The Trial Innovation Network (TIN) is a platform for multi-center trials and studies that encompass a wide-range of disciplines. Investigators do not need to apply for a specific RFA, but should propose a multi-center trial or study. The Network will prioritize proposals for multi-center clinical trials and studies with patient-oriented endpoints with potential for impact on clinical practice and operational innovation as well as proposals that foster collaborations with other NIH ICs over proposals seeking funding from NCATS.
The TIN established three Network Central IRBs (CIRBs): Johns Hopkins University School of Medicine, The University of Utah, and Vanderbilt University Medical Center. The Network CIRBs use the SMART IRB Reliance Agreement through the IRB Reliance Exchange (IREx; formally SMART IRB Exchange).
What Makes a Good Proposal for the Trial Innovation Network?
- An optimal submission includes:
- Principal Investigator willing to partner with the TIN through the life cycle of the project
- Opportunity to study an innovative operational approach to improve quality, efficacy, or cost of clinical research
- More than 60 days allotted for consultation prior to planned grant submission with substantial project development
- Includes a multi-center study design (3 or more institutions)
- Fosters broad collaboration within the CTSA Program and NIH Institutes and Centers
- Includes all populations affected by the health condition being studied
- Opportunity to provide academic evidence to improve clinical trial designs, conduct, and reportability
UAB is one of over 600 institutions that have joined SMART IRB. SMART IRB stands for "Streamlined, Multisite, Accelerated Resources for Trials". SMART IRB is an IRB reliance model designed to streamline the IRB review process for multi-site studies, while ensuring a high level of protection for research participants. SMART IRB can be used for a range from large, complex clinical trials to two-site collaborations.
As part of SMART IRB, institutions may choose to rely on another IRB or have their IRB act as the Reviewing IRB with other institutions relying on it. The Reviewing IRB takes on IRB oversight responsibilities associated with that study throughout its duration. Relying Institutions provide key local context information about state law, study team member training and qualifications, and any applicable conflict of interests. Investigators and institutions retain their respective responsibilities for the protection of human subjects, compliance with applicable laws, regulations, ethical standards, and the terms of institution's FWA.
UAB Single IRB Team
Application Instructions
Initial Review
- Institution Review Form Relying on an External IRB (Note: all research personnel listed on the Institutional Review Form Relying on an External 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
- Proposed consent form(s) (model downloaded from the CIRB website with UAB approved template language added - see below)
- Radiation Safety Approval
- Infection Control Approval
- Release of Drugs for Human Research Use
- Release of Pathology
- Form FDA 1572
Following review, investigators will receive authorization to submit to NCI IRB. Once authorization is received, the Study-Specific Worksheet About Local Context may be submitted to NCI CIRB to open the study. The NCI CIRB approval letter will be sent directly to the investigator/research staff by CIRB.
- NCI CIRB Approval Date
- NCI CIRB Expiration Date
- Number of consent forms renewed
- NCI CIRB Approval Letter (attachment)
- Current version of UAB consent form(s) for the protocol (attachment)
- 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); and
- NCI CIRB.
- Study Closure date: Date of Closure
- Reason for closure/termination
Approved Boilerplate Language
Rely on External IRB
- Institution Review Form Relying on an Outside IRB (All research personnel listed on the Personnel eForm 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
- 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
- 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).
UAB IRB Boilerplate Consent Form Language - ENGLISH
Institution Review Form Relying on Outside IRB
UAB SingleIRB Team
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
UAB Single IRB Team