Main description:

This book represents the first comprehensive, gold standard reader on research integrity in the biomedical sciences. Now more than ever, the responsible conduct of research (RCR) has become critically important as new technologies affect research practices in both positive and negative ways. Since learning to do science and practicing it brings researchers into contact with a vast array of ethical issues, it is critical to know the standards and how they are evolving. Indeed, research integrity requires scientists at all levels to operate ethically in a system that supports ethical practice. This unique, foundational text covers all the relevant areas -- subject protection, research misconduct and conflict of interest as well as newly quantified concerns about research bias and non-reproducibility, as well as other unique issues. Developed by renowned experts, this compelling title discusses the full range of practices and policies that should support research that is honestly produced and disseminated. It also specifically incorporates topics noted by the National Institutes of Health as essential and required for training in RCR. Getting to Good - Research Integrity in the Biomedical Sciences is a major contribution to the literature on bioethics and will serve as an invaluable resource for all researchers, students, administrators and professionals interested in research ethics and integrity.

Contents:

PREFACE

CONTENTS

CHAPTER 1. METHODOLOGY

Arthur L. Caplan

1.1. Why Most Published Research Findings Are False

John P. A. Ioannidis

1.2 The Controversy Surrounding Bone Morphogenetic Proteins in the Spine:

A Review of Current Research

Joshua W. Hustedt and Daniel J. Blizzard

1.3. Research Integrity and Everyday Practice of Science

Frederick Grinnell

1.4. Lessons from the Infuse Trials: Do We Need a Classification of Bias in

Scientific Publications and Editorials?

Sohaib Hashmi, Mohamed Noureldin, and Safdar N. Khan

CHAPTER 2. POLICY

Arthur L. Caplan

2.1. In Retrospect: Science-The Endless Frontier

Roger Pielke Jr

2.2. Publish or Perish Culture Encourages Scientists to Cut Corners

Virginia Barbour

2.3. "Something of an Adventure": Postwar NIH Research Ethos and the Guatemala STD Experiments

Kayte Spector-Bagdady and Paul A. Lombardo

2.4. Perverse Incentives

Paula Stephen

2.5. Flint Water Crisis Yields Hard Lessons in Science and Ethics

Katie L. Burke

CHAPTER 3. REPRODUCIBILITY

Arthur L. Caplan

3.1. What Does Research Reproducibility Mean?

Steven N. Goodman, Daniele Fanelli, and John P.A. Ioannidis

3.2. Limited Reproducibility of Research Findings: Implications for the Welfare of Research Participants and Considerations for Institutional Review Boards

Barbara K. Redman and Arthur L. Caplan

3.3. Quality Time

Monya Baker

CHAPTER 4. HUMAN SUBJECTS PROTECTION

Arthur L. Caplan

4.1. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

Stuart G. Nicholls, Tavis P. Hayes, Jamie C. Brehaut, Michael McDonald, Charles Weijer, Raphael Saginur, and Dean Fergusson

4.2. Pharmaceuticalisation and Ethical Review in South Asia: Issues of Scope and Authority for Practitioners and Policy Makers

Bob Simpson, Rekha Khatri, Deapica Ravindran, Tharindi Udalagama

4.3. Understanding the Functions and Operations of Data Monitoring Committees: Survey and Focus Group Findings

Karim A Calis, Patrick Archdeacon, Raymond Bain, David DeMets, Miriam Donohue, M Khair Elzarrad, Annemarie Forrest, John McEachern, Michael J Pencina, Jane Perlmutter, and Roger J Lewis

4.4. Women and Fetuses First? Women and Fetuses First? An Ethical Case for Giving Priority in Clinical Research Testing of Zika Vaccines to Pregnant Women

Kelly McBride Folkers and Arthur L. Caplan

4.5. Rethinking the Belmont Report?

Phoebe Friesen, Lisa Kearns, Barbara Redman, and Arthur L. Caplan

CHAPTER 5. RESPONSIBLE AUTHORSHIP

Arthur L. Caplan

5.1. The Problem of Publication-Pollution Denialism

Arthur L. Caplan

5.2. Addressing Research Misconduct and Detrimental Research

Practices: Current Knowledge and Issues

National Academy of Sciences

5.3. Exploring New Approaches

National Academy of Sciences

5.4. A Systematic Review of Research on the Meaning, Ethics and Practices of Authorship across Scholarly Disciplines

Ana Marusic, Lana Bosnjak, and Ana Jeroncic

5.5. The Disposable Author: How Pharmaceutical Marketing is Embraced within Medicine's Scholarly Literature

Alastair Matheson

5.6. Authorship Inflation in Medical Publications

Gaurie Tilak, Vinay Prasad, Annupam B. Jena

CHAPTER 6. MENTOR-MENTEE RESPONSIBILITIES AND RELATIONSHIPS

Arthur L. Caplan

6.1. Closing the Barn Door: Coping with Findings of Research Misconduct by Trainees in the Biomedical Sciences

Barbara K. Redman and Arthur L. Caplan

6.2. Mentoring and Research Misconduct: Analysis of Research Mentoring in Closed ORI Cases

David E. Wright, Sandra L. Titus, and Jered B. Cornelison

6.3. Mentorship Matters for the Biomedical Workforce

Sally J. Rockey

6.4. Professional Responsibility

C.K. Gunsalus

6.5. All You Need is Mentorship

Robert A. Weinberg, Maya Schuldiner, Hong Wu, Beth Stevens, Jens Nielsen, P. Robin Hiesinger, and Bassem A. Hassan

