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). 

How Does the Institutional Review Board Evaluate a New Proposed Research Study? 

Before The IRB Meets 

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. 

Risk Level Evaluation 

A reviewer examines the protocol and initial submission form to determine the overall risk level. This critical step dictates whether the study qualifies for an expedited review or requires review at a convened board meeting. Minimal risk studies that fall into one of nine expedited categories go to a designated reviewer. Studies presenting greater than minimal risk or that do not fit an expedited category must proceed to a full committee. 

Scheduling and Assignment 

WCG IRB assigns the project to a specific meeting and selects members to present the protocol, consent forms, and related materials. It may also include an independent consultant with specialized knowledge to support the process. 

Pre-Meeting Discussions 

WCG IRB releases the agenda and materials to the assigned group. The chair and members engage actively to identify potential concerns early in the process.  

During The IRB Meeting 

Establishing Quorum and Disclosures 

The chair, committee members, and administrative support staff convene at the scheduled time. The chair confirms attendance, requests conflict of interest disclosures, ensures that a quorum is present, and begins the session. The IRB then systematically discusses each item listed on the agenda. 

Study Presentation 

The assigned board member presents an overall summary of the research. This overview covers the purpose, medical merit, design, population, objectives, data collection methods, and any pending issues that need attention. 

Board Discussion 

The presenter invites questions from the group, and the chair moderates the conversation. Alternative ideas and constructive disagreements are encouraged to ensure a robust ethical analysis. 

Consent Form and Document Review 

The IRB then reviews the informed consent documents and other subject-facing materials, such as recruitment materials, alongside any proposed revisions. The committee ensures these forms meet DHHS and FDA regulatory requirements. It also evaluates supplementary materials like advertisements, enrollment scripts, information sheets, and questionnaires for appropriateness. A staff member records any additional revisions made during the meeting.  

Actions After the Meeting Concludes 

Voting and Determinations 

The lead presenter concludes by stating whether the project meets regulatory criteria for approval. If the criteria are unmet, the group generates a list of unresolved issues for the sponsor to address. The presenter then makes a motion, another person seconds it, and the group casts their votes. A member may vote in favor, vote against, or abstain. A simple majority of favorable votes determines the official outcome. 

Official Board Actions 

A new proposed study generally receives one of three determinations. The IRB grants full approval if no issues remain. They will issue a conditional approval if the project requires specific modifications or confirmation of minor document revisions. The IRB will defer the application if they cannot determine that the criteria for approval are met because significant concerns exist regarding safety, study design, or extensive consent form changes that require investigator input. 

Drafting Meeting Minutes 

An administrative professional captures detailed notes during the discussions. Following the session, the IRB utilizes these records to draft official minutes that document the key discussion points and final decisions for every evaluated protocol. This completes the initial review cycle and sets the stage for your trial to move forward safely.