Horizon hopes human research accreditation will boost confidence in COVID-19 studies

The Horizon Health Network has become the first health authority in Canada to receive national accreditation of its human research protection program.

It comes as Horizon is pursuing a number of COVID-19-related studies.

Horizon officials hope the independent stamp of approval from Human Research Accreditation Canada will help boost public confidence and participation.

"Essentially what it does is itprovides assurance that human research is being conducted safely and ethically," said Jacquelyn Legere, director of Horizon's human research protection program (HRPP).

"It also provides assurance that safeguards are in place to protect the well-being of the public when they serve as our research participants."

According to Human Research Accreditation Canada's website, accreditation further demonstrates that an organization has rigorous processesto produce reliable and credible data, upon which societal decisions are made.

Horizon has temporarily suspended nearly 500of its other studies so it can focus on COVID-19 patients and research, said Barry Strack, regional director of research services.

"We need to understand this infection because it is going to be with us potentially for years," he said. "And so we have to understand how this infection is interacting with our population and what it's doing."

He hopes to have a clinical trial for hospitalized COVID-19 patients open for enrolment by June.

It's an international clinical trial designed by the World Health Organization and sponsored, in Canada, by Sunnybrook Research Institute in Toronto.

New Brunswick doesn't have enough data for Horizon to do its own clinical trial, said Strack.

The province has had a total of 120 cases since the pandemic began, only two of which are still active and neither person is in hospital. No new cases have been confirmed since May 6.

International studies provide robust data to determine more quickly if the treatments are effective and safe, said Strack.

There's no minimum number of patients required for Horizon to participate in the clinical trial, he said. But the more, the better.

"They're designing these studies to explore a multitude of treatment options and for that you need literally thousands of patients."

The global enrolment is expected to be at least 7,000 patients, hesaid.

Horizon is looking at other international clinical trials as well,but the "landscape is shifting very rapidly," as researchers learn more about the virus every day, said Strack.

"What seemed like a good clinical trial idea, you know, a month ago may not be the best clinical trial idea next month."

So the research team is working closely with Horizon clinicians to assess the wide range of treatment options being studied to determined which ones might be "the most appropriate for New Brunswickers."

Effects on autoimmune, heart disease

One Horizon-led"observational" study already open for enrolment will look at how the coronavirus is impacting patients, including the effects of various treatments on patient outcomes, he said.

Horizon will participate in an international observational study on the impact of COVID-19 on people who take immunosuppressive medications for an autoimmune or rheumatic disease.

There will also be an observational study on how COVID-19 affects those with current or past heart disease differently than those with no history of heart disease.

Psychosocial impact

A Horizon-led research study already underway will examine the psychosocial impact of the coronavirus on the well-being of New Brunswickers whether it's their mental health, their access to health care, their education or finances, said Strack.

The study, run by Dr. Sarah Gander, invites people to complete an online survey, whether they've contracted COVID-19 or not.

Gander's research team has already received "hundreds" of inquiries, according toStrack. "So I wouldn't be surprised if they see many hundreds of completed surveys," he said.

Strack expects to see "several" other studies that look at how thevirus" behaves from a New Brunswick context"in the months ahead.

Could become national model

Meanwhile, later this month, Legere will share Horizon's experience withitshuman research protection program and becoming accredited.

She will present a webinar tothe Canadian Association of Research Administrators on May 28, along withamember of Human Research Accreditation Canada.

The human research protection program (HRPP) is the system Horizon uses to review the methodology, regulatory compliance and ethical conduct ofall researchat the regional health authority, saidStrack.

Although HRRPs are common in public and private organizations in the United States and Europe, they're relatively new in Canada, he said.

Horizon has hada research ethics board since the 1970s.

But about two years ago "we recognized that it would be better if we had a systematic way of assessing, reviewing and approving research studies," said Strack.

Health research involving humans is subject to a complex array of regulationsand practices. Establishing an HRPP would alloweach research project to be evaluated against the relevant guidelines, and to have the perspectives of the institution, the researcher,the publicand the research ethics board allreflected a so-calledshared responsibility model.

Once Horizon's leadership endorsed the idea, research servicesset to work.

And for the past year,Legere and her core team of four members haveworked "intensely" toward accreditation, developing new policies and operational procedures.

"We're pretty proud of our team," said Legere,whoreceived notification on March 26, but it was only publicly announced this week due to the pandemic.

"It's pretty exciting news for us and it's a big accomplishment."

What it meansfrom a practical and operational perspective,said Strack, is that Horizonhasconfidence the research being conducted adheres to the guidelines, laws, and regulations governing research involving humans.

"That makes for better research and, potentially, better health outcomes for New Brunswickers."

Oncology clinical trials unaffected

Horizon is assessing its capacity to resume some of the suspended clinical trials, but won't start any non-COVID-19-related ones because of the potential impact on hospital resources,said Strack.

Clinical trials that offer therapies for patients with no alternative treatments, such as certain oncology patients, have continued uninterrupted, he said.

One of the reasons the other clinical trials had to be suspended is they require require substantial support from various hospital departments, such as laboratory medicine, diagnostic imaging and pharmacy, said Strack.

During the pandemic, these departments had to focus their efforts on creating systems and processes for managing the intensive needs of COVID patients, he said.

Clinical trials also often require patients to make frequent visits to the hospital for non-essential procedures, and during the pandemic all patient visits have been restricted to patients requiring chemotherapy, dialysis, or other emergency procedures or assessments.