Abstract
Data management raises a number of issues, both regulatory and non-regulatory. Researchers should understand how data are defined by their particular institutions and regulatory authorities. Data are the bases of scientific communication and provide a strong defense against allegations of scientific misconduct. Authorization is often necessary before collection of data can commence. Proper handling, retention, and storage of data, especially that involving humans, are crucial for the researcher. Data ownership by the institution leads to a responsibility by the institution to educate all its researchers in responsible data management practices.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
Council on Governmental Relations (2006) Access to and retention of research data rights and responsibilities. Accessed April 27, 2010 from http://cogr.edu/ (under Educational Materials).
Eiseman, E., Bloom, G., Brower, J., Clancy, N., & Olmsted, S. (2003). Case studies of existing human tissue repositories: “Best Practices” for a biospecimen resource for the genomic and proteomic era. Accessed April 27, 2010 from http://biospecimens.cancer.gov/global/pdfs/RAND_REPORT.pdf.
Faden, R. R., Kass, N. E., Klag, M. J., & Krag, S. S. (2002). On the importance of research ethics and mentoring. American Journal of Bioethics, 2, 50–51.
Federal Acquisition Regulation (FAR), 48 CFR §27.401. (2005). https://www.acquisition.gov/far/current/html/Subpart%2027_4.html#wp1041836. Accessed April 27, 2010.
Food and Drug Administration. (2001). Bioresearch Monitoring Good Laboratory Practice Compliance Program 7348.808 Part I: Background. http://www.fda.gov/ICECI/EnforcementActions/BioresearchMonitoring/ucm133915.htm. Accessed April 27, 2010.
Giffels, J. (2010). Sharing data is a shared responsibility—commentary on: The essential nature of sharing in science. Science and Engineering Ethics (this issue).
Howard Hughes Medical Institute and Burroughs Wellcome Fund (2006) Making the right moves—a practical guide to scientific management for postdocs and new faculty, 2nd Ed. http://www.hhmi.org/resources/labmanagement/mtrmoves_download.html. Accessed April 27, 2010.
International Society for Biological and Environmental Repositories (ISBER). (2008). Best practices for repositories: Collection, storage, retrieval and distribution of biological materials for research. http://www.isber.org/Pubs/BestPractices2008.pdf. Accessed April 27, 2010.
Macrina, F. (2000). Scientific integrity: An introductory text with cases (2nd ed.). Washington, DC: ASM Press.
National Institutes of Health. (2003a). Grants policy statement footnote 12. http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part17.htm#footnotes. Accessed April 27, 2010.
National Institutes of Health. (2003b). Grants policy statement administrative requirements: Sharing of research data. http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part7.htm#_Toc54600133. Accessed April 27, 2010.
National Institutes of Health. (2003c). Grants policy statement administrative requirements: Record retention and access. http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part8.htm#_Toc54600143. Accessed April 27, 2010.
National Institutes of Health. (2004). Research repositories, databases, and the HIPAA privacy rule. http://privacyruleandresearch.nih.gov/research_repositories.asp. Accessed April 27, 2010.
Office of Human Research Protections. (1997). Issues to consider in the research use of stored data or tissues. http://www.hhs.gov/ohrp/humansubjects/guidance/reposit.htm. Accessed April 27, 2010.
Office of Human Research Protections. (2008). Guidance on research involving coded private information or biological specimens. http://www.hhs.gov/ohrp/humansubjects/guidance/cdebiol.htm. Accessed April 27, 2010.
Office of Human Research Protections. (2009). Protection of human subjects: IRB records, 45 CFR 46.115(b). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.115. Accessed April 27, 2010.
Office of Management and Budget Guidance for Grants and Agreements: Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (OMB Circular A-110), 2 CFR §215.36(a). (1999a). http://www.whitehouse.gov/omb/rewrite/circulars/a110/a110.html#36. Accessed April 27, 2010.
Office of Management and Budget Guidance for Grants and Agreements: Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (OMB Circular A-110), 2 CFR §215.36(d)(1). (1999b). http://www.whitehouse.gov/omb/rewrite/circulars/a110/a110.html. Accessed April 27, 2010.
Office of Management and Budget Guidance for Grants and Agreements: Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations (OMB Circular A-110), 2 CFR §215.36(d)(2). (1999c). http://www.whitehouse.gov/omb/rewrite/circulars/a110/a110.html. Accessed April 27, 2010.
Office of Research Integrity. (2009). Misconduct: Definition of research misconduct. http://ori.dhhs.gov/misconduct/definition_misconduct.shtml. Accessed April 27, 2010.
Public Health Service Policies on Research Misconduct, 42 CFR §93.106. (2005). http://ori.dhhs.gov/documents/FR_Doc_05-9643.shtml. Accessed April 27, 2010.
Steneck, N. (2004). Introduction to the responsible conduct of research. Washington: US Government Printing Office.
Vaught, J. B., Caboux, E., & Hainaut, P. (2010). International efforts to develop biospecimen best practices. Cancer Epidemiology, Biomarkers and Prevention, 19(4), 912–915.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Joshi, M., Krag, S.S. Issues in Data Management. Sci Eng Ethics 16, 743–748 (2010). https://doi.org/10.1007/s11948-010-9223-5
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s11948-010-9223-5