Bringing Clarity to IRB Correspondence HRPP 201 March 2009 Bringing Clarity to IRB Correspondence Bringing Clarity to IRB Correspondence

Bringing Clarity to IRB Correspondence HRPP 201 March 2009 Bringing Clarity to IRB Correspondence Issues with IRB Records Retention VHA Record Retention Requirements Current Issues Bringing Clarity to IRB Correspondence

IRB Records Definition of IRB Records HRPP 201 March 2009 IRB Records Definition of IRB Records DHHS FDA VA Definition of Investigator Records Bringing Clarity to IRB Correspondence

Record Retention: How Long? HRPP 201 March 2009 Record Retention: How Long? Investigator Records Common Rule FDA VHA Research Program Records Bringing Clarity to IRB Correspondence

Record Retention: Issues HRPP 201 March 2009 Record Retention: Issues Sponsor Contracts HIPAA Other Requirements Concept of “Permanent Records” Pending VHA Policy Scanning consent forms? Bringing Clarity to IRB Correspondence

HRPP 201 March 2009 Major Question How do you know everything is there that should be there when it needs to be there or is it even supposed to be there? Bringing Clarity to IRB Correspondence