Download or read book Responsible Conduct of Research written by Adil E. Shamoo and published by Oxford University Press. This book was released on 2009-02-12 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Ethical Conduct of Clinical Research Involving Children written by Institute of Medicine and published by National Academies Press. This book was released on 2004-07-09 with total page 445 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Download or read book Fostering Integrity in Research written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-01-13 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Responsible Science written by Committee on Science, Engineering, and Public Policy (U.S.). Panel on Scientific Responsibility and the Conduct of Research and published by National Academies. This book was released on 1992 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: Responsible Science is a comprehensive review of factors that influence the integrity of the research process. Volume I examines reports on the incidence of misconduct in science and reviews institutional and governmental efforts to handle cases of misconduct. The result of a two-year study by a panel of experts convened by the National Academy of Sciences, this book critically analyzes the impact of today's research environment on the traditional checks and balances that foster integrity in science. Responsible Science is a provocative examination of the role of educational efforts; research guidelines; and the contributions of individual scientists, mentors, and institutional officials in encouraging responsible research practices.

Download or read book Principles and Practice of Clinical Research written by John I. Gallin and published by Elsevier. This book was released on 2011-04-28 with total page 447 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition of this innovative work again provides a unique perspective on the clinical discovery process by providing input from experts within the NIH on the principles and practice of clinical research. Molecular medicine, genomics, and proteomics have opened vast opportunities for translation of basic science observations to the bedside through clinical research. As an introductory reference it gives clinical investigators in all fields an awareness of the tools required to ensure research protocols are well designed and comply with the rigorous regulatory requirements necessary to maximize the safety of research subjects. Complete with sections on the history of clinical research and ethics, copious figures and charts, and sample documents it serves as an excellent companion text for any course on clinical research and as a must-have reference for seasoned researchers.*Incorporates new chapters on Managing Conflicts of Interest in Human Subjects Research, Clinical Research from the Patient's Perspective, The Clinical Researcher and the Media, Data Management in Clinical Research, Evaluation of a Protocol Budget, Clinical Research from the Industry Perspective, and Genetics in Clinical Research *Addresses the vast opportunities for translation of basic science observations to the bedside through clinical research*Delves into data management and addresses how to collect data and use it for discovery*Contains valuable, up-to-date information on how to obtain funding from the federal government

Download or read book Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health written by National Institutes of Health (U.S.) and published by . This book was released on 1993 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book ORI Introduction to the Responsible Conduct of Research written by Nicholas Hans Steneck and published by Government Printing Office. This book was released on 2004 with total page 188 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Public Health Service Policy on Humane Care and Use of Laboratory Animals written by National Institutes of Health (U.S.). Office for Protection from Research Risks and published by . This book was released on 1986 with total page 40 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Women and Health Research written by Institute of Medicine and published by National Academies Press. This book was released on 1994-02-01 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Download or read book Introduction to the Responsible Conduct of Research rev Ed written by Nicholas H. Steneck and published by DIANE Publishing. This book was released on 2009-09 with total page 182 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report seeks to supplement existing resources by making a comprehensive overview of basic rules of the road for responsible research available to all U.S. Public Health Service-funded researchers. It has been prepared with the needs of small and mid-size research and institutions and beginning researchers in mind, but it may be used in other settings. Illustrations.

Download or read book Examining Core Elements of International Research Collaboration written by Institute of Medicine and published by National Academies Press. This book was released on 2011-09-29 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The globalization of science, engineering, and medical research is proceeding rapidly. The globalization of research has important implications for the U.S. research enterprise, for the U.S. government agencies, academic institutions, and companies that support and perform research, and for the world at large. As science and technology capabilities grow around the world, U.S.-based organizations are finding that international collaborations and partnerships provide unique opportunities to enhance research and training. At the same time, significant obstacles exist to smooth collaboration across national borders. Enhancing international collaboration requires recognition of differences in culture, legitimate national security needs, and critical needs in education and training. In response to these trends, the Government-University-Industry Research Roundtable (GUIRR) launched a Working Group on International Research Collaborations (I-Group) in 2008, following its meeting on New Partnerships on a Global Platform that June. As part of I-Group's continuing effort, a workshop on Examining Core Elements of International Research Collaboration was held July 26-27, 2010 in Washington, DC. One primary goal of the workshop is to better understand the risks involved in international research collaboration for organizations and individual participants, and the mechanisms that can be used to manage those risks. Issues to be addressed in the workshop include the following: (1) Cultural Differences and Nuances; (2) Legal Issues and Agreements; (3) Differences in Ethical Standards; (4) Research Integrity and the Responsible Conduct of Research; (5) Intellectual Property; (6) Risk Management; (7) Export Controls; and (8) Strategies for Developing Meaningful International Collaborations. The goal for the workshop and the summary, Examining Core Elements of International Research Collaboration, is to serve as an information resource for participants and others interested in international research collaborations. It will also aid I-Group in setting its future goals and priorities.

Download or read book The Ethics of Research with Human Subjects written by David B. Resnik and published by Springer. This book was released on 2018-01-09 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Returning Individual Research Results to Participants written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-08-23 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: When is it appropriate to return individual research results to participants? The immense interest in this question has been fostered by the growing movement toward greater transparency and participant engagement in the research enterprise. Yet, the risks of returning individual research resultsâ€"such as results with unknown validityâ€"and the associated burdens on the research enterprise are competing considerations. Returning Individual Research Results to Participants reviews the current evidence on the benefits, harms, and costs of returning individual research results, while also considering the ethical, social, operational, and regulatory aspects of the practice. This report includes 12 recommendations directed to various stakeholdersâ€"investigators, sponsors, research institutions, institutional review boards (IRBs), regulators, and participantsâ€"and are designed to help (1) support decision making regarding the return of results on a study-by-study basis, (2) promote high-quality individual research results, (3) foster participant understanding of individual research results, and (4) revise and harmonize current regulations.

Download or read book A Practical Guide to Writing a Ruth L Kirschstein NRSA Grant written by Andrew D. Hollenbach and published by Academic Press. This book was released on 2013-09-20 with total page 123 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to Writing a Ruth L. Kirschstein NRSA Grant provides F-Series grant applicants and mentors with insider knowledge on the process by which these grants are reviewed, the biases that contribute to the reviews, the extent of information required in an NRSA training grant, a deeper understanding of the exact purpose of each section of the application, and key suggestions and recommendations on how to best construct each and every section of the application. A Practical Guide to Writing a Ruth L. Kirschstein NRSA Grant is a solid resource for trainees and their mentors to use as a guide when constructing F30, F31, and F32 grant applications. - Covers F30, F31, and F32 grant applications - Detailed overview of the review process - Key suggestions on how to best construct each section of the application - Includes a checklist of required items

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.