Research Risk Benefit Analyses And Ethical Issues

Author : Comisión Europea,European Commission. Directorate-General for Research and Innovation,Europäische Kommission. Generaldirektion Forschung und Innovation
Publisher : Unknown
Page : 18 pages
File Size : 54,6 Mb
Release : 2013
Category : Ethics
ISBN : 9279288539

Get Book

Research, Risk-benefit Analyses and Ethical Issues by Comisión Europea,European Commission. Directorate-General for Research and Innovation,Europäische Kommission. Generaldirektion Forschung und Innovation Pdf

Ethics in research is a topic of common interest and ethical concerns raised in public debates should not be ignored. However, ethical issues should not be an obstacle for researchers, but a call to engagement. Ethical issues can be managed in the same way researchers manage other risks: by safeguarding exposure to threats or hazards: the task is to reduce risk and to develop means to safeguard shared societal values. The objective of this risk-benefit analyses and ethical issues guidance document is to help researchers comply with the requirements of the ethics reviews organised by the European Commission. It identifies the most common ethical issues - research on humans, data protection, animal testing, dual use etc. -, gives definitions and illustrates with examples. It provides researchers with practical tips how to ensure ethically sound research and assists them with enlisting the relevant European and international legislation for consultation -- EU Bookshop.

Author : Graeme Laurie,Edward Dove,Agomoni Ganguli-Mitra,Catriona McMillan,Emily Postan,Nayha Sethi,Annie Sorbie
Publisher : Unknown
Page : 444 pages
File Size : 47,7 Mb
Release : 2021-06-09
Category : Law
ISBN : 9781108576093

Get Book

The Cambridge Handbook of Health Research Regulation by Graeme Laurie,Edward Dove,Agomoni Ganguli-Mitra,Catriona McMillan,Emily Postan,Nayha Sethi,Annie Sorbie Pdf

The definitive reference guide to designing scientifically sound and ethically robust medical research, considering legal, ethical and practical issues.

Author : Franklin G. Miller
Publisher : Oxford University Press
Page : 336 pages
File Size : 50,8 Mb
Release : 2012-06-01
Category : Medical
ISBN : 9780199896219

Get Book

The Ethical Challenges of Human Research by Franklin G. Miller Pdf

The use of human beings as research subjects poses distinctive ethical issues. Subjects of medical research are exposed to risks of harm for the sake of generating scientific knowledge that can benefit future patients and society. Ethical analysis of the challenges posed by research involving human subjects requires careful attention to the contextual details of scientific experimentation. This book contains 22 essays by Franklin G. Miller on research ethics written over a 15-year period. With the exception of the first essay, all have been previously published in bioethics and medical journals. The book is arranged into four parts. Part One addresses a general ethical perspective on the protection of human subjects in clinical research, including paternalism in research regulation and acceptable limits to research risks. The essays in Part Two examine ethical issues in study design. It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data. Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model." An abiding theme, developed in many of the essays is that the ethics of clinical research is importantly different from the ethics of medical care.

Author : Kristin Shrader-Frechette
Publisher : Springer Science & Business Media
Page : 234 pages
File Size : 51,8 Mb
Release : 2012-12-06
Category : Technology & Engineering
ISBN : 9789400952416

Get Book

Risk Analysis and Scientific Method by Kristin Shrader-Frechette Pdf

Much of the work in this volume was supported by the National Science Foundation under Grant SES82-05112 from the Program in History and Philosophy of Science and the Division of Policy Research and Analysis. (Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author and do not necessarily reflect the views of the National Science Foundation. ) Several of these essays were written because of the impetus afforded by speaking invitations. An earlier version of Chapter 3 was presented in Berkeley in January 1983 at a Principal Investi gators' Conference sponsored by the National Science Foundation, Division of Policy Research and Analysis, Technology Assessment and Risk Assessment Group. In May 1982, an earlier version of Chapter 5 was presented at the meeting of the Society for Philos ophy and Technology, held in conjunction with the American Philosophical Association meeting, Western Division, in Columbus, Ohio. Finally, earlier versions of Chapter 6 were presented in Boston in December 1981 at the Boston Colloquium for the Philosophy of Science, as well as at the University of Delaware in January 1982 and at the Biennial Meeting of the Philosophy of Science Association held in Philadelphia in October 1982. An earlier version of this same chapter was published in Philosophy of Science Association 82, volume 1, ed. T. Nickles, Philosophy of Science Association, East Lansing, Michigan, 1982. A number of people have helped to make this book better than it might have been.

