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Research misconduct among clinical trial staff

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Abstract

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations.

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References

  1. 42 CFR, section 93.103

  2. Fowler, D. (2003) Protocol acuity scoring as a rational approach to clinical research management, Research Practitioner 4: 64–72.

    Google Scholar 

  3. Association of Clinical Research Professionals (2003). Application for CCRA and CCRC exams.

  4. 21 CFR, section 312.53

  5. Gamache, V. (2001) Chasing away phantom investigators, CenterWatch 8: 1.

    Google Scholar 

  6. Mueller, M. (2001) From delegation to specialization: nurses and clinical trial co-ordination, Nursing Inquiry 8: 182–190.

    Article  Google Scholar 

  7. Mueller, M., Mamo, L. (2002) The nurse clinical trial coordinator: benefits and drawbacks of the role, Research and Theory for Nursing Practice 16, 8: 33–42

    Article  Google Scholar 

  8. Institute of Medicine (2002) Integrity in Scientific Research, National Academy Press, Washington, DC.

    Google Scholar 

  9. This study was approved by the Committee for the Protection of Human Beings at the University of Pennsylvania and by the Human Investigation Committee at Wayne State University. The authors acknowledge ORI for assistance.

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Authors and Affiliations

  1. Dept of Medical Ethics, University of Pennsylvania, USA

    Barbara K. Redman PhD, RN, FAAN (Dean and Professor) & Jon F. Merz

  2. College of Nursing, Wayne State University, Cohn Building, Suite 112, 5557 Cass Ave., 48202, Detroit, MI, USA

    Barbara K. Redman PhD, RN, FAAN (Dean and Professor) & Thomas N. Templin

Authors
  1. Barbara K. Redman PhD, RN, FAAN
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  2. Thomas N. Templin
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  3. Jon F. Merz
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Corresponding author

Correspondence to Barbara K. Redman PhD, RN, FAAN.

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Redman, B.K., Templin, T.N. & Merz, J.F. Research misconduct among clinical trial staff. SCI ENG ETHICS 12, 481–489 (2006). https://doi.org/10.1007/s11948-006-0046-3

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  • DOI: https://doi.org/10.1007/s11948-006-0046-3

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