The Health Research Ethics Authority (HREA) is establishing a separate subcommittee whose express purpose is to review applications to conduct genetic or genomic research on human subjects.
The move, the authority says, is in response to an escalating interest to conduct the research on Newfoundlanders and Labradorians and the province’s health information systems and as a result of technological growth in the field.
“Projects for genetic and genomic research are on the cutting edge of science and are raising novel and complex questions about research ethics requiring specific and focused expertise,” reads a statement from the HREA.
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To stay in line with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, the national standards that guide ethics review, the new Health Research Ethics Board (HREB) subcommittee will be made up of experts in law, health research, ethics and clinical expertise, and representatives of the general public. As such, the HREA will conduct recruitment efforts for both local experts and those from across the country to serve on this or one of the other two HREB subcommittees — one for clinical trials, another for non-clinical.
“The creation of a genetic and genomic subcommittee of the HREB is a step towards strengthening the protections offered by the HREA and HREB in ensuring that all health research involving humans in this province is conducted in an ethical manner,” the statement reads.
“Additionally, enhancing the membership of the HREB to consider such applications will increase the efficiency of the review process.”
The HREA, which receives in excess of 300 applications from researchers annually, anticipates that there will be an increase in the number of proposals for genetic or genomic research.
St. John’s biotechnology firm Sequence Bio commended the HREA on the move and thanked government for facilitating a collaborative process.
“This is a positive step toward enabling meaningful research that could improve health outcomes for Newfoundlanders and Labradorians,” Mark Dobbin, chair of Sequence Bio’s board of directors said in the release.
“Timely, ethical regulation is a key step to achieving this. We commend the HREA’s commitment to ethical research and their support of this province’s genomics sector,” Sequence Bio’s CEO Chris Gardner added.
It’s a softening of a relationship between the two organizations, one that turned acrimonious this spring when Sequence Bio challenged the regulator and its board in provincial supreme court by filing a mandamus application seeking the courts to render a decision on its application for a genome pilot project. The very next day, the HREB clinical trial subcommittee denied approval of the Sequence Bio proposal 203 days after it was submitted. In response, Sequence Bio 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.
Earlier this month, Newfoundland and Labrador Supreme Court Justice Vikas Khaladkar ruled that Sequence Bioinformatics Inc. can continue to challenge the HREA and HREB in court.
