Division of Sponsored Programs

INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN RESEARCH SUBJECTS

In accordance with federal and institutional regulations, any undertaking in which University faculty, staff, or students investigate and/or collect data on human subjects for research purposes must be reviewed by the Institutional Review Board (IRB). It is the responsibility of each investigator to seek review of any study involving human subjects prior to initiation of the project.

Purpose and Mission
The IRB is a University committee composed of faculty members who are appointed by the institution and a community representative. The IRB is responsible for reviewing all research activities involving human subjects regardless of the source of funding. The mission of the IRB is to promote and safeguard research activity that involves human subjects within the academic community. A list of current IRB members is available here.

Required Procedures for Submitting Research Protocols for IRB Review

STEP 1: COMPLETE TRAINING

Meet the federally mandated educational requirement by completing the Collaborative Institutional Training Initiative (CITI) online training system. Click here for instructions on registering and using the CITI training system. At the end of the training, a Completion Report will be issued. This document must be attached to the application at the time of submission for the principal investigator and all other key personnel. If the Principal Investigator is a student, the faculty advisor must also complete the training and attach a copy of his or her Completion Report. Individuals must first complete the Basic Course; the Refresher Course is used only for recertification (every three years) of individuals who have previously completed the Basic Course and provided a completion report to the IRB. Certifications are valid for a period of three years, after which time investigators (including all key personnel and faculty advisors) must be recertified. The initial certification can take several hours to complete, depending on each individual's familiarity with human subjects research regulations. IRB proposals are not reviewed until all required certifications have been submitted. If an expired certificate is submitted with a new protocol, the investigator and the individual whose certificate has expired will be contacted and asked to provide an updated education certificate.

If an investigator has previously (prior to October 22, 2008) completed one of the NIH (Protecting Human Research Participants or Human Participant Protections Education for Research Teams) tutorials within the last three years, the IRB will continue to accept those certificates as evidence of meeting the federally-mandated educational requirement. However, if the date on the certificate is more than three years old, investigators are required to complete the CITI training module (Basic Course) before a research protocol will be reviewed by the IRB.

STEP 2: CLASSIFY THE RESEARCH

Classify the research project as an exempt, expedited, or full review study. The resources below may also assist in appropriately classifying the research. Researchers may contact IRB representatives with questions regarding the appropriate classification of research.

STEP 3: COMPLETE THE APPLICATION MATERIALS

Complete the appropriate application and write the research protocol narrative and other appropriate materials.

Exemption Certification Application
- Instructions
- Sample
Expedited/Full Review Application
Informed Consent Template
- Required Elements of Informed Consent
Research Involving Children as Subjects
- Guidance
- Form M: Research Involving Minors
- Child Assent Script Template (for children under the age of 7 years)
- Child Assent Form Template (for children between the ages of 7 and 12 years)
- Minor Assent Form Template (for minors between the ages of 13 and 17 years)
- Parent/Guardian Permission Form Template (for parents/guardians of minors of all ages)
Letter of Support Template for Off-Campus Research

STEP 4: SUBMIT APPLICATION MATERIALS

Submit the application and supplementary information, including the CITI Completion Report and all required attachments, to Sponsored Programs, Jones 414/Coates CPO 20. There is no deadline for exempt or expedited review applications; they are reviewed on an ongoing basis. Investigators can typically expect to receive notification of approval in approximately two weeks from the submission date. Approval times may be extended during the summer months and other times when faculty are away from campus. Applications submitted for full review must be received by Sponsored Programs by the 20th day of the month in order to be reviewed during the meeting scheduled for the following month. Applications submitted after the deadline will be scheduled for review at the next meeting. If full review applications are received during the summer months, a meeting will be scheduled for their review as soon as possible and typically within two weeks of receipt of the application.

Reporting Requirements and Forms

Form C: Continuing Review - (instructions) - Research protocols that have been approved by the IRB through either expedited or full review procedures are subject to annual review by the IRB if the project extends for more than one year. A completed and signed Form A must be submitted to the IRB prior to the anniversary date of the protocol’s approval for each year the study is active, up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms. To request approval to extend the project beyond the original approval period, Form B is required.
Form E: Request to Extend Project - (instructions) - Research protocols that have been approved by the IRB through either expedited or full review procedures are approved only for the period indicated on the approval notification. Form B is used to request approval to extend the project beyond the original date and must be submitted in advance of the project’s expiration date. Form B may be used to extend the project up to a maximum of three years from the original approval date. If the project is to continue beyond three years from the original approval date, the investigator is required to complete and submit for IRB review a new research protocol using the University’s current application forms.
Form R: Protocol Revision Form - (instructions) - Research protocols that have been approved by the IRB must have prior approval for any deviation from the original approved protocol. Form C is used to request approval to implement changes to a previously approved protocol.
Form F: Final Report - (instructions) - The final report must be filed with the IRB within 30 days of the project’s expiration date. If the project is not anticipated to be completed by the expiration, investigators may request an extension for up to three years from the original approval date. Once the final report has been filed, the protocol will be officially closed, and no further action may take place until a new protocol has been submitted for review and approved by the IRB as a new study.

Resources

Contact Information
IRB Chair: Dr. Dory Marken, 622-2331
IRB Administration: Gus Benson or Tiffany Hamblin, 622-3636