Version
1.2
Date Updated
Tuesday, January 5, 2016
Descripton

POLICY


  1. Administrative withdrawal of initial submissions of research is an action taken by OPRS to permanently withdraw a proposal after it has been reviewed and given either conditions required to secure approval or been deferred, and the investigator has not responded to the IRB’s request within 90 days. 
  2. Administrative withdrawal of an amendment to previously approved research is an action taken by OPRS to permanently withdraw the submission after it has been reviewed and given either conditions required to secure approval or been deferred, the investigator has not responded to the IRB’s request within 90 days, and the Assistant Director (AD) (or designee) has consulted with the Chair (or designee) to determine whether the withdrawal of the submission may affect subject safety. 
  3. Administrative withdrawal of continuing review is an action taken by OPRS to permanently withdraw the submission after it has been reviewed and given either conditions required to secure approval or been deferred, the investigator has not responded to the IRB’s request within the designated timeframe as indicated on the correspondence from the IRB, and the research has lapsed in IRB approval. 
  4. The RiSC software application (IRB #s 1, 2, 3) has a mechanism for the AD for each IRB (or designee) to monitor the status of the board’s protocols on a weekly or bi-weekly basis.