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Clinical Study Reflections: Another View

Commentary on: “Raising Suspicions with the Food and Drug Administration: Detecting Misconduct”

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Abstract

Federal regulations are the minimum requirements for conducting clinical studies. Some innovation would improve the situation of many involved in these studies, including: study subjects, those who monitor studies, and clinical investigators as well as Institutional Review Boards. Respecting patient and whistle-blower input; appreciating research staff contributions; and implementing a systems and partnership approach would foster quality and advance clinical research.

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Notes

  1. Dr. B. Moench noted as an example that the negative health effects of cigarette smoking were known in the 1940s—35 years before the public health efforts to curtail smoking.

  2. ICH provides more details regarding monitoring.

  3. FDA’s regulations have more requirements [than ICH] for records and for clinical investigator conduct.

  4. E.g. Investigation New Drugs (IND) or Investigational Device Exemptions (IDE).

  5. E.g. New Drug Applications (NDA); Pre-Market Applications (PMA); or Biologics License Applications (BLA).

  6. 21 CFR 50.23, 21 CFR 50.24.

  7. All of FDA’s regulations are in Title 21 of the Code of Federal Regulations. The Good Clinical Practices website that includes these regulations has been updated recently and many page locations have been changed. The regulations can be accessed at: http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/default.htm.

  8. 21 CFR 54.

  9. FDA does not track how many IRB’s audit their studies. It could be an interesting area for further research.

  10. Few scientists fabricate results from scratch or flatly plagiarize the work of others, but a surprising number engage in troubling degrees of fact-bending or deceit, according to the first large-scale survey of scientific misbehavior. More than five percent of scientists answering a confidential questionnaire admitted to having tossed out data because the information contradicted their previous research or said they had circumvented some human research protections. Ten percent admitted they had inappropriately included their names or those of others as authors on published research reports. And more than 15 percent admitted they had changed a study’s design or results to satisfy a sponsor, or ignored observations because they had a “gut feeling” they were inaccurate.

    None of those failings qualifies as outright scientific misconduct under the strict definition used by federal regulators. But they could take at least as large a toll on science as the rare, high-profile cases of clear-cut falsification, said Brian Martinson, an investigator with the Health Partners Research Foundation in Minneapolis, who led the study appearing in today's issue of the journal Nature. … Martinson and two colleagues—Melissa Anderson and Raymond deVries, both of the University of Minnesota—sent a survey to thousands of scientists funded by the National Institutes of Health and tallied the replies from the 3,247 who responded anonymously” (Weiss 2005, p. A03).

  11. Joan Didion reports in The Year of Magical Thinking (Didion 2005) that she provoked a negative reaction in her daughter’s ICU doctor by using the term, “edema.” She is a science/medical writer. As doctors more readily appreciate their patients [and their advocates] as partners, surely the differences in our languages will diminish.

  12. Two additional states contemplating such restrictions and similar initial US Congressional actions are also mentioned in the article (Singer 2009).

References

  • Code of Federal Regulations (CFR), Title 21, Part 50, Sections (§§) 23–54.

  • Code of Federal Regulations (CFR), Title 45, Part 46, Sections (§§) 101–505.

  • Department of Health and Human Services. (2004). Financial relationships and interests in research involving human subjects: Guidance for human subject protection. http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf.

  • Didion, J. (2005). The year of magical thinking. New York: Alfred A. Knopf.

    Google Scholar 

  • Hamrell, M. (2010). Raising suspicions with the Food and Drug Administration: Detecting misconduct. Science and Engineering Ethics. doi:10.1007/s11948-010-9232-4.

  • Hommel, C. (2009, August). Senior Health Policy Analyst, Good Clinical Practice Program, Office of Science and Health Coordination, Office of the Commissioner, FDA.

  • Senge, P. (1990). The fifth discipline, systems thinking. New York: Doubleday.

  • Singer, N. (2009). Vermont acts to make drug makers’ gifts public. New York Times, May 19, 2009, p. B-1.

  • Weiss, R. (2005). Many scientists admit to misconduct, degrees of deception vary in poll; Researchers say findings could hurt the field. The Washington Post, June 9, 2005, p. A03.

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  1. The Public Sector Consortium, Cambridge, MA, USA

    Patricia Spitzig

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  1. Patricia Spitzig
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Correspondence to Patricia Spitzig.

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Spitzig, P. Clinical Study Reflections: Another View. Sci Eng Ethics 16, 705–711 (2010). https://doi.org/10.1007/s11948-010-9235-1

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  • DOI: https://doi.org/10.1007/s11948-010-9235-1

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