Handbook of Bioethical Decisions. Volume II: Scientific Integrity and Institutional Ethics

Foreword: On Handbooks
Acknowledgements
Contents
Editors and Contributors
About the Editors
Contributors
Chapter 1: Introduction: Scientific Integrity and Institutional Ethics: Challenges and Perspectives
References
Part I: Research Ethics: Scientific Integrity and Research Misconduct
Chapter 2: Data Alteration
Philosophical/Normative Insights
What Are Data, When Should They Be Available and What Is Their Quality?
Varieties of Intended or Unintended Data Alteration
Data Fabrication/Falsification
Scientific Error
Questionable Research Practices (QRP)
Community-Based and Cultural Interpretations of Survey Data Relevance/Precision
Decision Points
Situations in Which Safeguards Against Improper Data Alteration Are at Risk
Decision Points
Suboptimal, Fragmented System or Optimal System?
More Optimal
Decision Points
Constant Rebirth of Research Ethics
References
Chapter 3: Research Misconduct and Questionable Research Practices
Introduction
Misconduct vs. QRPs and Fraud
Investigating Misconduct
Some Famous Cases of Misconduct or Alleged Misconduct
Prevalence Research Misconduct
Causes and Prevention of Misconduct
References
Chapter 4: Ethics of Authorship
Introduction
The Importance of Correct Authorship
Honorary or “Guest” Authorship
Ghost Authorship
Convenience Authorship
Multiple Authorships
Emergent Problems in Authorships
Junior Faculty Roles as Co-authors and the Need of Adequate Mentoring
Patients as Co-authors
Gender Gap in Authorship
Solving Authorship Disputes
Conclusions
References
Chapter 5: Dissemination of Research Results
Normative Arguments for and Against Comprehensive Results Dissemination
Normative Arguments in Favor of Comprehensive Results Dissemination
Retrospective Invalidation of a Prospectively Favorable Risk-Benefit Ratio
Limitation for Risk-Benefit Assessments
Negatively Impacting Patients’ Health
Suboptimal Resource Allocation
Losing Trust in Biomedicine
Normative Arguments Against Comprehensive Results Dissemination
Defining Terms in This Chapter’s Context
What Does “Results” Mean
What Does Dissemination Mean
Challenges in Research Results Dissemination: Status Quo Research Results Dissemination
Complete Reporting
Publication Bias
Selective Reporting
SPIN
Timely Reporting
Accessibility
Reporting Quality
Fostering Comprehensive Results Dissemination & Outlook
Approaches to Foster Comprehensive Results Dissemination
Registries
Preprints
Data Repositories
Other Formats
Outlook
References
Chapter 6: Conflicts of Interest in Research
Introduction
What Is a Conflict of Interest?
Conflicts of Financial Interest
Ethical Concerns
Preserving a Reliable Science
Protecting Human Subjects
Policy and Governance
Final Remarks
References
Chapter 7: A Priori Publication Agreements to Improve Adherence to Ethics in Research Publications
Introduction
Establishing Successful Research Teams
Team Dynamics
Establishing Overarching Principles
Detailing the Research Collaboration
A Priori Agreements
Introduction
Writing the Agreement
Specifics on the Conduct of Research
Specifics About Publishing
How Well Did We Do? Reality Check
Conclusion
References
Part II: Research Ethics: Conducting Ethical Research
Chapter 8: Freedom of Scientific Research and Primacy of Human Being: Practical and Epistemological Tensions
Introduction
Freedom of Scientific Research
Primacy of Human Being
Practical and Epistemological Tensions
Final Remarks
References
Chapter 9: Exploitation in Biomedical Research
Introduction
Exploitation in Context
Exploitation Theory
Obligations of Researchers and Sponsors
Obligations of Third Parties
Remediating Exploitation
Conclusion
References
Chapter 10: Selection of Research Subjects: Methodological and Ethical Issues
Introduction
Vulnerability
Risks and Benefits
Number of People Exposed
The Ethical Foundations
The Virtue Ethics
The Ethics of Wills or of Intentions
The Ethics of Principles
The Ethics of Responsibility
The Ethics of Rights
The Ethics of Consequences
The Ethics of Alterity
The Adequacy of Research Participant Selection
Final Remarks
Annexes
References
Chapter 11: Confidentiality and Privacy in Digital Clinical Trials
Introducción
International Protective Framework for Research with Human Subjects
Nüremberg Code (1947)
Declaration of Helsinki (1964)
Belmont Report (1979)
CIOMS Guidelines (1982)
Operational Guidelines for Ethics Committees That Review Biomedical Research (2000)
Universal Declaration on Bioethics and Human Rights (2005)
Privacy and Confidentiality of Health Data in Clinical Investigations
Regulatory Frameworks for Personal Data Protection
European Union: The General Data Protection Regulation (GDPR)
USA: Health Insurance Portability and Accountability Act
