Incidental Findings In Human Subjects Research

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Returning Individual Research Results to Participants

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309475201
Total Pages : 399 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Returning Individual Research Results to Participants by : National Academies of Sciences, Engineering, and Medicine

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.

Sharing Clinical Trial Data

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Medical Ethics Today

Author : British Medical Association
Publisher : John Wiley & Sons
ISBN 13 : 1444355643
Total Pages : 919 pages
Book Rating : 4.4/5 (443 download)

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Book Synopsis Medical Ethics Today by : British Medical Association

Download or read book Medical Ethics Today written by British Medical Association and published by John Wiley & Sons. This book was released on 2012-01-31 with total page 919 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is your source for authoritative and comprehensive guidance from the British Medical Association (BMA) Medical Ethics Department covering both routine and highly contentious medico-legal issues faced by health care professionals. The new edition updates the information from both the legal and ethical perspectives and reflects developments surrounding The Mental Capacity Act, Human Tissue Act, and revision of the Human Fertilisation and Embryology Act.

Registries for Evaluating Patient Outcomes

Author : Agency for Healthcare Research and Quality/AHRQ
Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Incidental Radiological Findings

Author : Sabine Weckbach
Publisher : Springer
ISBN 13 : 3319425811
Total Pages : 209 pages
Book Rating : 4.3/5 (194 download)

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Book Synopsis Incidental Radiological Findings by : Sabine Weckbach

Download or read book Incidental Radiological Findings written by Sabine Weckbach and published by Springer. This book was released on 2017-05-03 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers incidental radiological findings (IFs) from different perspectives, provides interesting ethical background information, highlights the differences between IFs in clinical routine and during research studies, explains the management of IFs with reference to practices in different countries. The prevalence of IFs is increasing due to the wider use of modern imaging modalities in routine clinical practice and large population-based cohort studies. The reporting of these findings may lead to further diagnostic investigations and treatment and must therefore be handled with knowledge and care. The management of IFs in clinical routine is regulated by the guidelines of the different academic societies, while management in the setting of research studies depends on a variety of factors. In general, IFs must be disclosed to the imaged subject if they are potentially clinically relevant, but subjects must also be protected from the consequences of false positive findings. This book, written by distinguished experts in their fields, discusses all these issues and will be of interest to radiologists, other clinicians, and radiographers/technicians.

Clinical Neuroradiology

Author : Frederik Barkhof
Publisher : Springer
ISBN 13 : 9783319685359
Total Pages : pages
Book Rating : 4.6/5 (853 download)

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Book Synopsis Clinical Neuroradiology by : Frederik Barkhof

Download or read book Clinical Neuroradiology written by Frederik Barkhof and published by Springer. This book was released on 2019-04-16 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This superbly illustrated textbook, endorsed by the European Society of Neuroradiology, explains in detail the clinical importance of neuroradiology in complementing history taking and physical examination during the workup of patients suspected of having neurological, neurosurgical, or psychiatric disorders. The role of imaging of the brain and spinal cord is described across the full range of relevant conditions, including, for example, cerebrovascular diseases, trauma, CSF disorders, developmental malformations, autoimmune diseases, epilepsy, tumors and tumor-like conditions, neurodegenerative diseases, metabolic conditions, and bipolar and depressive disorders. The structured approach to imaging and image analysis will ensure that the book is an invaluable resource for neuroradiologists in training and clinicians alike. Starting from the clinical indication, suggestions for imaging protocols are provided and checklists of common findings and aspects key to interpretation are presented. The book is published within the SpringerReference program, which combines thorough coverage with access to living editions constantly updated via a dynamic peer-review process.

