Noncompliance

The IRB will NOT approve any project if the principal investigator has begun data collection prior to receiving IRB approval. This policy is needed to assure compliance with and carry out the purpose of the federal regulations: that is to protect human subjects involved in research.

In any instance in which IRB requirements are not being followed, the IRB shall inform (within five (5) working days) the principal investigator and also the Vice President for Research, who will be asked to enforce the requirements. In the event that the principal investigator does not comply, the Vice President for Research will terminate the research. Such action will be accompanied by a letter to the principal investigator, stating the reason for the action. If unanticipated problems involving risks to the subjects or others, noncompliance by the researcher, or termination by the Vice President for Research occur, these will be reported to the Secretary of the Department of Health and Human Services, or other appropriate federal agency, by the Vice President for Research within seven (7) working days of the letter of termination to the principal investigator.