The Health Research Ethics Authority has issued a series of statements in the wake of recent concerns raised by Sequence Bio, a local biotechnology company.
This week, Sequence Bio CEO Chris Gardner told reporters that it took over 200 days for the HREA to make a decision on its NL Genome Project and 114 days for a decision on a cancer study.
He accused the HREA of “unlawfully” halting health research in the province.
Sequence Accuses HREA of Unlawfully Halting Health Research in NL
Meanwhile, the authority says the HREA Act was introduced in the aftermath of an incident involving a group of researchers from Baylor University in Texas, who came to the province to conduct genetic testing on Newfoundlanders in 1998. Their research was ultimately deemed to be unethical.
The HREA says it is aware of the concerns that have been raised by Sequence Bio about the process, and that it has taken what it calls a “balanced view” toward ongoing quality improvement. They have hired a consultant to review the act, bylaws and standard operating procedures for both the HREA and HREB and have initiated a review of the entire ethics review process, hired more staff and brought in incremental resources.
It says its mandate is to protect Newfoundlanders and Labradorians by ensuring that health research involving human subjects is conducted in an ethical manner.
Read the full statement below: