A Data Sources and Literature Review Findings

The Committee on Assessing Integrity in Research Environments explored various data sources in its effort to comprehensively address the task of providing the Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (DHHS) with a means for tracking the state of integrity in the research environment. In addition to reviewing the professional literature, the committee also reviewed relevant articles and editorials in the popular and scientific press, reviewed federal reports, and examined relevant regulations and guidelines. The committee invited experts to make public presentations, commissioned background papers, and sought additional expert technical assistance from knowledgeable individuals.

LITERATURE REVIEW

Search Terms

The committee began its review by conducting a preliminary literature 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.



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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct A Data Sources and Literature Review Findings The Committee on Assessing Integrity in Research Environments explored various data sources in its effort to comprehensively address the task of providing the Office of Research Integrity (ORI) of the U.S. Department of Health and Human Services (DHHS) with a means for tracking the state of integrity in the research environment. In addition to reviewing the professional literature, the committee also reviewed relevant articles and editorials in the popular and scientific press, reviewed federal reports, and examined relevant regulations and guidelines. The committee invited experts to make public presentations, commissioned background papers, and sought additional expert technical assistance from knowledgeable individuals. LITERATURE REVIEW Search Terms The committee began its review by conducting a preliminary literature 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.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct TABLE A-1 Search Terms Competitive behavior Conflict of interest Data access Data sharing Education and research integrity (integrity in research) Evaluation research Fabrication Falsification Mentoring Organization of research Organizational culture Organizational mistakes Peer review Plagiarism Professional ethics Public policies/guidelines Publication bias Quality control and research Research environments Research fraud Research integrity (integrity in research) Research misconduct Research moral and ethical aspect Research norms Research productivity Research standards Responsibility in research Retraction of publication Scientific error Scientific fraud Scientific integrity Scientific misconduct Selection bias University-industry relationships Whistle-blowers White-collar crime 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 databases. The most comprehensive and useful databases for the committee’s 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 Index 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 keywords 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 committee’s task, the entries were narrowed to those published in the past seven years. Note that this exclusion criterion was not inflexible and

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 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 eliminated. According to the committee’s task, articles and books that discussed 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, encompassing the specialties of dentistry, education, engineering, law, medicine, nature, nursing, nutrition, psychiatry, and research. Eighteen journals had three or more relevant articles (Table A-2). The committee’s 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 Journal Number of 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

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 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 & Engineering Ethics. Together, these four sources account for a full one-third of the listed items from journals. (Note that the majority of items from Science 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 (including 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 popular and scientific press, and pertinent web sites were continually surveyed for new data and information relevant to the committee’s task. The sponsors, invited speakers, and other researchers and professionals also provided literature for the committee’s 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 committee’s review. Among the meetings attended were the Research Conference on Research Integrity, sponsored by ORI; the Medical Research Summit,

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 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 Research: 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 different 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 committee’s own collective expertise. Committee members heard presentations and asked questions to explore fully the data, surrounding 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 Association 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 Association of Colleges and Schools; George Peterson, Accreditation Board for Engineering and Technology; James Rogers, Southern Association of Colleges 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 committee’s use.2 David H. Guston, associate professor and director, Pro 1   All written materials presented to the committee were reviewed and considered with respect to the committee’s task. This material can be examined by the public at the National Research Council’s Public Access Records Office, 2101 Constitution Avenue, NW, Room 171, Washington, DC 20418; telephone: (202) 334-3543. 2   Commissioned papers may be examined by the public. The public access files are maintained by the National Research Council, which can be reached at (202) 334-3543.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 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 prepared 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 University’s 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 Sciences’ report Responsible 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.

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct 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 Scientist’s 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 pedagogical approaches to the teaching of research ethics. The results of his

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Integrity in Scientific Research: Creating an Environment that Promotes Responsible Conduct searches provided the committee with a comprehensive overview of what literature was available and, equally importantly, what topics were significantly 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].