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Active campaign · FALCON trial
Review FALCON before recruitment opens.
FALCON is a planned McMaster study comparing the Lightning Process with activity pacing for Long COVID.
About 2 minutes to sign. No LCAC sign-up needed.
- Our ask
- Pause recruitment for independent scientific, ethical and patient-led review, and publish the full protocol and statistical analysis plan.
- Goals this supports
- Who can act
- McMaster University · HiREB · HAHSO
- Stage
- Preparing
- Sent
- Replies
- Resolved
- Next milestone
- Track replies to the 11 October follow-ups. HAHSO, the President and the Dean were asked to reply or give a response timeline by 22 October.
Active campaignCampaign updated: 16 Oct 2026
Latest status
HiREB confirms initial review; questions remain.
On 16 October, HiREB said FALCON had undergone initial board review and was back with the study team to address the board’s questions and concerns. HiREB said the community’s concerns were considered, but gave no timeline for answers to LCAC’s questions. Read the reply.
The reply does not confirm final ethics approval or the independent scientific, ethical and patient-led review LCAC requested. The full protocol, statistical analysis plan and detailed participant-protection answers remain outstanding in the campaign record.
The 11 October follow-ups requested a response or expected response date by 22 October. That is LCAC’s requested date, not a commitment from the recipients.
Registry checked 8 October: “Not yet recruiting”; estimated start November 2026. The record was last updated 13 July. This does not confirm current enrolment. View the trial record ↗
Full campaign timeline · Next steps
What happens next
LCAC will record further replies and check whether the requested documents and protections are confirmed. The other 11 October follow-ups requested a response or expected response date by 22 October.
No follow-up date has been announced. Read the planned HAHSO next step.
Full campaign timeline · August–October 2026
- 2 August 2026. The public petition launched.
- 23 August 2026. Robert DeRosa sent study-specific questions from his personal email to the investigator and institutional contacts. Busse replied on funding, publication plans, outcomes and patient partners. The HAHSO inquiry was forwarded to colleagues; this was a referral, not a substantive funding response.
- 24 August 2026. HiREB acknowledged the concerns, said the study had not yet undergone its ethics review, and undertook to share the concerns with the board. This describes the position on that date.
- 22 September 2026. The Sick Times reported on the petition and trial concerns, publishing further investigator correspondence about funding, delivery and design.
- 8 October 2026. The registry still lists “Not yet recruiting”, based on its 13 July update. The petition remains open. The replies reviewed have not confirmed that the five requests have been fulfilled.
- 11 October 2026. LCAC sent detailed follow-up letters to McMaster’s research office and HiREB, requesting a written response on independent review, trial documents and participant protections. Read the letters below.
- 11 October 2026. LCAC sent its funding follow-up to the HAHSO office, requesting a response by 22 October. Read the sent letter.
- 11 October 2026. LCAC followed up with McMaster’s President and Faculty of Health Sciences Dean, attaching its research-office letter. We asked the President’s office to identify a response coordinator and the Dean’s office to confirm handover of the August concerns and provide a Faculty response. A reply or expected response date was requested by 22 October.
- 13 October 2026. HiREB referred LCAC’s follow-up to a colleague for assistance, copying LCAC. This did not answer the participant-protection or review questions.
- 16 October 2026. HiREB confirmed initial board review, said the study team was addressing the board’s questions and concerns, and said the community’s concerns had been considered. No timeline for answers to LCAC’s questions was provided. Read the response.
Background
Why ask for a review?
FALCON is a planned McMaster University study comparing two approaches to managing Long COVID symptoms. The public trial record describes 100 adults assigned by chance to either the Lightning Process or activity pacing, with sessions and health questionnaires completed online.
The Lightning Process is a commercially branded programme intended to change thought patterns and responses to symptoms. Activity pacing balances activity and rest to avoid worsening symptoms.
Physical or mental effort can worsen Long COVID symptoms. LCAC seeks independent review and clear safeguards so the trial can give reliable answers about benefit and harm.
