Scientific Integrity Policy
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Case Studies in Research Misconduct and Human Subjects
Rules of the Road for those Conducting Federally Funded or Regulated Research: Case Studies in Research Misconduct and Human Subjects April 2, 2019 University of Maryland School of Medicine Baltimore, MD Robert P. Charrow General Counsel United States Department of Health and Human Services Introduction The materials that follow address three areas-misconduct in science, human subjects and privacy, and financial conflicts of interest. To help illustrate the application of the rules that pertain in each area, a number of hypothetical case studies are presented. You should read and be prepared to discuss each case study during the April 2 lecture. The government regulates research under two authorities. First, it regulates research that it funds. How much does the federal government spend annually on research? See Table 2. Second, a federal agency can regulate research on products that fall within its jurisdiction. Thus, by way of example, the Food and Drug Administration asserts jurisdiction over clinical drug trials even though those trials are privately funded. 1. Misconduct A. What is Research Misconduct? The Public Health Service ("PHS"), which includes NIH, defines "research misconduct" as follows: Research misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them. (b) Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. (c) Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. -
Integrating the History of Science Into Broader Discussions of Research Integrity and Fraud
HOS0010.1177/0073275320952268History of ScienceRoberts et al. 952268research-article2020 Introduction HOS History of Science 2020, Vol. 58(4) 354 –368 Integrating the history © The Author(s) 2020 of science into broader https://doi.org/10.1177/0073275320952268Article reuse guidelines: sagepub.com/journals-permissions discussions of research DOI: 10.1177/0073275320952268 integrity and fraud journals.sagepub.com/home/hos Lissa L. Roberts University of Twente, Netherlands H. Otto Sibum Uppsala University, Sweden Cyrus C. M. Mody Maastricht University, Netherlands Abstract This introductory article frames our special issue in terms of how historicizing research integrity and fraud can benefit current discussions of scientific conduct and the need to improve public trust in science. Keywords Research integrity, fraud, scientific conduct, scientific values, public trust Writing about research integrity and fraud in the midst of the Covid-19 crisis carries an extra sense of urgency. Voices of reason tell us to trust the experts, echoing both the (idealized) scientific method and Ronald Reagan’s response to Soviet promises regard- ing nuclear disarmament: “trust, but verify.” Great advice, but how easy is it really to identify trustworthy experts? Is the boundary between healthy skepticism and manufac- tured doubt a simple matter of distinguishing between valid laboratory and publishing protocols on one side and political, economic, or personal interests on the other? Should we follow those who rely on the Mertonian distinction between norm-bound -
Request for Information to Improve Federal Scientific Integrity Policies (86 FR 34064)
July 27, 2021 Office of Science and Technology Policy Executive Office of the President Eisenhower Executive Office Building 1650 Pennsylvania Avenue Washington, DC 20504 Submitted electronically to [email protected] Re: Request for Information to Improve Federal Scientific Integrity Policies (86 FR 34064) The American Association for the Advancement of Science (AAAS), Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of Public and Land-grant Universities (APLU), and Council on Governmental Relations (COGR), collectively the “Associations,” appreciate the opportunity to provide feedback to the White House Office of Science and Technology Policy (OSTP) to help improve the effectiveness of Federal scientific integrity policies in enhancing public trust in science. The Associations strongly support the efforts of the White House in addressing issues of federal scientific integrity and public trust in science. We further appreciate the swift issuance of the Presidential Memorandum on Restoring Trust in Government Through Scientific Integrity and Evidence-Based Policymaking and establishment of the Scientific Integrity Task Force. These actions seek to formalize and standardize scientific integrity through an all-of-government approach. Protecting the integrity of science and ensuring the use of evidence in policymaking should be a national priority across administrations. These efforts come at a critical time for the United States. Public trust in federal science has been shaken by anti-science rhetoric, lack of transparency, and questions about the integrity of science conducted and supported by the federal government. At the same time, building and maintaining trust in this science has never been more important as we confront continuing threats, including a global pandemic and climate change. -
Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions
