eligibility dates and eligibility tests results; changing dates on patient screening logs; creating records of interviews that did not occur; and creating records of patient visits that did not occur and inserting false records into medical charts.
Research misconduct may constitute serious or continuing noncompliance and may need to be reported to regulatory agencies and the HHS Office of Research Integrity (ORI). ORI is the federal agency that is responsible for the administration and oversight of Public Health Service (PHS) policies and funds. A condition for PHS support is investigating research misconduct and reporting evidence of misconduct to OIR.
Not all instances of noncompliance fall within the definition of research misconduct. For example, in most cases, failure to report unanticipated problems, protocol deviations without IRB approval, failing to obtain or properly document informed consent, and breaching confidentiality of subject data should not be considered research misconduct. Similarly, not all instances of research misconduct constitute noncompliance with regulations and policies governing the protection of human subjects.
The IRB may respond to allegations of research misconduct that has implications for human subject protections and may be regarded as serious or continuing noncompliance by following the steps described in 13.2, 13.3, and 13.4. Examples of allegations that the IRB may respond to include: backdating enrollment forms to make subjects eligible for participation; falsifying a lab report required for admission to a clinical trial; and intentionally reversing or blending end point results between treatment and control subjects to improve the statistics in violation of IRB approved protocols.
In many instances, however, issues of research misconduct fall outside of the scope of the IRB. The reporting and response to allegations of research misconduct should follow KSU's policies and procedures for research misconduct, which do not involve the IRB. If there is an allegation of research misconduct that has implications for human subjects, the IRB may defer responding to the allegation while a separate committee or disciplinary board completes an assessment and investigation of the allegation. A final report of the investigation will be provided to the IRB, and the IRB will determine if further action is needed to address issues of noncompliance. The IRB retains the authority to suspend approval of research while an investigation into research misconduct is ongoing when it believes suspension of approval is in the best interest of subjects.
The convened IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB approval, that has been associated with serious or continuing noncompliance, or that has been associated with substantive harm to the rights and welfare of human subjects. Any suspension or termination of approval shall include a statement of the reason for the IRB action.