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

The Handbook of Bioethical Decisions Volume II addresses and analyzes the most important ethical concerns and moral quandaries related to scientific integrity and institutional ethics. It counts on two parts, Part One: Research Ethics, which addresses issues related to Scientific Integrity, Research Misconduct and Conducting Ethical Research, and Part Two: Institutional Ethics and Bioethics Committees, which explores Institutional Ethics issues, Ethics and Bioethics Committees’ roles and scopes, and Bioethical Issues in Institutional Ethics. Consequently, the Handbook, Vol. II, offers a remarkable collection of works by outstanding international experts on institutional and research ethics, in order for bioethics practitioners to obtain better elements to address key issues related to integrity in research as well as to decision-making processes. In this fashion, this volume is a valuable resource for professionals working on different bioethical and biomedical fields, such as, ethics and bioethics committees, health care institutions, biomedical and pharmacological companies, and academic settings, among others. Chapter 26 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. 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