https://doi.org/10.1017/err.2020.18 . Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions Claire ROBINSON* , Christopher J. PORTIER**, Aleksandra ČAVOŠKI***, Robin MESNAGE****, Apolline ROGER*****, Peter CLAUSING******, Paul WHALEY*******, Hans MUILERMAN******** and https://www.cambridge.org/core/terms Angeliki LYSSIMACHOU********* The regulation of pesticides in the European Union (EU) relies on a network of hard law (legislation and implementing acts) and soft law (non-legally binding guidance documents and administrative and scientific practices). Both hard and soft laws govern how risk assessments are conducted, but a significant role is left to the latter. Europe’s pesticide regulation is one of the most stringent in the world. Its stated objectives are to ensure an independent, objective and transparent assessment of pesticides and achieve a high level of protection for health and environment. However, a growing body of evidence shows that pesticides that have passed through this process and are authorised for use may harm , subject to the Cambridge Core terms of use, available at humans, animals and the environment. The authors of the current paper – experts in toxicology, law and policy – identified shortcomings in the authorisation process, focusing on the EU assessment of the pesticide active substance glyphosate. The shortcomings mostly consist of failures to implement the hard or soft laws. But in some instances the law itself is responsible, as some provisions can only fail to achieve its objectives. Ways to improve the system are proposed, requiring changes in hard and soft laws as well as in administrative 30 Sep 2021 at 13:44:58 and scientific practices. -
Policy on Scientific Integrity
وزارة اﻟﺘﻌﻠﯿﻢ MINISTRY OF EDUCATION ﺟـﺎﻣﻌﺔ اﻟﺪﻣـﺎم UNIVERSITY OF DAMMAM اﻟﻤﺠﻠﺲ اﻟﻌﻠﻤﻲ THE SCIENTIFIC COUNCIL Policy on Scientific Integrity Part I Rules & Regulations Policy on Scientific Integrity 2 Table of Contents Article Pages # Introduction 4 Definition of Scientific Misconduct in Research & 4 Scientific Studies General Rules of Scientific Integrity 5 Prevention of Scientific Misconduct in Research & 10 Scientific Studies Violations of Scientific Integrity 11 Management of Possible Scientific Misconduct 13 Record Retention 14 Applicability 15 General Definitions 15 Acknowledgements 22 Appendices 22 NSTIP Rules of Scientific Integrity 22 3 Policy on Scientific Integrity 1. Introduction The University of Dammam (UOD) espouses to maintain the highest standards of research ethics and scientific integrity. To that end, UOD has developed a series of policies and associated initiatives to promote a culture of scientific integrity and research ethics in the conduct of all aspects of its research mission. This commitment includes programs to educate all institutional members of such standards and to monitor the conduct of all scientific endeavors. This Policy for Scientific Integrity consists of four parts. They are: Part I: Rules and Regulations Part II: Rules for Scientific Publications, Authorship and Copyrights Part III: Research Conflict of Commitment and Conflict of Interest Part IV: Procedures for Evaluation and Management of Scientific Misconduct and Research Conflict of Commitment & Conflict of Interest In their collective, these parts articulate the institutional guidelines for proper scientific conduct and provides a detailed description of the institution’s management of any potential aberration to that standard. 2. Definition of Misconduct in Scientific Research Integrity Misconduct in research and scientific studies means fabrication, falsification, and/or plagiarism, in proposing, performing, or reviewing research, or in reporting research results. -
Managing Allegations of Scientific Misconduct: A
MANAGING ALLEGATIONS OF SCIENTIFIC MISCONDUCT: A Guidance Document for Editors January 2000 Office of Research Integrity Office of Public Health and Science U.S. Department of Health and Human Services http://ori.dhhs.gov 1 TABLE OF CONTENTS I. Role of Editors in Responding to Scientific Misconduct .............. 1 II. Purpose of Guidelines ................................................................... 2 III. Definitions ..................................................................................... 2 IV. Procedure for Handling Suspect Manuscripts .............................. 3 V. Responding to ORI Requests for Assistance ............................... 4 VI. Correcting the Literature ............................................................... 5 VII. Helpful Editorial Policies ............................................................... 5 VIII. Conclusion .................................................................................... 8 References ................................................................................................. 9 Appendix A: ORI Case Examples of Suspect Manuscripts ..................... 11 ORI Information and Technical Assistance . Inside Back Cover 2 MANAGING ALLEGATIONS OF SCIENTIFIC MISCONDUCT: A Guidance Document for Editors* I. Role of Editors in Responding to Scientific Misconduct The role editors should play in responding to scientific misconduct has been articulated by their colleagues, asserted by two national reports, and demonstrated by the scientific misconduct allegations -
