Parties Responsible for Preparation and Distribution of Correspondence

Internal Adverse Events

Correspondence surrounding adverse events reviewed at the IRB meeting will be drafted by the AEC and approved by the IRB Chair or Vice Chair. The IRB Chair or Vice Chair will ensure the report is distributed to all applicable parties.

Study Termination or Suspension

For studies in OSIRIS, the IRB Chair or his designee will suspend or terminate the study within the system. Correspondence is sent to the Principal Investigator as well as to all listed co-investigators and research staff. The study moves to a “suspended” or “terminated” state and the consent documents are no longer accessible. For paper studies, reports surrounding study termination or suspension will be drafted by the IRB staff and approved by the IRB Chair or Vice Chair. The IRB Chair or Vice Chair will ensure the report is distributed to all applicable parties.

Serious or Continuing Non-Compliance and Unanticipated Problems Involving Risks to Human Subjects or Others

Correspondence related to determinations of serious or continuing non-compliance or that involve risk to subjects related to ECO-HSR compliance report activities will be prepared by the Co-Director of the RCCO or his/her designee for approval by the IRB Chair and Associate Legal Counsel.

Correspondence related to determinations of serious or continuing non-compliance or that involve risks to human subjects or others related to unanticipated problems will be drafted by the Research Review Coordinator (RRC) for review and approval by the Co-Director of the RCCO, the IRB Chair and Legal Counsel.
After review and comment by the above parties, the Authorized Institutional Official will review, approve and sign the report and ensure the report is distributed to all applicable parties.

Compliance Activity Reports

Correspondence related to Compliance Activity Reports where the study remains active and no serious or continuing non-compliance were identified or protocol modifications were required will be prepared by the Education and Compliance Office staff for signature of the Co-Director of the Research Conduct and Compliance Office.

Correspondence related to a Compliance Activity Report which resulted in a determination of serious or continuing non-compliance; an unanticipated problem involving risks to human subjects or others; or study termination or suspension will be performed in the same manner as other determinations of this kind.

When a protocol modification is necessary as the Compliance Activity Report, the correspondence associated with the protocol modification will be drafted by the IRB staff with input from the Education and Compliance Office for signature by the IRB Chair or Vice Chair.