Editor

Emanuel, Ezekiel J

Place of Publication

New York, NY

Publisher

Oxford University Press

Publication Date

2008

Physical Description

xx, 827 p. : ill. ; 29 cm.

Subjects

Human Experimentation - ethics

Ethics, Research

Ethics Committees, Research

Research Subjects - legislation & jurisprudence

Abstract

I: Selected history of research with humans

Walter Reed and the yellow fever experiments by Susan E. Lederer

Nazi medical experiments by Paul J. Weindling

Imperial Japanese experiments in China by Takashi Tsuchiya

Randomized controlled trial of streptomycin by Alan Yoshioka

Salk polio vaccine field trial of 1954 by Marcia L. Meldrum

Jewish chronic disease hospital case by John D. Arras

Hepatitis experiments at the Willowbrook State School by Walter M. Robinson and Brandon T. Unruh

Tuskegee syphilis experiment by James H. Jones

HIV research by John Y. Killen Jr.

Gelsinger case by Robert Steinbrook II: Codes, declarations, and other ethical guidance for research with humans

Ethical framework for biomedical research by Ezekiel J. Emanuel, David Wendler and Christine Grady

Nuremberg code by George J. Annas and Michael A. Grodin

Declaration of Helsinki by Richard E. Ashcroft

Belmont report by Tom L. Beauchamp

Regulations for the protection of humans in research in the United States: The common rule by Joan P. Porter and Greg Koski

International ethical guidance rrom the Council for International Organizations of Medical Sciences by Juhana E. ldanpaan-Heikkila and Sev S. Fluss

Council of Europe by Peteris Zilgalvis

European Community directives on data protection and clinical trials by Deryck Beyleveld and Sebastian Sethe

National bioethics commissions and research ethics by Eric M. Meslin and Summer Johnson III. Context, purpose, and value of clinical research

Exploitation in clinical research by Alan Wertheimer

Nature, scope, and justification of Clinical Research : what Is research? Who Is a subject? by Robert J. Levine

Four paradigms of clinical research and research oversight by Ezekiel J. Emanuel and Christine Grady

Role of patient advocates and public representatives in research by Rebecca Dresser IV. Scientific design

Equipoise and randomization by Steven Joffe and Robert D. Truog

Ethics of placebo-controlled trials by Franklin G. Miller

Challenge experiments by Franklin G. Miller and Donald L. Rosenstein

Emergency research by Jason H. T. Karlawish

Research with biological samples by David Wendler

Genetic diagnostic, pedigree, and screening research by Eric T. Juengst and Aaron Goldenberg

Deception in clinical research by David Wendler and Franklin G. Miller

Epidemiology : observational studies on human populations by Douglas L. Weed and Robert E. McKeown

Behavioral and social science research by Felice J. Levine and Paula R. Skedsvold

Phase I Oncology research by Manish Agrawal and Ezekiel J. Emanuel

Surgical innovation and research by Grant R. Gillett V. Participant selection Sect. A. Fair Participant selection

What Is fair participant selection? by Leslie A. Meltzer and James F. Childress

Incentives for research participants by Neal Dickert and Christine Grady

Recruiting research participants by Franklin G. Miller

Sect. B. Special populations

Research involving women by Christine Grady and Colleen Denny

Research with ethnic and minority populations by Bernard Lo and Nesrin Garan

Research involving economically disadvantaged participants by Carol Levine

Research involving those at risk for impaired decision-making capacity by Donald L. Rosenstein and Franklin G. Miller

Research with children by Alan R. Fleischman and Lauren K. Collogan

Research with captive populations :prisoners, students, and soldiers by Valerie H. Bonham and Jonathan D. Moreno

Research with identifiable and targeted communities by Morris W. Foster and Richard R. Sharp

Research with healthy volunteers by Albert R. Jensen and Franklin G. Miller

Research with fetuses, embryos, and stem cells by Ronald M. Green VI. Risk-benefit assessments

Risk-benefit analysis and the net risks test by David Wendler and Franklin G. Miller

Assessing and comparing potential benefits and risks of harm by Nancy M. P. King and Larry R. Churchill

Risk-benefit assessment in pediatric research by Sumeeta Varma and David Wendler VII. Independent review and oversight

Origins and policies that govern institutional review boards by Charles R. McCarthy