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher : Unknown
Page : 614 pages
File Size : 48,5 Mb
Release : 1978
Category : Human experimentation in medicine
ISBN : UCSD:31822000897728

Get Book

The Belmont Report by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research Pdf

Author : Susan Bull
Publisher : Springer Nature
Page : 250 pages
File Size : 44,5 Mb
Release : 2024
Category : Electronic
ISBN : 9783031418044

Get Book

Research Ethics in Epidemics and Pandemics by Susan Bull Pdf

Author : Tom L. Beauchamp
Publisher : Unknown
Page : 456 pages
File Size : 44,7 Mb
Release : 1982
Category : Business & Economics
ISBN : STANFORD:36105039308429

Get Book

Ethical Issues in Social Science Research by Tom L. Beauchamp Pdf

Author : Bernard Lo
Publisher : Lippincott Williams & Wilkins
Page : 302 pages
File Size : 42,6 Mb
Release : 2012-03-28
Category : Medical
ISBN : 9781451152777

Get Book

Ethical Issues in Clinical Research by Bernard Lo Pdf

This book teaches researchers how to resolve the ethical dilemmas that can arise at any stage in clinical research. In addition to explaining pertinent regulations and laws, Dr. Lo helps investigators understand the gaps and uncertainties in regulations, as well as situations in which merely complying with the law may not fulfill ethical responsibilities. Most chapters include real-life examples that the author walks through, discussing the salient issues and how to approach them. This book can be used in courses on research ethics that are required or encouraged by major National Institutes of Health grants in academic health centers.

Author : Lotte Asveld,Sabine Roeser
Publisher : Earthscan
Page : 305 pages
File Size : 50,6 Mb
Release : 2012
Category : Business & Economics
ISBN : 9781849772990

Get Book

The Ethics of Technological Risk by Lotte Asveld,Sabine Roeser Pdf

First published in 2008.

Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
Publisher : National Academies Press
Page : 445 pages
File Size : 52,8 Mb
Release : 2004-07-09
Category : Medical
ISBN : 9780309133388

Get Book

Ethical Conduct of Clinical Research Involving Children by Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children Pdf

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.

Author : Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research,Board on Health Sciences Policy,Institute of Medicine
Publisher : National Academies Press
Page : 284 pages
File Size : 51,9 Mb
Release : 2007-01-22
Category : Political Science
ISBN : 9780309164603

Get Book

Ethical Considerations for Research Involving Prisoners by Committee on Ethical Considerations for Revisions to DHHS Regulations for Protection of Prisoners Involved in Research,Board on Health Sciences Policy,Institute of Medicine Pdf

In the past 30 years, the population of prisoners in the United States has expanded almost 5-fold, correctional facilities are increasingly overcrowded, and more of the country's disadvantaged populations—racial minorities, women, people with mental illness, and people with communicable diseases such as HIV/AIDS, hepatitis C, and tuberculosis—are under correctional supervision. Because prisoners face restrictions on liberty and autonomy, have limited privacy, and often receive inadequate health care, they require specific protections when involved in research, particularly in today's correctional settings. Given these issues, the Department of Health and Human Services' Office for Human Research Protections commissioned the Institute of Medicine to review the ethical considerations regarding research involving prisoners. The resulting analysis contained in this book, Ethical Considerations for Research Involving Prisoners, emphasizes five broad actions to provide prisoners involved in research with critically important protections: • expand the definition of "prisoner"; • ensure universally and consistently applied standards of protection; • shift from a category-based to a risk-benefit approach to research review; • update the ethical framework to include collaborative responsibility; and • enhance systematic oversight of research involving prisoners.

