Communication Plan for Single IRB Review Institutions can use this template to document key communication roles, such as submitting initial and continuing reviews, amendments, and reportable events to the Reviewing IRB; providing conflict of interest management plans to the Reviewing IRB; and providing IRB-approved documents and communicating Reviewing IRB determinations to relying site study teams.
Consultations: Expert Advice and Guidance Prepare to serve as a Reviewing IRB or Relying Institution by consulting with an IRB experienced in the conduct, review, and oversight of multisite research.
SMART IRB
Evaluation Checklists for the Use of Central IRBs These checklists are designed to assist organizations with adoption of a central IRB model, including institutional self-assessment of readiness, institution/sponsor evaluation of a central IRB, and central IRB evaluation of an institution.
Clinical Trials Transformation Initiative
FAQs Frequently asked questions covering eligibility, how to join, agreement provisions, and other important topics.
Fees and Costing Models under NIH sIRB Policy Points to consider regarding charging, structuring, and justifying fees for single IRB review, as well as federal regulations on direct/indirect costs.
Institution v. IRB Responsibilities A guide to the regulatory purview of a reviewing IRB and the role and responsibilities of Relying Institutions.
SMART IRB Harmonization Steering Committee
IRB Reliance Agreement Worksheet - SAMPLE This worksheet walks the user through a series of yes/no questions to determine whether a reliance agreement is necessary/appropriate.
Letter of Acknowledgement, Template If not using the SMART IRB Online Reliance System to coordinate and document study-specific reliance arrangements, institutions may use this template to document the Reviewing IRB and Relying Institutions for a specific study.
SMART IRB
Local Considerations: Institutional Profile Captures institutional, local, and state requirements that a Reviewing IRB may need to apply to its review and oversight of studies on behalf of another institution as well as information about an institution's IRB(s), if applicable.
SMART IRB Harmonization Steering Committee
Local Considerations: Protocol-specific Document Allows a Reviewing IRB to collect variations across participating sites regarding key information about study teams (e.g., training and conflicts of interests) and variations in study conduct (e.g., ancillary reviews required; HIPAA requirements; subject population).
SMART IRB Harmonization Steering Committee
Local Context Survey A Reviewing IRB POC may use this survey to obtain key local context information from Relying Institutions.
Overall PI (and Lead Study Team) Checklist This checklist helps an Overall PI (and Lead Study Team, where applicable) understand and fulfill his/her responsibilities, particularly for studies using the SMART IRB SOPs, which require identification of a Lead Study Team.
Relying Site Investigator Checklist This checklist helps site investigators and study teams understand and fulfill their responsibilities when a study has been ceded to an external institution.
Relying Site Study Team Survey The Overall Principal Investigator and/or Lead Study Team may use this survey to obtain key information from a relying site study team to determine whether particular regulatory or institutional requirements should be communicated to the Reviewing IRB.
Reviewing IRB Instructions for Relying Site Study Teams A Reviewing IRB may use this template to communicate key information to Relying Site Study Teams about the reliance arrangement and next steps after finalizing the arrangement.
SOP Manual, SMART IRB Standard operating procedures (SOPs) for establishing and implementing reliance provide clarity during the review and conduct of research using the SMART IRB Agreement.
Webinar: SMART Talk - Harmonization - Reportable Events Recommendations from the SMART IRB Reportable Events working group, including harmonized definitions, policies, and procedures for prompt reporting of noncompliance and unanticipated problems for studies using a single IRB. View Slide Deck
