Ethics board must rule on projects within 30 days: N.L. Supreme Court judge
Sequence Bio went to court after a decision hadn't been made on its application in almost 7 months
A Newfoundland and Labrador Supreme Court judge has sided with a St. John's-based biotechnology firm that went to court in order to force the ethics authority and board to make faster decisions.
Justice Vikas Khaladkar ruled that the province's Health Research Ethics Board must consider and decide on applications within 30 days. The Health Research Ethics Authority for Newfoundland and Labrador was also named as a defendant.
Sequence Bio said its application to the ethics board — for a genome pilot project that the company said will explore the genetic makeup of the province's residents — was plagued by delays.
It filed its application requesting ethics approval with the board on Aug. 23, 2017. The company launched legal proceedings on March 13, 2018, saying it did so because it had not yet received a decision, after almost seven months since the filing date.
One day after that, the ethics board told the company its application had been rejected.
Board: 30 days only to consider applications
The board argued it is only required to consider the application within 30 days, and doesn't have to make a decision on whether to greenlight or reject an application within that time frame.
Specifically, the board argued in court documents that it has as many as eight proposals to consider at one meeting, and many are lengthy. The one from Sequence Bio, for example, was 950 pages.
But the judge disagreed with those arguments.
"Additional resources need to be made available to the board so that there are an appropriate number of skilled staff members available to review the applications," said Khaladkar in his written decision.
He said there "appears to be insufficient staff" hired to thoroughly review applications.
"Surely 10 volunteer board members ought not to have the burden of reviewing in detail each and every proposal placed on their shoulders?" Khaladkar writes in his judgement.
However, if more resources are not going to be available to review applications, then "the House of Assembly needs to amend the legislation so that more time is made available to the board to do its job," Khaladkar said in the decision.
But he warned that could cause research proponents to "lose their competitive edge."
With files from Mark Quinn and Rob Antle