Reconstructing Research Integrity: Beyond Denial

Description

This book exposes significant threats to research integrity and identifies policies and practices that can reverse these trends. It is focused on human research and US policy. Recent assessments have shown inadequacies in institutions, policies, and practices that seriously compromise ethics. The presumed self-regulatory nature of the scientific endeavor has been exposed to have allowed unabated areas of poor-quality science, an incomplete and inaccessible scientific record, conflicts of interest, differing notions of accountability, virtually no evidence base to direct research integrity policy, and a growing sense of alienation, moral injury and even revolt among scientists. Reconstructing Research Integrity aims to capture ways of vigorously moving toward scientific and ethical rigor, including self-correction and emerging or already-successful initiatives. The book begins with analysis of the full system of institutions, policies, and practices involved in production, dissemination, and application of research, including an examination of the blind spots in research ethics ideology, policy, and practice. The book then identifies policies and practices that can reverse harmful ethical trends, such as strengthening Responsible Conduct of Research (RCR) training and improving self-regulation in the scientific community. Finally, the book discusses the constant evolution of research ethics and integrity, which is illustrated by emerging research fields like gene editing and data science. This book will be of interest to all research administrators in academic, commercial and government positions; to policy advisors at the National Science Foundation and at the National Academies of Science, Engineering, and Medicine; to graduate students in research ethics; to advanced bioethics education programs across the globe; and to researchers and consultants in ELSI (ethical, legal, and social implications) programs. Preface Reference Contents Abbreviations Chapter 1: Research Integrity as a System Characteristic: Coordinated, Harmonized, with Incentives/Compliance in Alignment Introduction to Research Integrity Current Regulation and Directions for Reform Issue Unaddressed in Regulation but Important to Research Integrity How Widely Have Research Integrity Issues Affected Research Sectors? Industry Influence Government Agency Support for Science Integrity Standard Setting Groups Assuring Valid Science National Academy of Sciences (NAS) 2017 Study, “Fostering Integrity in Research” Studies from Social Psychology and Organizational Science Suggest a more Complex Integrity System Methods Conclusion References Chapter 2: Blind Spots in Research Integrity Policy: How to Identify and Resolve Them Current Blind Spots Affecting Research Integrity in Biomedical Science How Are Blind Spots Detected? Examples of Blind Spots in Research Practice/Governance; Impact on Research Integrity Continued Use of the Metaphor “Bad Apple” to Describe Research Integrity Deviations Hyperindividualization of Research Integrity Policy; Group Influences Organizational Support of Ethical Behavior or Neutralization of Unethical Behavior? Limited Consideration of Justice in Research Integrity Institutional Trust in Science: Underdeveloped Element of Research Integrity, Prone to Being a Blind Spot Challenges Necessary to Upset “Cognitive Locks” in Order to Reach Research Integrity Additional Areas of Theory from Related Disciplines that Would Support Move to Research Integrity Policy Sciences Examples from Sociocultural Disciplines Conclusion References Chapter 3: Evidence-Based Research Integrity Policy Lessons from Translational Science, Regulatory Science, Meta-Science, and Science Policy Translational Science Regulatory Science Meta-Science Science Policy Precision of Scientific Standards Evidence of Scientific Quality Needing Attention Clarity of Scientific Standards Standards of Evidence in Research Integrity Decisions Measurement Instruments and Methods for Use in Research Integrity Research Syntheses, their Social Production and Methods Illuminative of Ethics Limitations to an Evidence-Based Approach to Research Integrity and Especially to the Current State of Evidence Base Conclusion References Chapter 4: Responsible Conduct of Research (RCR) Instruction Supporting Research Integrity Lines of Investigation Evaluating RCR Training Lines of Basic Research with Strong Implications for Robust RCR Training