Science and Technology Issues in the 117Th Congress
Science and Technology Issues in the 117th Congress May 5, 2021 Congressional Research Service https://crsreports.congress.gov R46787 SUMMARY R46787 Science and Technology Issues in the 117th May 5, 2021 Congress Frank Gottron, The federal government supports scientific and technological advancement directly by funding Coordinator and performing research and development, and indirectly by creating and maintaining policies Specialist in Science and that encourage private sector efforts. Additionally, the federal government regulates many Technology Policy aspects of S&T activities. This report briefly outlines a key set of science and technology policy th issues that may come before the 117 Congress. Brian E. Humphreys, Coordinator Many of these issues carry over from previous Congresses, and represent areas of continuing Analyst in Science and Member interest. Examples include policies on taxation, trade, intellectual property, Technology Policy commercialization of basic scientific research and other overarching issues that affect scientific and technological progress. Other issues may represent new or rapidly evolving areas affected by the threats of pandemic diseases, climate change, and malicious cyber activities, among others. Examples covered in this report include infectious disease modeling and forecasting, digital contact tracing and digital exposure notification, hydrogen pipelines, and expansion of emerging information and communications technologies such as 5G. These and other S&T-related issues that may come before the 117th Congress are grouped into 10 categories. Overarching S&T Policy Issues, Agriculture, Biotechnology and Biomedical Research and Development, Climate Change and Water, Defense, Energy, Homeland Security, Information Technology, Physical and Material Sciences, and Space. Each of these categories includes concise analysis of multiple policy issues. -
ENERI Manual Research Integrity and Ethics
ENERI Deliverable D3.1 Appendix: Manual ENERI Manual Research Integrity and Ethics Bart Penders | David Shaw | Peter Lutz | David Townend Lloyd Akrong | Olga Zvonareva Maastricht University 1 Table of Contents Introduction: the manual to the manual .................................................................................................. 3 It’s alive .......................................................................................................................................... 3 1. Research Integrity ............................................................................................................................... 4 1.1. Conceptual issues ........................................................................................................................ 5 1.1.1. The Researcher in Society - towards the “virtuous researcher” ........................................... 5 1.1.2 Research, Evidence and Truth? ............................................................................................. 9 1.1.3 Detrimental Research Practices and Research Misconduct ................................................. 12 1.1.4 Social Responsibility .......................................................................................................... 14 1.2. Practical Issues .......................................................................................................................... 18 1.2.1. Plagiarism .......................................................................................................................... -
How Scientific Misconduct Harms Prior Collaborators
A Service of Leibniz-Informationszentrum econstor Wirtschaft Leibniz Information Centre Make Your Publications Visible. zbw for Economics Hussinger, Katrin; Pellens, Maikel Working Paper Guilt by association: How scientific misconduct harms prior collaborators ZEW Discussion Papers, No. 17-051 Provided in Cooperation with: ZEW - Leibniz Centre for European Economic Research Suggested Citation: Hussinger, Katrin; Pellens, Maikel (2017) : Guilt by association: How scientific misconduct harms prior collaborators, ZEW Discussion Papers, No. 17-051, Zentrum für Europäische Wirtschaftsforschung (ZEW), Mannheim, http://nbn-resolving.de/urn:nbn:de:bsz:180-madoc-436888 This Version is available at: http://hdl.handle.net/10419/171327 Standard-Nutzungsbedingungen: Terms of use: Die Dokumente auf EconStor dürfen zu eigenen wissenschaftlichen Documents in EconStor may be saved and copied for your Zwecken und zum Privatgebrauch gespeichert und kopiert werden. personal and scholarly purposes. Sie dürfen die Dokumente nicht für öffentliche oder kommerzielle You are not to copy documents for public or commercial Zwecke vervielfältigen, öffentlich ausstellen, öffentlich zugänglich purposes, to exhibit the documents publicly, to make them machen, vertreiben oder anderweitig nutzen. publicly available on the internet, or to distribute or otherwise use the documents in public. Sofern die Verfasser die Dokumente unter Open-Content-Lizenzen (insbesondere CC-Lizenzen) zur Verfügung gestellt haben sollten, If the documents have been made available under an Open gelten abweichend von diesen Nutzungsbedingungen die in der dort Content Licence (especially Creative Commons Licences), you genannten Lizenz gewährten Nutzungsrechte. may exercise further usage rights as specified in the indicated licence. www.econstor.eu Dis cus si on Paper No. 17-051 Guilt by Association: How Scientific Misconduct Harms Prior Collaborators Katrin Hussinger and Maikel Pellens Dis cus si on Paper No. -
