In reviewing research protocols involving human participants, an Institutional Review Board (IRB) can employ one of three types of review procedures, including exempt, expedited, or full board review, in compliance with the Department of Health and Human Services (DHHS) regulations for the protection of human participants.  Research that involves prisoners, is more than minimal risk, or is not covered by the expedited review or exempt categories will require full board review.

At FRI, full IRB review is required for most new studies to ensure a thorough review and to provide the greatest protection to our research participants. It is also required for most continuing reviews as well as for many amendments.

The IRB will conduct a systematic review of the submitted material, discussing the risk/benefit analysis, informed consent, selection of subjects, privacy and confidentiality, monitoring and observation, additional safeguards, recruitment methods, methodology, and the purpose and background of the protocol.  Once the risks have been identified, the IRB will assess whether the research presents greater than minimal risk, and the timeframe for continuing review.  Typically, the IRB will review a minimal risk study once a year and a greater than minimal risk study every six months.

To apply for full board review, the investigator must submit a complete application, including supporting documentation such as:

  • Protocol;
  • Consent forms;
  • Recruitment materials;
  • Surveys or interview questions;
  • Letters of agreement or other supporting documents to assure the IRB that appropriate coordination has been done with the outside organization or facility that will be used as a research site;
  • Supplemental applications, if the research involves a vulnerable population.

In a full board review, the IRB can vote to approve, approve with contingencies, disapprove, or defer a review until another meeting.

Materials should be submitted to the IRB office approximately 3-4 weeks prior to the next IRB meeting.