Responsible Conduct of Research Training and Quality of Science Strengthened Approaches to RCR Training Recommendations Relevance of Higher Education Research to Traditional RCR Conclusion References Chapter 5: Emerging, Evolving Self-Regulation by the Scientific Community Introduction Examples of Scientific Self-Correction/Self-Governance and Suggestions for Improvement Prominent Case Examples of the Evolution of Science Self-Governance Preclinical Research Human Experiments with Hepatitis (Halpern) When External Regulation Was Deemed Necessary Dual Use Research Integrity and Research Misconduct Regulations Institutional Corruption Framework Characterizing the Task Ahead, with Guidance from the Institutional Corruption Framework (IC) Core Institutions as Conduits for Science’s Core Goals Reproducibility Project Cancer Biology as Example Reforms Supporting Science’s Core Goals; Lessons from East Asia Discussion and Conclusion References Chapter 6: Conflict of Interest and Commitment and Research Integrity Background State of COI as an Issue Case Studies COI Management and Regulation Regulation Scientific Self-Regulation and Other Prudent Practices COI Management Supporting Translational Science Institutional Conflicts of Interest (ICOI) Necessary Conditions/Consequences More Radical Approaches Important New Approaches An Area where Standards for COI Are Well Described: Data Safety Monitoring Boards COI and Conflict of Commitment as a National Security Issue Summary References Chapter 7: Institutional Responsibilities for Research Integrity Social Framework and Trustworthiness Responsibility for Coordinated Quality of Research Produced Under the Network of Institutions Examples of Research Integrity Innovation, and Needed Reform in Research Misconduct Management Research Institutions in the Industrial Sector Research Integrity Guardrails from Regulators, Funders, Journals, and Research Infrastructure Regulators Funders Journals Research Infrastructure Navigating Institutional Responsibilities for Research Integrity; Among Competing Institutional Logics Assuring Research Competence and Responsibility to Conduct Trustworthy Research Navigating Competing Institutional Logics: Market Logic; Research Integrity Logic Lessons From the Theory of Institutional Corruption; A Lens for Return to Basic Scientific Values Science Institutions and Public Policy Conclusion References Chapter 8: Science Evaluation: Peer Review, Bibliometrics, and Research Impact Assessment Peer Review Peer Review in Funding Decisions Issues In Peer Review as a Practice, Consequences and Solutions, With Most Focus on Publication Peer Review Consequences and Solutions Bibliometrics or Infometrics to Evaluate Research Performance Toward Fairer Use of Bibliometrics to Support Research Integrity Citation Metrics Embedded in Scientific Structures Research Impact Evaluation Ethical Imperatives to Test Reforms Summary: State of Science Evaluation and Ethics Conclusion References Chapter 9: Research Integrity in Emerging Technologies: Gene Editing and Artificial Intelligence (AI) Research in Medicine Research Integrity in Emerging Technologies Human Gene Therapy/Editing Research Better Practices AI Research in the Biomedical Sciences Accountability for Improved AI Research and Development Other Ethical Views Governance/Regulatory Oversight/Ethical Debates in Research in Emerging Technologies Innovation Ethics as a Distinct Field Conclusion References Chapter 10: Research Integrity as Moral Reform: Constitutional Recalibration Moral Reform; Constitutional Recalibration Other Frames By Which to Understand Research Integrity There Is No Crisis (See Fanelli Quote at Chapter Beginning) Addressing Current Research Integrity Problems Including Those Currently Neglected/Conflicted Strengthening Science Self-Regulation Data Ownership/Sharing in Health Research Conflict of Interest in Research Policy and Practice Steps to Research Integrity Imperative to Move to Research Integrity Constructing the Policy Base to Support Research Integrity Potential Lines of Empirical Research/Normative Analysis Arguably The Most Problematic Issues The Bottom Line Limitations References Appendix Case: Open Access—Plan S and OSTP Policy Case: Cochrane Case: Commercial Determinants of Health and Research Integrity Case: Scientific Integrity: DHHS Agencies Reporting and Addressing Political Interference Case: Predatory Journals and Conferences (IAP, 2022) Case: Retraction Watch Case: ClinicalTrials.gov References Index