Steps toward preregistration of research on research integrity.

BACKGROUND: A proposal to encourage the preregistration of research on research integrity was developed and adopted as the Amsterdam Agenda at the 5th World Conference on Research Integrity (Amsterdam, 2017). This paper reports on the degree to which abstracts of the 6th World Conference in Research Integrity (Hong Kong, 2019) reported on preregistered research. METHODS: Conference registration data on participants presenting a paper or a poster at 6th WCRI were made available to the research team. Because the data set was too small for inferential statistics this report is limited to a basic description of results and some recommendations that should be considered when taking further steps to improve preregistration. RESULTS: 19% of the 308 presenters preregistered their research. Of the 56 usable cases, less than half provided information on the six key elements of the Amsterdam Agenda. Others provided information that invalidated their data, such as an uninformative URL. There was no discernable difference between qualitative and quantitative research. CONCLUSIONS: Some presenters at the WCRI have preregistered their research on research integrity, but further steps are needed to increase frequency and completeness of preregistration. One approach to increase preregistration would be to make it a requirement for research presented at the World Conferences on Research Integrity.

The MICHR Genomic DNA BioLibrary: An Empirical Study of the Ethics of Biorepository Development.

In this article, we report on an effort to study the development and usefulness of a large, broad-use, opt-in biorepository for genomic research, focusing on three ethical issues: providing appropriate understanding, recruiting in ways that do not comprise autonomous decisions, and assessing costs versus benefits. We conclude the following: (a) Understanding can be improved by separating the task of informing subjects from documenting informed consent (Common Rule) and permission to use personal health information and samples for research (Health Insurance Portability and Accountability Act [HIPAA]); however, regulations might have to be changed to accommodate this approach. (b) Changing recruiting methods increases efficiency but can interfere with subject autonomy. (c) Finally, we propose a framework for the objective evaluation of the utility of biorepositories and suggest that more attention needs to be paid to use and sustainability.

Content Analysis of Major Textbooks and Online Resources Used in Responsible Conduct of Research Instruction.

Instruction in the responsible conduct of research (RCR) is required for all trainees funded by the National Institues of Health (NIH) or National Science Foundation (NSF). A recent Delphi study identified 53 key topics in 7 core areas that RCR education experts felt should be included in this instruction, which is required of many trainees in clinical and translational research. We performed a content analysis of major textbooks and online resources used in RCR instruction to determine the extent to which the 53 key topics identified in the Delphi study are covered by these resources. Textbooks and online resources used in RCR education at Clinical and Translational Science Award institutions were identified via survey. These resources were subjected to a content analysis. The 53 key topics identified in the Delphi study formed the basis of these analyses. We identified 10 textbooks and 1 online resource currently in use. Of the 53 key topics, only 4 were included in all 11 resources, and another 12 were included in 10. Twenty-three topics were covered in fewer than 65% of the resources, and two topics were absent from nearly all. Educators in clinical and translational research should be aware of key topics that are not covered in the RCR textbooks and online resources they may use and should consider augmenting discussion of such topics with other materials.

The problem of plagiarism.

Plagiarism is a form of research misconduct and a serious violation of the norms of science. It is the misrepresentation of another's ideas or words as one's own, without proper acknowledgement of the original source. Certain aspects of plagiarism make it less straightforward than this definition suggests. Over the past 30 years, the U.S. Federal Government has developed and refined its policies on misconduct, and Federal agencies, as well as research institutions, have established approaches to responding to allegations and instances of plagiarism. At present, efforts to avert plagiarism focus on plagiarism-detection software and instructional strategies.

Instruction in the responsible conduct of research: an inventory of programs and materials within CTSAs.

