Conflict of Interest and Noncompliance

6.1 - Whistleblower Policy
6.2 - Investigator Noncompliance
6.3 - Investigator Conflict of Interest

6.1 Whistleblower Policy

The IRB is required to review allegations of misconduct and to take action to protect human subjects. Call the Office of Research Compliance at (860) 486-8802 if you have a concern about a study.

Reviewing complaints and allegations of non-compliance is critical to the IRB's ability to protect human subjects. A climate free of fear of sanction is required to foster appropriate reports and ensure a fair review of allegations. Retaliation against good faith "whistle blowers" is illegal and will not be tolerated at this institution. Whistle blowers who report IRB related concerns may use other mechanisms at the University for protection from retaliation. For information about the whistle blower's policy at the University, contact the Office of Audit, Compliance and Ethics at (860) 486-0031.

6.2 Investigator Noncompliance

The IRB is required to review allegations of investigator noncompliance with IRB-approved protocols as well as Federal regulations and University policy pertaining to human subject research. The IRB will also review allegations of misconduct that violate the rights of research subjects. Incidents of noncompliance will be reviewed by the IRB for corrective action appropriate to the incident. In all cases the IRB's primary concern will be to protect the welfare of the research subjects.

The IRB will report to the federal Office for Human Research Protections (OHRP), and any other sponsoring Federal department or agency head:

• any serious or continuing noncompliance with the regulations or requirements of the IRB
• any injuries to human subjects or other unanticipated problems involving risks to subjects or others, and any suspension or termination of IRB approval for research to appropriate institutional officials.

6.3 Investigator Conflict of Interest

The University's Board of Trustees approved policy on Conflict of Interest in Research applies to all situations involving "significant financial interest." After the University's Conflict of Interests (COI) Committee has determined if a conflict exists, it will forward the information to the IRB. The IRB will determine whether the conflict is permissible in the context of the protocol and, if so, whether the conflict warrants disclosure to subjects as part of the informed consent process.