Models of institutional review board function by Angela J. Bowen

Evaluating the effectiveness of institutional review boards by Marjorie A. Speers

Data and safety monitoring boards by Lawrence M. Friedman and Eleanor B. Schron

Food and drug administration and drug development : historic, scientific, and ethical considerations by Robert Temple and Sara F. Goldkind VIII. Informed consent

History of informed consent in clinical research by Erika Blacksher and Jonathan D. Moreno

Philosophical justifications of informed consent in research by Dan W. Brock

Legal and regulatory standards of informed consent in research by Alexander M. Capron

Therapeutic misconception by Paul S. Appelbaum and Charles W. Lidz

Empirical issues in informed consent for research by James H. Flory, David Wendler and Ezekiel J. Emanuel

Assent requirement in pediatric research by David Wendler IX. Respect for human research participants

Confidentiality by James G. Hodge Jr. and Lawrence O. Gostin

Liability and compensation for injury of research subjects by Wendy K. Mariner

Obligation to ensure access to beneficial treatments for research participants at the conclusion of clinical trials by James V. Lavery X. Multinational research

Appropriate ethical standards by Ruth Macklin

Benefits to host countries by Ezekiel J. Emanuel

Standard of care in multinational research by Soren Holm and John Harris

Responsiveness to host community health needs by Alex John London XI. Clinical investigator behavior

Conflict of interest in medical research : historical developments by Trudo Lemmens

Concept of conflicts of interest by Ezekiel J. Emanuel and Dennis F. Thompson

Empirical data on donflicts of interest by Lindsay A. Hampson, Justin E. Bekelman and Cary P. Gross

Industrialization of academic science and threats to scientific integrity by Eric G. Campbell and David Blumenthal

Fraud, fabrication, and falsification by David B. Resnik

Obligation to publish and disseminate results by Drummond Rennie.

ISBN

9780195168655

0195168658

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Kelowna Library

Surrey Library

Victoria Library

Abbotsford Library

Call Number

W20.55 H9 O98 2008

Copies

Author

Liu, Margaret B

Davis, Kate

Edition

2nd ed.

Place of Publication

Hoboken, NJ

Publisher

Wiley-Blackwell

Publication Date

2010

Physical Description

xviii, 406 p. : ill. ; 25 cm.

Subjects

Clinical Trials as Topic - legislation & jurisprudence

Clinical Trials as Topic - ethics

Device Approval

Drug Approval

United States

Handbooks

ISBN

9781405195157

Language

English

Material Type

Book

Audience

Professional

Location

Kelowna Library

Call Number

QV771.4 L783c 2010

Copies

Author

Stone, Judy

Place of Publication

Cumberland, MD

Publisher

Mountainside MD Press

Publication Date

2010

Series

R2 Library

Subjects

Clinical Trials

Biomedical Research - ethics

Biomedical Research - methods

Human Experimentation

United States

ISBN

9780974917818

0974917818

Language

English

Material Type

Ebook

Audience

Professional

Location

Internet

Website Notes

This R2 title is licensed for one BC Cancer staff user at a time only. Authentication via HealthBC sign in required. Use your BC Cancer staff username and ID when prompted.

Author

Beer, Tomasz M

Axmaker, Larry

Place of Publication

New York, NY

Publisher

DiaMedica Publishing

Publication Date

2012

Physical Description

xxvi, 166 p. : ill. ; 23 cm.