Read the concerns and evidence.
About the trial and who can act
- The Lightning Process is a commercially branded mind-body training programme. The trial describes it as using discussion, gentle movement and meditation-like techniques to change thought patterns and responses to symptoms. Its core sessions take place over three consecutive days, with preparation and follow-up.
- Activity pacing means balancing activity and rest within a person’s available energy, aiming to avoid making symptoms worse. The study compares the Lightning Process with a structured programme of pacing sessions.
Read the registered study description and interventions.
- McMaster University and the study team. McMaster is the registered lead sponsor. The study team can address the design and disclosure requests. Read the draft to McMaster’s research office.
- Hamilton Integrated Research Ethics Board (HiREB). HiREB says the community’s concerns were considered during initial review. Read the 16 October reply.
- Hamilton Academic Health Sciences Organization (HAHSO). The funder can clarify the funding and related requirements. Read LCAC’s sent funding follow-up.
FALCON: background, concerns and evidence
What is FALCON?
FALCON is a planned McMaster University trial for people with Long COVID. It compares the Lightning Process, a mind-body programme intended to change thought patterns and responses to symptoms, with activity pacing, which balances activity and rest to avoid worsening symptoms.
LCAC is asking for an independent review before recruitment opens, with clear participant protections and public trial documents. Read the registered trial description.
The methods and protections need scrutiny.
- Outcomes and expectations. Participants and providers know which approach is assigned. Analysts and interpreters do not know the assignments until the primary analysis and interpretation. Its primary outcome is self-reported fatigue at 12 months. LCAC asks for a measure of physical function that does not rely only on questionnaires, alongside patient reports. No objective biomarker endpoints are listed in the registered outcomes reviewed on 8 October 2026.
- Participant protections. The registry includes post-exertional malaise and adverse-event measures. The full study plan (protocol) is needed to assess how worsening symptoms are detected between visits and when participants can withdraw, treatment should stop or worsening symptoms should trigger medical assessment.
- Transparency before recruitment. The registry promises a public protocol at study commencement. LCAC asks for the protocol, analysis plan and relevant disclosures before recruitment so concerns can be assessed while changes are still possible.
What we’re asking for
Five asks for McMaster.
These are the changes LCAC is seeking. Open each item for the response received and what remains unresolved. The petition’s six requests are grouped into five themes here.
How the five themes match the petition’s six requests
- Review before recruitment: petition request 1.
- Funding and commercial relationships: request 2.
- Protocol and analysis plan: request 3.
- Function and harm measures: requests 4 and 5, tracked together.
- Meaningful patient involvement: request 6.
01
Review the trial before recruitment opens. An independent scientific, ethical and patient-led review should address the design, participant protections and commercial relationships before recruitment begins.
Response and outstanding questions
Still open: Confirmation of an independent scientific, ethical and patient-led review addressing the petition’s concerns. HiREB confirms initial ethics review. This does not confirm the independent review LCAC requested.
Received: On 23 August, Dr. Jason Busse told Robert DeRosa that recruitment would not begin without ethics approval. On 24 August, HiREB acknowledged LCAC’s concerns and said it would share them with the board for consideration during review. On 16 October, HiREB said those concerns were considered during initial review and the study team was addressing the board’s questions. This does not confirm the independent review requested.
Review requestedCorrespondence through 16 Oct 2026
02
Disclose funding and commercial relationships. Publish funding sources, practitioner payments, relevant conflicts and any licensing or materials arrangements before recruitment.
Response and outstanding questions
Still open: Fuller disclosure of payment arrangements, licensing or materials costs, and relevant financial and non-financial conflicts before recruitment. Busse described conflict disclosure as part of publication.
Received: Busse’s 23 August reply identified $188,904 from HAHSO and said therapists would receive their usual hourly rates. His published correspondence with The Sick Times also describes contracted Lightning Process practitioners and a team member trained in its delivery.
