considered resolved, and the OSP staff in consultation with the IRB Chair will provide a letter to the principal investigator indicating that the matter is resolved.

The HRPP specialist will provide advice to the IRB regarding the applicable regulations during the review process, assist the IRB in documenting the review, answer questions about the review process, maintain records as required by state and federal laws or regulations, and serve as a liaison with the funding agency or agencies. In cases where the IRB determines that there is serious or continuing noncompliance, OSP will also provide a letter notifying KSU's Institutional Official of the noncompliance. If applicable, OSP will also notify the funding agency and OHRP of the noncompliance.

Research misconduct includes but is not limited to fabrication, falsification and plagiarism. Research misconduct in human subjects research may occur in the proposal, conduct or reviewing of research, or reporting of research results. Examples of misconduct in human subjects research may include: substituting one subject's record for another's; altering 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,