CHAPTER 7. PLAGIARISM

Arthur L. Caplan

7.1. Plagarism in Research

Gert Helgesson and Stefan Eriksson

7.2. Text-based plagiarism in scientific publishing: Issues, developments and education

Yongyan Li

7.3. Avoiding Plagiarism, Self-plagiarism, and Other Questionable Writing Practices: A Guide to Ethical Writing

Miguel Roig

7.4. 'Dear "Plagiarist': A Scientist Calls Out His Double-Crosser

Adam Marcus and Ivan Oransky

7.5. Defining the Role of Authors and Contributors

International Committee of Medical Journal Editors

CHAPTER 8. PEER REVIEW

Arthur L. Caplan

8.1. Let's Make Peer Review Scientific

Drummond Rennie

8.2. A Stronger Post-Publication Culture is Needed for Better Science

Hilda Bastian

8.3. Reviewing Post-Publication Peer Review

Paul Knoepfler

CHAPTER 9. RESEARCH MISCONDUCT

Arthur L. Caplan

9.1. Shattuck Lecture - Misconduct in Medical Research

John D. Dingell

9.2. Ethical Modernization: Research Misconduct and Research Ethics Reforms in Korea following the Hwang Affair

Jongyoung Kim and Kibeom Park

9.3. Research Misconduct and Data Fraud in Clinical Trials: Prevalence and Causal Factors

Stephen L. George

9.4. Repairing Research Integrity

Sandra L. Titus, James A. Wells and Lawrence J. Rhoades

CHAPTER 10. WHISTLEBLOWING

Arthur L. Caplan

10.1. Integrity and Misconduct in Research

Commission on Research Integrity

10.2. Whistle-Blower Breaks His Silence

David Cyranoski

10.3. No One Likes a Snitch

Barbara Redman and Arthur Caplan

CHAPTER 11. CONFLICT OF INTEREST

Arthur L. Caplan

11.1. Sugar Industry Influence on The Scientific Agenda of The National Institute of Dental Research's 1971 National Caries Program: A Historical Analysis of Internal Documents

Cristin E. Kearns, Stanton A. Glantz, and Laura A. Schmidt

11.2. Lessons Learned from the Gene Therapy Trial for Ornithine Transcarbamylase Deficiency

James M. Wilson

11.3. Patient Perspectives On Physician Conflict Of Interest In Industry-Sponsored Clinical Trials For Multiple Sclerosis Therapeutics

Andrew J. Solomon

11.4. Industry Support of Medical Research: Important Opportunity or Treacherous Pitfall?

William M. Tierney, Eric M. Meslin, and Kurt Kroenke

CHAPTER 12. DATA ACQUISITION, MANAGEMENT AND TRANSPARENCY

Arthur L. Caplan

12.1. Opentrials: Towards a Collaborative Open Database of All Available Information on All Clinical Trials

Ben Goldacre and Jonathan Gray

12.2. International Charter of Principles for Sharing Bio-specimens and Data

Deborah Mascalzoni, Edward S Dove, Yaffa Rubinstein, Hugh JS Dawkins, Anna Kole,

Pauline McCormack, Simon Woods, Olaf Riess, Franz Schaefer, Hanns Lochmuller,

Bartha M Knoppers, and Mats Hansson

12.3. Facilitating a Culture of Responsible and Effective Sharing of Cancer Genome Data

Lillian L Siu, Mark Lawler, David Haussler, Bartha Maria Knoppers, Jeremy Lewin, Daniel J Vis, Rachel G Liao, Fabrice Andre, Ian Banks, J Carl Barrett, Carlos Caldas, Anamaria Aranha Camargo, Rebecca C Fitzgerald, Mao Mao, John E Mattison, William Pao, William R Sellers, Patrick Sullivan, Bin Tean Teh, Robyn L Ward, Jean Claude ZenKlusen, Charles L Sawyers, and Emile E Voest

CHAPTER 13. INTERNATIONAL RESEARCH INVOLVING RESOURCE-CONSTRAINED COUNTRIES

Arthur L. Caplan

13.1. The H3Africa Policy Framework: Negotiating Airness in Genomics

Jantina de Vries, Paulina Tindana, Katherine Littler, Miche` le Ramsay, Charles Rotimi, Akin Abayomi, Nicola Mulder, and Bongani M. Mayosi

13.2. Sponsorship in Non-commercial Clinical Trials: Definitions, Challenges and the Role of Good Clinical Practices Guidelines

Raffaella Ravinett, Katelijne De Nys, Marleen Boelaert, Ermias Diro, Graeme Meintjes, Yeka Adoke, Harry Tagbor, and Minne Casteels

13.3. Improving the Informed Consent Process in International Collaborative Rare Disease Research: Effective Consent for Effective Research

Sabina Gainott, Cathy Turner, Simon Woods, Anna Kole, Pauline McCormack, Hanns Lochmuller, Olaf Riess, Volker Straub, Manuel Posada, Domenica Taruscio, and Deborah Mascalzoni

13.4. The Standard of Care Debate: Can Research in Developing Countries Be Both Ethical and Responsive To Those Countries' Health Needs?

David Wendler, Ezekiel J. Emanuel, and Reidar K. Lie

APPENDIX: Montreal Statement on Research Integrity in Cross-Boundary Research Collaborations, 2013