Section 22
Violations of CORIHS Policies

CORIHS has the authority to suspend, terminate, or place restrictions on any study in which the investigator has not met the policy or procedural requirements addressed in this Handbook, and/or in the event where information is disclosed to the Office of Research Compliance and/or CORIHS that indicates that the rights and/or welfare of human subjects are at risk.

Reports of violations of this policy will be brought before CORIHS at a convened meeting. CORIHS will make a determination regarding the need for additional information/further investigation or need for immediate action. The affected Chair and Dean will be copied on all correspondence between the committee and the involved parties. Upon determination that a violation of this policy has occurred, possible sanctions considered by CORIHS may include, for example, requiring that the activity in question be suspended (temporarily or permanently), and/or establishment of a corrective action plan involving close oversight of investigator and project activities, suspension of an investigator from human subjects research, etc.

In situations where subject safety is involved and/or the violations are apparent, the Chair of CORIHS, in consultation with other IRB members and/or administrators as appropriate, may take immediate action (e.g., suspend the activity/activities in question) prior to review by the full committee.

In accordance with our Federal Wide Assurance, the following violations will be reported by the Institutional Official to the VP for Research, OHRP, and FDA where applicable:

  1. Unanticipated problems involving risks to subjects or others,
  2. Serious or continuing noncompliance with applicable federal regulations governing human subject protections,
  3. Serious or continuing noncompliance with determinations made by the IRB, and
  4. Any suspension or termination of IRB approval
    5.

If CORIHS determines that the violation involves possible scholarly or scientific misconduct, the Vice President for Research will be notified, via the Institutional Official, and appropriate action will be taken in accordance with established University assurances, policies, and procedures.

All reports/allegations regarding human subject research activities made to the Office of Research Compliance and/or CORIHS will be held confidential, to the extent allowed by law.

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Last Updated: 2004-04-28