show your work
  • A broken culture
  • The challenge of precision medicine
  • Inventing a discipline.
American taxpayers spend $30 billion annually funding biomedical research. By some estimates, half of the results from these studies can't be replicated elsewhere -- the science is simply wrong. Often, research institutes and academia emphasize publishing results over getting the right answers, incentivizing poor experimental design, improper methods, and sloppy statistics. Bad science doesn't just hold back medical progress, it can sign the equivalent of a death sentence. How are those with breast cancer helped when the cell on which 900 papers are based turns out not to be a breast cancer cell at all? How effective could a new treatment for ALS be when it failed to cure even the mice it was initially tested on? Science journalist Richard F. Harris reveals these urgent issues with anecdotes, personal stories, and interviews with the nation's top biomedical researchers.
Medical Library (Lane)
online resource (xxiv, 255 pages) : illustrations
  • The past, present and future of human nature / Samuel Gorovitz
  • Unethical contexts for ethical questions / David Ehrenfeld
  • Human subject protections: some thoughts on costs and benefits in the humanistic disciplines / C. Kristina Gunsalus
  • Secret state experiments and medical ethics / Jonathan Moreno
  • Cross-cultural considerations in medical ethics: the case of human subjects research / Marcia Angell
  • Reproductive rights and health in the developing world / Ruth Macklin
  • Genetic testing of human embryos: ethical challenges and policy choices / Kathy Hudson, Susannah Baruch & Gail Javitt
  • Choosing our children: the uneasy alliance of law and ethics in John Robertson's thought / Karen Lebacqz
  • The heart disease epidemic that wasn't: lessons learned from death certificate statistics / Harry M. Rosenberg
  • Recent history of end-of-life care and implications for the future / James Flory & Ezekiel Emanuel
  • The pragmatic power and promise of theoretical environmental ethics: forging a new discourse / J. Baird Callicott
  • The expanding circle and moral community - naturally speaking / Chalmers Clark
  • Science, conservation and global security / George M. Woodwell
  • Energy, technology and climate: running out of gas / David Goodstein.
Medical Library (Lane)
xix, 300 p. ; 23 cm.
  • What You Need To Know About Research Ethics Before Deciding on What You Want To Study Designing a Clinical Research Study Writing Consent and Assent Documents Getting the Protocol Approved Conducting the Study-- Special Populations Ethical Considerations in Genetics Research Ethical Considerations in Use of Tissue for Laboratory Investigations Ethical Considerations in Use of Stored Tissue Confidentiality Issues Research in Emergency Medicine Reporting of Adverse Events FDA Radiation Safety Issues Participation of Subjects in Multi-Site Trials Participation of Subjects in Multiple Studies Conduct of Pharmaceutical Industry Research Case Histories, Learning from Experience Appendix.
  • (source: Nielsen Book Data)9780122107511 20160528
This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. It walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol. It includes a chapter containing Case Histories. It contains information on conducting clinical research within the pharmaceutical industry. An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations. Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations.
(source: Nielsen Book Data)9780122107511 20160528
online resource
  • The necessity and challenges of clinical research involving children
  • Regulatory framework for protecting child participants in research
  • Defining, interpreting, and applying concepts of risk and benefit in clinical research involving children
  • Understanding and agreeing to children's participation in clinical research
  • Payments related to children's participation in clinical research
  • Regulatory compliance, accreditation, and quality improvement
  • Responsible research involving children.
Medical Library (Lane)
534 p.
Businesses that produce bioscience products - gene tests and therapies, pharmaceuticals, vaccines, and medical devices - are regularly confronted with ethical issues concerning these technologies. Conflicts exist between those who support advancements in bioscience and those who fear the consequences of unfettered scientific license. As the debate surrounding bioscience grows, it will be increasingly important for business managers to consider the larger consequences of their work. This groundbreaking book follows industry research, development, and marketing of medical and bioscience products across a variety of fields, including biotechnology, pharmaceuticals, and bio-agriculture. Compelling and current case studies highlight the ethical decisions business managers frequently face. With the increasing visibility and public expectation placed on businesses in this sector, managers need to understand the ethical and social issues. This book addresses that need and provides a framework for incorporating ethical analysis in business decision making.
