POLICY STATEMENT

Performance sites for human subjects research outside the control of the investigator will receive notice of research activities performed under the jurisdiction of the IRB. The IRB will designate UAB-affiliated sites which regularly perform UAB human subjects research activity. Other performance sites shall be termed "non-UAB-affiliated" performance sites.

With regard to performance sites for human subjects research, the investigator will:

Identify proposed performance sites and describe the types of research activities proposed for each site for review by the IRB;
Notify the UAB IRB of any changes in performance sites for approved research;
Notify each performance site of proposed research activities through:
- Communication to the designated contact person at each UAB-affiliated site; or
- Written documentation of an entity’s willingness to serve as a performance site by a suitably authorized individual;
For each non-UAB-affiliated performance site, inform the UAB IRB of the following:
- 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;
- Provide documentation of local IRB approval of research from non-UAB performance sites, when applicable;
Notify performance sites of UAB IRB approvals of research activity, if requested;
Comply with a performance site’s policies and procedures related to the conduct of research activities.

The OIRB will:

Verify changes to and permissions from performance sites related to proposed or approved research activities;
Upon request, notify UAB-affiliated performance sites of IRB approval of research after both initial and continuing review.

The IRB and OIRB will implement procedures to effect the purposes of this policy. (See Procedure for Identification and Communication of Human Subjects Research to [PRO124] Non-UAB [PRO152] Performance Sites.)

When a research protocol is submitted for UAB IRB review that involves a collaboration of sites research populations at non-UAB-affiliated performance sites, the UAB IRB will accept the review by the local IRB or Independent Ethics Committee (IEC) to satisfy the UAB IRB’s local context review requirements.

When a non-UAB-affiliated performance site and its attendant local IRB do not operate under a Federalwide Assurance from the Office for Human Research Protections, the agreement to accept local IRB determinations for local context review requirements shall be described in writing. In all cases, the UAB IRB shall request documentation of approval from the local IRB/IEC at the time of review. When no such local context review and documentation is available, then the UAB IRB will obtain a consultation from an individual familiar with the cultural background, local context, and community attitudes of the location in which the research is being conducted in order to meet its local context review requirements.

When collaborating sites are relying on UAB IRB approval local context will be assesses according to PRO124 Procedure for Identification and Communication of Human Subjects Research to Non-UAB-Affiliated Performance Sites.