Author : Institute of Medicine,Committee on Assessing Genetic Risks
Publisher : National Academies Press
Page : 353 pages
File Size : 43,7 Mb
Release : 1994-01-01
Category : Medical
ISBN : 9780309047982

Get Book

Assessing Genetic Risks by Institute of Medicine,Committee on Assessing Genetic Risks Pdf

Raising hopes for disease treatment and prevention, but also the specter of discrimination and "designer genes," genetic testing is potentially one of the most socially explosive developments of our time. This book presents a current assessment of this rapidly evolving field, offering principles for actions and research and recommendations on key issues in genetic testing and screening. Advantages of early genetic knowledge are balanced with issues associated with such knowledge: availability of treatment, privacy and discrimination, personal decision-making, public health objectives, cost, and more. Among the important issues covered: Quality control in genetic testing. Appropriate roles for public agencies, private health practitioners, and laboratories. Value-neutral education and counseling for persons considering testing. Use of test results in insurance, employment, and other settings.

Author : National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on Population
Publisher : National Academies Press
Page : 102 pages
File Size : 46,5 Mb
Release : 2015-09-18
Category : Science
ISBN : 9780309378123

Get Book

Sharing Research Data to Improve Public Health in Africa by National Academies of Sciences, Engineering, and Medicine,Division of Behavioral and Social Sciences and Education,Committee on Population Pdf

Sharing research data on public health issues can promote expanded scientific inquiry and has the potential to advance improvements in public health. Although sharing data is the norm in some research fields, sharing of data in public health is not as firmly established. In March 2015, the National Research Council organized an international conference in Stellenbosch, South Africa, to explore the benefits of and barriers to sharing research data within the African context. The workshop brought together public health researchers and epidemiologists primarily from the African continent, along with selected international experts, to talk about the benefits and challenges of sharing data to improve public health, and to discuss potential actions to guide future work related to public health research data sharing. Sharing Research Data to Improve Public Health in Africa summarizes the presentations and discussions from this workshop.

Author : Bernadette Mazurek Melnyk, PhD, RN, CPNP/ PMHNP, FNAP, FAAN,Dianne Morrison-Beedy, PhD, RN, WHNP, FNAP, FAANP, FAAN
Publisher : Springer Publishing Company
Page : 496 pages
File Size : 50,9 Mb
Release : 2012-04-23
Category : Medical
ISBN : 9780826109583

Get Book

Intervention Research by Bernadette Mazurek Melnyk, PhD, RN, CPNP/ PMHNP, FNAP, FAAN,Dianne Morrison-Beedy, PhD, RN, WHNP, FNAP, FAANP, FAAN Pdf

2012 First Place AJN Book of the Year Award Winner in Nursing Research! "This is a resource for success and should be a part of any researcher's library."--Doody's Medical Reviews This book is a practical, user-friendly guide for health care researchers across multiple disciplines who are involved in intervention research. It provides all of the essential elements needed for understanding how to design, conduct, analyze, and fund intervention studies that are replicable and can withstand the scrutiny of the Institutional Review Board and peer review. Developed from an annual continuing education workshop on intervention studies conducted by Dr. Melnyk, this text is the most comprehensive body of information available on this topic. Contributors address the design of interventions that are ethically considerate and sensitive to culture, race/ethnicity, and gender, minimizing threats to external and internal validity, measurement, and budgeting. The guide explores such implementation issues as subject recruitment and retention, data management, and specialized settings, cost analysis, and explaining intervention effects. The text also guides readers in writing grant applications that fund , and addresses how to move intervention study findings into the real world. A unique addition to the book is the availability of digital examples of progress reports, final reports, and research grant applications that have received funding from the National Institutes of Health and other relevant organizations. This text is a valuable resource for all health care professionals conducting research and for doctoral students in health care studies. Key Features: Presents the essential tools for designing, conducting, analyzing, and funding intervention studies Designed for use by health care professionals conducting intervention research Provides comprehensive, accessible guidelines for doctoral students across all health care disciplines Instructs readers on writing grant applications that fund Includes digital examples of funded research grants, progress reports, and final reports

Author : Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross
Publisher : Oxford University Press, USA
Page : 479 pages
File Size : 51,8 Mb
Release : 2015
Category : Medical
ISBN : 9780198732860

Get Book

Field Trials of Health Interventions by Peter G. Smith,R. H. Morrow,Richard H. Morrow,David A. Ross Pdf

"IEA, International Epidemiological Association, Welcome Trust."