Seton Hall University

Review Process

Federal Guidelines

For Federal regulations governing human subject research, go to the Health and Human Services website.

In accordance with the University's Assurance Agreement, when appropriate, the following will be reported to institutional officials, the federal Office of Human Research Protections, and/or other governmental agencies: any unanticipated problems involving risks to subjects or others; serious or continuing non-compliance with pertinent federal regulations or the requirements of the IRB; and suspension or termination of IRB approval of research protocols.

Non-compliance with IRB requirements will result in withdrawal of IRB approval and in the suspension or termination of the research.

Federal regulations require that all applications submitted to the IRB be screened to determine if the research is exempt from or requires a review. It is the IRB, not the researcher, that makes this decision. Accordingly, all applications are initially reviewed by a subcommittee of members of the IRB to determine whether a proposal will be considered under exempt, expedited or full Board review. The results of this initial review are announced at the first subsequent meeting of the full Board. Any member of the IRB, however, may ask that a proposal be given the consideration of the entire Board. In this event, the decision of the initial review is superseded by the decision of the full Board. The Board's decision is then recorded in the minutes.

Continuing Review 

(See also guidelines on the Health and Human Services website.)
Protocols will undergo the federally mandated continuing review no later than 12 months after initial approval has been granted. If risks to subjects are regarded as extraordinary, re-review at more frequent intervals may be required. Please notice that after one year, the approval of the study is no longer valid and needs to go through such review. An IRB continuing review form needs to be filled out and sent in to the IRB office within 30 days before the existing approval expires. The IRB office will send a letter and the continuing review form within 30 days prior the deadline. The researchers can also download the continuing review form, fill it out and mail/e-mail it to the office so that it arrives at the office before the IRB approval expires.

Annual Progress Report

Studies that were reviewed and approved by the Research Ethics Committee of the SHU IRB as exempt or expedited research will be required to submit an annual progress report.  This report serves the purpose of maintaining communication and interaction between an investigator and the IRB regarding the activities of a previously approved study.  Similar to continuing review, the annual progress report needs to be filled out and sent to the IRB office within 30 days of the study expiration date.

Final Study Review

All studies that were reviewed an approved by the SHU IRB are required to submit a Final Review of Human Subjects Research Investigation form. This form and submissions serves as formal notification to the IRB that the investigator has completed all planned activities related to the study.