Trust and Integrity in Biomedical Research


Book Description

Highly Commended in the Basis of Medicine, 2011 BMA Medical Book Awards. British Medical Association 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.




Fostering Integrity in Research


Book Description

The integrity of knowledge that emerges from research is based on individual and collective adherence to core values of objectivity, honesty, openness, fairness, accountability, and stewardship. Integrity in science means that the organizations in which research is conducted encourage those involved to exemplify these values in every step of the research process. Understanding the dynamics that support â€" or distort â€" practices that uphold the integrity of research by all participants ensures that the research enterprise advances knowledge. The 1992 report Responsible Science: Ensuring the Integrity of the Research Process evaluated issues related to scientific responsibility and the conduct of research. It provided a valuable service in describing and analyzing a very complicated set of issues, and has served as a crucial basis for thinking about research integrity for more than two decades. However, as experience has accumulated with various forms of research misconduct, detrimental research practices, and other forms of misconduct, as subsequent empirical research has revealed more about the nature of scientific misconduct, and because technological and social changes have altered the environment in which science is conducted, it is clear that the framework established more than two decades ago needs to be updated. Responsible Science served as a valuable benchmark to set the context for this most recent analysis and to help guide the committee's thought process. Fostering Integrity in Research identifies best practices in research and recommends practical options for discouraging and addressing research misconduct and detrimental research practices.




Public Trust in Medical Research?


Book Description

It has been claimed by fertility experts that embryos can be screened for 6,000 diseases, thereby the risk of x-linked diseases can be minimised by 'cherry-picking' male embryos that do not carry the abnormal gene. If medical scientists continue to strive for cures, genetic aberrance in human could be a phenomenon of the past...This challenging book explores issues of professional integrity and ethics underpinning medical research. It includes real-life case studies where public trust in medical research has been misplaced and encourages medical professionals to adhere to professional codes of conduct and be informed about their decision making process. It is vital reading for undergraduate and postgraduate students of medicine, law, sociology and social policy, philosophy, health related research and ethics. Practising researchers in medicine and the pharmaceutical industry, and their managers will find it invaluable. The text provides motivation for academics and educators with an interest in research and governance. Healthcare policy makers and shapers, patient rights groups, campaigners and the general media will find the information enlightening. "Over the last four decades, medicine has given hope to many people and saved many lives as a result of the ability of the physicians and surgeons to develop new treatments and innovative surgical techniques. While we can celebrate the success of medical science, we should also critically examine some of these developments against principles and in the light of public opinion." - Philip Cheung.




Responsible Conduct of Research


Book Description

Recent scandals and controversies, such as data fabrication in federally funded science, data manipulation and distortion in private industry, and human embryonic stem cell research, illustrate the importance of ethics in science. Responsible Conduct of Research, now in a completely updated second edition, provides an introduction to the social, ethical, and legal issues facing scientists today.




Conflict of Interest in Medical Research, Education, and Practice


Book Description

Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.




The Ethics of Research with Human Subjects


Book Description

This book provides a framework for approaching ethical and policy dilemmas in research with human subjects from the perspective of trust. It explains how trust is important not only between investigators and subjects but also between and among other stakeholders involved in the research enterprise, including research staff, sponsors, institutions, communities, oversight committees, government agencies, and the general public. The book argues that trust should be viewed as a distinct ethical principle for research with human subjects that complements other principles, such as autonomy, beneficence, non-maleficence, and justice. The book applies the principle of trust to numerous issues, including informed consent, confidentiality, risk minimization, risks and benefits, protection of vulnerable subjects, experimental design, research integrity, and research oversight.This work also includes discussions of the history of research involving human subjects, moral theories and principles, contemporary cases, and proposed regulatory reforms. The book is useful for undergraduate and graduate students studying ethical policy issues related to research with human subjects, as well as for scientists and scholars who are interested in thinking about this topic from the perspective of trust.




Scientific Integrity


Book Description

This widely adopted textbook provides the essential content and skill-building tools for teaching the responsible conduct of scientific research. Scientific Integrity covers the breadth of concerns faced by scientists: protection of animal and human experimental subjects, scientific publication, intellectual property, conflict of interest, collaboration, record keeping, mentoring, and the social and ethical responsibilities of scientists. Learning activities and resources designed to elucidate the principles of Scientific Integrity include Dozens of highly relevant, interactive case studies for discussion in class or online Numerous print and online resources covering the newest research guidelines, regulations, mandates and policies Discussion questions, role-playing exercises, and survey tools to promote critical thought Documents including published rules of conduct, sample experimentation protocols, and patent applications The new edition of Scientific Integrity responds to significant recent changes—new mandates, policies, laws, and other developments—in the field of responsible conduct of research. Dr. Macrina plants the seeds of awareness of existing, changing, and emerging standards in scientific conduct and provides the tools to promote critical thinking in the use of that information. Scientific Integrity is the original turnkey text to guide the next generations of scientists as well as practicing researchers in the essential skills and approaches for the responsible conduct of science.




