Common Elements of IRB Assessments
Like every institutional review board (IRB) – commercial or local – Advarra is subject to inspections from time to time. The Food and Drug Administration (FDA) inspects IRBs to ensure human participants’ rights and welfare are properly protected. The Association for the Accreditation of Human Research Protection Programs (AAHRPP) regularly examines us as part of our accreditation maintenance. Additionally, many of our clients audit the IRB.
It’s critical for the IRB to follow appropriate regulations and guidance in its reviews, ensure reviews are conducted free of bias and conflict of interest (COI), and conduct due diligence to confirm quality is upheld for the studies they oversee. We welcome these inspections and audits at Advarra, as they help us continue to improve our processes while ensuring participants are properly protected.
Most IRB inspections and audits focus on some common elements. This blog aims to provide an overview of such items to help you understand the standards to which Advarra’s IRB and others are measured against.
IRB Assessments Overview
Let’s take a quick look at some of the entities most commonly inspecting IRBs.
IRBs can expect formal FDA inspections every few years, but there’s always a possibility of the agency showing up unexpectedly for an ad hoc inspection. The FDA inspects IRBs to ensure participants’ rights and welfare are being appropriately protected, which also helps confirm expectations set by IRB clients and the IRB itself.
Typically, when the FDA performs an inspection, they request to review specific studies. If the inspection entity provides the names of the studies in advance, this enables us to pull all necessary information ahead of time to provide inspectors and notify the study sponsors of the upcoming inspection (as applicable), preparing them as well.
While AAHRPP accreditation is purely voluntary, it is a rigorous process underscoring Advarra’s commitment to high-quality IRB reviews and scrupulous standards of quality, ethics, and protections for human research participants. To receive AAHRPP accreditation, there are certain requirements:
- Self-assessment, application, and peer review of application
- Site visits
- Annual reports to confirm ongoing compliance and maintain accreditation
IRB clients, including industry sponsors, contract research organizations (CROs), research sites, and others, typically have choices when selecting an IRB for a given study. By and large they seek an IRB with a strong reputation for quality and compliance – these are fundamental expectations.
Selecting a less-than-compliant IRB can not only jeopardize participant safety but also impact study data and the research organization’s reputation with regulatory agencies and the general public. It’s important for certain clients to evaluate their IRB partners just like they would conduct a risk assessment with any other vendor.
Compliance with Applicable Regulations
Abiding by the appropriate research regulations is the right thing to do, it’s legally required, and it’s the heart of the IRB’s mission.
We note “applicable regulations” as the regulatory requirements can vary depending on the study in question. Inspectors are concerned with not only whether the IRB follows the regulations but also whether the IRB applies the regulations appropriately to a given study. Not all oversight requirements are appropriate for all studies, and an IRB should carefully review each study to determine the applicable regulatory requirements and what is best for that study’s participants.
Compliance with Standard Operating Procedures and Organizational Policies
Our policies, standard operating procedures (SOPs), and work instructions are designed to bridge the gap between what must happen and how to accomplish it. They also help fill in the blanks and flesh out requirements when regulatory guidance leaves room for local interpretation.
When policies and SOPs align with regulatory requirements, it enables compliance. These documented processes further prove to our stakeholders that we do what we say we are going to do. If a sponsor is concerned about how the IRB handled a particular review, the IRB should be able to use these policies and procedures to explain why things played out as they did. IRB meeting minutes are critical as the source of documentation of an IRB review and determination.
Compliance with Other Requirements
In addition to adhering to federal requirements and organizational polices, IRBs may have additional obligations to meet. AAHRPP accreditation is one such example. At Advarra, AAHRPP accreditation helps provide further evidence of the thoughtful processes and expert insights that power our HRPP, since everything we do is to protect participants.
Independence of Review
As an independent IRB, Advarra has firewalls and policies to guarantee the decision-making independence of these panels. These structural safeguards and corporate policies – which should be in place at any IRB – ensure the open deliberation that embodies the spirit of the regulations. Examining IRB policies and SOPs, as well as reviewing IRB meeting minutes, can help inspectors confirm reviews are conducted independently, without outside priorities influencing the decision.
Some may perceive that the effectiveness of commercial institutional review boards is limited by business interests. However, commercial IRBs must adhere to the same regulatory requirements and quality standards expected of any IRB – the influence of COI is a concern for all IRBs, not just commercial ones. Commercial IRBs and COIs may just get more attention because of the nature of the business.
At Advarra, we ensure independence of IRB review in several ways, including:
- Company policies
- A reminder at the outset of every IRB meeting for board members to recuse themselves from discussion if they have a COI
- Structuring the organization to keep the IRB completely shielded from business priorities and unaware of the fees associated with review services, so that members focus only on the needs of research participants
In our highly regulated clinical research industry, regular inspections are standard practice. IRBs often inspect research sites to confirm researchers are doing what they said they’d do; likewise, IRBs can expect regular inspections by stakeholders. These regular checks ensure that we are doing our best to protect study participants and move research forward.