(source: Nielsen Book Data)9780804742498 20160610
Green Library
viii, 345 p. ; 24 cm.
  • (source: Nielsen Book Data)9780195148466 20160528
This is a comprehensive introduction to the ethical issues at stake in the conduct of biomedical research, with extensive use of case examples. Its content parallels the recommendations of the Commission on Research Integrity, and deals with ethical issues in the use of animal and humans in research. It includes chapters on intellectual property, authorship, peer review, and conflicts of interest. As of October 2000, all personnel involved in research supported by the Public Health Service, including NIH, must receive the equivalent of 15 hours of training and education in research ethics. This book will be a convenient text for such short courses or seminars, and an excellent guidebook for all.
(source: Nielsen Book Data)9780195148466 20160528
viii, 345 pages : illustrations ; 24 cm
Medical Library (Lane)
computer files (xix, 300 pages ; 23 cm)
  • Introduction to the art and science of clinical research
  • What you need to know about clinical research ethics
  • What you need to know about the regulation of clinical research
  • Designing a clinical research study
  • Selecting subjects for clinical studies
  • Risks and benefits in clinical research
  • Recruiting subjects
  • Informed consent
  • Privacy and confidentiality
  • The "ethics" section
  • Procedures and methods
  • Statistics, data collection and management, and record keeping
  • Use of human biological materials
  • Special issues raised by evolving areas of clinical research
  • Case histories : learning from experience.
Medical Library (Lane)
online resource (viii, 187 pages) ; 24 cm
  • Information technologies and 21st-century clinical practice : ethics and the electronic health record
  • Ancient professions and intelligent machines : the ethical challenge of computational decision support
  • Health privacy, data protection, and trust
  • Professionalism, programming, and pedagogy
  • Safety, standards, and interoperability
  • The e-health industry : markets, vendors, and regulators
  • Digital health : ubiquitous, virtual, remote, robotic
  • Biomedical research from genomes to populations : big data and the growth of knowledge.
Medical Library (Lane)
xviii, 267 p. : ill. ; 24 cm.
  • Financial conflicts of interest in biomedical research / Josephine Johnston
  • Conflicts between commercial and scientific roles in academic health research / Neetika Prabhakar Cox, Christopher Heaney, and Robert M. Cook-Deegan
  • From conflict to confluence of interest : the coevolution of academic entrepreneurship and intellectual property rights / Henry Etzkowitz
  • Ties that bind : relationships among academia, industry, and government in life sciences research / Eric G. Campbell ... [et al.]
  • Conflict of interest in financial services : a contractual risk-management analysis / John R. Boatright
  • The law and ethics of lawyers' conflict of interest / Robert Lawry
  • Sustaining credibility in a context of conflicts : the challenge for journalism / Deni Elliott
  • Some principles require principals : why banning "conflicts of interest" won't solve incentive problems in biomedical research / William M. Sage
  • Current regulations, comparison of guidelines, and considerations for policy development / David Perlman
  • Financial conflicts of interest in research with human subjects : a clinical research organization's perspective / Douglas Peddicord.
News of financial entanglements among biomedical companies and researchers has increasingly called into question the worth and integrity of medical studies, nearly three-fifths of which are funded by industry. This volume assesses the ethical, quantitative, and qualitative questions posed by the current financing of biomedical research. The ten essays collected here reflect the wide range of opinions about perceived financial conflicts of interest in medical studies. The opening section provides an overview of the issue, describing the origins of, and concerns raised by, dubious financial arrangements; explaining how certain common situations intensify problematic funding structures; weighing the risks and benefits of commercialized research funding; and detailing the nature, extent, and consequences of the present relationship among academe, government, and industry in the health sciences. The second section compares how the idea of conflicts of interest differs in biomedical research, legal work, and journalism. It includes a challenging look at the term itself and an argument for managed financial incentives. The final section describes and analyzes the existing regulatory regime, poses questions and directions for future self and external regulation, and provides perspectives from a third-party research company. This considered, balanced discussion will interest scholars of bioethics, public health, and health policy.
