Procedure

Investigator Responsibilities

For all non-UAB sites relying on UAB IRB approval, the Investigator:

Identifies all non-UAB performance sites and describes the types of research activities proposed for each site in the IRB application eForm (FOR200).
Submits a revised IRB application eForm when performance sites are added or removed and describes the type of research activity proposed for review by the IRB.
Submits site-specific amendments and/or reportable events that affect any or all sites relying on the UAB IRB approval.
Notifies performance sites of intent to perform research.
Provides the completed Institution Review Form Relying on Outside IRB (GUI320) to provide sufficient local context information, collects relevant information from non-UAB performance sites, and provides the following documentation:
- Informed consent form to be used at the non-UAB site, based on the IRB approved study-specific template, including any site-specific language;
- Relevant ancillary review approvals required from external sites;
- Financial Conflict of Interest Management plans from the local site, if applicable;
- Policies, state or local laws, or other local norms at the non-UAB site, that would require special attention during the IRB review at UAB;
- Attestation from the non-UAB principal investigator confirming that the non-UAB performance site as adequate resources and expertise to perform the proposed research;
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, if applicable;
- Provides a statement that all IRB approvals have been obtained at the time of IRB continuing review, if applicable;
Provides updated information (e.g., accrual progress, etc.) for non-UAB sites or a copy of documents of continuing IRB review and approval on an annual basis, as applicable.
Informs non-UAB performance sites about relevant UAB expectations and policies (e.g., event reporting), and trains in research-related procedures, as necessary, all performance site personnel involved in the research.
Refers questions from non-UAB performance sites to the UAB Office of the IRB (OIRB), as necessary.

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 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 electronic research administration (ERA) system, 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 IRB application eForm or other submission materials such as:
- Contract,
- Subcontract, or
- 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 IRB application eForm or other submission materials, if applicable.
Identifies and refers to the OIRB Director any designated performance site “engaged in research” utilizing a designated non-UAB IRB that is not AAHRPP accredited or does not operate under a FWA.
Evaluates whether a consultant may be necessary for local context review and refers to Chair.
Establishes reliance under the terms of the SMART IRB agreement or prepares and submits Institutional Authorization Agreement (IAA) to Institutional Official for signature after the IRB has reviewed and agreed to serve as the IRB of record.
Notifies the OIRB Director of any potential unanticipated problems or potential non-compliance, as soon as it is reported to the OIRB and follows-up with the results of the subsequent IRB determination.

Administrative Staff:

Assists in the review of protocols to ascertain involvement of non-UAB performance sites relying on UAB IRB approval
Requests documentation from the investigator of non-UAB performance sites
Enters the non-UAB performance site(s) into the ERA system
Processes materials pertaining to non-UAB performance sites

OIRB Director:

Coordinates with the Vice President of Research (or designee) to determine whether reliance on a non-AAHRPP accredited IRB is appropriate.
Evaluates and determines need for reliance under the SMART IRB agreement, an IAA or an Individual Investigator Agreement (IIA) with entity not operating under a FWA.
Informs the relying institution of any reportable events, such as unanticipated problems or serious non-compliance, prior to reporting to federal agencies or sponsors, and provides an opportunity for feedback.

IRB Responsibilities

Primary Reviewer(s) or Expedited Reviewer:

Reviews IRB application eForm and funding application or request to amend the IRB application eForm to identify and ascertain concordance in all documents pertaining to performance sites.
Reviews protocol submission documents to ensure that
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.
Performance site additions may be approved by the expedited procedures if they are following the same protocol that has already been reviewed and approved.

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 or designee:

Reviews and signs IAAs with performance sites and IIAs, when appropriate.