IRB Application Guidelines
Loma Linda University’s Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects. The IRB will review all human studies conducted under the auspices of any Loma Linda University Adventist Health Sciences Center (LLUAHSC) entity (i.e., LLU, LLUMC, BMC, the Faculty Practice Groups). LLU gives assurance that these institutions will comply with U.S. Department of Health and Human Services regulations for the protection of human research subjects in all applicable studies.
IS IT HUMAN SUBJECT RESEARCH?
For guidance, see Human Studies General Information: What is Human Subject Research?
IRB Results: Investigators will be notified in writing of the results of IRB review. Approval will include a determination of the level of risk to subjects, length of approval period, and a certified copy of the approved consent form. The process from submission to receipt of approval takes approximately 2 to 4 weeks, depending on investigator’s availability to respond to IRB recommendations.
Approval Expiration: The IRB office will send investigators a report form near the close of the approval period. This form requires information about the status of the study, whether an extension is requested, number of subjects enrolled, and adverse effects occurring, together with a copy of the consent form used.
USE OF RADIATION/RADIOACTIVE MATERIALS
Human studies involving non-routine use of radioactive materials and ionizing radiation require that applications be submitted concurrently to both the IRB and LLU’s Radiation Safety Committee. Application forms are available here. Guidelines as to what kinds of studies require such review appear in the IRB Application, Item VI-D. Final IRB approval will be withheld pending completion of Radiation Safety Committee review.
FOR ASSISTANCE WITH IRB APPLICATIONS
Research Affairs - Research Protection Programs (the IRB office) serves the administrative needs of the IRB and assists investigators with the submission process. IRB staff are available to answer questions and preview consent documents. Investigators involved in human subject research for the first time are particularly encouraged to avail themselves of this service. For additional copies of the IRB application, information about submission deadlines, and other assistance, call the IRB office at ext. 44531.
Submitting for Expedited Review or Exempt Status
The process for obtaining expedited review or exempt status is similar to regular IRB review except that applications may be submitted at any time and two sets of application materials including original are needed. The IRB office, with the assistance of the IRB chair, will determine if the application qualifies for expedited review or exempt status. If it qualifies for exempt status, the investigator will receive a letter from the IRB documenting this determination. The time required for expedited review depends on the availability of the investigator to make any necessary corrections and the availability of the IRB chair, usually only a few days.