Subjects

Neoplasms - therapy

Clinical Trials as Topic

Decision Making

Antineoplastic Protocols

Therapies, Investigational

Biomedical Research

United States

ISBN

9780982321973

Language

English

Material Type

Book

Audience

Patient or Public

Location

Vancouver Library

Vancouver Cancer Info Ctr

Kelowna Cancer Info Ctr

Victoria Cancer Info Ctr

Abbotsford Cancer Info Ctr

Prince George Cancer Info Ctr

Call Number

QZ267 B415 2012

Copies

Author

Ernst, Edzard

Smith, Kevin

Place of Publication

Cham, Switzerland

Publisher

Springer International Publishing AG

Publication Date

2018

Subjects

Complementary Therapies - ethics

Complementary Therapies - legislation & jurisprudence

Evidence-Based Medicine

Ethics, Medical

Clinical Competence - legislation & jurisprudence

Abstract

This book reveals the numerous ways in which moral, ethical and legal principles are being violated by those who provide, recommend or sell ?complementary and alternative medicine? (CAM). The book analyses both academic literature and internet sources that promote CAM. Additionally the book presents a number of brief scenarios, both hypothetical and real-life, about individuals who use CAM or who fall prey to ethically dubious CAM practitioners. The events and conundrums described in these scenarios could happen to almost anyone. Professor emeritus of complementary medicine Edzard Ernst together with bioethicist Kevin Smith provide a thorough and authoritative ethical analysis of a range of CAM modalities, including acupuncture, chiropractic, herbalism, and homeopathy. This book could and should interest all medical professionals who have contact to complementary medicine and will be an invaluable reference for patients deliberating which course of treatment to adopt. - Cover

ISBN

9783319699400

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

WB890 E71 2018

Copies

Alternate Title

How to meet international quality standard in clinical research

Author

Cingi, Cemal

Muluk, Nuray Bayar

Place of Publication

Cham, Switzerland

Publisher

Springer

Publication Date

2016

Series

EBSCOhost eBook

Subjects

Clinical Trials as Topic

Biomedical Research

Ethics, Research

Data Accuracy

Total Quality Management - standards

Internationality

Practice Guideline

Abstract

Table of Contents:

Chapter 1: Clinical Trials: Historical Aspects and Importance and New Drug Developments -- Chapter 2: The Definition of GCP -- Chapter 3: The Principles of GCP -- Chapter 4: The Drug Development Process and Evolution of Regulations -- Chapter 5: Planning Clinical Research -- Chapter 6: Preparation of Ethics Committee (IRB) Proposal -- Chapter 7: Preparation of Informed Consent -- Chapter 8: Preparation of Findings Tables -- Chapter 9: Setting the Ideal Statistical Methods -- Chapter 10: The Duties of a Clinical Research Coordinator

-- Chapter 11: The Duties of Clinical Researchers -- Chapter 12: The Phases of Clinical Studies -- Chapter 13: Safety in Clinical Trials -- Chapter 14: Setting the Size -- Chapter 15: Setting the Ideal Method -- Chapter 16: Ethics of Clinical Research -- Chapter 17: Recruitment and Enrolment -- Chapter 18: Why We Need Clinical Consent and Other Documentation -- Chapter 19: Monitoring the Trial -- Chapter 20: Inspection -- Chapter 21: Ethics: Institutional Review Board/Independent Ethics Committee (IRB/IEC) -- Chapter 22: Responsibilities of the Investigator -- Chapter 23: Responsibilities of the Sponsor -- Chapter 24: Clinical Trial Protocols

ISBN

9783319443430

9783319443447

Language

English

Material Type

Ebook

Audience

Professional

Location

Internet

Website Notes

This EBSCO title is licensed for one BC Cancer staff user at a time only. Authentication via HealthBC sign in required. Use your BC Cancer staff username and ID when prompted.

Alternate Title

Ethical conduct for research involving humans : TCPS2

Corporate Author

Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada

Edition

2nd ed.

Place of Publication

[Ottawa, ON]

Publisher

Interagency Secretariat on Research Ethics

Publication Date

2010

Subjects

Ethics, Research

Research

Research Subjects

Ethics Committees

Ethical Review

Human Experimentation - ethics

Informed Consent

Public Policy

Canada

ISBN

9781100172378

Language

English

Material Type

Book

Online

Audience

Professional

Location

Internet

Website Notes

2nd URL for the most recent information on amendments

Author

Norris, Deborrah

Edition

4th ed.

Place of Publication

Medford, NJ

Publisher

Plexus Pub.

Publication Date

2009

Physical Description

x, 157 p. : ill. ; 28 cm.

Subjects

Clinical Trials as Topic - standards

Clinical Trials as Topic - methods

Records as Topic - standards

Research Design - standards

Data Collection - methods

United States

Handbooks

ISBN

9780937548707

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

QV771.4 N854c 2009

Copies

Corporate Author

Queen's Printer

Place of Publication

[Victoria, BC?]