(source: Nielsen Book Data)9780801896262 20160604
Green Library
online resource (ix, 429 pages) : illustrations ; 24 cm
  • Scientific research and ethics
  • Ethical decision making
  • Data acquisition and management
  • Mentoring and collaboration
  • Collaboration between academia and private industry
  • Authorship
  • Publication and peer review
  • Misconduct in research
  • Intellectual property
  • Conflicts of interest and scientific objectivity
  • The use of animals in research
  • The protection of human subjects in research
  • Protecting vulnerable human subjects in research
  • Genetics, cloning, and stem cell research
  • International research.
Medical Library (Lane)
online resource (xvi, 207 pages)
The Management of Scientific Integrity within Academic Medical Centers discusses the impact scientific misconduct has in eight complex case studies. Authors look at multifaceted mixtures of improper behavior, poor communication, cultural issues, adverse medical/health issues, interpersonal problems and misunderstandings to illustrate the challenge of identifying and managing what went wrong and how current policies have led to the establishment of quasi legal processes within academic institutions. The book reviews the current global regulations and concludes with a section authored by a US federal court judge who provides his perspective on the adequacy of current regulations and policies.
Medical Library (Lane)
online resource (xx, 184 pages) ; 21 cm
Medical Library (Lane)
vii, 75 p. ; 24 cm.
  • Experiments of Concern.- The Ethics of Dual-Use Research.- Dissemination of Dual-Use Research Results.- Options for the Regulation of Dual-Use Experiments and Information.
  • (source: Nielsen Book Data)9781402083112 20160605
What Is the Dual-Use Dilemma? The so-called "dual-use dilemma" arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of sci- tific research sometimes has the potential to be used for harm as well as for good. A dual-use dilemma is an ethical dilemma, and an ethical dilemma for the researcher (and for those who have the power or authority to assist or impede the researcher's work, e. g. , governments). It is an ethical dilemma since it is about promoting good in the context of the potential for also causing harm, e. g. , the p- motion of health in the context of providing the wherewithal for the killing of in- cents. It is an ethical dilemma for the researcher not because he or she is aiming at anything other than a good outcome; typically, the researcher intends no harm, but only good. Rather, the dilemma arises for the researcher because of the potential actions of others. Malevolent non-researchers might steal dangerous biological agents produced by the researcher; alternatively, other researchers-or at least their governments or leadership-might use the results of the original researcher's work for malevolent purposes. The malevolent purposes in question include bioterrorism, biowarfare and blackmail for financial gain.
(source: Nielsen Book Data)9781402083112 20160605
dx.doi.org SpringerLink
computer files (xii, 343 pages ; 25 cm)
Medical Library (Lane)
1 online resource.
Federal regulations that govern research misconduct in biomedicine have not been able to prevent an ongoing series of high-profile cases of fabricating, falsifying, or plagiarizing scientific research. In this book, Barbara Redman looks critically at current research misconduct policy and proposes a new approach that emphasizes institutional context and improved oversight. Current policy attempts to control risk at the individual level. But Redman argues that a fair and effective policy must reflect the context in which the behavior in question is embedded. As journalists who covered many research misconduct cases observed, the roots of fraud "lie in the barrel, not in the bad apples that occasionally roll into view." Drawing on literature in related fields -- including moral psychology, the policy sciences, the organizational sciences, and law -- as well as analyses of misconduct cases, Redman considers research misconduct from various perspectives. She also examines in detail a series of clinical research cases in which repeated misconduct went undetected and finds laxity of oversight, little attention to harm done, and inadequate correction of the scientific record. Study questions enhance the book's value for graduate and professional courses in research ethics. Redman argues that the goals of any research misconduct policy should be to protect scientific capital (knowledge, scientists, institutions, norms of science), support fair competition, contain harms to end users and to the public trust, and enable science to meet its societal obligations.
