The Review Process: Board Actions
The Board may take a variety of actions upon review of a submission.
Approve
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 WCG IRB 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 through a Certificate of Action (COA).
Outcome Documentation:
Once your study has been reviewed, we will prepare and send the outcome documents to you and all designated contacts (via ClinSphere® eReview Manager or WCG IRBNet), including:
- Certificate of Action (this will convey the Board’s action as well as any special Board determinations, requirements, or other necessary information). (Initial review COAs for sites list all materials approved to date for the protocol.) Note: Canadian panel Certificates of Action are signed (they serve as the REBA form for the review); however US regulatory guidelines in 45 CFR 46.109(d) require written notification of the IRB’s actions but do not require signatures on IRB action notification letters and therefore US Certificates of Action are not signed.
- Copies of all approved participant materials (such as diaries, ID cards, etc.) and advertisements (these documents are labelled with the date the IRB originally approved them; they are not labelled with the date each individual site received approval of them). Note: When the Board approves participant materials and/or advertisements, any redlined changes that were provided by the submitter or required by the Board for approval will remain visible in the outcome document(s); however, recipients are expected to accept the tracked changes in the document before using it. Do not make any additional modifications (including font size and other visual effects) to the approved materials.
- Copy of the Board-approved consent form (when applicable), ready for use.
- Description of the changes to the consent form (depending on the type and extent of the Board’s changes).
Bracketed placeholders (<< xx >>) will appear in protocol-level approved consent forms; the brackets may appear in red text for enhanced visibility. These are text fields that will be populated by IRB staff with customized language for each PI/site using information provided by the site. The following table outlines the description of commonly bracketed sections you can expect to see:
| Placeholder title and text field | Information that will populate per PI |
|---|---|
| Investigator information <<CF-Main Investigator Full Name-Title>> | INVESTIGATOR: Full Name Address |
| Study Related Phone Numbers <<CF-Main User Defined #1>> | XXX-XXX-XXXX XXX-XXX-XXXX (24 hours) OR XXX-XXX-XXXX (24 hours) |
| California research subjects Bill of Rights language <<CF-Main User Defined #2>> <<CF-Main California Bill of Rights>> | , as well as a signed and dated copy of the Experimental Subject’s Bill of Rights |
| Conflict of Interest Disclosure <<CF-Main Financial Disclosure>> | Site submitted or Board directed conflict of interest statement |
| SMO name to be included in the Confidentiality section <<CF-Main User Defined #3>> <<CF-Main SMO Company 1>> <<CF-Main SMO Company 2>> | , [SMO Company Name], an agent for the study doctor, |
| Institution name to be included in the Confidentiality section <<CF-Main User Defined #4>> <<CF-Main Affiliated IN Language 1>> <<CF-Main Affiliated IN Language 2>> | , the institution where the research is being done, |
| Site Payment <<CF-Main Payment for Part. Paragraph>> | Site specific compensation language or template compensation language with site specific payment amounts incorporated |
| SMO name in the HIPAA section <<CF-Main User Defined #5>> <<CF-Main SMO Company 1>> <<CF-Main SMO Company 2>> | , [SMO Company Name], an agent for the study doctor, |
| Institution name in the HIPAA section <<CF-Main User Defined #6>> <<CF-Main Affiliated IN Language 1>> <<CF-Main Affiliated IN Language 2>> | , the institution where the research is being done, |
Please note that the table above explains the most common situations where these text fields will be used. Additional text fields may be included based on individual consent form and/or state requirements.
When advertisements or participant materials are approved, WCG IRB will provide a copy of the approved participant material(s) and/or advertisement(s) bearing an IRB approval stamp and a unique IRB identifier number (which corresponds to the identifier for that item on the Certificate of Action). The stamped copy is for your records and is not intended as the copy to be disseminated to participants (it may also include annotations indicating changes the IRB requires as a condition of approval). WCG requires that the approved material be used with all required changes made and without any other alteration from what was approved; WCG does not have an expectation that a copy displaying the IRB stamp and/or unique identifier will be used. (Changes to phone numbers or contact names referenced in approved advertisements and participant materials, and corrections to spelling do not need to be submitted for IRB review.)
Since WCG does not require the submitter to use the version with the IRB approval stamp/identifier, requests for WCG to re-issue a document with the approval stamp or identifier moved to a different area in the document will not be fulfilled.
Please note that if your organization is using the (legacy) WCG IRB Connexus Teams feature, the Team manager(s) is/are responsible for updating members of the Team in WCG IRB Connexus, but WCG IRB staff must be notified via the Contact Information Update Form when the Team name or designated Team email changes (if WCG IRB staff are not notified of changes to the team name or email, Team members may not receive notifications when documents require pre-review authorization). The Team name appears on the distribution list on the Certificate of Action when applicable.
Approval with Conditions
“Approval with conditions” means the Board has reviewed a submission and determined it meets the requirements for approval but requires specific changes to the study and/or study documents as outlined by the Board before final approval can be provided.
You will receive written notification of the conditions promptly after the review.
Once you submit the requested information, your submission will be re-reviewed. Once that review is complete and all information is confirmed, you will receive your approval documents.
It is important to note that the study, change in research, or other submitted material is not approved until we confirm that any/all of the condition(s) have been satisfied. This process does not allow you to begin research related activities until you receive your final approval documents.
Disapprove
“Disapprove” means the submission does not meet the criteria for approval and the IRB considers the research to have extensive deficiencies. Disapproval may occur for a variety of reasons, most of which involve participant safety and/or scientific validity. Disapproval is communicated to the investigator by letter, in which the reasons for disapproval are explained.
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, and the Board expects the research will continue as previously approved.
Reconsideration of a disapproval decision may be requested. Additional information may be provided to the Board for its consideration. The investigator may appear before the Board in person or via teleconference, if desired.
Defer
“Defer” means the IRB determines that the submission does not meet the criteria for approval and also does not meet the criteria for “Disapprove.” The Board takes a ‘deferred’ action to remove an item from board consideration at a scheduled meeting and obtain additional information or clarification. When the IRB takes this action, it will summarize its reasons and recommendations, if any.
When the Board takes a “defer” action on a change in research, the change cannot be implemented, and the Board expects the research will continue as previously approved.
Staff and/or board members follow up as directed with the investigator or sponsor to address the reasons for deferring the item. Reconsideration of a deferral may be requested. Additional information may be provided to the Board for its consideration. The investigator may appear before the Board in person or via teleconference, if desired.
Staff prepare the item and reschedule it for the Board to complete its review.
Incomplete submissions and inaccurate information. If answers on the WCG IRB submission form are left blank, the answers don’t make sense, or they conflict with the protocol, the Board is unable to make an appropriate decision and may defer the item to request further information.
Pull
The Board may “pull” an agenda item at the request of the submitter, WCG IRB 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.