Full IRB Review
The standard process for IRB Review and applies to all research that does not qualify for Exempt or Expedited Review.
Full committee review is the standard process for the approval of research involving human subjects. Research protocols that are not eligible for either an exemption or expedited review will be placed on the agenda for the next convened meeting of the IRB. The committee meets monthly. A quorum of committee members must be present in order for the committee to vote. The IRB administrator designates a primary reviewer for each protocol from among the members of the committee. This committee member will review the submission in advance of the meeting and may contact the principal investigator to clarify questions that are likely to come up at the meeting. This committee member will present the protocol at the committee meeting along with the member's recommendations regarding approval, modification, deferral or disapproval of the protocol as well as any suggested revisions to the consent form. All committee members review each protocol placed on the agenda for the convened meeting. The committee then discusses the protocol and votes for approval, modification, deferral pending the receipt of additional information, or disapproval.
The IRB cannot approve a protocol unless:
- risks to subjects are minimized;
- risks to subjects are reasonable in relation to anticipated benefits;
- selection of subjects is equitable (through recruitment materials);
- informed consent is adequate and appropriately documented;
- where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects;
- where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data; and
- appropriate safeguards have been included to protect vulnerable subjects.