The National Institutes of Health (NIH) require instruction in the responsible conduct of research (RCR) as a component of any Clinical and Translational Science Award (CTSA). The Educational Materials Group of the NIH CTSA Consortium's Clinical Research Ethics Key Function Committee (CRE-KFC) conducted a survey of the 38 institutions that held CTSA funding as of January 2009 to determine how they satisfy RCR training requirements. An 8-item questionnaire was sent by email to directors of the Clinical Research Ethics, the Educational and Career Development, and the Regulatory Knowledge cores. We received 78 completed surveys from 38 CTSAs (100%). We found that there is no unified approach to RCR training across CTSAs, many programs lack a coherent plan for RCR instruction, and most CTSAs have not developed unique instructional materials tailored to the needs of clinical and translational scientists. We recommend collaboration among CTSAs and across CTSA key function committees to address these weaknesses. We also requested that institutions send electronic copies of original RCR training materials to share among CTSAs via the CTSpedia website. Twenty institutions submitted at least one educational product. The CTSpedia now contains more than 90 RCR resources.

The history, purpose, and future of instruction in the responsible conduct of research.

This article discusses the key decisions and steps that have partially formalized instruction in the responsible conduct of research (RCR) in U.S. research institutions, the different purposes for offering and/or requiring such instruction, and suggestions for what needs to be done to enhance the professional development of researchers in the future. RCR education has developed during three distinct eras: the 1980s, when policy makers were most concerned with defining and investigating research misconduct; the 1990s, when there was significant but highly decentralized growth in RCR instruction; and the years since 2000, when there have been a series of reforms and educational developments. There is still a need for scientists, universities, and professional societies to develop consensus on best ethical practices in many areas of scientific research. More also needs to be learned about assessing the quality of RCR instruction and the effects of training on researchers' behavior. To help set the course for RCR instruction in the future, more effort and funding need to be directed to studying actual research behavior and the factors that influence it; RCR educators and administrators must develop a common vocabulary and framework for developing and evaluating the impact of RCR instruction; and research institutions and funding agencies alike need to take a more active role in promoting and supporting RCR instruction.

Fostering integrity in research: definitions, current knowledge, and future directions.

Over the last 25 years, a small but growing body of research on research behavior has slowly provided a more complete and critical understanding of research practices, particularly in the biomedical and behavioral sciences. The results of this research suggest that some earlier assumptions about irresponsible conduct are not reliable, leading to the conclusion that there is a need to change the way we think about and regulate research behavior. This paper begins with suggestions for more precise definitions of the terms "responsible conduct of research," "research ethics," and "research integrity." It then summarizes the findings presented in some of the more important studies of research behavior, looking first at levels of occurrence and then impact. Based on this summary, the paper concludes with general observations about priorities and recommendations for steps to improve the effectiveness of efforts to respond to misconduct and foster higher standards for integrity in research.

The role of professional societies in promoting integrity in research.

OBJECTIVES: To summarize what is known about and to offer suggestions for steps professional societies can take to foster greater integrity in research. METHODS: Analysis of research literature on research integrity. RESULTS: Research on research integrity has identified 3 areas for concerns about integrity: 1) research misconduct, 2) questionable research practices, and 3) the research environment. CONCLUSIONS: It is suggested that professional societies should 1) undertake a careful assessment of needs and possible problems in their research areas, 2) develop resources to address specific problems, and 3) take more active roles in promoting integrity in research among their members.

Role of the institutional animal care and use committee in monitoring research.

During the 1980s, federal regulations transferred significant portions of the responsibility for monitoring the care and use of research animals from animal care programs to Institutional Animal Care and Use Committees (IACUCs). After a brief review of the history of the regulation of the use of animals in research preceding and during the 4 decades following World War II, this article raises 4 problems associated with the role IACUCs currently play in monitoring the use of animals in research: (a) lack of expertise, (b) diverted resources, (c) conflict of interest, and (d) restrictions of academic freedom. It is concluded that the care and treatment of animals used in research would be served better and organized more rationally if the day-to-day responsibilities for approving projects and caring for animals were separated more clearly from broader, oversight functions, with the former being assigned to animal care programs and the latter to IACUCs.