When UAB is Prime and Arranging Single IRB Review
When the proposed reviewing IRB is the UAB IRB, a letter of support must be obtained from the Office of the IRB prior to submission of the application for funding.
- Study Title
- Brief Description of the study
- Full Board Review or Expedited Review
- Study Sponsor
- Estimated number of sites
- Name of each site
- Whether it is anticipated that additional sites may be in the future
- Whether the same procedures are implemented at all sites
- Whether participants are consented at each site
- Whether the study may enroll participants using a foreign language consent forms
- Age or age range of participants
- Confirmation that the funding application will budget for single IRB fees
- Anticipated study start date
- Duration of the study
- Length of Award​
Information about Review by the UAB IRB
Initial Review includes both the initial review by the UAB IRB as the single IRB, as well as the initial review performed by the Relying Human Research Protections Programs (HRPPs). Each stakeholder has responsibilities during this stage.
The Lead Study Team is responsible for making the submission to the UAB IRB, on behalf of all participating sites.
The Lead Study Team becomes the primary liaison for communication between the UAB IRB and the Participating Study Teams.
During the initial review stage, the Participating Study Teams are responsible for completing all of the non-IRB requirements at their local institution (Relying HRPP requirements).
The Participating Study Teams are also responsible for communicating necessary information to the Lead Study Team, so that the Lead Study Team can evaluate the information and determine whether it should be submitted to the single IRB for review. This could include site-specific differences in the recruitment or consent process, or other information that could affect IRB approval at UAB.
The single IRB must review and approve studies according to applicable regulations and policies. In order to do this for all of the participating sites, the single IRB will consider and address the information that has been provided by the Participating Study Teams and their Relying HRPPs.
The UAB IRB may also act as the Privacy Board for HIPAA determinations, such that the Relying HRPP does not need to fulfill this role. This is a role that will be defined in the Reliance Agreement.
The UAB IRB will communicate with the Lead Study Team about IRB-related decisions and determinations that are part of the initial review.
Ongoing Review and Oversight:
Ongoing reviews include continuing review, amendments, and reporting of problems and events. This includes audits, compliance, and safety monitoring as well.
The Lead Study Team is responsible for much of this oversight, ensuring that the required submissions to the UAB IRB occur on behalf of the entire study, while also ensuring the study is monitored appropriately.
The Lead Study Team remains the primary liaison for communication between the Participating Study Teams and the UAB IRB. Therefore, they must have a clear communication plan in place.
The Participating Study Teams have similar responsibilities over the life of the study. They remain responsible for managing all of the non-IRB, HRPP requirements at their institution. They must maintain adequate and clear communication with the Lead Study Team to ensure that they have all UAB IRB approvals that they need and that the UAB IRB receives all relevant information about problems and events during the study. This is likely to include site-specific amendments to the protocol or consent document, changes that result from ongoing review by the Relying HRPP (such as changes in conflict of interest management plans), and local problems and events.
The Relying HRPP also has ongoing review and oversight responsibilities over the life of the study. The Relying HRPP continues to work with the Participating Study Team to review and meet local requirements outside of IRB review. If any changes or concerns are identified through the Relying HRPP’s review, the UAB IRB must be notified (through the Lead Study Team) to determine if changes are needed to the protocol or consent documents. The Relying HRPP also continues to perform compliance monitoring of the research, according to their institutional policies.
Though the Relying HRPP is not required to make IRB determinations regarding problems, events, and non-compliance, they may need to provide valuable assistance to help resolve these concerns. The Relying HRPP and the UAB IRB will maintain communication, such that they can both assist the participating study team in resolving and preventing future problems. It is important that all of these stakeholders work together to create solutions that are in the best interest of the research participants.
Over the life of the study, the UAB IRB will continue to perform all of the typical IRB functions for review and approval of the research as it progresses. The UAB IRB may work with the Relying HRPP to perform compliance monitoring and will continue to have open communication with each institution to ensure research is performed.
UAB Single IRB Team