Procedures for Retrospective Review of Bias in Research - Appendix A

Summary of time frames and responsibilities associated with Retrospective Review of Bias in Research procedures

 

Owner Task Number of Days Business or Calendar Triggering Event
University Preliminary Assessment, Review, Determination, report to sponsor (if bias is found) 120 Calendar Determination that a Review is necessary
DCDM/Preliminary Assessment Team Conduct Preliminary Assessment 14 Calendar Discovery of facts that could trigger a Review
DCDM Preliminary Assessment Report 10 Calendar Preliminary Assess Team determination
DCDM/AVP Identify RRC Chair 10 Calendar Preliminary Assessment Report sent
RRC Chair Identify and Contact members of RRC 10 Calendar Receiving Review request
DCDM, AVP, RRC Chair Draft RRC Charge 7 Calendar Receiving Preliminary Assessment Report
RRC Retrospective Review 21 Calendar Standing up and Charging RRC
RRC Complete and communicate Review Report 14 Calendar Complete Review
Conflicted Investigator Appeal 14 Calendar RRC providing finding
VPRI Decide Appeal 14 Calendar Receiving Investigator Appeal
RRC Chair (if second review required by VPRI decision) Begin Second Review 5 Business VPRI decision overruling first RRC

If New Evidence Identified During Appeal

Owner Task Number of Days Business or Calendar Triggering Event
DCDM Inform VPRI and Investigator of receiving new Evidence 5 Business Receiving New Evidence
VPRI Determine whether new Evidence could materially affect the Review and, if so, remand to RRC 5 Business Notification from DCDM of new Evidence
DCDM If remanded, inform funding agency of new Evidence and remand 1 Business Review remanded to consider new Evidence
RRC Review new Evidence and notify as required 10 Business Receiving request from VPRI

New Evidence Identified After Final Appeal

Owner Task Number of Days Business or Calendar  Triggering Event
DCDM Review and submit new evidence to AVP, Responsible Administrator, and RRC Chair 10 Business Receiving new Evidence
RRC Chair Provide new evidence to RRC 10 Business Receiving Evidence from DCDM
RRC Review new evidence 14 Business Receiving new Evidence from RRC Chair
RRC Chair Communicate RRC determination 1 Business RRC determination
AVP/DCDM Provide Evidence and RRC determination to VPRI 5 Business Receiving RRC determination
VPRI Make determination on new Evidence 10 Business Receiving notice from AVP/DCDM
DCDM Inform sponsor if decision is reversed or remanded based on new evidence 5 Business Receiving VPRI decision