UAB is a Site - Rely on External IRB

UAB is a Site - Rely on External IRB

Institutional Review Board (IRB) Single IRB UAB is a Site - Rely on External IRB

UAB is a Site - Rely on External IRB

 

Rely on External IRB

UAB may be a participating site in a multi-site research study and rely on an external IRB. The external IRB may include an institutional IRB (e.g., Vanderbilt) or an independent IRB (e.g.; Quorum or Advarra). This type of review is abbreviated at UAB, but still requires that you submit a new research application (which will include the Institution Review Form​) through IRAP. 

When a UAB PI requests an external IRB review of his/her human subjects research, this is considered requesting a ceded review (the UAB IRB relies on the external IRB for research oversight) and a reliance agreement must be executed prior to the research being conducted.  You may contact the UAB IRB prior to submitting your application to discuss the reliance agreement options or if the external IRB has already agreed to be the IRB of record and has provided an authorization agreement, you may upload it into IRAP with your submission.

Application Instructions

Initial Review

UAB investigators and/or their research staff must submit the following materials, as applicable, for initial review in IRAP:
  • Institution Review Form Relying on an External IRB (All research personnel listed on the Institution Review Form Relying on Outside IRB form are to be listed on the Responsible Personnel List (RPL) on file with OSP).
  • Protocol Oversight Review Form and/or Protocol Review Committee Approval
  • ​Outside IRB-approved consent form or template consent form with UAB IRB Consent Form Boilerplate Language incorporated (track changes version)
    • ​If outside IRB will incorporate UAB IRB Consent Form Boilerplate Language, the outside IRB-approved consent form or template consent form may be provided without the language incorporated
  • Outside IRB-approved protocol materials
The following materials should also be included, as applicable, for initial review in IRAP:
  • ​Fiscal Approval Process (FAP) review email
  • Radiation Safety Approval
  • Infection Control Approval
  • Release of Drugs for Human Research Use
  • Release of Pathology
  • Form FDA 1572

Submissions after Initial Approval

Continuing Reviews

The investigator/research staff must submit continuing review information for each study in IRAP. The continuing review submission in IRAP must contain the following information:
  • ​External IRB approval or determination letter
  • Current version of UAB consent form(s) for the protocol

Changes in Study Personnel 

Investigator/Research staff must provide any changes in UAB study personnel by amendment in IRAP. All research personnel are to be listed on the Responsible Personnel List (RPL) on file with OSP.

Change in Funding 

Changes in funding may include: new funding, continuing with new OSP numbers, funding ending, or additional funding received. The investigator/research staff must provide any changes in funding, along with the applicable OSP number(s) by amendment in IRAP. 

Reportable Problems that Occur Locally 

The investigator/research staff must submit the Problem Report for any reportable problems that occur locally to:
  • UAB IRB (see POL006 UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB, PRO106 UAB Procedure to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB).
Study Closure 

The investigator/research staff must submit study closure information for each study as a continuing review submission in IRAP.  An Investigator's Progress Report is not required.  The submission should contain the study closure memo from the reviewing IRB.  

Approved Boilerplate Language 

Study-specific model or template informed consent documents will be provided by the lead site and the UAB approved boilerplate language added to the specified sections. Note: The boilerplate language should also be added to the appropriate sections of new or revised consent documents provided after amendment or continuing review approvals.

UAB IRB Boilerplate Consent Form Language - ENGLISH
 
NCI Central IRB​ ​​​​​​​​​​​

Institution Review Form