Partly clarifiedReply 23 Aug 2026
03
Publish the protocol and analysis plan. Publish the full study plan (protocol) and the plan for analysing its results before recruitment so the methods can be assessed.
Response and outstanding questions
Still open: Public access to both documents before recruitment. These responses did not supply the documents or confirm that timing.
Received: On 23 August, Busse said he was open to a detailed protocol report and would raise publication with the study team. He described publishing an analysis plan before analyses. The registry says the protocol will be public at study commencement.
Publication requestedReply 23 Aug 2026
04
Use robust measures of function and harm. Add an objective measure of function and explain how worsening symptoms, withdrawal and access to medical care will be handled.
Response and outstanding questions
Still open: A measure of physical function that does not rely only on questionnaires, and clear procedures for protecting participants. LCAC is asking how harm will be detected and addressed, rather than claiming it is absent from the registry.
Received: Busse explained the use of patient-reported outcomes and the active pacing comparison. The registry includes post-exertional malaise, adverse events and serious adverse events.
Request outstandingReply 23 Aug 2026
05
Make patient involvement clear and meaningful. Explain how people living with Long COVID shaped the intervention, outcomes and protections, and their role in reviewing the concerns raised.
Response and outstanding questions
Still open: An account of what patient partners influenced and how patients will participate in the design review. LCAC acknowledges the reported involvement; its extent and decision-making role remain to be clarified.
Received: On 23 August, Busse told Robert DeRosa that patient partners were team members and had reviewed the protocol.
Patient input reportedReply 23 Aug 2026
HiREB update: 16 Oct 2026 · Other entries retain their source dates
ClinicalTrials.gov NCT07697261
Ways to help
More ways to take part.
Share the petition, personalize an email, or help examine one research question. Choose what fits your energy; joining LCAC is not required.
Ask McMaster for a public response
Personalize a draft asking for independent review and public trial documents before recruitment.
Read and personalize the email Why this mattersEmailed about FALCON? Share your correspondence.
Send LCAC your email and any reply. No response yet? Your original email is useful too.
Share correspondencePrivate submission. We will ask separately before publishing any part.
Read the latest updateHelp clarify who can take part in FALCON
Compare two public descriptions of one eligibility rule and send LCAC a short, sourced note.
See the document-review task Why this mattersHave other evidence or expertise to contribute? Contribute at your own pace, with no fixed time commitment. Offer evidence or expertise →
Drafts and review tasks
Draft emails, a funding letter and a review task.
Choose an email draft or review task, or read LCAC’s sent HAHSO letter.
Show 4 items
About 5–10 minutes · Email
Write to McMaster’s research office.
Ask for a public response on the outstanding review and disclosure requests.
Recipient: vprsrch@mcmaster.ca, the institutional Office of the Vice-President, Research. Check McMaster’s official contact listing ↗
Replace or remove the brackets and send only what reflects your views.
Using webmail? Copy the subject and message below into a new email.
Read the prepared message
Subject: FALCON: independent review before recruitment
Dear Office of the Vice-President, Research, I support the call to pause recruitment for FALCON (NCT07697261) until an independent scientific, ethical and patient-led review has addressed the concerns raised about the trial. [Optional: Add a sentence about why trustworthy Long COVID research matters to you.] Please publish the full protocol, statistical analysis plan and the review’s findings before recruitment begins. Please explain how McMaster will respond to the outstanding requests and when a public response can be expected. People with Long COVID need research that produces reliable answers and protects participants. Thank you, [Your name] Campaign background: https://longcovidaction.ca/falcon
What happens next
Received a reply? Forward it to hello@longcovidaction.ca or share it through the form for review.
HiREB outreach
Reply received.
HiREB confirmed initial review and consideration of community concerns on 16 October. The email action is now closed; the campaign’s five asks remain open. Read the reply.
Already emailed? Share your correspondence.
Archived HiREB email draft
This was the earlier outreach draft; it is retained for the campaign record.
