catagories full board research review

Overview

Research that does not qualify for either Exempt status or Expedited Review must be submitted to the CHS for a full review by a quorum of IRB members at a convened meeting.  The application process remains the same as for the other levels of review, but investigators should note that a Full Review can take up to two months from the time of submission.  Investigators should also be aware that the initial Full Review process frequently does not result in an outright approval of the research; minor or major revisions and written clarifications are often requested.

A completed CHS application, along with all required attachments, must be submitted to the CHS before Thursday of the first week of the month if the application is to be placed on that month’s agenda.

Materials for each scheduled IRB meeting are provided to each IRB member approximately one week in advance of the meeting.

All protocols submitted for Full Review are assigned to one or more primary (and/or secondary) reviewer(s) who will present the protocol to the full IRB for discussion.  These reviewers will review the protocol, the proposed informed consent document(s), and any recruitment materials, including advertisements intended to be seen or heard by potential subjects.  Primary reviewers may contact the PI for any additional information, as necessary.  Reviewers are guaranteed anonymity, which they may waive by way of contacting the PI; the CHS office will not disclose the names of primary reviewers or IRB committee members.


How to Apply for Full Board Review

To apply for Full Board Review, one signed original and 13 copies of the Application for New Approval Form (pdf|doc) and all supporting documents are needed, plus 3 copies of the full protocol/investigator’s brochure, if applicable.

Drop-off applications at 2540 Maile Way, Spalding Hall 253, University of Hawaii Manoa, Honolulu, HI 96822.

Allow up to two months for review.


Notes:

Incomplete applications will not be reviewed.