Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Experiment Videos

Research misconduct among clinical trial staff.

Barbara K Redman1, Thomas N Templin, Jon F Merz

  • 1College of Nursing, Wayne State University, Cohn Building, Suite 112, 5557 Cass Ave., Detroit, MI 48202, USA. ae9080@wayne.edu

Science and Engineering Ethics
|August 16, 2006
PubMed
Summary

Scientific misconduct in clinical trials involving 39 staff was investigated. Findings show inadequate workload, training, and supervision enable misconduct, necessitating stricter institutional oversight and updated regulations for research integrity.

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Research Misconduct in Academia: Examining the Views of Academics in a Public University in Ghana.

Science and engineering ethics·2026
Same author

What Should Be Roles of Industry and the Public in Diagnostic Research?

AMA journal of ethics·2025
Same author

INSPECT-SR: a tool for assessing trustworthiness of randomised controlled trials.

medRxiv : the preprint server for health sciences·2025
Same author

Editorial: Regulatory science and meta science as components of regulation of medical products and practices.

Frontiers in medicine·2025
Same author

Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework.

BMC medical ethics·2024
Same author

Patient Consent for Medical Student Pelvic Exams under Anesthesia: An Exploratory Retrospective Chart Review.

The Journal of clinical ethics·2024

Area of Science:

  • Clinical Research
  • Scientific Integrity
  • Research Ethics

Background:

  • The Office of Research Integrity (ORI) investigated 39 clinical trial staff for misconduct between 1993 and 2002.
  • Analysis of ORI case records identified enabling factors such as workload, training, and supervision deficiencies.

Purpose of the Study:

  • To analyze practices contributing to scientific misconduct in clinical trials.
  • To evaluate the adequacy of current regulations concerning clinical trial staff oversight.
  • To propose recommendations for enhancing research integrity and human subjects protection.

Main Methods:

  • Review of Office of Research Integrity (ORI) case records.
  • Analysis of practices related to workload, training, and supervision of clinical trial staff.

Related Experiment Videos

Main Results:

  • Deficiencies in workload management, training, and supervision were identified as significant factors enabling scientific misconduct.
  • Current ORI regulations do not assign responsibility to investigators or institutions for the supervision and training of clinical trial staff.

Conclusions:

  • Stricter institutional and professional association standards are needed beyond federal regulations.
  • The definition of research misconduct should include intentional or negligent mismanagement of scientific projects.
  • Enhanced oversight is crucial for protecting human subjects, ensuring data reliability, and maintaining trust in clinical research.