Dear Hamilton Integrated Research Ethics Board, I am writing about participant protections in FALCON (NCT07697261). I understand that HiREB has acknowledged Robert DeRosa’s August concerns, and I would appreciate an update on how they are being considered. [Optional: Add a sentence about why participant protection matters to you.] Please explain how the review will address worsening symptoms after exertion, informed consent and participants’ ability to withdraw without pressure. Please support publication of the participant information and consent materials before recruitment, and provide a public summary of the safeguards where possible. Please let me know when a response can be expected. Thank you, [Your name] Campaign background: https://longcovidaction.ca/falcon
About 30–60 minutes · Review
Help clarify who can take part.
Compare one eligibility rule in two documents. No research credentials or full trial review needed.
LCAC has noticed differing descriptions of the “readiness to change” score used to determine eligibility. Your task is to help develop a precise question about which rule applies, why it is used and whether the public registration needs updating.
- Start with the registration. Read inclusion criterion 6 in the ClinicalTrials.gov eligibility section ↗. The version checked on 8 October was last updated on 13 July 2026.
- Compare the later explanation. Read the 28 August correction on page 8 of the investigator’s published correspondence ↗. A plain-text version is also available ↗.
- Send 3–5 brief bullets. Identify the sources and dates, explain the requirement in your own words, and say what differs or needs clarification. You can suggest one question for the study team.
A brief or partial note is welcome. No personal medical history needed.
What happens next
LCAC will check notes against the sources and use relevant findings in a clarification request. Publication is not guaranteed.
Funding follow-up · HAHSO
Our funding follow-up to HAHSO.
Sent 11 October 2026 · Response requested by 22 October
LCAC asked HAHSO to answer the funding, oversight and disclosure questions first sent on 23 August.
Sent to the HAHSO office (hahso@mcmaster.ca), addressed to Sarah Bouma and Dr. Ahmed Khan, with a request to forward it to the responsible person. Check McMaster’s HAHSO office listing ↗
You can also read the full text below.
Read the full HAHSO letter
Sent · 11 October 2026
To: Sarah Bouma and Dr. Ahmed Khan, Hamilton Academic Health Sciences Organization (HAHSO)
Re: FALCON funding - follow-up on my 23 August 2026 inquiry (NCT07697261)
Dear Sarah Bouma and Dr. Ahmed Khan,
I am writing for Long COVID Action Canada to follow up on my 23 August 2026 email about funding for FALCON (NCT07697261), McMaster's trial comparing activity pacing with the Lightning Process for Long COVID. Clare Mitchell replied that day, saying she no longer worked for HAHSO and forwarding my inquiry to you. I am requesting a substantive written response.
Dr. Jason Busse's August correspondence identified HAHSO funding of $188,904. The source and reported amount are therefore already part of the record. I am seeking details of the award's conditions, assessment, oversight and transparency.
ClinicalTrials.gov, checked on 8 October 2026, lists FALCON as "Not yet recruiting," with an estimated November 2026 study start. The record was last updated on 13 July. This is the published registry information, not confirmation of current enrolment. Clarity before recruitment would help patients understand how the concerns raised are being considered.
Please address the following:
- Responsibility for the inquiry. Which person or office received the August referral, and who is responsible for responding? Please describe any consideration undertaken so far and indicate when a substantive response can reasonably be expected.
- The award and its conditions. Please confirm the reported amount and identify the grant stream, award reference, funding period and applicable terms. What conditions govern scientific review, participant protections, changes to the study and release of funds? Links to relevant policies and a shareable summary of the award conditions would be helpful.
- Review, oversight and independent scrutiny. What scientific or methodological assessment informed the funding decision, and what patient involvement was considered? What process allows HAHSO to consider concerns raised after an award? Please explain the respective responsibilities of HAHSO, the institution, investigators and the research ethics board, including reporting or reassessment requirements. Within its funding role, what can HAHSO do to support an independent scientific, ethical and patient-led review of the design, participant protections and relevant commercial relationships before recruitment?