(source: Nielsen Book Data)9780262019811 20160614
online resource (x, 77 pages) ; 23 cm
Medical Library (Lane)
online resource (xiii, 236 pages ; 25 cm)
  • Five concepts of competence
  • Consent, vulnerability and research
  • Gewirth's theory of agency rights
  • Proportionality, precaution and judgments of competence
  • The competences of cognitively vulnerable groups
  • Cognitive vulnerability and consent to biomedical research
  • Cognitive vulnerability and consent to biomedical research in England and Wales
  • Cognitive vulnerability and consent to biomedical research in the United States.
Enhanced knowledge of the nature and causes of mental disorder have led increasingly to a need for the recruitment of a cognitively vulnerablea (TM) participants in biomedical research. These individuals often fall into the a grey areaa (TM) between obvious decisional competence and obvious decisional incompetence and, as a result, may not be recognised as having the legal capacity to make such decisions themselves. At the core of the ethical debate surrounding the participation of cognitively vulnerable individuals in research is when, if at all, we should judge them decisionally and legally.
Medical Library (Lane)
computer files (xviii, 357 pages : illustrations)
  • Pt. 1. Research biobanking : the traditional approach
  • Consent to biobank research : one size fits all? / Bjørn Hofmann, Jan Helge Solbakk, Søren Holm
  • What no one knows cannot hurt you : the limits of informed consent in the emerging world of biobanking / Arthur L. Caplan
  • Users and uses of the biopolitics of consent : a study of DNA banks / Pascal Ducournau and Anne Cambon-Thomsen
  • Information rights on the edge of ignorance / Anne Maria Skrikerud
  • The dubious uniqueness of genetic information / Anne Maria Skrikerud
  • Duties and rights of biobank participants : principled autonomy, consent, voluntariness and privacy / Lars Øystein Ursin
  • Biobanking and disclosure of research results : addressing the tension between professional boundaries and moral intuition / Lynn G. Dressler
  • Biobanks and our common good / Erik Christensen
  • Trust, distrust and co-production : the relationship between research biobanks and donors / Pascal Ducournau and Roger Strand
  • Scientific citizenship, benefit, and protection in population-based research / Vilhj́almur Árnason
  • Pt. 2. Research Biobanking : towards a new conceptual approach
  • Mapping the language of research biobanking : an analogical approach / Bjørn Hofmann, Jan Helge Solbakk, Søren Holm
  • The use of analogical reasoning in umbilical cord blood biobanking / Bjørn Hofmann, Jan Helge Solbakk, Søren Holm
  • The Alexandria plan : creating libraries for human tissue research and therapeutic use / Laurie Zoloth
  • The art of biocollections / Anne Hambro Alnæs
  • The health dugnard : biobank participation as the solidary pursuit of the common good / Lars Øystein Ursin and Berge Solberg
  • Embodied gifting : reflections on the role of information in biobank recruitment / Klaus Hoeyer
  • Conscription to biobank research? / Bjørn Hofmann, Jan Helge Solbakk, Søren Holm
  • Ownership rights in research biobanks : do we need a new king of 'biological property'? / Paula Lobato de Faria
  • Legal challenges and strategies in the regulation of research biobanking / Elisabeth Rynning
  • Annexation of life : the biopolitics of industrial biology / Jan Reinert Karlsen and Roger Strand
  • In the ruins of Babel : should biobank regulations be harmonized / Jan Reinert Karlsen, Jan Helge Solbak, and Roger Strand.
Medical Library (Lane)
x, 369 pages, [8] pages of plates : illustrations (some color) ; 25 cm
Her name was Henrietta Lacks, but scientists know her as HeLa. She was a poor Southern tobacco farmer, yet her cells--taken without her knowledge--became one of the most important tools in medicine. The first "immortal" human cells grown in culture, they are still alive today, though she has been dead for more than sixty years. HeLa cells were vital for developing the polio vaccine; uncovered secrets of cancer and viruses; helped lead to in vitro fertilization, cloning, and gene mapping; and have been bought and sold by the billions. Yet Henrietta Lacks is buried in an unmarked grave. Her family did not learn of her "immortality" until more than twenty years after her death, when scientists began using her husband and children in research without informed consent. The story of the Lacks family is inextricably connected to the dark history of experimentation on African Americans, the birth of bioethics, and the legal battles over whether we control the stuff we are made of--From publisher description.
Medical Library (Lane)


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