Writing clinical research protocols : ethical considerations /
DeRenzo, Evan G.
Writing clinical research protocols : ethical considerations / Evan G. DeRenzo and Joel Moss. - Burlington, MA ; London : Elsevier Academic, ©2006. - 1 online resource (xix, 300 pages)
Includes bibliographical references and index.
Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience. What You Need To Know About Research Ethics Before Deciding on What You Want To Study -- Designing a Clinical Research Study -- Writing Consent and Assent Documents -- Getting the Protocol Approved -- Conducting the Study; Special Populations -- Ethical Considerations in Genetics Research -- Ethical Considerations in Use of Tissue for Laboratory Investigations -- Ethical Considerations in Use of Stored Tissue -- Confidentiality Issues -- Research in Emergency Medicine -- Reporting of Adverse Events -- FDA -- Radiation Safety Issues -- Participation of Subjects in Multi-Site Trials -- Participation of Subjects in Multiple Studies -- Conduct of Pharmaceutical Industry Research -- Case Histories, Learning from Experience -- Appendix.
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. It 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 will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations.
English.
9780122107511 0122107519 0080454208 9780080454207 1280633417 9781280633416 9786610633418 661063341X
90127:90127 Elsevier Science & Technology http://www.sciencedirect.com
GBA4Y1082 bnb
101258295 DNLM
Clinical trials.
Human experimentation in medicine.
Medical protocols.
Writing.
Biology--research
Clinical Trials
Human Experimentation
Clinical Protocols
Writing
Ethics
Biomedical Research--ethics
Clinical Protocols--standards
Études cliniques.
Expérimentation humaine en médecine.
Protocoles médicaux.
Écriture.
writing (processes)
HEALTH & FITNESS--Alternative Therapies.
MEDICAL--Healing.
HEALTH & FITNESS--Healing.
BODY, MIND & SPIRIT--Healing--General.
Writing
Medical protocols
Human experimentation in medicine
Clinical trials
Electronic books.
Electronic information resources [MESH]
Electronic information resources
R853.P75 / D47 2006eb
615.50724
2005 L-599 W 20.5 / D431w 2006
Writing clinical research protocols : ethical considerations / Evan G. DeRenzo and Joel Moss. - Burlington, MA ; London : Elsevier Academic, ©2006. - 1 online resource (xix, 300 pages)
Includes bibliographical references and index.
Introduction to the art and science of clinical research -- What you need to know about clinical research ethics -- What you need to know about the regulation of clinical research -- Designing a clinical research study -- Selecting subjects for clinical studies -- Risks and benefits in clinical research -- Recruiting subjects -- Informed consent -- Privacy and confidentiality -- The "ethics" section -- Procedures and methods -- Statistics, data collection and management, and record keeping -- Use of human biological materials -- Special issues raised by evolving areas of clinical research -- Case histories : learning from experience. What You Need To Know About Research Ethics Before Deciding on What You Want To Study -- Designing a Clinical Research Study -- Writing Consent and Assent Documents -- Getting the Protocol Approved -- Conducting the Study; Special Populations -- Ethical Considerations in Genetics Research -- Ethical Considerations in Use of Tissue for Laboratory Investigations -- Ethical Considerations in Use of Stored Tissue -- Confidentiality Issues -- Research in Emergency Medicine -- Reporting of Adverse Events -- FDA -- Radiation Safety Issues -- Participation of Subjects in Multi-Site Trials -- Participation of Subjects in Multiple Studies -- Conduct of Pharmaceutical Industry Research -- Case Histories, Learning from Experience -- Appendix.
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. It 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 will be an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process. * Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol * Includes a chapter containing Case Histories * Contains information on conducting clinical research within the pharmaceutical industry * An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations * Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations.
English.
9780122107511 0122107519 0080454208 9780080454207 1280633417 9781280633416 9786610633418 661063341X
90127:90127 Elsevier Science & Technology http://www.sciencedirect.com
GBA4Y1082 bnb
101258295 DNLM
Clinical trials.
Human experimentation in medicine.
Medical protocols.
Writing.
Biology--research
Clinical Trials
Human Experimentation
Clinical Protocols
Writing
Ethics
Biomedical Research--ethics
Clinical Protocols--standards
Études cliniques.
Expérimentation humaine en médecine.
Protocoles médicaux.
Écriture.
writing (processes)
HEALTH & FITNESS--Alternative Therapies.
MEDICAL--Healing.
HEALTH & FITNESS--Healing.
BODY, MIND & SPIRIT--Healing--General.
Writing
Medical protocols
Human experimentation in medicine
Clinical trials
Electronic books.
Electronic information resources [MESH]
Electronic information resources
R853.P75 / D47 2006eb
615.50724
2005 L-599 W 20.5 / D431w 2006