FALCON correspondence

August 23-24, 2026 · Redacted public copy prepared October 13, 2026

Prepared from the original email messages in Robert DeRosa’s inbox. This is a reformatted transcript, not an image of the original email. Email addresses have been redacted from the displayed headers; Telephone numbers, email addresses and Erin Bell’s postal address are redacted in the signatures. The original classification label, "Hamilton Health Sciences - Internal", is retained. Message routing and security headers, automated external-sender notices and the duplicate quoted original message are omitted. Only the August 24 acknowledgement and the original August 23 request are included. The substantive wording, including original spelling, is retained; line wrapping and spacing are normalized.

HiREB acknowledgement from Erin Bell

From: Erin Bell [REDACTED: email address]
To: Robert DeRosa [REDACTED: email address]
Date: August 24, 2026, 11:35:59 a.m. EDT (15:35:59 UTC)
Subject: RE: Request for appropriate ethics review of FALCON concerns before recruitment

Hamilton Health Sciences - Internal

Hello Robert,

Thank you for reaching out to the HiREB with your concerns about the research study. I confirm receipt of the email below.

This study has not yet undergone ethical review by HiREB and recruitment to the study has not started. I'll share your concerns with the REB so that they can be considered during their review.

Sincerely, Erin Erin Bell (she/her) HiREB Manager Hamilton Integrated Research Ethics Board (HiREB) [REDACTED: postal address] Email: [REDACTED: email address] Phone: [REDACTED: telephone number and extension]

Original request from Robert DeRosa

From: Robert DeRosa [REDACTED: email address]
To: Hamilton Integrated Research Ethics Board (HiREB) [REDACTED: email address]
Date: August 23, 2026, 5:56:40 a.m. EDT (09:56:40 UTC)
Subject: Request for appropriate ethics review of FALCON concerns before recruitment

Dear Hamilton Integrated Research Ethics Board,

I am submitting patient-safety and research-ethics concerns regarding the planned FALCON Long COVID trial, NCT07697261. A petition requesting that recruitment not begin until independent scientific, ethical and patient-led review has surpassed 1,250 verified signatures and had 1,291 as of August 23.

The concerns most directly relevant to HiREB include informed consent for a commercially branded thought- and behaviour-focused intervention; the risk of post-exertional worsening; how deterioration will be detected between scheduled follow-ups; real-time adverse-event reporting; withdrawal, stopping and escalation criteria; management of expectancy and reporting effects in an open-label study; relevant financial and non-financial conflicts; and meaningful patient involvement in reviewing protections and outcomes.

I am not asking HiREB to disclose confidential deliberations. I am asking you to confirm receipt, explain the appropriate process for ensuring these documented concerns are considered before recruitment, and identify any public information that can be provided about participant protection and conflict management.

I would appreciate confirmation of receipt by Tuesday, August 25, together with guidance on the appropriate process. If this belongs through a different formal route, please forward it or tell me exactly where it should be sent.

Thank you,

Robert DeRosa, Long COVID patient advocate [REDACTED: telephone number] [REDACTED: email address]

Petition: https://www.change.org/p/long-covid-patients-deserve-better-pause-mcmaster-s-falcon-lightning-process-trial