Anticipate and Communicate

Author : Presidential Commission for the Study of Bioethical Issues
Publisher : CreateSpace
ISBN 13 : 9781508807643
Total Pages : 156 pages
Book Rating : 4.8/5 (76 download)

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Book Synopsis Anticipate and Communicate by : Presidential Commission for the Study of Bioethical Issues

Download or read book Anticipate and Communicate written by Presidential Commission for the Study of Bioethical Issues and published by CreateSpace. This book was released on 2015-03-11 with total page 156 pages. Available in PDF, EPUB and Kindle. Book excerpt: Anticipate and Communicate is the Bioethics Commission's sixth major report. In this report the Bioethics Commission offers specific recommendations for the management of incidental and secondary findings in clinical, research and direct-to-consumer settings. Emerging medical technologies, changing cost structures, and evolving medical practice make the likelihood of discovering incidental and secondary findings across contexts a growing certainty. Such findings can be lifesaving, but also can lead to uncertainty and distress if they are unexpected or identify conditions for which no effective treatment is available.

The Belmont Report

Author : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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

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:

Conducting Biosocial Surveys

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309157064
Total Pages : 124 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Conducting Biosocial Surveys by : National Research Council

Download or read book Conducting Biosocial Surveys written by National Research Council and published by National Academies Press. This book was released on 2010-10-02 with total page 124 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen a growing tendency for social scientists to collect biological specimens such as blood, urine, and saliva as part of large-scale household surveys. By combining biological and social data, scientists are opening up new fields of inquiry and are able for the first time to address many new questions and connections. But including biospecimens in social surveys also adds a great deal of complexity and cost to the investigator's task. Along with the usual concerns about informed consent, privacy issues, and the best ways to collect, store, and share data, researchers now face a variety of issues that are much less familiar or that appear in a new light. In particular, collecting and storing human biological materials for use in social science research raises additional legal, ethical, and social issues, as well as practical issues related to the storage, retrieval, and sharing of data. For example, acquiring biological data and linking them to social science databases requires a more complex informed consent process, the development of a biorepository, the establishment of data sharing policies, and the creation of a process for deciding how the data are going to be shared and used for secondary analysis-all of which add cost to a survey and require additional time and attention from the investigators. These issues also are likely to be unfamiliar to social scientists who have not worked with biological specimens in the past. Adding to the attraction of collecting biospecimens but also to the complexity of sharing and protecting the data is the fact that this is an era of incredibly rapid gains in our understanding of complex biological and physiological phenomena. Thus the tradeoffs between the risks and opportunities of expanding access to research data are constantly changing. Conducting Biosocial Surveys offers findings and recommendations concerning the best approaches to the collection, storage, use, and sharing of biospecimens gathered in social science surveys and the digital representations of biological data derived therefrom. It is aimed at researchers interested in carrying out such surveys, their institutions, and their funding agencies.

Beyond the HIPAA Privacy Rule

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

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.

Finding What Works in Health Care

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

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.

Misch's Avoiding Complications in Oral Implantology

Author : Carl E. Misch
Publisher : Elsevier Health Sciences
ISBN 13 : 0323390153
Total Pages : 907 pages
Book Rating : 4.3/5 (233 download)

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Book Synopsis Misch's Avoiding Complications in Oral Implantology by : Carl E. Misch

Download or read book Misch's Avoiding Complications in Oral Implantology written by Carl E. Misch and published by Elsevier Health Sciences. This book was released on 2017-03-24 with total page 907 pages. Available in PDF, EPUB and Kindle. Book excerpt: See how to effectively manage ALL dental implant complications throughout ALL phases of treatment! Avoiding Complications in Oral Implantology provides evidence-based management protocols for a wide range of implant problems such as placement complications, malpositioning, bleeding, infection, and nerve injuries. Hundreds of high-quality, full-color photos and illustrations clearly demonstrate the complications and their resolution. Edited by Carl Misch and Randolph Resnik — both well-known names in dental implantology and prosthodontics — and with a team of expert contributors, this authoritative guide helps you handle the implant-related complications that can occur as more and more patients choose dental implants. - Expert authors are joined by a panel of recognized leaders in implant dentistry — many of whom are associated with the Misch International Implant Institute — to share their extensive experience with handling complications through all phases of treatment. - Comprehensive approach to complications that occur in the different phases of oral implantology provides the knowledge and skills you need to handle treatment planning, implant placement, post-operative complications, prostheses-related complications, and more. - Over 1,000 images include full-color clinical photographs, radiographs, line drawings, and diagrams, clearly demonstrating complications, procedures, and outcomes. - Management protocols developed by world-renowned dental implantologists provide a proven system and authoritative guidance in managing complications with dental implants. - Evidence-based solutions make it easier to manage a wide variety of clinical problems associated with dental implants, with state-of-the-art guidance supported by the best available research.

