What procedure is used during review?

It is important to note that IRB procedures and decision-making are not arbitrary. The IRB follows guidelines set up by the federal government for the functioning of IRBs. Each member of the IRB has a copy of these extensive guidelines to use in their attempt to ensure consistent protection of human research subjects. Specific criteria is used in determining whether a particular research project can be approved. A worksheet guides each reviewer through an assessment of the research in light of this criteria.

Review procedures vary depending on the level of review:

• Research qualifying for Exempt status (Level I review) is reviewed by at least one IRB member, who determines whether to approve the Exempt status or elevate the review to the next level.
• An Expedited (Level II) review is undertaken by two IRB members and the IRB chair, who decide whether to approve the proposed research (with or without stipulations and modifications) or elevate it to the next level.
• A Full (Level III) review requires a meeting of the entire IRB committee. A quorum must be present and a majority decide whether to approve or disapprove the proposed research.

Based on the review, the IRB can decide to take one of the following actions:

• Approve. We will notify you in writing to indicate that you may commence your study.
• Approve with stipulations. We will give you written details regarding what modifications are suggested or required to the protocol and/or to the consent form. Once you have submitted the changes, we will provide you with a letter giving you final approval.
• Defer/Table. If the Committee feels that they have insufficient information to make a decision, or if they recommend major changes in the protocol or consent form, they may delay making a decision on an application. We will give you explicit, written information about what you need to change in order to resubmit an application for review at a future meeting.
• Disapprove or Remove ongoing approval. The primary reason for disapproval is that the potential benefits of the research do not outweigh the risks to the subjects. We will notify you in writing of the reasons for the decision and give you the opportunity to respond in writing and in person to the Committee.

All continuing protocols and studies must be reviewed at least annually; some may be reviewed more often.
Procedure for a Full review:

The IRB process is designed to foster open discussion and debate at convened meetings of the full membership. Our IRB uses a "primary reviewer" system which assigns studies to a primary and a secondary reviewer who receive the entire packet of materials submitted by a researcher. The primary and secondary reviewers are encouraged to contact the researcher in order to clarify questions.

All other members of the committee receive, at a minimum, a copy of consent documents and a copy of the completed application form. If a research protocol is involved, each reviewer also receives a summary of the protocol that provides enough detail to determine the appropriateness of the study.

All members of the committee have access to the complete documentation of an application. At the convened meeting of the IRB, the application is presented by the primary and secondary reviewers who make their recommendation for action. After other IRB members ask questions for clarification, anyone on the committee may make a motion for approval or disapproval.

An investigator can be a member of the IRB; however, the investigator-as-member cannot participate in the review and approval process for any project in which he or she has a present or potential conflict of interest. Where the investigator-member has a conflicting interest, he or she will be present only to provide information requested by the other members of the Committee. He or she will be absent from the meeting room during the discussion and voting phases of the review process; the minutes of the IRB meeting will reflect that these requirements have been met.

A quorum is met by the presence of a majority of the total number of members; the quorum must include at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of the members present at the meeting. Informal discussion may occur in the event that a quorum is not present. No action can be taken without a quorum. The minutes will reflect when a quorum is not present.

You and any members of your research team are welcome to attend the IRB meeting so that members may ask questions about your proposal. You may be asked to give a short summary of your project and respond to questions of the reviewers, but you will be asked to leave the room while the committee engages in final discussion and votes on their decision. You will be notified in writing of the decision of the IRB.