St. John's company wants court to speed up application process for genome project
A local biotechnology firm is going to Newfoundland and Labrador Supreme Court to force health research ethics officials to make a decision on its application for a genome pilot project in the province.
In court documents, Sequence Bio says its project will explore the genetic makeup of the province's residents, securely connect that to their health data, and return certain genetic results to them if they want.
But the company indicated those plans remain in limbo.
"The research may not be carried out unless the approval is granted," Sequence Bio noted in court documents.
The company filed its Supreme Court application this week, in an effort to move that process along.
The Health Research Ethics Authority for Newfoundland and Labrador and Health Ethics Research Board are both named as defendants.
Application submitted in August
Sequence Bio says it submitted its research application to the authority in August 2017, requesting ethics approval.
The company said its application was supposed to be forwarded to the ethics board within days, and the deadline for a decision was in late September.
But Sequence Bio's court filings describe a series of delays.
In essence, the court action is aimed at forcing the ethics authority and board to carry out their duties in accordance with legislation, to make a decision one way or another on the application.
The matter is due in court later this month.
Pilot project would involve 2,500 volunteers
In an email to CBC News, Sequence Bio president and CEO Chris Gardner said the company has been denied more than 10 requests for meetings with the ethics authority — despite requirements to have such requests accommodated.
"When the person who makes the rules does not follow them, there is no easy choice," Gardner noted.
"Because of the failings of the (authority), Sequence Bio has yet to be granted approval on its research project after 197 days. We have crafted a proposal that meets and exceeds the highest ethical standards."
According to Gardner, Sequence Bio's proposed N.L. genome pilot project would involve studying the DNA and health records of 2,500 consenting volunteers, "to build on existing local research and better understand the diseases that impact our province the most."
DNA would be obtained through a simple saliva sample, he said.
"What makes our research most meaningful is that we are aiming to do it in a way that benefits the lives of individuals, families and communities in Newfoundland and Labrador for generations to come," Gardner said.
He said the company is "exhausting all possible opportunities to work constructively with our regulator."
Meanwhile, Sandra Veenstra, ethics director with the Health Research Ethics Authority, said the authority is not able to comment on matters that are before the courts.
Issued raised in legislature
The Opposition brought up the issue in the House of Assembly last week.
"Sequence Bio has now been waiting over six months for something that would take less than four weeks in another province, waiting to invest hundreds of millions of dollars," PC MHA David Brazil said on March 8.
"Can the minister explain why this delay is still occurring?"
Health Minister John Haggie replied.
"There have been challenges with recruiting for the Health Research Ethics Board, which were temporary and transient and have been remedied," Haggie said.
"The application is being considered. It is complicated. Outside expertise has been brought in. Both parties have taken that expertise advice and are now working through the process. It has to be done properly."
