Getting to Good
Research Integrity in the Biomedical Sciences
Herausgegeben:Caplan, Arthur L.; Redman, Barbara K.
Getting to Good
Research Integrity in the Biomedical Sciences
Herausgegeben:Caplan, Arthur L.; Redman, Barbara K.
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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.…mehr
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- Produktdetails
- Verlag: Springer / Springer International Publishing / Springer, Berlin
- Artikelnr. des Verlages: 978-3-030-09598-7
- Softcover reprint of the original 1st ed. 2018
- Seitenzahl: 596
- Erscheinungstermin: 15. Januar 2019
- Englisch
- Abmessung: 279mm x 210mm x 30mm
- Gewicht: 1606g
- ISBN-13: 9783030095987
- ISBN-10: 3030095983
- Artikelnr.: 57116619
- Verlag: Springer / Springer International Publishing / Springer, Berlin
- Artikelnr. des Verlages: 978-3-030-09598-7
- Softcover reprint of the original 1st ed. 2018
- Seitenzahl: 596
- Erscheinungstermin: 15. Januar 2019
- Englisch
- Abmessung: 279mm x 210mm x 30mm
- Gewicht: 1606g
- ISBN-13: 9783030095987
- ISBN-10: 3030095983
- Artikelnr.: 57116619
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 Lochmüller,
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 Lochmüller, 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
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 Lochmüller,
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 Lochmüller, 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