Cardiovascular Magnetic Resonance

Author : Warren J. Manning
Publisher : Elsevier Health Sciences
ISBN 13 : 0323497373
Total Pages : 797 pages
Book Rating : 4.3/5 (234 download)

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Book Synopsis Cardiovascular Magnetic Resonance by : Warren J. Manning

Download or read book Cardiovascular Magnetic Resonance written by Warren J. Manning and published by Elsevier Health Sciences. This book was released on 2018-04-26 with total page 797 pages. Available in PDF, EPUB and Kindle. Book excerpt: - Provides state-of-the-art coverage of CMR technologies and guidelines, including basic principles, imaging techniques, ischemic heart disease, right ventricular and congenital heart disease, vascular and pericardium conditions, and functional cardiovascular disease. - Includes new chapters on non-cardiac pathology, pacemaker safety, economics of CMR, and guidelines as well as new coverage of myocarditis and its diagnosis and assessment of prognosis by cardiovascular magnetic resonance, and the use of PET/CMR imaging of the heart, especially in sarcoidosis. - Features more than 1,100 high-quality images representing today's CMR imaging. - Covers T1, T2 and ECV mapping, as well as T2* imaging in iron overload, which has been shown to save lives in patients with thalassaemia major - Discusses the cost-effectiveness of CMR. - Provides state-of-the-art coverage of CMR technologies and guidelines, including basic principles, imaging techniques, ischemic heart disease, right ventricular and congenital heart disease, vascular and pericardium conditions, and functional cardiovascular disease. - Includes new chapters on non-cardiac pathology, pacemaker safety, economics of CMR, and guidelines as well as new coverage of myocarditis and its diagnosis and assessment of prognosis by cardiovascular magnetic resonance, and the use of PET/CMR imaging of the heart, especially in sarcoidosis. - Features more than 1,100 high-quality images representing today's CMR imaging. - Covers T1, T2 and ECV mapping, as well as T2* imaging in iron overload, which has been shown to save lives in patients with thalassaemia major. - Discusses the cost-effectiveness of CMR. - Expert ConsultTM eBook version included with purchase. This enhanced eBook experience allows you to search all of the text, figures, and references from the book on a variety of devices.

The SAGE Encyclopedia of Communication Research Methods

Author : Mike Allen
Publisher : SAGE Publications
ISBN 13 : 1483381420
Total Pages : 2013 pages
Book Rating : 4.4/5 (833 download)

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Book Synopsis The SAGE Encyclopedia of Communication Research Methods by : Mike Allen

