Full 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 (except for August). 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. He or she will present the protocol at the committee meeting along with his or her 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;
• 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.

Review of Recruitment Materials
The IRB has the responsibility to ensure equitable selection of research subjects. In order to fulfill this responsibility, the IRB reviews the methods and materials that investigators use to recruit subjects. If subjects will be recruited through advertisements, including Internet advertisements, the investigator will be required to provide the entire text of the advertisement to the IRB. The IRB will review the information contained in the advertisement and the mode of its communication to determine whether recruitment procedures afford adequate protection to subjects.

Any recruitment materials should be limited to:

1. The investigator's name and department;
2. The purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study;
3. A straightforward and truthful description of the potential benefits, if any, to the subject from participation in the study; and
4. The location of the research and the person to contact for further information.

Actions by the IRB
The IRB will decide upon one of the following actions by a majority vote of the members present: 1) Approval: 2) Approval with Modification(s) Requested; 3) Committee Deferral; 4) Disapproval. Members present vote for, against or abstain. No Committee may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB. IRB members with an interest in a research application under review may participate in the discussion. The member must leave the room during the deliberation and vote. This absence will be noted in the minutes.

The actions are delineated below:

1. Approval: Approval signifies that the IRB has accepted the protocol, informed consent form(s), and other study documentation as submitted. An approval letter and validated informed consent form(s) will be returned to the investigator. Enrollment of research subjects may begin as soon as the approval letter and validated consent form are received. A validated consent form has two dates: the "effective date" which is the date of IRB approval, and the "expiration date." The expiration date is the date set by the IRB for completion of continuing review. Approval may be valid for up to one year, at which time continuing review must be done. Following continuing review, a new consent form with two new dates will be issued to the investigator. Expired consent forms may not be used.

2. Approval with Modification(s) Requested: The IRB may give its approval contingent upon the Principal Investigator making specific revisions that are detailed in the IRB comment letter. These changes must be reviewed by the IRB chair or IRB aministrator prior to commencement of the research. An approval letter and validated informed consent form(s) will be returned to the Principal Investigator following this review.

3. Committee Deferral: The IRB may determine that the Principal Investigator needs to clarify certain issues, submit revised materials and/or attend a meeting to discuss the issues. If the protocol is deferred, the comment letter will document the reasons for deferral and specify the additional information that is needed.

4. Disapproval: The IRB may disapprove the protocol, informed consent form(s), and other study documentation as submitted. The written notification of the IRB's decision will include a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

Reconsideration
The investigator may request, in writing, reconsideration of a decision made by the Committee concerning a research protocol. In the event of a request for reconsideration, the IRB will establish a subcommittee to discuss the protocol with the investigator. Outside experts and consultants may be asked to appear before the subcommittee to discuss the particular details of the research. The investigator must be present to address the specific concerns of the Committee. The results of the subcommittee review, including recommendations, shall be reported to the full Committee at the next scheduled meeting. The full Committee will discuss the recommendations of the subcommittee and review any new materials that have been submitted. The Committee may accept or reject the recommendation of the subcommittee. The decision of the full Committee will be binding except that the Institution may always disapprove a study that has been approved by the Committee. The investigator will be informed in writing of the final decision.