Ethics Review Boards I read the last news release again to comb through it and see if I can get anything else out of it.
Sona stated:
“its previously announced clinical, in-field evaluation studies for its rapid detection, COVID-19 antigen test that commenced in July continue and are now expected to return their full results within two weeks.
The delays have been due to *ethics review board approvals* and a need to make study modifications to *accommodate regulatory updates*, including for study enrolment criteria and assessment at point of care settings, as well as for test handling procedures.”
Health Canada Ethics Review Board:
https://www.canada.ca/en/health-canada/services/science-research/science-advice-decision-making/research-ethics-board.html
“The REB reviews all research involving human subjects that is:
- Carried out by Health Canada or PHAC (intramural);
- Performed by Health Canada or PHAC in collaboration with external researchers;
- Carried out on Health Canada or PHAC premises;
- Conducted under contract to Health Canada or PHAC; and/or
- Funded by Health Canada or PHAC through grants and contributions to external researchers.”
The FDA refers to this as an “IRB” or Institutional Review Board:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
This furthur demonstrates that Sona has been in contact with review boards and regulatory organizations, leading up the their final submission, which should be very quickly stamped and approved, considering the lengthy communication between Sona and the regulatory organizations.
Other companies submitted their EUA request and hoped for the best. Sona found out all the required steps to gain approval, and has been quietly doing them all behind the scenes.