Assessing Research Misconduct Allegations Involving Clinical Research

An allegation of wrongdoing in research involving human subjects must be assessed to determine under which PHS regulation or policy it should be handled. For ORI, the question is whether it is an allegation of research misconduct that falls under the PHS definition in 42 C. F. R. 93. The following are examples of falsification and fabrication that have formed the basis for PHS findings of research misconduct in clinical research. Generally, these incidents occurred in the context of conducting clinical research or reporting data (internally or externally), publishing data or results, or including data or research records in grant applications or progress reports.

FALSIFICATION

  • substituting one subject's record for that of another subject;
  • falsely reporting to a data coordinating center that certain clinical trial staff, who were certified to perform the procedures on the subjects, had done so, when they had not;
  • altering the dates and results from subjects' eligibility visits;
  • altering the dates on patient screening logs and/or submitting the same log with altered dates on multiple occasions;
  • failing to update the patients' status and representing data from prior contacts as being current;
  • altering the results of particular tests on blood samples to show that the test accurately predicted a disease or relapse;
  • backdating follow-up interviews to fit the time window determined by the study protocol; and
  • falsifying the times that blood samples were drawn from human subjects.

FABRICATION

  • creating records of interviews of subjects that were never performed;
  • making up progress notes for patient visits that never took place and inserting them into the medical record to support published and unpublished research reports; and
  • preparing records for calls and follow-up contacts to subjects who had already died.

 


Source URL: https://ori.hhs.gov/assessing-research-misconduct-allegations-involving-clinical-research