SECTION 39

RESEARCH NON-COMPLIANCE

Allegations of research noncompliance with federal and state laws, rules and regulations and institutional policies and procedures are referred to the Office of Human Research Protection (OHRP). The Chairman of the Human Assurance Committee (HAC) may refer a study for review to OHRP. Should OHRP determine that the alleged practices appear to (1) cause injury or any other anticipated problems involving risks including but not limited to, physical, social, psychological, confidentiality, financial or emotional, to subjects or others or (2) constitute serious or continuing noncompliance with HAC Policies or Procedures, then the OHRP may recommend further action to the HAC Chairman.

The HAC Chairman may suspend the study pending a timely investigation and review. The Chairperson may recommend to the full HAC that the study should be terminated. The HAC has the authority to suspend or terminate protocols that are found to be non-compliant with federal and state laws, rules and regulations and institutional policies and procedures. Other sanctions imposed by the HAC and/or OHRP may include, but are not limited to, routine compliance audits, letters of reprimand and restrictions on serving as an investigator on human subjects protocols. Suspensions or terminations are reported to the appropriate institutional officials responsible for the federal wide assurance (FWA) and the human research protections program (HRPP)Serious or continuing noncompliance will require reporting to both sponsor and/or federal agencies.