PROCEDURE

Investigator Responsibilities

For all non-UAB-affiliated performance sites, the Investigator:

• Identifies all non-UAB affiliated performance sites and describes the types of research activities proposed for each site in FOR200 Human Subjects Protocol (HSP) for review by the IRB;
• Notifies performance sites of intent to perform research;
  • Provides the following information:
  • Whether the performance site has its own IRB;
  • Whether a performance site’s IRB has approved or disapproved the research;
  • Whether a performance site intends to rely on UAB’s IRB;
  • Documentation of local IRB approval of research from non-UAB-affiliated performance sites, when applicable;
  • IRB approval from IRB operating under a Federalwide Assurance (FWA); or
• Maintains written documentation of sites' willingness to serve as a performance site;
  • Maintains all copies of continuing, timely IRB approvals for all performance sites engaged in research:
  • Provides a statement that all IRB approvals have been obtained at the time of IRB continuing review;
• Provides a copy of documents of continuing IRB review and approval as requested by the IRB or OIRB;
• Submits protocol amendment when performance sites are added or removed;
• Informs and trains in research-related procedures, as necessary, all performance site personnel involved in the research.

OIRB Responsibilities

The Senior Staff:

• Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
• Documents performance sites on GUI308 checklist for new or GUI310 continuing IRB review;
• Documents requirements of DoD (GUI339) or DOE (GUI338) are met, if applicable;
• Verifies that investigator has submitted appropriate documentation for performance sites; if not, requests appropriate documentation from investigator;
• Makes notation of additional performance site(s) in IRB database, as necessary;
• Evaluates performance sites to determine whether they are or are not engaged in research as defined in OHRP guidance;
• Requests from investigator documentation verifying the willingness of a performance site(s) to be involved with the research if the performance site(s) is “not engaged in research” unless included with the HSP or other submission materials such as:
  • Contract,
  • Subcontract,
  • Memorandum of Understanding (MOU);
• Requests the IRB approval from all designated performance sites “engaged in research” utilizing a designated non-UAB IRB operating under a FWA, unless included with the HSP or other submission materials;
• Identifies and refers to the OIRB Director any designated performance site “engaged in research” utilizing a designated non-UAB IRB that does not operate under a FWA;
• Evaluates if consultant may be necessary for local context review and refers to Chair.

The Administrative Staff:

• Assists in the review of protocols to ascertain involvement of non-UAB-affiliated performance sites;
• Requests documentation from the investigator of non-UAB-affiliated performance sites.

The Clerical Staff:

• Enters in IRB database non-UAB-affiliated performance sites as instructed by administrative and/or senior staff;
• Processes materials pertaining to non-UAB-affiliated performance sites;
• Files performance site documentation in IRB record.

The OIRB Director:

• Evaluates and determines need for MOU with entity not operating under a FWA;
• Prepares and submits MOU to Institutional Official for review and approval.

The Primary Reviewer, or experienced reviewer for expedited review:

• Reviews IRB submission and funding application to identify and ascertain concordance in all documents pertaining to performance sites;
• Identifies the need for consultation from an individual (Consultant to the IRB) familiar with the cultural background, local context and community attitudes if the performance site does not have a local IRB/IEC to provide this review and refers request to Chair.

The IRB Chair (or designee):

• Assesses whether local context review is satisfied. If not, makes determination in accordance with POL014 policy on, PRO114 procedure for IRB use of consultants.

Institutional Responsibilities

The Institutional Official:

• Reviews and signs MOUs with performance sites, when applicable.

Approved on March 1, 2010, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director