- Payments and relevant interests. Busse has described payments to therapists at their usual hourly rates. Please clarify what the approved budget provides for contracted practitioners, training, licensing or intervention materials, where applicable. What financial and non-financial interests were disclosed by applicants and relevant reviewers, and how are they assessed or managed?
- Public documents before recruitment. What does this award require concerning publication of the full protocol and statistical analysis plan? LCAC is asking that both be public before recruitment. Can HAHSO support that timing, and explain any existing expectations about publication, disclosure and dissemination? If documents are already available, please provide links. Please also explain whether concerns arising from those documents can be referred for further assessment.
LCAC's record acknowledges investigator replies and HiREB's acknowledgment of our concerns. Those communications have clarified some matters; they do not by themselves establish that the outstanding requests have been fulfilled. Funding oversight and ethics review have distinct responsibilities, and I am seeking a clear account of HAHSO's role.
Please acknowledge receipt and confirm that this has reached the responsible office. I would appreciate a substantive written response by 22 October 2026, ahead of the estimated November start. If that timing is not feasible, please indicate when you can respond. I would welcome a response suitable for inclusion in the public campaign record. If a question belongs elsewhere, identify the responsible office while addressing the matters within HAHSO's remit. Please distinguish steps already completed from proposed actions.
People with Long COVID need research they can assess and trust. Clear answers would help.
Thank you for considering these requests.
Sincerely,
Robert DeRosa
Founder, Long COVID Action Canada
Long COVID patient advocate
What happens next
We will record a reply, or the absence of one by 22 October, before deciding on the next follow-up or a public email action.
The HAHSO email action remains paused. Choose one of the current FALCON actions.
Public contacts and responsibilities
Public contacts
Who can act.
Use the McMaster draft for outstanding campaign questions. HiREB outreach has closed following its reply. Already emailed? Share your correspondence.
| Person or office | Campaign questions | Public email |
|---|---|---|
| Dr. Jason BussePrincipal investigator, FALCON | Trial design, protocol, outcomes and publication plans | bussejw@mcmaster.caPublic contact source |
| Hamilton Integrated Research Ethics Board (HiREB)Research ethics board | Ethics review, informed consent and participant protections | hireb@hhsc.caPublic contact source |
| Dr. Gianni Parise · research officeVice-President, Research, McMaster | Institutional research oversight and response to the review request | vprsrch@mcmaster.caPublic contact source |
| Dr. Nancy Baxter · dean’s officeDean and Vice-President, Health Sciences, McMaster | Faculty leadership and response to the campaign’s concerns | deanfhs@mcmaster.caPublic contact source |
| Dr. Susan Tighe · president’s officePresident and Vice-Chancellor, McMaster | University leadership and institutional accountability | president@mcmaster.caPublic contact source |
| Hamilton Academic Health Sciences Organization (HAHSO)Reported funding body · HAHSO Administration | Funding transparency, grant conditions and oversightContact listed for reference. The public HAHSO email action remains paused pending LCAC’s follow-up. | hahso@mcmaster.caPublic contact source · HAHSO Administration |
Public contact sources checked 13 October 2026. Office addresses are used for institutional leaders. A listing does not imply agreement with the campaign. The HAHSO action remains paused.
Correspondence
Replies received.
Replies and referrals to Robert DeRosa and LCAC, including HiREB’s 16 October review-status update. None confirms the independent review requested.
