When the Board takes an "approve" action on new research (or a change in research), it is accepting oversight (or continued oversight) of the research and allowing the research to go forward as approved.

When the approval is based on Board-required consent form modifications, the investigator will be provided with a finalized consent form with the required modifications incorporated by WIRB staff. When the approval is based on Board-required modifications to other materials, the investigator is responsible for incorporating the changes prior to using the materials. Such modifications will be indicated on the items or in a letter.

Approval is usually communicated to the investigator by a Certificate of Approval (COA).

Upon approval of a new study, the following are prepared and sent to the PI, Sponsor or CRO, SMO and institution (as applicable):

A Certificate of Approval

A copy of the Board-approved consent form (when applicable) ready for use.

Depending on the type and extent of the Board's changes, a redline of the changes to the consent form. Redlines annotated with legend codes are accompanied by the WIRB Legend "Reasons for Change."

Explanatory letters if directed by Board or otherwise necessary. Letters are used to communicate special Board determinations or other necessary information.

An "Approve in Principle" action is only used when a federal funding agency requires IRB approval before grant monies can be released, and the investigator does not have the funding to complete the research proposal until the grant monies are released. The Board takes this action if it appears the research will be acceptable when the proposal is completed. The Board's determination is communicated by letter (no Certificate of Approval issued), and does not grant approval for initiation of activities involving human subjects. Upon completion of the research proposal, the protocol, consent form, and other required elements must be submitted to WIRB and approved before activities involving human subjects can begin.

An "approvable" determination indicates the research as reviewed is acceptable to the Board. For new research, an "approvable" action is only taken prior to investigator selection, and the research cannot go forward until the Board approves an investigator. Consent forms and subject materials found approvable by the Board may be subsequently modified by the Board.

When the Board takes an "approvable" action on an audio or video script, the script may not be used until the Board issues an approval of the item in its final format (i.e., the audio or video recording).

An "approvable" action is communicated to the submitter by letter. (A COA is not issued for approvable studies and scripts, and an approval stamp is not affixed to consent documents found approvable.) If the Board action is Approvable As Modified, the final audio or video product must contain the modifications directed by the Board.

When the Board takes a "disapprove" action on new research, it is rejecting oversight of the project as submitted, and the research is not allowed to go forward.

When the Board takes a "disapprove" action on a change in research, the change cannot be implemented, but the Board expects the research will continue as previously approved.

Disapproval may occur for a variety of reasons, most of which involve subject safety and/or scientific validity. Disapproval is communicated to the investigator by letter, in which the reasons for disapproval are explained.

Reconsideration of a disapproval may be requested and is taken to the same panel which voted the disapproval. Additional information may be made available to the Board before the reconsideration meeting. The investigator may appear before the Board in person or via teleconferencing, if desired.

The Board takes a "table" action to remove an item from Board consideration at a scheduled meeting to obtain additional information or clarification. Staff and/or Board members follow up as directed with the investigator or sponsor to address the reasons for tabling the item. Staff then prepare the item and reschedule it for the Board to complete its review. A tabled item is brought back to the same panel that tabled it. Additional information may be provided to the Board for its consideration. The investigator may appear before the Board in person or via teleconferencing, if desired.

The Board may "pull" an agenda item at the request of the submitter, WIRB staff, or the Board itself. An item generally is pulled before the Board begins consideration of the item in a meeting due to missing or incomplete review information.

Staff and/or Board members follow up as directed with the investigator or sponsor to address the reasons for pulling the item.

In accord with 21 CFR §56.109(e) and 45 CFR §46.109(d), WIRB notifies investigators in writing of the Board's decision to approve or disapprove proposed research activities, or of modifications required to secure approval. The notification includes a statement of the reasons for the Board's decisions and offers opportunity to address the Board in writing or in person.

Requests for reconsiderations are given the same priority in scheduling as new review requests. The reconsideration will be reviewed by the panel which originally reviewed the request. There is no fee for the review. Requests for reconsideration and supporting materials may be directed to the WIRB contact identified in the letter which conveyed the Board's action and rationale.