Understanding the Roles of Lay and Professional Reviewers
Institutional Review Boards (IRBs) serve as a critical safeguard in protecting the rights and welfare of individuals who participate in research. At the foundation of every IRB is a diverse group of members who work together to ensure that studies are ethically and responsibly reviewed. Federal regulations outline specific IRB member requirements, including the inclusion of both professional (scientific) and lay (nonscientific) reviewers. Each plays a unique and essential role in the review process.
Federal Requirements for IRB Membership
The U.S. Department of Health and Human Services (HHS) outlines the minimum composition of an IRB in 45 CFR 46.107. These requirements include:
A minimum of five members with varying backgrounds to promote complete and adequate review of research activities.
At least one member whose primary concerns are in scientific areas.
At least one member whose primary concerns are in nonscientific areas.
Consideration of gender, race, cultural backgrounds, and sensitivity to community attitudes.
These rules help ensure a range of expertise and perspectives, reducing bias and improving the quality and fairness of the IRB’s decisions.
Professional (Scientific) Reviewers
Professional reviewers, often called scientific members, have specific training or expertise in areas directly related to research. This may include:
Biomedical sciences
Clinical practice
Psychology
Epidemiology
Public health
Social sciences
Scientific reviewers are responsible for evaluating the research design, methodology, risk/benefit analysis, and scientific merit of a study. They assess whether risks to participants are minimized and justified and whether procedures are consistent with sound research principles. For more complex clinical studies, scientific reviewers may also review elements such as investigational drug use or statistical validity.
Their insights ensure that research meets high standards for safety, rigor, and relevance.
Lay (Nonscientific) Reviewers
Lay reviewers—also called nonscientific or community members—do not have formal training in science or research. Their professional backgrounds may include:
Education
Administration
Law
Business
Community service
Their primary function is to represent the participant’s perspective. Lay reviewers assess whether the research is understandable to the general public, especially in materials like the informed consent form. They consider the appropriateness of recruitment practices, the use of plain language, and the cultural or social implications of the research.
Because they approach protocols without a technical lens, lay reviewers often raise important ethical or clarity issues that scientific reviewers may overlook.
A Balanced Approach to Ethical Oversight
The combination of scientific and lay reviewers fosters a more comprehensive and equitable review process. Together, they provide:
Scientific integrity, ensuring the research is methodologically sound.
Ethical clarity, protecting participants’ rights and autonomy.
Diverse perspectives, accounting for social, cultural, and community impact.
This balance is required not just by HHS regulations but also by the U.S. Food and Drug Administration (FDA) in 21 CFR 56.107, reinforcing that all federally regulated IRBs must uphold these standards.
How Solutions IRB Ensures Compliance
At Solutions IRB, we carefully construct our review panels to meet and exceed these IRB member requirements. Our IRB includes a mix of professionals with subject matter expertise and dedicated lay reviewers who represent the broader community. Each application benefits from a multi-perspective review process that ensures participant protections are never compromised, and scientific rigor is upheld.
Our commitment to compliance, clarity, and community representation means researchers can trust that their protocols are reviewed thoroughly, fairly, and in line with federal guidelines.