Noncompliance. JERI R. BARNEY, JD HRPP COMPLIANCE MANAGER Yale University Human Research Protection Program www.yale.edu/hrpp December 13, 2012. Today’s Discussion. HRPP Compliance Unit What is Noncompliance? Minor Noncompliance Serious Noncompliance Continuing Noncompliance
JERI R. BARNEY, JD
HRPP COMPLIANCE MANAGER
Human Research Protection Program
December 13, 2012
To facilitate compliance with the federal regulations (and University policies) and protection of research participants
Examples of minor noncompliance may include, but are not limited to, the following:
Principal Investigators, co/sub-investigators, research personnel, or other individuals who believe that an instance of serious or continuing noncompliance has occurred must report it to the IRB within five (5) working days of becoming aware of the noncompliance.
All instances of minor noncompliance should be summarized for the IRB at the time of continuing review.
Form can be found at http://www.yale.edu/hrpp/forms-templates/biomedical.html
45 CFR 46.109(e)
21 CFR 56.109(f)
Current template language:
This letter serves as a reminder that the above-cited protocol is due for reapproval by the HIC. It is the primary responsibility of the Principal Investigator to ensure continued reapproval status for protocols. All protocols must be reviewed and approved annually by the HIC unless shorter intervals have been specified.
It is a violation of Yale policy and federal regulations to continue human research activities after the (IRB) approval period has expired. If the HIC does not receive renewal materials within reasonable time to review and reapprove this research by its current expiration date, all enrollment, research activities and intervention on previously enrolled subjects must stop.
If the approval of this protocol lapses, and if the research activities (including the analysis of identifiable private information) are supported by a sponsored award(s), no further expenses related to the research activities may be incurred and charged to the sponsored award(s) until the protocol has been reapproved. Should the research activities no longer involve human participants and you are only conducting data analysis of de-identified data, IRB approval is no longer required but the IRB does require notification of this change in order to close the study. Note also that some research sponsors may require documentation that IRB approval is no longer required.
Call HRPP Compliance Manager at 785-6471 or send email to firstname.lastname@example.org
Call HRPP office directly at 785-4688