METADATA
last updated: 2026-03-18 RT
file_name: _context-commentary_regulatory-irb.md
category: regulatory
subcategory: irb
gfile_url: https://docs.google.com/document/d/1sE0sSdbNQQdnjboL018-i4POE-zEj8hSqsGKJFyKYkA
words: 1232
tokens: 1716


CONTENT

## Context
An Institutional Review Board (IRB) is an independent ethics committee that reviews and approves research involving human subjects. Any clinical study collecting specimens from human participants, including the clinical performance studies needed for FDA Emergency Use Authorization (EUA) submissions, requires IRB approval before it can begin. The IRB evaluates whether the study design adequately protects participants' rights, safety, and welfare.

This `regulatory/irb` subcategory contains two files from FloodLAMP's IRB process: a clinical study protocol and an informed consent form, both dated April 2021 (Protocol 20210401). The protocol, titled "FloodLAMP COVID-19 Biobank and Test Validation Protocol" outlined a study to collect up to 100,000 consented clinical specimens across multiple U.S. sites to evaluate FloodLAMP's molecular COVID-19 assays (QuickColor RT-LAMP, QuickFluor RT-LAMP, and EasyPCR RT-qPCR) and a home collection kit. The informed consent form documented voluntary participation, specimen handling, de-identification procedures, and participant rights.

The relationship between the IRB and FDA EUA submissions is sequential rather than direct: IRB approval is a prerequisite for conducting a clinical study, and the clinical study generates the performance data that gets submitted to the FDA as part of an EUA application. The IRB itself does not appear in the EUA submission. Rather, it serves as the regulatory gatekeeper that must approve the study before clinical specimens can be collected from human participants. FloodLAMP needed clinical performance data — positive and negative percent agreement against an EUA-authorized high-sensitivity PCR comparator — to support its 2nd round of EUA submissions for pooling, asymptomatic, and the new serial screening claims. Generating that data required running a clinical study on human specimens, and running that study required IRB approval.

Note that this IRB is not related to FloodLAMP's first round of EUA submissions in March of 2021. The Stanford Clinical Lab performed the clinical study for those submissions, using banked samples.

FloodLAMP obtained IRB approval through WCG (formerly Western Institutional Review Board), a well-known commercial IRB. The protocol was broad and flexible, designed to cover three collection modalities: co-located sites adjacent to existing testing programs (such as Stanford or San Francisco city testing sites), independently operated FloodLAMP collection sites, and distributed home collection kits. The study also included provisions for the FloodLAMP Mobile App, pooled specimen collection, and multiple swab types.

Despite obtaining IRB approval and preparing a detailed protocol, FloodLAMP never executed the clinical study, due to the FDA's decision to decline further review of FloodLAMP's second round of EUA and Pre-EUA submissions. Later in FloodLAMP's trajectory, around mid-2022, a new clinical study design was developed that attempted to address some of these constraints. The design integrated clinical data collection into an active surveillance testing program (which could be school or workplace-based), using an enrichment strategy to solve the low-prevalence problem and a cascading cohort structure to maximize data yield per positive event. This study design may be able to collect clinical performance data at a fraction of the cost of a typical standalone trial. The design is documented in a companion file (`_AI_digestion_irb_new-clinical-study-design`) and may be of interest to researchers or organizations facing similar challenges in generating clinical data for novel diagnostics during periods of variable disease prevalence.

Other parts of the archive document the FDA submission process itself. The `regulatory/fl-fda-submissions` and `regulatory/fl-fda-correspondence` subcategories in the `regulatory` category contain the EUA applications and related correspondence that these IRB documents were intended to support.

