Blue Flower

WIC Principal Investigator (PI) 

  • Ensure that human subject research activities do not begin at any site until IRB approval is obtained in writing from the WIC IRB of record.
  • Notify PIs at collaborating sites of all IRB of record determinations and communications, including those for initial review, continuing review, amendments, and reportable events.
  • Follow the directives and policies of the IRB of record as well as those of your own institution (if different) and comply with any additional site specific requirements (e.g. Safety Committee approvals, CITI Training, COI Disclosures).
  • While study interventions or activities may differ by site, ensure that each site listed on the Project Description and Review Request Form has and follows the same overall protocol.
  • Upon request, provide access to records for audit by the IRB of Record.

 

PI at Collaborating Site(s)

  • Do not initiate human subject research activities until notification of IRB approval is received from the PI at the institution serving as the WIC IRB.
  • Follow the IRB approved protocol.
  • Report adverse events and deviations from the protocol that occur at your site to both the WIC PI and your institution’s IRB.
  • Follow the directives and policies of the IRB of record as well as those of your own institution (if different) and comply with any additional site specific requirements (e.g. Safety Committee, CITI Training, COI Disclosures).
  • Upon request, provide access to records for audit by the local IRB or the IRB of record.