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A Data Sources and Literature Review Findings The Committee on Assessing Integrity in Research Environments ex- plored various data sources in its effort to comprehensively address the task of providing the Office of Research Integrity (ORI) of the U.S. Depart- ment of Health and Human Services (DHHS) with a means for tracking the state of integrity in the research environment. In addition to review- ing the professional literature, the committee also reviewed relevant ar- ticles and editorials in the popular and scientific press, reviewed federal reports, and examined relevant regulations and guidelines. The commit- tee invited experts to make public presentations, commissioned back- ground papers, and sought additional expert technical assistance from knowledgeable individuals. LITERATURE REVIEW Search Terms The committee began its review by conducting a preliminary litera- ture search. During and after its first meeting, the committee compiled a list of suggested search terms to be used while conducting literature searches (Table A-1). Committee members, Institute of Medicine staff, and the study sponsor suggested terms. 135
136 APPENDIX A TABLE A-1 Search Terms Competitive behavior Research environments Conflict of interest Research fraud Data access Research integrity (integrity in research) Data sharing Research misconduct Education and research integrity Research moral and ethical aspect (integrity in research) Research norms Evaluation research Research productivity Fabrication Research standards Falsification Responsibility in research Mentoring Retraction of publication Organization of research Scientific error Organizational culture Scientific fraud Organizational mistakes Scientific integrity Peer review Scientific misconduct Plagiarism Selection bias Professional ethics University-industry relationships Public policies/guidelines Whistle-blowers Publication bias White-collar crime Quality control and research Databases Searches were performed in OVID in the following databases: AGRICOLA, BioethicsLine, Biosis Previews, CSA-Life Science, ERIC, Medline, PsycInfo, Sociological Abstracts, and Wilson/Biological and Agricultural Index (a description of OVID and of each of the databases can be found at http://www.ovid.com/products/databases/index.cfm). Significant overlap was found among the articles identified in the data- bases. The most comprehensive and useful databases for the committeeâs purposes were BioethicsLine, Medline, and PsycInfo, as the majority of articles identified in AGRICOLA, Biosis Previews, CSA-Life Science, ERIC, Sociological Abstracts, and Wilson/Biological and Agricultural In- dex were also listed in one or more of those three databases (BioethicsLine, Medline, and PsycInfo). Results of Preliminary Literature Search The initial search of the databases mentioned above, using the key- words listed in Table A-1, yielded more than 16,000 citations. The first round of screening eliminated entries that were not in English, duplicate listings, and duplicate articles in different journals. For the purposes of the committeeâs task, the entries were narrowed to those published in the past seven years. Note that this exclusion criterion was not inflexible and
DATA SOURCES AND LITERATURE REVIEW FINDINGS 137 that some articles and books published before 1996 (such as those of historical interest or published by leaders in the field) were retained in the list. Although the fact that a citation was for a news item, an editorial, or a letter was not a strict exclusionary criterion, most news items, editorials, and letters were not included. By using these criteria, the list was reduced to slightly more than 800 items. In a case-by-case review of the remaining 800 items, articles and books on completely unrelated topics were elimi- nated. According to the committeeâs task, articles and books that dis- cussed topics that were unrelated to the research environment were also eliminated. The final list contained 331 items from journals (including primarily articles and reviews, as well as selected editorials, letters, and news items) and 25 books. The articles retained were published in 132 different journals, encom- passing the specialties of dentistry, education, engineering, law, medi- cine, nature, nursing, nutrition, psychiatry, and research. Eighteen jour- nals had three or more relevant articles (Table A-2). The committeeâs search revealed a trend similar to that identified by Steneck (2000), in that several journals stand out as leaders in publishing articles on research integrity and the research environment, including Science, the Journal of TABLE A-2 Number of Relevant Articles, by Journal Number of Journal Relevant Articles Science 34 Journal of the American Medical Association 31 Academic Medicine 27 Science & Engineering Ethics 22 BMJ (British Medical Journal) 16 Lancet 9 Nature 8 Accountability in Research 5 Journal of Dental Research 5 Professional Ethics 5 Journal of Higher Education 4 Journal of Law, Medicine & Ethics 4 Proceedings of the Society for Experimental Biology & Medicine 4 Annals of Emergency Medicine 3 College Student Journal 3 Critical Reviews in Biomedical Engineering 3 Ethics & Behavior 3 Journal of Medical Ethics 3
138 APPENDIX A TABLE A-3 Number of Relevant Articles, by Category Category Number of Citations Books 25 Codes of ethics 12 Conflict of interest 47 Education 34 Integrity 64 Methodology/evaluation 4 Misconduct 67 Oversight 23 Publications 43 Whistle-blowers 12 the American Medical Association, Academic Medicine, and Science & Engi- neering Ethics. Together, these four sources account for a full one-third of the listed items from journals. (Note that the majority of items from Sci- ence are news items or editorials.) The 331 articles were sorted into 10 major categories, as shown in Table A-3. The categories used were codes of ethics; conflict of interest (including funding and intellectual property); education (including mentoring, training, and staff development); integrity (including ethics, morals, and responsible conduct of research); methodology/evaluation (including assessment); misconduct (including fraud); oversight (includ- ing monitoring, accreditation, and peer review); publications (including plagiarism and authorship); and whistle-blowers. Books, which tend to cover more than one specific area, are listed separately in Table A-3. This collection of current literature was available to the committee for its review and analysis over the course of its deliberations. Additional Literature and Resources Over the course of the study, current professional literature, the popu- lar and scientific press, and pertinent web sites were continually sur- veyed for new data and information relevant to the committeeâs task. The sponsors, invited speakers, and other researchers and professionals also provided literature for the committeeâs review and consideration. In addition, Institute of Medicine staff attended professional scientific meetings and symposia during the course of the study to bring back the latest information about integrity in research issues for the committeeâs review. Among the meetings attended were the Research Conference on Research Integrity, sponsored by ORI; the Medical Research Summit,