### Archive Files Not Converted to Markdown
`IRB - FloodLAMP Case Report Form 20210401 v01.docx`
`IRB - FloodLAMP Case Report Form 20210401 v01.pdf`
`IRB - FloodLAMP Home Collection Kit Instructions for Use.pdf`
`IRB - FloodLAMP Study Advertisement.pdf`
`IRB - Instructions for Use - FloodLAMP QuickFluor COVID-19 Test.pdf`

Also included are 10 additional IRBs, consent forms, and clinical study designs from other organizations, located in the `IRBs and Consents from Others` subfolder:
`American Cancer Society event LIABILITY WAIVER AND RELEASE OF CLAIMS.pdf`
`Arizona Dept of Health Services informed consent.pdf`
`Color Genomics IRB.docx`
`Color Genomics IRB.pdf`
`EmpowerDX (Eurofins) consent form.docx`
`EmpowerDX (Eurofins) consent form.pdf`
`Lucira Screenshot_2021-02-17 COVID-19 Test Study.png`
`NextEraEnergy PCR Testing Patient Consent Form.pdf`
`Stanford Catch Consent.docx`
`Stanford Catch Consent.pdf`


## Commentary
The IRB process was handled through WCG (Western Institutional Review Board), with a total cost of $11,360 over two years including a renewal. On top of this was another approximately $10K of regulatory consulting. This was a considerable expense for a small company. Even more burdensome than the cost was the time required to prepare the IRB. Overall the IRB was a painful process and sore spot, especially since the clinical study was never actually conducted. The IRB approval and the detailed protocol it covered remained unused.

The experience highlighted what appeared to be a cumbersome and inefficient process. The IRB pathway felt siloed, with limited templates, examples, or structured support available for small organizations navigating it for the first time, particularly during a public health emergency when speed should have been a priority. For a small company attempting to bring a new diagnostic test through the regulatory pathway during an active pandemic, the combination of IRB costs, the time required to prepare the protocol, and the separate expense of actually running a clinical study created significant barriers to generating the clinical data that the FDA required.

To illustrate the broader cost picture: FloodLAMP received a quote of approximately $100,000 from a clinical research organization to manage participant recruitment and sourcing alone, targeting roughly 40 positive specimens. This did not include running the tests themselves; a separate CLIA laboratory was needed for that. These costs reflected the broader pandemic dynamic, where demand for clinical services far outstripped supply and pricing reflected that imbalance. This seems like an especially crazy state of affairs given the high proportion of positive people and those exposed in the population.

The IRB and clinical study process, as experienced, suggests an area where standardization and streamlining could benefit the field, both in routine times and especially during public health emergencies. The barriers to generating clinical performance data disproportionately affect small companies and organizations that lack established clinical trial infrastructure, institutional IRB relationships, or the budgets to absorb six-figure study costs. If decentralized and low-cost diagnostic testing is to play a meaningful role in future pandemic response, the regulatory pathway for generating the required clinical data may need to be correspondingly accessible.

The FDA did recognize elements of this problem. Through a collaboration with the NIH, the Rapid Acceleration of Diagnostics (RADx) program established the Independent Test Assessment Program (ITAP), which provided standardized evaluation protocols, data reporting mechanisms, and targeted outreach to test developers to accelerate regulatory review and authorization. ITAP facilitated the authorization of a number of at-home and point-of-care COVID-19 tests, and the model has since been extended to other diagnostics including multiplex respiratory panels, mpox, and hepatitis. However, ITAP's COVID-19 focus was primarily on rapid antigen tests, and the program's resources and outreach were oriented toward developers with tests already authorized in other markets or at a relatively advanced stage. While ITAP likely accelerated some authorizations, it was initiated late in the pandemic and did not address the more fundamental barriers and inefficiencies of the overall EUA clinical study and IRB process, and it was not readily accessible to smaller, earlier-stage companies and organizations developing novel testing approaches. For more on FloodLAMP's engagement with RADx-related programs, see the archive files in the `various/fl-proposals` subcategory and the archive file `various/external-programs-reports/_AI_RADx Program Overview - NIH Rapid Acceleration of Diagnostics.md`.