Regulation in Latin America
Where We Are Going: Digital Clinical Trials
The Paradigm Shift and the Tendency to Generate Digital Data: Challenges for Privacy and Confidentiality
Other Issues to Consider in Relation to Personal Data Protection
Need for Specific Regulations
Novel Bioethical Aspects
Digital Informed Consents
Using Artificial Intelligence
Final Remarks
References
Chapter 12: Dematerialization and Intellectual Property in the Biosciences
Introduction
Bioethical Concerns Arising Out of Intellectual Property for Genetic Inventions
Effects of Dematerialization on Access and Benefit Sharing for Genetic Resources
Dematerialization and Bioethical Decision Making
References
Part III: Institutional Ethics and Bioethics Committees: Principles, Roles and Perspectives
Chapter 13: The Ethics of Biomedical Practitioners: A Brief Historical Introduction
Physicians’ Oaths: Ancient to Eighteenth Century
Later Hippocratic Influence
Midwives Oaths and Nurses Pledges
Codes of Physicians Ethics 1647–1957
Percival’s Innovation
The AMA’s Professional Codes of Ethics
Replacing Social Compacts with Professional Principles
Research Ethics Before, During, and in the Aftermath of the Nazi Period
Prewar and Interwar Period Research Ethics
Nazi Medical Ethics
Postwar Medical Ethics
The Nuremberg Code
The 1948 Declarations of Geneva
The 1964 Declaration of Helsinki
The 1970–1980s: Rights Revolutions to the Birth of Bioethics
The 1972 Patients’ Bill of Right
The 1976 Belmont Report and the Creation of Acronym Committees (e.g., IRBs)
Ethics Codes for Bioethicists
Anti-Vivisectionism and Animal Rights: Nineteenth and Twentieth Centuries
Rules Regarding Animals and the 3Rs
The AWA, Inventing Speciesism and Animal Rights
Self-Imposed Ethical Principles for Benchside Biomedical Sciences
The Gordon Moratorium and the Asilomar Principles, 1973–1975
Guidelines for Good Publication Practice
Conclusion
References
Chapter 14: Principles of Institutional Ethics
Introduction
The Moral Responsibility of Institutions and Its Objectives
The Concept of Moral Responsibility
From the “Amorality” of Science…
To the “Morality” of Scientific Institutions
In the Days of “Piloted Science”
The Origins and Objectives of Institutional Ethics
The Objectives
Assist Professionals in Fulfilling Their Ethical Obligations
Training and Pedagogy
Respect for Ethical Rules for the Benefit of Research Subjects and Patients
Integrate Social Values ​​into the Development of Public Policies and Involve Citizens
Preserve the Image and Credibility of Scientific Institutions
How Do the Institutions Fulfill Their Ethical Mission?
A Common Requirement Set Out by a Variety of Institutions
A Common Requirement
A Variety of Institutions
Micro-ethics
The Independence of Members
The Autonomy of the Committees
Is Procedural Ethics the Main Feature of Bioethics?
The Reductionism of Procedural Ethics and Its Consequences
Conclusion
References
Chapter 15: Institutional Review Board (IRB): US Perspectives
Introduction
Defining the Role and Purpose of Irbs
IRB Composition and Performance of Administrative Tasks
Defining Human Subjects Research, Levels of Risk, and Levels of IRB Review
U.S. Federal Regulations and Human Subject Research
FDA-Regulated Drugs or Devices
Compliance
Revised Common Rule and Single IRB
Research Involving Special Populations
Vulnerable Populations
Subpart B: Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Subpart D: Additional Protections for Children Involved as Subjects in Research
46.404: Minimal Risk
46.405: Greater Than Minimal Risk with a Prospect for Direct Benefit
46.406: Greater Than Minimal Risk Without Prospect for Direct Benefit
Requirements for Consent and Assent
Research Involving Individuals with Impaired Decision-Making
Prospective Assessment of Occurrence of Suicidal Ideation and Behavior in Clinical Trials
Non-research IRB Functions
Summary
References
Chapter 16: Decision Making Within Institutions
Bioethics Committees as Main Actors of Institutional Ethics: Roles, Functions, Approaches, Processes
The International and Intercultural Dialogue: Global Institutionalised Ethics?
The Governance of Techno-science: New Challenges for Institutional Ethics?
The Toolbox of a Rights-Centred Institutional Ethics
References
Chapter 17: Scientific Advances, Ethical Oversight and Legal Institutionality
Introduction
Law, Science and Technology: Towards a New Model?
Law, Science and Technology: Necessary Legal Institutionality
(Bio) Ethics and Law: A Necessary Symbiosis
The Transformation of Legal Institutionality
Use of Softlaw
Overlap or Confusion with Bioethics
The Direct Influence of International Human Rights Law Relative to Genetics and Biotechnology on Domestic Laws
New Rights’ Holders?