Publisher

Queen's Printer

Publication Date

1985

Subjects

Human Rights - legislation & jurisprudence - Canada

Ethics - legislation & jurisprudence - Canada

Patient Advocay - legislation & jurisprudence - Canada

ISBN

771884737

Language

English

Material Type

Pamphlet

Audience

Professional

Location

Vancouver Library Pamphlet File

Copies

Author

Green, Stephanie

Crowley, John

Benedetti, Jacqueline

Edition

3rd ed.

Place of Publication

Boca Raton, FL

Publisher

CRC Press/Taylor & Francis Group

Publication Date

2016

Physical Description

xi, 252 p. : ill. ; 22 cm.

Series

Interdisciplinary statistics series

Chapman & Hall/CRC interdisciplinary statistics series

Subjects

Clinical Trials as Topic -- standards

Neoplasms -- therapy

Clinical Trials as Topic

Data Interpretation, Statistical

Statistics

ISBN

9781138199118

Language

English

Material Type

Book

Audience

Professional

Location

Victoria Library

Call Number

HA29 G812 2016

Copies

Editor

Cook, Thomas D

DeMets, David L

Place of Publication

Boca Raton, Fla.

Publisher

Chapman & Hall/CRC

Publication Date

2007

Physical Description

xxiii, 439 p. : ill. ; 24 cm.

Series

Texts in statistical science

Subjects

Clinical Trials as Topic - methods

Data Collection - methods

Research Design

Statistics as Topic

Statistics - methods

ISBN

9781584880271

1584440279

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Victoria Library

Call Number

HA29 I61 2007

Copies

Author

Klees, Edward

Horvitz, H. Robert

Place of Publication

Cold Spring Harbor, NY

Publisher

Cold Spring Harbor Laboratory Press

Publication Date

2014

Physical Description

xiii, 142 p. ll. ; 24 cm.

Subjects

Research Personnel - economics

Biomedical Research - organization & administration

Consultants - legislation & jurisprudence

Contracts - legislation & jurisprudence

Conflict of Interest

Biotechnology - legislation & jurisprudence

Drug Industry - legislation & jurisprudence

Intellectual Property

United States

ISBN

9781621821076

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

W20.5 K63 2014

Copies

Editor

Klimaszewski, Angela D

Edition

3rd ed.

Place of Publication

Pittsburgh, PA

Publisher

Oncology Nursing Society

Publication Date

2016

Physical Description

xvii, 644 p. ; 28 cm

Series

R2 Library

Subjects

Clinical Trials as Topic - nursing

Neoplasms - nursing

Clinical Nursing Research

ISBN

1935864378

9781935864370

9781935864707

Language

English

Material Type

Ebook

Book

Audience

Professional

Location

Internet

Abbotsford Library

Kelowna Library

Call Number

WY156 M254 2016

Website Notes

This R2 title is licensed for one BC Cancer staff user at a time only. Authentication via HealthBC sign in required. Use your BC Cancer staff username and ID when prompted.

Copies

Editor

Klimaszewski, Angela D

Edition

2nd ed.

Place of Publication

Pittsburgh, PA

Publisher

Oncology Nursing Press, Inc.

Publication Date

2008

Physical Description

xix, 535 p. : ill. ; 28 cm.

Subjects

Clinical Trials as Topic - nursing

Neoplasms - nursing

Clinical Nursing Research

ISBN

9781890504717

1890504718

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Victoria Library

Call Number

WY156 M294 2008

Copies

Editor

Hulley, Stephen B

Edition

3rd ed.

Place of Publication

Philadelphia, PA

Publisher

Lippincott Williams & Wilkins

Publication Date

2007

Physical Description

xv, 367 p. : ill. ; 26 cm.

Subjects

Epidemiologic Methods

Research Design

Clinical Trials as Topic

Abstract

Getting started: the anatomy and physiology of clinical research

Conceiving the research question

Choosing the study subjects : specification, sampling, and recruitment

Planning the measurements : precision and accuracy

Getting ready to estimate sample size : hypotheses and underlying principles

Estimating sample size and power : applications and examples

Designing a cohort study

Designing cross-sectional and case-control studies

Enhancing causal inference in observational studies

Designing a randomized blinded trial

Alternative trial designs and implementation issues

Designing studies of medical tests

Utilizing existing databases

Addressing ethical issues

Designing questionnaries and interviews

Data management

Implementing the study and quality control

Community and international studies

Writing and funding a research proposal

ISBN

9780781782104

0781782104

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

WA950 D485 2007

Copies

Author

Hulley, Stephen B.

