The province's Health Research Ethics Authority is defending its work following criticism from researchers claiming the regulator's decisions have been "unfair."
"The Health Research Ethics Authority is confident that the health research ethics review process that we have had in place since the inception of the HREA in 2011 has led to sound outcomes," said an email to CBC News from the authority's board of directors.
St. John's-based biotech company, Sequence Bio, said the ethics board is "broken." It's calling on the province to replace the current board with an outside, independent regulator.
Sequence Bio leaders spoke out after two of the company's genetic research applications — one to study colorectal cancer and another to launch a NL Genome Pilot Project — were rejected by the research regulator many months after they were submitted for review.
"Speaking with researchers all across this province, they are coming up against similar delays and nonsensical rejections that don't follow Canadian best practices and the rules," said the company's CEO Chris Gardner.
Must maintain independence
The authority said it's crucial that it remains independent from the influence of the provincial government.
"The authority is legislatively independent from government in our process and operations. The maintenance of this independence is important to ensuring that research is reviewed by people with expertise in clinical practice, law, research methods and ethics," said its statement.
The regulator said it was created in reaction to unethical research in the late 1990s.
"The HREA Act was introduced 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," said the email signed by Sandra Veenstra, the authority's ethics director.
The authority also says it's important the public has faith in its decisions.
"The members of our health research ethics board are experts in their field — clinicians, ethicists, lawyers, privacy experts, and health researchers, as well as public representatives … While we are committed to continuous improvement, it is imperative that we recognize the integrity of this review, because our mandate is to protect Newfoundlanders and Labradorians by ensuring that health research involving human subjects is conducted in an ethical manner."
Sequence Bio binder
Sequence Bio recently released more than 100 pages of emails and letters from members of the province's research community that the company says supports its claims.
Health Minister John Haggie is reviewing the material Sequence Bio has compiled and will comment on it later.
Sequence Bio is appealing the regulator's decisions and has made a court application asking a judge to compel the regulator to follow the legislation that it is governed by.
The case is due back in court in early June.