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Handling Misconduct - Preliminary Assessment
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unpublished research reports; and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.
PHS research misconduct regulations generally do
not supersede or create an alternative to the established procedures
for resolving fiscal or criminal improprieties or cases of abuse of
animal and human subjects. In the absence of evidence of
falsification or fabrication of the research record as described
above, the following problems would not be considered as research
misconduct by ORI, but would be forwarded to the appropriate agency,
such as FDA and/or the Office for Human Research Protections (OHRP):
- failing to report an adverse event with a patient to the sponsor or the
Institutional Review Board (IRB);
- deviating from the protocol (e.g., entering an ineligible subject in a
trial, or administering an off-protocol drug);
- forging a physician's signature on medical orders;
- failing to obtain or properly document, informed consent;
- breaching human subject confidentiality; and
- failing to obtain IRB and/or Food and Drug Administration (FDA) approval
for changes implemented in an approved protocol.
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Assurance