Scientific Integrity and Ethics in the Geosciences


Book Description

Science is built on trust. The assumption is that scientists will conduct their work with integrity, honesty, and a strict adherence to scientific protocols. Written by geoscientists for geoscientists, Scientific Integrity and Ethics in the Geosciences acquaints readers with the fundamental principles of scientific ethics and shows how they apply to everyday work in the classroom, laboratory, and field. Resources are provided throughout to help discuss and implement principles of scientific integrity and ethics. Volume highlights include: Examples of international and national codes and policies Exploration of the role of professional societies in scientific integrity and ethics References to scientific integrity and ethics in publications and research data Discussion of science integrity, ethics, and geoethics in education Extensive coverage of data applications Scientific Integrity and Ethics in the Geosciences is a valuable resource for students, faculty, instructors, and scientists in the geosciences and beyond. It is also useful for geoscientists working in industry, government, and policymaking. Read an interview with the editors to find out more: https://eos.org/editors-vox/ethics-crucial-for-the-future-of-the-geosciences




Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age


Book Description

As digital technologies are expanding the power and reach of research, they are also raising complex issues. These include complications in ensuring the validity of research data; standards that do not keep pace with the high rate of innovation; restrictions on data sharing that reduce the ability of researchers to verify results and build on previous research; and huge increases in the amount of data being generated, creating severe challenges in preserving that data for long-term use. Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age examines the consequences of the changes affecting research data with respect to three issues - integrity, accessibility, and stewardship-and finds a need for a new approach to the design and the management of research projects. The report recommends that all researchers receive appropriate training in the management of research data, and calls on researchers to make all research data, methods, and other information underlying results publicly accessible in a timely manner. The book also sees the stewardship of research data as a critical long-term task for the research enterprise and its stakeholders. Individual researchers, research institutions, research sponsors, professional societies, and journals involved in scientific, engineering, and medical research will find this book an essential guide to the principles affecting research data in the digital age.




Understanding Medical Professionalism


Book Description

A groundbreaking text on how to deliver the highest quality patient care through professionalism in daily medical practice Five Star Doody’s Review: “This is an outstanding book for all clinicians and professors, indeed for everyone in medicine to help mentor and self-police the medical profession.” "Understanding Medical Professionalism is a 'must-have' for all involved in the healing arts. The book demystifies professionalism, bringing it from a philosophical, mystical concept to a practical everyday set of behaviors. The twelve chapters, in a uniform way, provide wonderful, real-life stories that illustrate the challenges faced by practitioners, describe ways to deal with those challenges, and help develop the personal and institutional skills necessary to provide excellent and compassionate care." -- Carlos A. Pellegrini, MD, FACS, FRCSI (Hon.), The Henry N. Harkins Professor and Chair, Department of Surgery, University of Washington "Insightful, practical, and authoritative. Building on their own research and that of others, Levinson et al. offer a comprehensive discussion of medical professionalism from the refreshing perspective of behavioral skills and an enabling healthcare system. Understanding Medical Professionalism has fundamentally reframed the professionalism debate and will likely remain the definitive work in this field for quite some time." -- David G. Nichols, MD, President and CEO, The American Board of Pediatrics "The authors' ambitious goal of providing a framework for the continuum of physician development of professional behaviors, from student through expert senior clinician, has been met. Students will find the text modular and instructive; residents will benefit from the reinforcement of positive professional behaviors and explication of strategies to excel in this competency; educational program directors will find the framework and tools for assessment and strategies for remediation enriching; and the expert professional will find subtle opportunities to grow to mastership of this most important physician competency." -- Thomas J. Nasca, MD, MACP, Chief Executive Officer, Accreditation Council for Graduate Medical Education, Professor of Medicine, Jefferson Medical College "The authors offer a framework and an approach to medical professionalism that enable us to understand it, teach it, and incorporate it into our day-to-day lives as health professionals. It is a much needed addition to our armamentarium as we work to align the education of health professionals with the needs and expectations of the society we serve." -- George E. Thibault, MD, President, Josiah Macy Jr. Foundation