Download or read book The SAGE Encyclopedia of Communication Research Methods written by Mike Allen and published by SAGE Publications. This book was released on 2017-04-11 with total page 2013 pages. Available in PDF, EPUB and Kindle. Book excerpt: Communication research is evolving and changing in a world of online journals, open-access, and new ways of obtaining data and conducting experiments via the Internet. Although there are generic encyclopedias describing basic social science research methodologies in general, until now there has been no comprehensive A-to-Z reference work exploring methods specific to communication and media studies. Our entries, authored by key figures in the field, focus on special considerations when applied specifically to communication research, accompanied by engaging examples from the literature of communication, journalism, and media studies. Entries cover every step of the research process, from the creative development of research topics and questions to literature reviews, selection of best methods (whether quantitative, qualitative, or mixed) for analyzing research results and publishing research findings, whether in traditional media or via new media outlets. In addition to expected entries covering the basics of theories and methods traditionally used in communication research, other entries discuss important trends influencing the future of that research, including contemporary practical issues students will face in communication professions, the influences of globalization on research, use of new recording technologies in fieldwork, and the challenges and opportunities related to studying online multi-media environments. Email, texting, cellphone video, and blogging are shown not only as topics of research but also as means of collecting and analyzing data. Still other entries delve into considerations of accountability, copyright, confidentiality, data ownership and security, privacy, and other aspects of conducting an ethical research program. Features: 652 signed entries are contained in an authoritative work spanning four volumes available in choice of electronic or print formats. Although organized A-to-Z, front matter includes a Reader’s Guide grouping entries thematically to help students interested in a specific aspect of communication research to more easily locate directly related entries. Back matter includes a Chronology of the development of the field of communication research; a Resource Guide to classic books, journals, and associations; a Glossary introducing the terminology of the field; and a detailed Index. Entries conclude with References/Further Readings and Cross-References to related entries to guide students further in their research journeys. The Index, Reader’s Guide themes, and Cross-References combine to provide robust search-and-browse in the e-version.

The Prevention and Treatment of Missing Data in Clinical Trials

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 030918651X
Total Pages : 163 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis The Prevention and Treatment of Missing Data in Clinical Trials by : National Research Council

Download or read book The Prevention and Treatment of Missing Data in Clinical Trials written by National Research Council and published by National Academies Press. This book was released on 2010-12-21 with total page 163 pages. Available in PDF, EPUB and Kindle. Book excerpt: Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

International Ethical Guidelines for Health-Related Research Involving Humans

Author : Council for International Organizations of Medical Sciences (CIOMS)
Publisher : World Health Organization
ISBN 13 : 9789290360889
Total Pages : 0 pages
Book Rating : 4.3/5 (68 download)

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Book Synopsis International Ethical Guidelines for Health-Related Research Involving Humans by : Council for International Organizations of Medical Sciences (CIOMS)

Download or read book International Ethical Guidelines for Health-Related Research Involving Humans written by Council for International Organizations of Medical Sciences (CIOMS) and published by World Health Organization. This book was released on 2017-01-31 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: "In the new 2016 version of the ethical guidelines, CIOMS provides answers to a number of pressing issues in research ethics. The Council does so by stressing the need for research having scientific and social value, by providing special guidelines for health-related research in low-resource settings, by detailing the provisions for involving vulnerable groups in research and for describing under what conditions biological samples and health-related data can be used for research."--Page 4 de la couverture.

Secondary Findings in Genomic Research

Author :
Publisher : Academic Press
ISBN 13 : 0128165499
Total Pages : 244 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Secondary Findings in Genomic Research by :

Download or read book Secondary Findings in Genomic Research written by and published by Academic Press. This book was released on 2020-03-04 with total page 244 pages. Available in PDF, EPUB and Kindle. Book excerpt: Secondary Findings in Genomic Research offers a single, highly accessible resource on interpreting, managing and disclosing secondary findings in genomic research. With chapters written by experts in the field, this book is the first to concisely explain the ethical and practical issues raised by secondary genomics findings for a multi and interdisciplinary audience of genomic researchers, translational scientists, clinicians, medical students, genetic counselors, ethicists, legal experts and law students, public policy specialists and regulators. Contributors from Europe, North America, and Asia effectively synthesize perspectives from a spectrum of different scientific, societal, and global contexts, and offer pragmatic approaches to a range of topics, including oversight, governance and policy surrounding secondary genomic results, criteria for identifying results for return, communication and consent, stakeholders' attitudes and perspectives, disclosing results, and clinical, patient-centered protocols.