Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics, along with a glossary, making it an invaluable resource for scientists collaborating in clinical trials, physician investigators, clinical research fellows, and more. Walks investigators and trainees through the identification of the ethical aspects of each section of a clinical research protocol Includes case histories that illustrate key points Contains information on conducting clinical research within the pharmaceutical industry Includes internet resources and worldwide web addresses for important research ethics documents and regulations Contains a chapter on Study Design and Methodology that is purposely expanded to explicitly address biostatistical considerations

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  • Author : Evan DeRenzo
  • Publisher : Academic Press
  • Pages : 370 pages
  • ISBN : 0123869544
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKEthical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
  • Author : Evan DeRenzo,Eric A. Singer,Joel Moss
  • Publisher : Academic Press
  • Release : 12 June 2020
GET THIS BOOKEthical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics,

Ethical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol
  • Author : Evan DeRenzo,Eric A. Singer,Joel Moss
  • Publisher : Academic Press
  • Release : 10 July 2020
GET THIS BOOKEthical Considerations When Preparing a Clinical Research Protocol

Ethical Considerations When Preparing a Clinical Research Protocol, Second Edition, provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. It includes practical information on ethical principles in clinical research, how to design appropriate research studies, how to consent and assent documents, how to get protocols approved, special populations, confidentiality issues, and the reporting of adverse events. The book's valuable appendix includes a listing of web resources about research ethics,

Writing Clinical Research Protocols

Writing Clinical Research Protocols
  • Author : Evan DeRenzo,Joel Moss
  • Publisher : Elsevier
  • Release : 08 September 2005
GET THIS BOOKWriting Clinical Research Protocols

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This

Tri-council Policy Statement

Tri-council Policy Statement
  • Author : Anonim
  • Publisher : Unknown Publisher
  • Release : 17 May 2022
GET THIS BOOKTri-council Policy Statement

This document is a joint policy of Canada's three federal research agencies, the Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council of Canada, and the Social Sciences and Humanities Research Council of Canada. This updated version replaces the TCPS 2 (2010) as the official human research ethics policy of these agencies.

Reviewing Clinical Trials

Reviewing Clinical Trials
  • Author : Chinese University of Hong Kong,Chinese University of Hong Kong. Clinical Trials Centre,Washington, DC. Association for the Accreditation of Human research Protection Programs, Inc
  • Publisher : Unknown Publisher
  • Release : 17 May 2022
GET THIS BOOKReviewing Clinical Trials

The idea for this manual came from Pfizer in the US, which provided the Clinical Trials Centre at The University of Hong Kong, Hong Kong SAR, PR China with a nonbinding grant for its development. The general project layout protocol was accepted by Pfizer in July 2009. Pfizer has not in any way interfered with the project, except for providing nonbinding comments to the final product. The entire text of this manual was written by Johan PE Karlberg. Marjorie A Speers

Health Science Research

Health Science Research
  • Author : Jennifer Peat
  • Publisher : SAGE
  • Release : 01 March 2013
GET THIS BOOKHealth Science Research

For research to be effective, it is essential that every aspect of the study is well planned. Health Science Research has been written to help researchers from all disciplines conduct their studies with this kind of integrity. Each chapter covers a specific area fo conducting a study, including: - formulating the research question - preparing a grant application - subject recruitment - data collection and analysis - interpreting the results of the study This informative text is designed to be

Bioethics in Medicine and Society

Bioethics in Medicine and Society
  • Author : Thomas F. Heston,Sujoy Ray
  • Publisher : BoD – Books on Demand
  • Release : 19 May 2021
GET THIS BOOKBioethics in Medicine and Society

Bioethics is the application of ethics to the broad field of medicine, including the ethics of patient care, research, and public health. In this book, prominent authors from around the globe discuss the complexities of bioethics as they apply to our current world. Topics range from the philosophical bioethics of the evolution of thinking about marriage from a religious standpoint to the bioethics of radiation protection to value-based medicine and cancer screening for breast cancer. Bioethics in Medicine and Society

A Practical Guide for Health Researchers

A Practical Guide for Health Researchers
  • Author : M. F. Fathalla,Mahmoud F. Fathalla
  • Publisher : WHOROEM
  • Release : 17 May 2022
GET THIS BOOKA Practical Guide for Health Researchers

Health researchers, the intended audience of this book, are not limited to scientists pursuing a research career. They include health professionals, administrators, policymakers and non-governmental organizations, among others, who can and should use the scientific method to guide their work for improving the health of individuals and communities. Even if they do not pursue much research themselves, they need to grasp the principles of the scientific method, to understand the value and also the limitations of science, and to be

Ethics in Qualitative Research

Ethics in Qualitative Research
  • Author : Tina Miller,Maxine Birch,Melanie Mauthner,Julie Jessop
  • Publisher : SAGE
  • Release : 13 September 2012
GET THIS BOOKEthics in Qualitative Research

This fresh, confident second edition expands its focus on the theoretical and practical aspects of doing qualitative research in light of new ethical dilemmas facing researchers today. In a climate of significant social and technological change, researchers must respond to increased ethical regulation and scrutiny of research. New sources, types of data and modes of accessing participants are all challenging and reconfiguring traditional ideas of the research relationship. This engaging textbook explores key ethical dilemmas - including research boundaries, informed

Systematic Reviews in Educational Research

Systematic Reviews in Educational Research
  • Author : Olaf Zawacki-Richter,Michael Kerres,Svenja Bedenlier,Melissa Bond,Katja Buntins
  • Publisher : Springer Nature
  • Release : 21 November 2019
GET THIS BOOKSystematic Reviews in Educational Research

In this open access edited volume, international researchers of the field describe and discuss the systematic review method in its application to research in education. Alongside fundamental methodical considerations, reflections and practice examples are included and provide an introduction and overview on systematic reviews in education research.

Responsible Research

Responsible Research
  • Author : Institute of Medicine,Committee on Assessing the System for Protecting Human Research Participants
  • Publisher : National Academies Press
  • Release : 06 February 2003
GET THIS BOOKResponsible Research

When 18-year-old Jesse Gelsinger died in a gene transfer study at the University of Pennsylvania, the national spotlight focused on the procedures used to ensure research participants’ safety and their capacity to safeguard the well-being of those who volunteer for research studies. Responsible Research outlines a three-pronged approach to ensure the protection of every participant through the establishment of effective Human Research Participant Protection Programs (HRPPPs). The approach includes: Improved research review processes, Recognition and integration of research participants’ contributions

Sharing Clinical Trial Data

Sharing Clinical Trial Data
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Responsible Sharing of Clinical Trial Data
  • Publisher : National Academies Press
  • Release : 20 April 2015
GET THIS BOOKSharing Clinical Trial Data

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