A Window into WCG’s IRB Meeting Deliberations

The purpose and mission of Institutional Review Boards (IRBs) are to protect the rights and welfare of the participants who choose to participate in research. The IRB does this by conducting a thorough analysis of the proposed research study before its implementation. This analysis includes a review of its scientific merit, ethical considerations to include human participants, and if applicable, any relevant local perspectives on the research study. The review is guided by the regulatory framework under federal regulations: the Department of Health and Human Services (DHHS) (§45 CFR 46) and the U.S. Food and Drug Administration (FDA) (§21 CFR 50 and §21 CFR 56).

WCG IRB Review Process for a New Proposed Research Study:

Step 1: Initial administrative assessment

After WCG IRB receives a new proposed research study, a designated staff member will assess whether all required documents have been submitted. Missing or incomplete submissions lead to communication with the Investigator or sponsor until all the required documents are provided and the submission packet is ready to initiate the review process.

Step 2: Assessment of the overall risk and review level required  

A designated reviewer will review the Protocol document and initial review submission form, to do a preliminary assessment of risk level. Reviewers follow the regulatory guidelines and guidance documents issued by both DHHS and FDA to make this determination.

Evaluation of the overall risk level is a critical step because this is a determinant of whether a study can be reviewed by an expedited (designated) review process or via a convened board meeting.  Minimal risk research studies that fit into one of the nine categories described per 45 CFR 46.110 are directed to a designated reviewer, while greater than minimal risk studies and those that do not fit into a category are sent for review at a convened board meeting.

Step 3: Scheduling a new research study for a convened Board meeting

The study is assigned to a Board meeting with specific Board members assigned to present the protocol, consent form(s), and other documents associated with the study. The assignment is based on a board member’s qualifications, experience, and expertise. If necessary, an independent consultant with specialized expertise may also be assigned to facilitate the review process.

Step 4: Release of meeting agenda and start of pre-Board discussions and review process

Staff will inform the board members that their agenda and materials are available for review. Prior to the board meeting, the chair and the board members actively engage with each other to discuss the study and identify any issues or concerns. During this period the chair may also reach out to the Investigator or sponsor to resolve any identified issues and clarify queries raised by the board members that come up during their review. Additionally, the chair can utilize the expertise of WCG consultants, or other internal experts to facilitate the review process.   

Step 5: Convened Board meeting

The board members, the chair, and administrative support staff meet at the scheduled time. Before the meeting starts, the chair ensures that all board members are present, and requests disclosure of any conflict of interests in the studies that will be reviewed in the meeting. Next, the chair confirms that a quorum has been established and starts the meeting. The studies listed in the agenda are systematically discussed one at a time.

For a new proposed research study, the assigned board member presents the study to the board. The presentation generally includes an overall summary of the study (purpose, scientific/medical merit, study design and population, objectives, and data collection and analysis), regulatory status of the investigational product (if applicable), a list of key findings, and any issues or concerns identified including any pending items that need to be addressed by the sponsor or investigator.

Next, the board member invites questions from the rest of the board members, and discussions are moderated by the chair. During the discussions, it is important to note that board members need not agree on the status of all the issues or concerns being discussed, disagreements and alternative ideas are welcome.

The consent form presenter then presents the consent form(s) with proposed revisions to the board. Another staff member will capture any additional revisions to the consent form(s) made during the meeting. The board’s objective is to ensure that the consent form(s) meets the guidelines as indicated in the regulations (21 CFR 50 and 45 CFR 46).

If any additional documents are provided in the submissions packet, such as advertisements, enrollment scripts, information sheets, questionnaires, or emergency cards, these are reviewed for their appropriateness.

The board member will conclude the presentation with a statement of whether they believe the study meets the regulatory criteria for approval. If the criteria are not met, a list of unresolved issues that may need to be addressed by the sponsor or investigator is generated.

An administrative staff member captures notes from the board’s discussions. After the meeting concludes, the notes are utilized to draft the official meeting minutes to capture the various discussion points for all reviewed research studies on the agenda.

Step 6: Board’s action on the new proposed research study

Most commonly, a new proposed research study may receive one of three types of Board action after board review: (1) if there are no pending issues identified, then the study is approved, (2) if there are pending issues that only require confirmation of board’s revisions to study documents or clear requests for modifications to the research, then the study is conditionally approved for confirmation or submission of the requested modifications or documents, or (3) the study is deferred when the issues significantly impact the criteria for approval, such as concerns regarding study design, potential safety issues, uncertainty regarding the investigational product, and when the consent form(s) require extensive revisions that cannot be made by the Board without input from the investigator or sponsor.

Generally, the presenter makes the motion for one of the above-noted actions, another member seconds the motion, and the chair calls on all the board members to cast their vote. A board member may vote in favor, against, or may abstain from voting. The voting is tallied, and a simple majority of favorable votes results in an official board action. This completes the initial review of a new proposed research study to the WCG IRB.