Monthly Website Update: February 2022

Dear Northwestern Research Community,

The IRB Office Compliance Team updated the Post-Approval Monitoring (PAM) checklists to reflect feedback from the research community.  The updated checklists can be found at the bottom of the Checklists & Worksheets page. The following checklists were updated:

• HRP-427 - Post Approval Monitoring - Drug or Device Clinical Trial - COMPLIANCE
• HRP-428 - Post Approval Monitoring - Participant File - COMPLIANCE
• HRP-429 - Post Approval Monitoring - Biomedical Research - COMPLIANCE
• HRP-430 - Post Approval Monitoring - Social Behavioral Research - COMPLIANCE
• HRP-1405 - Post Approval Monitoring - Data Review, Registries, or Specimen Collection - COMPLIANCE
• HRP-1406 - Post Approval Monitoring - Studies Under External IRB Review - COMPLIANCE
• HRP-1407 - Post Approval Monitoring - Site File - COMPLIANCE
• HRP-1409 - Post Approval Monitoring - Humanitarian Use Device (HUD) - COMPLIANCE

A new Minors Acting as Research Study Team Members Policy is available. This policy addresses minors, i.e., persons who are under age 18, acting as research interns or volunteers for human participant research studies at Northwestern University. This policy is not intended to limit or prohibit minors as human research participants. 

• HRP-1004 - Minors as Study Team Members - GENERAL- POLICY

Other documents were also updated this month, including:

• HRP-305 - Quorum and Expertise - GENERAL - WORKSHEET