Scientific Integrity
Scientific Integrity SCIENTIFIC INTEGRITY The Rules of Academic Research by Kees Schuyt Translated by Kristen Gehrman LEIDEN UNIVERSITY PRESS Translation: Kristen Gehrman Cover design: Geert de Koning Lay-out: Friedemann bvba ISBN 978 90 8728 230 1 e-ISBN 978 94 0060 218 2 (PDF) e-ISBN 978 94 0060 219 9 (ePUB) nur 737, 738 © Kees Schuyt / Leiden University Press, 2019 This work is licensed under the Creative Commons Attribution-NonCommercial 4.0 International License. To view a copy of this license, visit http://creativecommons.org/ licenses/by-nc/4.0/. This book is distributed in North America by the University of Chicago Press www.press.uchicago.edu. Table of contents Foreword 7 Introduction 9 Chapter 1 Scientific integrity: an exploration of an elusive concept 13 1.1 Discredited by fraud 13 1.2 Integrity as a standard linked to one’s position 15 1.3 Integrity as a standard for one’s own behavior 18 1.4 Scientific values and the basic standards of integrity 21 1.5 Scientific integrity in practice: an initial exploration 25 Chapter 2 The codification of behavioral standards for scientific research 31 2.1 Muddying the waters of science: the Stapel affair 31 2.2 Some examples of fraud 32 2.3 Four conceptual distinctions 35 2.4 The emergence of norms in scientific practice 36 2.5 A case study: the codification of norms in the Netherlands 41 2.6 The Netherlands Code of Conduct for Scientific Practice of 2004/2012/2014 45 2.7 The Netherlands Code of Conduct for Research Integrity of 2018 49 Chapter 3 Scientific fraud: lessons from history -
Open-Ended Responses
Progress and Problems: Government Scientists Report on Scientific Integrity at Four Agencies Appendix D: Open-ended Responses Below are all open-ended responses received on the survey. Responses have not been edited for grammar or spelling errors. They are displayed as respondents wrote them, with identifying information redacted to protect anonymity. In some cases, large portions of responses had to be concealed to protect the identities of respondents. Question 39. How do you think the mission of the [AGENCY] and the integrity of the scientific work produced by the [AGENCY] could best be improved? The below open-ended responses are sorted by agency and categorized by subject, in order of frequency. The percentages in each category represent the proportion of coded text on that topic, rather than the proportion of respondents. CDC Twenty-six percent (467) of the 1,764 CDC survey respondents provided written responses. Management and Leadership (Mentioned in 26% of coded responses) Reduce/relax the beaurocratic procedures especially regarding publication of scientific work As a leading federal government agency, CDC should pay more attention to avoid nepotism within the same unit (branch or maybe division). This is especially a problem in the leadership level. It created unfair situation to other employee. People who enjoy these advantage often tend to chose their own favorite colleagues in important tasks, or assignments. This in turns created more opportunities to promote people of their own circle. The best man/woman for the particular task could therefore sacrifice because of this established culture of nepotism. OMB is a pain in the ass - the Paperwork Reduction Act is a joke. -
White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update
CSE’s White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update Editorial Policy Committee (2011-2012) www.CouncilScienceEditors.org CSE’s White Paper on Promoting Integrity in Scientific Journal Publications, 2012 Update Editorial Policy Committee (2011-2012) www.CounsilScienceEditors.org Kristi Overgaard (Chair) Daniel Salsbury American Orthopaedic Society for Sports Medicine Proceedings of the National Academy of Sciences Patricia Baskin Mary Scheetz American Academy of Neurology Research Integrity Consulting, LLC Elizabeth Blalock Diane Scott-Lichter Journal of Investigative Dermatology American Association for Cancer Research Howard Browman Gene P. Snyder Institute of Marine Research, Storebø, Norway Envision Pharma Bruce Dancik Anna Trudgett NRC Research Press, University of Alberta American Society of Hematology Wim D’Haeze Arena Pharmaceuticals, Inc. Editorial Policy Committee (2008-2009) Robert L. Edsall Heather Goodell (Chair) American Academy of Family Physicians American Heart Association Jill Filler Elizabeth Blalock American Society for Pharmacology and Experimental Therapeutics Journal of Investigative Dermatology Heather Goodell Bruce Dancik American Heart Association NRC Research Press, University of Alberta Angela Hartley Robert L. Edsall Association of Women’s Health, Obstetric and Neonatal Nurses American Academy of Family Physicians Kenneth Kornfield Jill Filler American Society of Clinical Neurology American Society for Pharmacology and Experimental Therapeutics Christine Laine Angela Hartley