Cummings, Steven R.

Browner, Warren S.

Edition

4th ed.

Place of Publication

Philadelphia, PA

Publisher

Wolters Kluwer/Lippincott Williams & Wilkins

Publication Date

2013

Physical Description

xiii, 367 p. : ill. ; 26 cm.

Subjects

Epidemiologic Methods

Research Design

Clinical Trials as Topic

ISBN

9781608318049

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

WA950 H913 2013

Copies

Author

Green, Stephanie

Crowley, John

Benedetti, Jacqueline

Edition

2nd ed.

Place of Publication

Boca Raton

Publisher

Chapman & Hall

Publication Date

2003

Physical Description

xi, 265 p. : ill. ; 23 cm.

Series

Interdisciplinary statistics series

Subjects

Clinical Trials - standards

Neoplasms - therapy

Clinical Trials

Data Interpretation, Statistical

ISBN

1584883022 (alk. paper)

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

HA29 G812 2003

Copies

Editor

Crowley, John

Place of Publication

New York, NY

Publisher

Marcel Dekker, Inc.

Publication Date

2001

Subjects

Clinical Trials - statistics & numerical data

Neoplasms - therapy

Data Interpretation, Statistical

Research Design

ISBN

0824790251

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Kelowna Library

Call Number

HA29 H236c 2001

Copies

Author

Irvine, Donald

Place of Publication

Abingdon, UK

Publisher

Radcliffe Medical Press

Publication Date

2003

Physical Description

ix, 247 p. ; 24 cm.

Subjects

Delivery of Health Care - organization & administration

Quality Assurance, Health Care

Physician-Patient Relations

Public Opinion

Clinical Competence - legislation & jurisprudence

Homicide

Malpractice - legislation & jurisprudence

Medical Staff, Hospital - legislation & jurisprudence

Organizational Culture

Great Britain

ISBN

9781857759778

185775977X

Language

English

Material Type

Book

Audience

Professional

Location

Vancouver Library

Call Number

W 84 I72d 2003

Copies

Editor

Cooper, Laurence J.N.

Mittendor, Elizabeth A.

Moyes, Judy

Place of Publication

Hoboken, NJ

Publisher

John Wiley & Sons, Inc.

Publication Date

2018

Series

EBSCOhost eBook

Translational oncology

Subjects

Neoplasms - therapy

Translational Medical Research

Immunomodulation

Clinical Trials as Topic

Abstract

Table of Contents:

Chapter 1 -- Translation in Immunology: The Role of Translational Biomarkers to Guide Clinical Use of Immunotherapy for Cancer -- Chapter 2 Monoclonal Antibody Therapy -- Chapter 3 Somatic Mutations and Immunotherapy -- Chapter 4 Checkpoint Blockade -- Chapter 5 Myeloid Leukemia Vaccines -- Chapter 6 Cancer Vaccines for Solid Tumors -- Chapter 7 Immunotherapy with Non?Genetically Modified T Cells -- Chapter 8 Immunotherapy with Genetically Modified T Cells -- Chapter 9 Immunomodulation with Adjuvants and Cytokines -- Chapter 10 Immune Cell Migration in Cancer and Immunotherapy -- Chapter 11 Repurposing of Drugs for Immunotherapy -- Chapter 12 Immunomodulation with Radiation -- Chapter 13 Good Manufacturing Practices Facilities for Cellular Therapy -- Chapter 14 T Cell Receptor Mimic Antibodies -- Chapter 15 Stem Cell Transplantation for Treatment of Malignancy -- Chapter 16 Natural Killer Cell?Based Immunotherapy -- Chapter 17 Immunologic Monitoring in Immuno-Oncology -- Chapter 18 Cell-Based Therapies for Canine Cancer -- Chapter 19 Interaction between Targeted Therapy and Immunotherapy

ISBN

9781118123225

9781118684504

9781118684528

Language

English

Material Type

Ebook

Audience

Professional

Location

Internet

Website Notes

This EBSCO title is licensed for one BC Cancer staff user at a time only. Authentication via HealthBC sign in required. Use your BC Cancer staff username and ID when prompted.