Mask study raises concern
Health-care workers launch complaint, saying research puts them at risk.
A McMaster University study examining whether surgical masks provide health-care workers with similar protection to N95 respirators has triggered a formal complaint alleging the lives of participants are being needlessly placed at risk.
In an April 19 letter to the federal research ethics panel, a coalition of health-care practitioners allege the study “exposes health-care workers to COVID-19 infection” by allowing them to wear surgical masks instead of N95 respirators when caring for patients.
The complaint to Canada’s Secretariat on Responsible Conduct of Research (SRCR) states there is “ample research” to support the transmission of COVID-19 through aerosols that can be spread through the air and inhaled, requiring respirators as the “minimum line of safety protection for at-risk workers.”
Signed by 17 Canadian and international researchers, physicians and academics, the complaint letter says the “weight of historic and contemporary evidence” points to surgical masks as providing “little to no protection from inhalation of small infectious particles...The results of such a study are indefensible.”
The study, which proposes to give health-care participants “either medical masks or N95 respirators when providing medical care to patients with COVID-19,” is simply measuring the effects of masking protocols already in place in hospitals across much of the country, says its lead investigator.
But nurse unions advising members to protect themselves from aerosol transmission by wearing respirators whenever treating COVID patients say vulnerable workers should not be asked to increase their risk for a study.
Dr. Kevin Hedges, an occupational and industrial hygienist and former president of the advocacy group Workplace Health Without Borders, calls the research unethical.
“It’s like going on a construction site and giving half of the workers helmets and the other half no helmets and seeing if there’s a difference,” he said. “We all know there’s a difference between them. It’s a pointless study. But the problem is the health-care workers are being put at risk.”
The group is asking the federal government to stop the ongoing study and ensure formal letters of apology are sent to participants.
The allegations renew a fractious and evolving debate over how COVID-19 is transmitted.
While transmission theories initially focused on respiratory “droplets” that spread to people and surfaces through things like coughing or sneezing, growing research has found strong evidence for tiny aerosols that can travel on air currents for hours. That increasingly accepted airborne transmission theory has been linked to a call for N95 respirators for health-care workers.
Dr. Mark Loeb, the study’s lead investigator and a professor of pathology and molecular medicine at McMaster, says his study is an ethical and important examination of a vital health-care safety question that remains unanswered.
“There are still differences in opinion in terms of the extent that aerosolization is the dominant form of transmission,” he said in an interview. “I want to do a trial to determine what is the safest thing for health-care workers.”
Loeb said health-care professionals involved in the study are using the same masking protocols they would normally.
For routine patient care that doesn’t involve close contact, most nurses in Canada continue to wear surgical masks, he said. For so-called “aerosolgenerating” procedures, such as intubating a patient, N95 masks are common to account for the higher risks, he said.
“Everything in place continues to be in place in their place of work. Even if they are using a surgical mask, they can switch to an N95 mask if they wish … It’s a safe trial.”
Vicki McKenna, president of the Ontario Nurses’ Association, calls the study “surreal” given the stakes involved for health-care workers.
“We’re in the middle of a pandemic and you’re trying to do a study putting people at risk when we know so little about this virus and we believe it could be airborne?” she said. “There’s lots of ways to test the effectiveness of masks and using nurses as guinea pigs is not one of them. It’s ridiculous.”
McKenna rejects Loeb’s assertion that the study does not influence current mask-wearing protocols, saying that nurses in Ontario commonly wear N95 masks during routine patient care since the province gave them an option last October.
In a Nov. 24 letter to McMaster officials, McKenna wrote: “We are stunned by the callous nature of this research study and the unimaginable risk at which it places the lives of health-care workers.”
Asking nurses to voluntarily wear surgical masks conflicts with the “strong legal imperative to require employers to give their workers access to N95 respirators or equivalent or better,” it reads.
In a written statement to the Star, a McMaster spokesperson said: “The university has a clear process to ensure that all research is carried out in a safe and ethical manner. The study protocol was reviewed and approved by the Hamilton Integrated Research Ethics Board which included the assurance of safety for all participants and the protocol was also endorsed by the Chief Public Health Office of Canada.”
In December, the Canadian Federation of Nurses Unions sent a letter to Dr. Theresa Tam, chief public health officer of Canada, saying the national agency’s November acknowledgment of aerosol transmission shifted the ethical basis upon which the study was first approved.
“We find it deeply troubling that this project was given ethics approval amid the circumstances in which health-care workers are currently operating,” the federation’s letter reads.
A response letter from PHAC confirmed that Tam provided a letter of support for the research proposal “with the understanding that it will undergo a rigorous peer-review process.”
Linda Silas, president of the federation, which represents close to 200,000 nurses and nursing students, says she was “shocked” by the lack of response to the concerns her group shared with the federal government and PHAC.
“When our appeals … didn’t work, we then took our plea directly to health-care workers saying, ‘Do not participate.’ ”
McKenna’s ONA did the same thing with her 68,000 members.
“We put the message out that we didn’t believe this was acceptable and encouraged people not to participate if they were approached.” A description of the study posted in March 2020 says researchers were seeking 576 health-care practitioners from a dozen hospitals in Quebec, Alberta and Ontario. Among the eight listed Ontario hospitals are Hamilton Health Sciences and St. Joseph’s Healthcare in Hamilton, Ottawa Hospital, and in Toronto, St. Joseph’s and St. Michael’s.
“As best I know, no nurse has participated at Hamilton Health Sciences or St. Joseph’s (in Hamilton) or the Ottawa hospital,” says McKenna, who was unaware of the full list of hospitals.
Loeb said about half of the desired number of participants have been recruited so far, even though the study was supposed to be completed April 1.
That time frame has been extended, Loeb confirmed. He did not provide an expected completion date. He also indicated the search for participants has been expanded internationally.
A section of the consent form titled “What are the risks or harms of participating in the study,” says they are “minimal,” including slight bruising or redness from submitting blood specimens or nasal swabs.
“It is unclear if risk of infection with COVID-19 will be higher with one method versus the other. There is a possibility that the medical mask is not as protective as the N95 respirator (another possibility is that the N95 respirator is not as protective as the medical mask),” it reads.
The debate over health-care masking has been growing for more than a year.
A Star investigation in May 2020 raised early concerns about aerosol spread of the virus amid a lack of N95 masks available for health-care workers in Canada.
In response, a group of Toronto infectious disease specialists and epidemiologists vigorously dismissed the concerns in a public letter that says, “COVID-19 is almost exclusively spread via droplets” and that “misinformation” has fuelled a “belief this disease is airborne, and that wearing N95 masks will reduce health-care worker risk, when the evidence and the science say otherwise.”
Since then, aerosol transmission of the disease has received far greater attention and acknowledgment.
A paper published in the Lancet on April 15 titled “Ten scientific reasons in support of airborne transmission of SARSCoV-2” concludes that there is “consistent, strong evidence” that the virus spreads through airborne transmission.
In February, Quebec’s workplace safety board began requiring health-care workers in hospitals, clinics, long-term care homes and private residences wear N95 respirators, citing “new scientific knowledge.”
The ONA has filed a judicial review seeking a directive that would recognize aerosol transmission and require healthcare worker access to N95 respirators. The first hearing date for that review is scheduled for May 12.
Current Workplace Safety and Insurance Board data in Ontario place “nursing and residential care facilities” at the top of the list of COVID-19 worker compensation claims at 7,718. Hospitals are second at 2,836.