Returning Individual Research Results to Participants
Returning Individual Research Results to Participants

Author: National Academies of Sciences, Engineering, and Medicine

Publisher: National Academies Press

Published: 2018-08-23

Total Pages: 399

ISBN-13: 0309475201

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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.

Finding What Works in Health Care
Finding What Works in Health Care

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2011-07-20

Total Pages: 267

ISBN-13: 0309164257

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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.

Individual Participant Data Meta-Analysis
Individual Participant Data Meta-Analysis

Author: Richard D. Riley

Publisher: John Wiley & Sons

Published: 2021-06-08

Total Pages: 38

ISBN-13: 1119333725

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Individual Participant Data Meta-Analysis: A Handbook for Healthcare Research provides a comprehensive introduction to the fundamental principles and methods that healthcare researchers need when considering, conducting or using individual participant data (IPD) meta-analysis projects. Written and edited by researchers with substantial experience in the field, the book details key concepts and practical guidance for each stage of an IPD meta-analysis project, alongside illustrated examples and summary learning points. Split into five parts, the book chapters take the reader through the journey from initiating and planning IPD projects to obtaining, checking, and meta-analysing IPD, and appraising and reporting findings. The book initially focuses on the synthesis of IPD from randomised trials to evaluate treatment effects, including the evaluation of participant-level effect modifiers (treatment-covariate interactions). Detailed extension is then made to specialist topics such as diagnostic test accuracy, prognostic factors, risk prediction models, and advanced statistical topics such as multivariate and network meta-analysis, power calculations, and missing data. Intended for a broad audience, the book will enable the reader to: Understand the advantages of the IPD approach and decide when it is needed over a conventional systematic review Recognise the scope, resources and challenges of IPD meta-analysis projects Appreciate the importance of a multi-disciplinary project team and close collaboration with the original study investigators Understand how to obtain, check, manage and harmonise IPD from multiple studies Examine risk of bias (quality) of IPD and minimise potential biases throughout the project Understand fundamental statistical methods for IPD meta-analysis, including two-stage and one-stage approaches (and their differences), and statistical software to implement them Clearly report and disseminate IPD meta-analyses to inform policy, practice and future research Critically appraise existing IPD meta-analysis projects Address specialist topics such as effect modification, multiple correlated outcomes, multiple treatment comparisons, non-linear relationships, test accuracy at multiple thresholds, multiple imputation, and developing and validating clinical prediction models Detailed examples and case studies are provided throughout.

Conducting Research with Human Participants
Conducting Research with Human Participants

Author: Nathan Durdella

Publisher: SAGE Publications

Published: 2022-02-15

Total Pages: 343

ISBN-13: 1544348606

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Conducting Research with Human Participants: An IRB Guide for Students and Faculty by Nathan Durdella is the only guidebook students and faculty will need to navigate the IRB process and secure swift approval of research protocols. This book serves as an advisor to walk researchers through all the details of drafting, submission, and revision of materials for Institutional Review Boards so they can complete their research projects or dissertations faster. This text walks readers through the history of Institutional Review Boards, the contemporary context of ethical research, strategies to effectively draft, submit, and revise an IRB protocol, and guidance on working with an approved protocol in the field. The latest updates to the Common Rule and other regulatory frameworks, including special protections for working with vulnerable groups, are covered throughout the text. Not every research project goes according to plan, so adverse events and reporting receive special coverage. A final chapter on ethical research practices beyond IRB compliance encourages researchers to think through how to exit the field of research and ensure their research benefits the individuals, families, and communities in which they work. Take the guesswork out of the IRB process from start to finish with this handy guide.

Individual and Society
Individual and Society

Author: Lizabeth A. Crawford

Publisher: Routledge

Published: 2018-03-09

Total Pages: 800

ISBN-13: 1351978667

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Unlike other texts for undergraduate sociological social psychology courses, this text presents the three distinct traditions in sociological social psychology—symbolic interactionism, social structure and personality, and group processes and structures—and emphasizes the different theoretical frameworks within which social psychological analyses are conducted within each research tradition. With this approach, the authors make clear the link between sociological social psychology, theory, and methodology. Students will gain a better understanding of how and why social psychologists trained in sociology ask particular kinds of questions; the types of research they are involved in; and how their findings have been, or can be, applied to contemporary societal patterns and problems. This new, second edition includes the latest research on topics related to current events and changing societal patterns; more detailed discussions on intersectionality, social media, and contemporary social movements; as well as a new concluding chapter that asks students to reflect on what they have learned about sociological social psychology and its applicability to contemporary social issues. Engaging exercises and group activities are also embedded within in each chapter to enhance students’ understanding of key concepts, theories, methods and research findings within the field and how they relate to everyday life.

Sharing Clinical Trial Data
Sharing Clinical Trial Data

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-04-20

Total Pages: 236

ISBN-13: 0309316324

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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.

Cochrane Handbook for Systematic Reviews of Interventions
Cochrane Handbook for Systematic Reviews of Interventions

Author: Julian P. T. Higgins

Publisher: Wiley

Published: 2008-11-24

Total Pages: 672

ISBN-13: 9780470699515

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Healthcare providers, consumers, researchers and policy makers are inundated with unmanageable amounts of information, including evidence from healthcare research. It has become impossible for all to have the time and resources to find, appraise and interpret this evidence and incorporate it into healthcare decisions. Cochrane Reviews respond to this challenge by identifying, appraising and synthesizing research-based evidence and presenting it in a standardized format, published in The Cochrane Library (www.thecochranelibrary.com). The Cochrane Handbook for Systematic Reviews of Interventions contains methodological guidance for the preparation and maintenance of Cochrane intervention reviews. Written in a clear and accessible format, it is the essential manual for all those preparing, maintaining and reading Cochrane reviews. Many of the principles and methods described here are appropriate for systematic reviews applied to other types of research and to systematic reviews of interventions undertaken by others. It is hoped therefore that this book will be invaluable to all those who want to understand the role of systematic reviews, critically appraise published reviews or perform reviews themselves.

Rethinking Clinical Trials and Redefining Responsibility for Research Participants
Rethinking Clinical Trials and Redefining Responsibility for Research Participants

Author: Ike Iyioke

Publisher: Ethics International Press

Published: 2023-11-25

Total Pages: 261

ISBN-13: 1804411000

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This is a new treatment of clinical research ethics in an African context, and an indispensable resource for researchers, students, policy makers and research institutions interested in African research ethics. In re-appraising the African philosophical notion of selfhood, it argues for the need to re-conceptualize responsibility in clinical trials, pushing researchers to go beyond autonomy-based considerations based on the individual only, and to develop clinical trials that appropriately embed research subjects within their community and their environment. The African standpoint stresses communalism and communitarianism. As such, responsibility for, and by, the individual can only make sense through the community in which the individual is rooted. The book emphasizes the African viewpoint by making explicit the importance of the self in the re-contextualized arena of the community. It forces research ethicists to go beyond autonomy-based considerations for the individual only, and to appropriately embed research subjects within their community and their environment.

Rehabilitation Research - E-Book
Rehabilitation Research - E-Book

Author: Catherine H. Balthazar

Publisher: Elsevier Health Sciences

Published: 2021-07-03

Total Pages: 509

ISBN-13: 0323680445

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- UPDATED! Revised evidence-based content throughout provides students and rehabilitation practitioners with the most current information. - UPDATED! Coverage of the latest research methods and references ensures content is current and applicable for today's PT, OT, and SLP students. - NEW! Analysis and Interpretation of Data from Single Subject Designs chapter. - NEW! Content on evaluating the quality of online and open-access journals.