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The Health Ethics Research Authority has issued a statement defending itself against allegations by Sequence Bio.

“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. Notwithstanding that this group had approval from a research ethics board in Texas, their procedures used in the conduct of research here in this province did not meet appropriate standards.  At the time, because they were unaffiliated with Memorial University or Eastern Health, there was no body in the province with the authority to review their research and protect Newfoundlanders and Labradorians.

“We are aware of the concerns that have been raised by Sequence Bio about the HREA/HREB process. In fact, the HREA decided to proactively seek input from researchers in a 2017 survey in an attempt to understand researchers’ concerns and respond to them. The HREA Board of Directors has taken a balanced view toward ongoing quality improvement that addresses concerns raised by researchers and keeps abreast of advances in health research ethics review best practices.  We have begun to implement a number of steps including hiring a consultant to review the Act, bylaws and standard operating procedures for both the HREA and the HREB. We have initiated a LEAN review of the entire ethics review process, hired additional staff and brought on incremental resources. We have recruited new members to the HREB and continue this recruitment actively. We have increased the extent of legal advice being provided to the HREB on its processes when needed and are engaged in other independent peer review processes. We are strongly committed to upholding the highest ethics standards for the review of research and to be an organization where continued quality improvement is an ongoing commitment.

“This said, while our processes continue to undergo ongoing quality improvement, the HREA 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. HREA staff are qualified and experienced in the field of health research ethics review. The members of our HREB are experts in their field – clinicians, ethicists, lawyers, privacy experts, and health researchers, as well as public representatives. They are highly qualified to consider matters of health research ethics. 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.”

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