These exchanges describe the position on their dates. Private details are redacted; substantive wording and original classification labels are retained.
| Date | From | What they said | Read the exchange |
|---|---|---|---|
| HiREB · Mandy HindleInitial-review status update | Initial board review took place; the study team is addressing the board’s questions and concerns. Community concerns were considered. No timeline for answers to LCAC’s questions was provided. | Read the reply text | |
| HiREBInternal referral | Referred LCAC’s follow-up to a colleague for assistance, copying LCAC. | Timeline record |
Earlier replies · August 2026
| Date | From | What they said | Read the exchange |
|---|---|---|---|
| Dr. Jason BusseInvestigator response | Discussed funding, publication plans, outcomes and patient partners; stated that the trial would not begin without ethics approval. | ||
| HiREB · Erin BellAcknowledgement | Said the study had not yet undergone HiREB review and recruitment had not started; would share the concerns with the board. | ||
| Clare MitchellHAHSO referral | Said she no longer worked for HAHSO and forwarded the inquiry to Sarah Bouma and Dr. Ahmed Khan. This did not answer the funding or oversight questions. |
August text and PDF versions include the exchanges and original requests, with redacted screenshots. The 16 October entry links to a reformatted transcript of that reply body. The 13 October referral is summarized in the timeline.
Documents and sources
Check the record.
Coverage by The Sick Times
People with Long COVID demand pause of McMaster University clinical trial ↗
Reporting by Simon Spichak, 22 September 2026.
Watch Miles Griffis explain the concerns in The Sick Times’ accompanying video.
September 2026 coverage reflects information available at publication. See Latest status for subsequent developments.
Read the video transcript
The Sick Times, September 2026. Original reporting and wording; the figures and trial status describe that time. The closing invitation to comment refers to the original social-media reel.
Over 1,700 people have signed a petition calling for a review of a Canadian clinical trial testing a pseudoscientific mind-body program for Long COVID.
Researchers at McMaster University are planning to test an expensive program called the Lightning Process, even though Long COVID is a biological disease.
The program has been heavily criticized by experts and called quackery. Plus, some UK health guidelines actually recommend against it for similar diseases like myalgic encephalomyelitis or ME, which some people with Long COVID have.
The program has also been accused of exploiting vulnerable people with Long COVID and has faced pushback from regulators for false advertising.
And on top of all of this, a BBC undercover investigation found the coaches of the program falsely told people with Long COVID that quote almost anyone can recover from the disease by changing their thoughts, language, and actions.
The petition calls for objective outcome measures of the plethora of biological abnormalities found in Long COVID as the proposed study currently lists subjective measures.
It also calls for an independent review of the trial's design, transparency, participant protections, and its commercial conflicts.
Our reporter, Simon Spichak, asked one of the investigators about the trial and how the program has been accused of pseudoscience by outside experts.
The researcher said that he was not an expert in the program and that it was controversial but did not address any of the claims on pseudoscience.
Simon also found that the trial will contract Lightning Process coaches, which means that the program will be profiting off of the trial.
With little funding for Long COVID in Canada, petition author Robert DeRosa says it feels like, quote, the dark ages, unquote, with researchers trialing interventions like this.
Read more at TheSickTimes.org and comment “news” to get more stories in your inbox like this.
Supporter email drafts: the McMaster email is available above. The HiREB draft is archived following its reply. The sent HAHSO funding letter is linked below.
HiREB’s 16 October initial-review status update — public reply transcript.
HiREB’s 24 August acknowledgement and the original request — redacted PDF, text version and email screenshot.
LCAC letters sent 11 October 2026
- Letter to McMaster: independent review and trial documents (PDF, 2 pages) · Accessible PDF (2 pages) · Accessible text version.
- Letter to HiREB: participant protections and ethics review (PDF, 2 pages) · Accessible PDF (2 pages) · Accessible text version.
- Letter to HAHSO: funding conditions and oversight (PDF, 2 pages) · Accessible PDF (3 pages) · Accessible text version.
- FALCON registration: ClinicalTrials.gov NCT07697261 ↗ — registered methods, outcomes and recruitment status.
- The public petition ↗ — the requested change and signatures.
- Investigator correspondence published by The Sick Times ↗ — replies to journalist Simon Spichak, 24–28 August 2026.
- FALCON registry summary on Veeva ↗ — a study summary, not the full protocol.
The replies and referrals above cover August–October 2026. Each entry identifies its date and source. The published journalist exchange is a separate record. Statements about the registry refer to the version checked on 8 October 2026.