Control Mechanisms
Ex Ante Controls
Ex Post Controls
The Discursive Paradigm of Some Conflicting Issues
Personal Data: The Potential of Big Data and the Need for Its Criminal Protection
The Ambivalence of Genetic Engineering: From Therapy to Eugenics and Enhacement
Security in Biological and Cybernetic Settings
Criminal Law before Artificial Intelligence
Final Remarks
References
Chapter 18: Membership and Structure of Institutional Bioethics Committees
Introduction
Three Functions of HECs
Function 1: Case Consultation
Function 2: Policy Development, Review, and Implementation
Function 3: Education
HEC Constitution and Authority
Location and Accountability
Leadership
Membership and Structure
Bylaws
Conclusion
References
Chapter 19: Foundations of Bioethical Decision-Making in Bioethics and Biolaw
Introduction
Bioethics as the Ethics of Life
The Intrinsic Value of Life and Bioethical Judgment
The Principle of Responsibility in Bioethics and Biolaw
The Person and Its Boundaries
Affectivity and Physicality in Medical Treatment
Limits to Personhood in Biomedicine
The Rights of the Body in Bioethics and Biolaw
The Ethics of the Good Life
Benefit, Utility, and Quality of Life
Can the Good Life Be Measured?
Justice and Freedom in Health Care
A Biomedical Sphere of Justice
Biomedical Justice Principles
Virtues and Ethos
Hippocratic Virtues
Ethos of Responsibility
Judgment and Practice
The Application Problem
A Hermeneutic-Critical Model of Applied Ethics
References
Chapter 20: ‘Just Doing Bioethics’: Policy, Principle, and Process
Introduction
Doing Bioethics
‘Just Doing Bioethics’
Principle
Process
Franklin’s Critique
A Fresh Start
Foundations
Hierarchy and Community
Opacity and Balancing
Questions Now Arising
Plugging in Again
Conclusions
References
Chapter 21: Ethics Education and Institutional Ethics Committees
Introduction
Institutional Ethics Committees (IECs)
Clinical Ethics Consultation
Functions of Institutional Ethics Committees
Consultation
Case Analysis
Policy Development
Ethics Education
Ethics Education
Conclusion
References
Chapter 22: The New Role of Ethics Committees in Emergency Use of Unproven Interventions Outside Research
Introduction
Definitions of Basic Terms and Methodology
Definitions
Methodology
Conflict of Interests
Literature Review
The Declaration of Helsinki: No Role for Ethics Committees
The CIOMS-WHO International Research Ethics Guidelines: No Role for Ethics Committees
WHO Early Guidance and Documents (2014–2015) on the Ethics of Emergency Use of Unproven Interventions Outside Research: No Role for Ethics Committees
WHO Latest Guidance (2016–2022) on Ethics of Emergency Use of Unproven Interventions Outside Research: A New Role for Ethics Committees
Final Considerations: The Future of Ethical Review in Emergency Use of Unproven Interventions Outside Research
References
Chapter 23: The Ethics of Resource Allocation in Pandemics: A Bayesian Model
Moral Disagreement
A Bayesian Model for Resource Allocation
First Rule: Substantial Competence
Second Rule: Priority to the Most Urgent Cases
Third Rule: Effectiveness
Fourth Rule: Maximization
Fifth Rule: Selection
Final Remarks
References
Part IV: Bioethical Issues in Institutional Ethics: Social Responsibility and Institutional Liability
Chapter 24: Scientific Knowledge and Social Responsibility
Science and Technology Between Promises and Risks
Four Steps and Four Leading Ideas
Why to Start with the Post-World War II: Science as a Value Per Se
Rio Declaration and Precaution: Science and Uncertainty
Responsible Research and Innovation (RRI): Science Lost?
UN Sustainable Development Goals (Sdgs): Science Regained?
How the Exploration Has Been Carried Out
Discussion of the Results of the First Exploration
Lines for Further Research
References
Chapter 25: Conscientious Objection
Introduction
When Is a Refusal to Provide a Medical Service a Conscientious Objection?
Reasons for Accommodating Conscientious Objectors
Reasons for Limiting or Denying Accommodation
Institutional Management of Conscientious Objection
Reasonable Accommodation Requirements
Procedures for Reviewing Requests for Accommodation
Objections to Reasonable Accommodation
Conclusion
References
Chapter 26: Institutional Liability in Research
Background, Definitions and Review of Literature
What are the Moral or Ethical Issues?
Liability Concerns – What Are the Risks for Institutions, Individuals, and Ideas?
Discovering the Problem
Evaluating Why Things Happened
Mitigation of Situation-Specific Issues
Institution-Wide Improvements
Mitigating Risk with Emerging Issues
Institutional Liability Assessment Tool
Institutional Liability Assessment Tool
References
Chapter 27: Research Assessments Should Recognize Responsible Research Practices. Narrative Review of a Lively Debate and Promising Developments
Brief Introduction to Research Assessments
Problems and Innovative Actions
Content
An Exaggerated Focus on Research Outputs
Quantity Over Quality
Inappropriate Use of Metrics
Narrow Views of Impact
Obstacle to Diversity
Procedure
Assessors
Research Environments
Coordination
Way Forward
References
Chapter 28: Coercion in Mental Health Treatment
Introduction
The Argument from Dignity
The Argument from Informed Consent
The Argument from Consequences
A Proposal on the Requirements
References
Index