Identification and Communication of Human Subjects Research to UAB-Affiliated Performance Sites- PRO152   

Procedure
 

Investigator Responsibilities

Investigator:

• Identifies all performance sites where UAB-engaged research will be conducted and includes a list of those sites in FOR200 IRB application eForm for review by the IRB;
• Notifies performance sites of intent to perform research;
• Provides written documentation of site’s willingness to serve as a performance site and/or IRB approval;
• Submits modifications to the  IRB application eForm adding and removing performance sites as they occur;
• Informs and trains, as necessary, all performance site personnel who are assisting in the research regarding the protocol and their research-related duties and functions;
• Ensures appropriate IRB oversight is obtained prior to engaging performance site personnel in human subjects research activities;
• Provides IRB approval to performance sites, as requested.

OIRB Responsibilities

Reviewing Staff:

• Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
• Documents performance sites in the electronic research administration (ERA) system;
• Verifies that investigator has submitted appropriate documentation for performance sites (for some studies, such as those performed with the Jefferson County Department of Health, the investigator may have to provide IRB approval and/or documentation of site’s willingness to serve as a performance site);
• Requests appropriate documentation from investigator regarding performance site, if not included with the protocol submission materials, if applicable

Administrative Staff:

• Examines  IRB application eForm for performance site listings;
• Enters other performance sites into ERA, as necessary;
• Provides requested reports to external performance sites;
• Sends IRB protocol approval to investigator.

IRB Responsibilities

The Primary Reviewer, or experienced reviewer for expedited review procedure review:

• Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
• Verifies that investigator has submitted appropriate documentation for performance sites.