DATA SOURCES AND LITERATURE REVIEW FINDINGS 139 sponsored by Health Care Compliance Association, Inova Institute of Research and Education, Medical Device Manufacturers Association and the Department of Energy; and, Promoting Responsible Conduct of Re- search: Policies, Challenges, and Opportunities, a conference sponsored by Public Responsibility in Medicine and Research. INVITED PRESENTATIONS Over the course of the study, the committee received and considered information from organizations and individuals representing many dif- ferent perspectives on research integrity issues.1 The committee believed that it was important to receive input directly from junior and senior researchers and administrators who routinely address issues of integrity in research in their work (Box A-1). Speakers and topics were chosen to complement, expand upon, and fill gaps in the committeeâs own collective expertise. Committee members heard presentations and asked questions to explore fully the data, sur- rounding issues, and unique perspectives that each speaker provided. TECHNICAL ASSISTANCE The committee sought additional expert technical assistance over the course of the study via phone, e-mail, and personal communications with the following individuals: Barbara Brittingham, New England Associa- tion of Schools and Colleges; Steven Crow, North Central Association of Colleges and Schools; Beth Fisher, University of Pittsburgh; Alasdair MacIntyre, Notre Dame University; Jean Morse, Middle States Associa- tion of Colleges and Schools; George Peterson, Accreditation Board for Engineering and Technology; James Rogers, Southern Association of Col- leges and Schools; David Smith, The Poynter Center for the Study of Ethics and American Institutions; David Stevens, Liaison Committee on Medical Education; and Naomi Zigmond, University of Pittsburgh. COMMISSIONED PAPERS The committee commissioned several background papers for the committeeâs use.2 David H. Guston, associate professor and director, Pro- 1All written materials presented to the committee were reviewed and considered with respect to the committeeâs task. This material can be examined by the public at the National Research Councilâs Public Access Records Office, 2101 Constitution Avenue, NW, Room 171, Washington, DC 20418; telephone: (202) 334-3543. 2Commissioned papers may be examined by the public. The public access files are main- tained by the National Research Council, which can be reached at (202) 334-3543.
140 APPENDIX A BOX A-1 Invited Presentations Perspective of the National Science Foundation Christine Boesz National Science Foundation Overview of Responsible Science (1992) Rosemary Chalk Institute of Medicine Convocation on Scientific Conduct (1994) and Planning Workshop for a Guide for Education in Responsible Science (1997) Robin Schoen Board on Life Sciences, National Research Council Overview of Committee on Science, Engineering, and Public Policy (COSEPUP) Series on Education and Careers in Science Deborah Stine COSEPUP Proposed Common Federal Definition of Research Misconduct and Procedures: A Town Meeting (1999) Chris Pascal Office of Research Integrity, DHHS Assessing the Integrity of Publicly Funded Research, a background report pre- pared for the November 2000 ORI Research Conference on Research Integrity Nicholas Steneck University of Michigan Organizations and Integrity: Some Lessons from Managerial Misconduct Peter Yeager Boston University Perspectives on the Research Environment Howard Schachman University of California, Berkeley gram in Public Policy at Rutgers Universityâs E. J. Bloustein School of Planning and Public Policy, was commissioned to write a review of the changes with regard to research integrity that have taken place in the 10 years since publication of the National Academy of Sciencesâ report Re- sponsible Science: Ensuring the Integrity of the Research Process (NAS, 1992). His work provided some of the background material for Chapter 1 and is the basis for Appendix C.
DATA SOURCES AND LITERATURE REVIEW FINDINGS 141 RCR Training at the National Institutes of Health (NIH) Joan Schwartz Assistant Director Office of Intramural Research, NIH Scientific Integrity from a Legal Perspective Barbara Mishkin Hogan and Hartson Integrity in the Business Environment Bart Victor Vanderbilt University Perspectives on Scientific Integrity and the Research Environment Harold Varmus Memorial Sloan-Kettering Cancer Center Research Integrity in Graduate Education Melissa Anderson University of Minnesota The Human Side of Research Integrity: A Young Scientistâs Perspective Peter S. Fiske RAPT Industries Perspectives on Research Integrity and the Research Environment Stephanie Bird Massachusetts Institute of Technology Perspectives on Research Integrity and the Research Environment Ruth Fischbach College of Physicians and Surgeons, Columbia University Kenneth D. Pimple, director of Teaching Research Ethics Programs at the Poynter Center for the Study of Ethics and American Institutions, was commissioned to write an opinion piece on his personal reflections on the research environment in the United States and to prepare two literature reviews on the following areas of research: (1) empirical assessments of the moral climate in institutions and (2) empirical evaluations of peda- gogical approaches to the teaching of research ethics. The results of his
142 APPENDIX A searches provided the committee with a comprehensive overview of what literature was available and, equally importantly, what topics were sig- nificantly lacking scholarly attention in the literature. REFERENCES NAS (National Academy of Sciences). 1992. Responsible Science: Ensuring the Integrity of the Research Process, Vol. 1. Washington, DC: National Academy Press. Steneck NH. 2000. Assessing the integrity of publicly funded research. Investigating Research Integrity: Proceedings of the First ORI Research Conference on Research Integrity, November 2000. [Online] Available: http://ori.dhhs.gov/html/publications/rcri.html [Accessed March 14, 2002].