Newfoundland and Labrador Supreme Court Justice Vikas Khaladkar has ruled that Sequence Bioinformatics Inc. can continue to challenge its regulator — the Health Research Ethics Authority (HREA) and its board (HREB) — in court.
“This decision is a positive step to having clarity on this matter and ensuring that important research and clinical trials are made available to the people of this province,” Sequence Bio CEO Chris Gardner said in a statement. “We look forward to a resolution that will benefit all researchers.”
In late March, the biotechnology company filed a mandamus application seeking the courts to compel the board to render a decision on a proposal. The very next day, the HREB clinical trial subcommittee denied approval of the Sequence Bio project proposal 203 days after it was submitted. In response, the company amended its application to seek an order declaring that the board is lawfully obligated to decide on a research application within the legislated 30 days of receipt.
In a hearing last week, legal counsel for the HREB argued that the case didn’t warrant being presented to the courts because “there is no live issue.”
Sequence Bio’s lawyer countered they “have a live interest in determining whether the Board must respond to their research proposals within 30 days or whether the Board has an unlimited period of time to do so” and argued that the matter is not moot and still “a matter of importance.”
In his written decision, Khaladkar stated that since the issue is likely to affect other individuals or organizations hoping to conduct health research in this province, “the issue is, therefore, one of public importance.”
The HREB also suggested that court intervention could impede the board’s duty to make decisions on research proposals.
On this matter, Khaladkar disagreed, stating that while the board’s ability and expertise were not in question, “there is nothing in a section of a statute containing a time limitation that requires the expertise of a human ethicist to interpret.”
Furthermore, he ruled that the only impediment to the HREB would be a requirement to speed up its processing of proposals.
The HREA has said it won’t comment on any matters before the courts, but has released statements defending their efforts since being created in 2011 “in the aftermath of a well-publicized episode where researchers from an American university – Baylor University in Texas – came to this province and conducted genetic research that ultimately was deemed to be unethical.”
The authority defends its track record, its staff and its board and says that last year it began surveying researchers in an effort to understand concerns about the process and address them.
Since then, the HREA stated, they have hired a consultant to review the act, bylaws and standard operating procedures; started a lean review; hired additional staff and incremental resources; recruited and continue to recruit new members to the board; bolstered legal advice offered to the board when required; and engaged in other independent peer review processes.
“We are strongly committed to upholding the highest ethics standards for the review of research and to be an organization where continued quality improvement is an ongoing commitment,” an emailed statement reads.
Meanwhile, Sequence Bio has pumped the brakes on its efforts to rally more researchers to their side by giving them an avenue to share their account of similar issues with the HREA and HREB at itsabouttimenl.ca.
The website is still active, but promotion of it on Sequence Bio’s social media channels has been scaled back considerably.
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