Managing data for integrity: poli...
Science and Engineering Ethics (2006) 12, 23-39 Science and Engineering Ethics, Volume 12, Issue 1, 2006 23 Keywords: research integrity data management training mentor principal investigator ABSTRACT: Management of the research data is an extremely important responsibility of the Principal Investigator (PI) and other members of the research team. Without accurate data, no worthwhile conclusions can be drawn from the research study. Integrity in data management is critical to the success of the research group and to public trust in the research outcomes. One of the primary responsibilities of the PI is to provide proper training to the junior members of the lab. This effort can be buttressed by institutional data policies that are implemented at the group level. Extensive and frequent guidance in good research practices by the PI and other senior research staff is critical to the proper training of new scientists. Many scientists think of data management as how you collect the data, record and maintain it. These are important but not sufficient to ensure the quality of the data for purposes of interpretation, reporting, and publication. This article is intended to explore data management in a more comprehensive way that takes into consideration the positive contributions that can be made by institutions and laboratories in adopting data policies, holding regular lab meetings to review and discuss the data, and providing formal training of young scientists in the principles and skills in interpreting and reporting the data. Managing Data for Integrity: Policies and Procedures for Ensuring the Accuracy and Quality of the Data in the Laboratory Chris B. Pascal* Director, Office of Research Integrity, Department of Health and Human Services, USA * The opinions expressed herein are those of the author and do not necessarily represent the views of the Office of Research Integrity, the U.S. Department of Health and Human Services, or any other federal agency. This paper was presented at the 6th International Bioethics Conference on the subject of ���The Responsible Conduct of Basic and Clinical Research���, held in Warsaw, Poland, 3-4 June 2005. Address for correspondence: Chris B. Pascal, J.D., Director, Office of Research Integrity, Office of Public Health and Science, Department of Health and Human Services, 1100 Wootton Parkway, Suite 750, Tower Building, Rockville, MD. 20852, USA email: firstname.lastname@example.org. 1353-3452: 2006. Published by Opragen Publications, http://www.opragen.co.uk.
C. B. Pascal 24 Science and Engineering Ethics, Volume 12, Issue 1, 2006 As many readers already know, the U.S. Office of Research Intergrity (ORI) has an abiding interest in providing education in the responsible conduct of research (RCR). ORI has provided financial resources for research institutions to develop educational products in various RCR areas such as managing conflicts of interest, peer review, authorship, and data management. Many of these products are web based and are posted on the ORI website.1 An important part of ORI���s mission is focused on the integrity of the research process, such as the accuracy of the research data and research publications, and the prevention of, or reduction of, research misconduct. Because accurate scientific results are critical to the advancement of science, an argument can be made that the proper management of the data, and in particular, the quality and accuracy of the data, is the most important element in ensuring scientific integrity and public confidence in research results and findings. Responsible Research at the Individual Level In 2002, the Institute of Medicine,2 issued a report on research integrity stating that ���the responsible conduct of research is not distinct from research on the contrary, competency in research encompasses the responsible conduct of that research and the capacity of ethical decision making.��� Another way to address this issue, is to say that one cannot separate responsible research from the competency or quality of that research. By the same token, lack of knowledge, skills, and experience in research is in most instances invariably fatal to research quality. In discussing RCR at the individual level, the IOM report2 (p.5) lists the following qualities needed by investigators to conduct responsible research��� ��� intellectual honesty in proposing, performing, and reporting research ��� accuracy in representing contributions ��� fairness in peer review ��� transparency in conflicts of interest ��� protection of human subjects humane care of animals and ��� adherence to mutual responsibilities between investigators and research teams Almost all of these principles and concepts are related to the quality of the research data in some way. Intellectual honesty in proposing, performing, and reporting research certainly encompasses accuracy in describing data collection efforts, reporting data from prior studies, and the inclusion of preliminary data in the application in order to demonstrate the feasibility of the research proposal. Accuracy in representing contributions includes a fair and accurate description of the contributions of the lead author and making sure that other authors receive appropriate credit for their data or data interpretations included in the manuscript or proposal. Fairness in peer review requires that the reviewer give appropriate acknowledgment to the author if the data appear sound, data interpretations are
Managing Data for Integrity Science and Engineering Ethics, Volume 12, Issue 1, 2006 25 appropriate, the methodology is appropriate to the type of research involved and the proposed article makes a contribution to the literature. If data criticisms are made, the reviewer must have adequate justification for those criticisms. Conflicts of interest may affect the interpretation and reporting (or withholding of data). When conflicts are disclosed, the reader of a journal article or user of the data may take into account the potential bias of the investigator. However, this may be insufficient to ensure the integrity of the data. If the conflict is very impactful, such as a large stake in the research project, the conflict may lead to apparent or real bias. Although an outsider may be aware that bias could exist, he or she may have a difficult or impossible task in coming up with an accurate account of the level of the bias and how harmful it may be to the safety of the study and the quality of the data. In such circumstances, the institution or investigator should assume direct responsibility for ensuring the quality and reliability of the data. If that cannot be accomplished, the institution may need to completely bar the investigator from participation in the study. Data validity and reliability is certainly important in both human research and animal research. If the plan for data collection, interpretation, and reporting is vague or piecemeal, it may not be possible for researchers to make sound conclusions about the data. Hence, poorly designed studies may pose unnecessary risks to human subjects or animals, suggesting that it may not be inappropriate to conduct the study at all. Certainly, if there is more than minimal risk involved, the investigator, institution, and IRB should seriously consider not going forward with the proposed research. If the study is worth doing, it is important to collect and use the data in a way that advances science and benefits the public. This means the data must be valid, reliable, and interpreted and reported in a reasonable fashion. Adherence to mutual responsibilities of research teams certainly includes data responsibilities. The lead investigator has responsibility to establish the data collection procedures, make sure the research team understands its responsibilities, and provide training and supervision as needed. Likewise, the members of the research team need to be diligent in following the procedures, asking questions as needed, and letting the PI know if there are problems with the data. Data issues are clearly important throughout the research process as indicated by how often they are linked to the RCR issues identified by the IOM report concerning responsibilities at the individual level of research. Responsible Research at the Institutional Level The IOM2 (p.5) recommends that the institution address RCR by the following��� ��� provide leadership in RCR ��� encourage respect for everyone involved ��� promote productive interactions between trainees and mentors ��� advocate adherence to rules regarding the conduct of research ��� conduct thorough inquiries and investigations into alleged misconduct ��� offer educational opportunities in RCR