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Tier II Review Procedures

The primary mission of the Iona IRB is to ensure that all Iona College faculty, students, and staff conduct research in a manner that complies with the highest ethical standards.  The two-tiered system developed by the Iona IRB is a reflection of similar approaches at many other institutions and is intended to ensure timely review of all projects.  Student research-class projects in particular could overwhelm the Board by virtue of sheer numbers.  Thus, Tier I applications are reviewed by the Board, while the Tier II applications are delegated to departmental groups for review. 
 
The same ethical standards must be met regardless of application type, but Tier II applications are restricted in scope and level of risk.  Moreover, faculty may not submit Tier II applications with the exception of projects and studies intended for teaching purposes. 
 
Departments (or groups of departments) wishing to establish a Tier II review process must meet the following minimum standards.
  • A person within the department should be designated the Coordinator and primary point of contact for all applications.
  • A group of reviewers within the department should be identified.
  • The Coordinator and all reviewers must complete the CITI training course and maintain current certification.
  • A signed paper copy of each Tier II application must be provided to the Coordinator by the applicant.  Each application should be assigned a protocol number.  This document must be maintained for a minimum of three years, in a location or manner that limits access to authorized personnel.  The Coordinator must be able to produce the original, signed copy for inspection within a reasonable period of time (24-48 hours) if asked to do so by the Chair of the IRB or an accrediting or reviewing body that has the legal right to view the document.
  • It is strongly recommended that a systematic application (protocol) numbering system be developed that includes  the academic year (or semester within an academic year).  If a letter-based suffix or prefix is included, it should not use the letters “IRB.”
  • Each application must be reviewed by the Coordinator and at least one additional reviewer.  In those cases in which the Coordinator is the Supervisor of the Principal Investigator (see Tier II application form), two reviewers are required.
  • If the Coordinator is concerned that an application is not clearly within the guidelines established for a Tier II designation, he or she should contact the Chair of the IRB for clarification or guidance.
  • A record of reviewer names and comments must be maintained for each application; a record of any modification to the original application must be maintained as well.  It is strongly recommended that the Coordinator require submission of an electronic copy of each Tier II application and that the Coordinator distribute the electronic copy for review.  Use of a systematic numbering system will facilitate document coordination. 
  • The Coordinator must strive to provide timely distribution and initial review of all Tier II applications.  It is recommended that a target of 3-5 days be established (beginning with receipt of the completed application and ending with feedback to the applicant regarding acceptance or required revisions).  The Coordinator must notify the applicant in writing (paper or electronic) that the application is approved and data collection can begin.
  • Once data collection is finished, all consent forms should be returned to the Coordinator (or departmental designee) for storage.  As with the applications, these documents must be maintained for a minimum of three years, in a location and manner that limits access to authorized personnel.  The Coordinator must be able to produce the original, signed consent forms for inspection within a reasonable period of time (24-48 hours) if asked to do so by the Chair of the IRB or an accrediting or reviewing body that has the legal right to view the documents.  As a practical matter, the Coordinator may want to require that all consent forms carry the protocol number of the approved application.
In addition to the requirements described above, the departmental groups may wish to consider the following options.  To further streamline and expedite the review process, departments may wish to restrict Tier II application content beyond what has been established by the IRB.  Departments with small numbers of faculty or few Tier II applications may create joint groups or establish an arrangement with a larger department with a designated Coordinator.  Departmental Coordinators are strongly encouraged to become members of the IRB.